Papers - MITSUHASHI Toshiharu

Assessing Vulnerability to Surges in Suicide-Related Tweets Using Japan Census Data: Case-Only Study. Reviewed International journal

Toshiharu Mitsuhashi

JMIR formative research   7   e47798   2023.8

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Authorship：Lead author,　Last author,　Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

BACKGROUND: As the use of social media becomes more widespread, its impact on health cannot be ignored. However, limited research has been conducted on the relationship between social media and suicide. Little is known about individuals' vulnerable to suicide, especially when social media suicide information is extremely prevalent. OBJECTIVE: This study aims to identify the characteristics underlying individuals' vulnerability to suicide brought about by an increase in suicide-related tweets, thereby contributing to public health. METHODS: A case-only design was used to investigate vulnerability to suicide using individual data of people who died by suicide and tweet data from January 1, 2011, through December 31, 2014. Mortality data were obtained from Japanese government statistics, and tweet data were provided by a commercial service. Tweet data identified the days when suicide-related tweets surged, and the date-keyed merging was performed by considering 3 and 7 lag days. For the merged data set for analysis, the logistic regression model was fitted with one of the personal characteristics of interest as a dependent variable and the dichotomous exposure variable. This analysis was performed to estimate the interaction between the surges in suicide-related tweets and personal characteristics of the suicide victims as case-only odds ratios (ORs) with 95% CIs. For the sensitivity analysis, unexpected deaths other than suicide were considered. RESULTS: During the study period, there were 159,490 suicides and 115,072 unexpected deaths, and the number of suicide-related tweets was 2,804,999. Following the 3-day lag of a highly tweeted day, there were significant interactions for those who were aged 40 years or younger (OR 1.09, 95% CI 1.03-1.15), male (OR 1.12, 95% CI 1.07-1.18), divorced (OR 1.11, 95% CI 1.03 1.19), unemployed (OR 1.12, 95% CI 1.02-1.22), and living in urban areas (OR 1.26, 95% CI 1.17 1.35). By contrast, widowed individuals had significantly lower interactions (OR 0.83, 95% CI 0.77-0.89). Except for unemployment, significant relationships were also observed for the 7-day lag. For the sensitivity analysis, no significant interactions were observed for other unexpected deaths in the 3-day lag, and only the widowed had a significantly larger interaction than those who were married (OR 1.08, 95% CI 1.02-1.15) in the 7-day lag. CONCLUSIONS: This study revealed the interactions of personal characteristics associated with susceptibility to suicide-related tweets. In addition, a few significant relationships were observed in the sensitivity analysis, suggesting that such an interaction is specific to suicide deaths. In other words, individuals with these characteristics, such as being young, male, unemployed, and divorced, may be vulnerable to surges in suicide-related tweets. Thus, minimizing public health strain by identifying people who are vulnerable and susceptible to a surge in suicide-related information on the internet is necessary.

DOI： 10.2196/47798

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Effects of indium exposure on respiratory symptoms: a retrospective cohort study in Japanese workers using health checkup data. Reviewed International journal

Toshiharu Mitsuhashi

PeerJ   8   e8413   2020

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Authorship：Lead author,　Last author,　Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

Background: Indium compounds are known health hazards for lung cancer and interstitial pneumonia. Furthermore, they are related to emphysema, alveolar proteinosis, and cholesterol granuloma. In Japan, laws were revised in 2013 to tighten regulations on indium exposure in workplaces. However, its impact on the health of workers who handle indium has not been evaluated. This study aimed to investigate whether subjective respiratory symptoms in these workers have reduced after the 2013 amendment in the regulations. Methods: The subjects were workers from certain areas of Japan who had undergone health checkups between January 1, 2013, and June 30, 2015. Indium-handling and non-handling workers were categorized into the exposed and less-exposed groups, respectively. Based on the findings of health checkups during this period, the hazard ratio of subjective respiratory symptoms (cough, sputum production, shortness of breath, and palpitation) and its 95% confidence intervals (CIs) were calculated with the less-exposed group as the reference. The Prentice-Williams-Peterson model was used for calculation, and a model that adjusted for coarse analysis and potential confounding factors was adopted. Results: Overall, 2,561 workers (from 22 companies) who underwent 6,033 health checkups were included. The total person-years were 2,562.8 years, and 162 outcome events occurred. The hazard ratios of the exposed group were 1.65 (95% CI [1.14-2.39]: p = 0.008) and 1.61 (95% CI [1.04-2.50]: p = 0.032) in the crude and adjusted models, respectively. Conclusion: Indium-handling workers had a high hazard of the subjective respiratory symptoms than non-indium -handling workers despite stricter regulations on indium exposure in workplaces. This indicates the need for further changes to the legislation to protect the health of workers exposed to harmful substances in workplaces. Further studies including larger diverse cohorts are needed to validate our findings.

DOI： 10.7717/peerj.8413

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Effects of two-week e-learning on eHealth literacy: a randomized controlled trial of Japanese Internet users. Reviewed International journal

Toshiharu Mitsuhashi

PeerJ   6   e5251   2018

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Authorship：Lead author,　Last author,　Corresponding author   Language：English   Publishing type：Research paper (scientific journal)  

Background: The Internet is widely used as a source of information by people searching for medical or healthcare information. However, information found on the Internet has several drawbacks, and the ability to consume accurate health information on the Internet (eHealth literacy) is increasingly important. This study's goal was to clarify the extent to which eHealth literacy is improved after e-learning in a randomized controlled trial. Methods: Data were collected on 301 Japanese adults through an online survey. Participants were assigned to the intervention (e-learning about eHealth literacy) group or the control group in a 1:1 ratio. The intervention group included 148 participants, and 153 participants were in the control group. The participants provided information at baseline on demographic characteristics, self-rated health, and frequency of Internet searching. The eHealth Literacy Scale (eHEALS), which was the main measure of eHealth literacy, and data on secondary outcomes (the Healthy Eating Literacy Scale and skill for evaluating retrieved search results) were obtained at baseline and at follow-up. The score difference was calculated by subtracting the score at baseline from the score at follow-up. Linear regression analysis and multinomial regression analysis were performed using the differences in score as the dependent variables and the intervention as the explanatory variable. Intention-to-treat analysis was employed. Results: The results from participants who responded to all of the questions both times were analyzed (134 in the intervention group and 148 in the control group). eHEALS increased 1.57 points due to the intervention effect (Δ score change = 1.57; 95% CI [0.09-3.05]; p = 0.037). Skills for evaluating retrieved search results improved more in the intervention group than in the control group (relative risk ratio = 2.47; 95% Confidence Interval: 1.33, 4.59; p = 0.004). There were no large differences at baseline between the intervention and control groups in the eHEALS, Healthy Eating Literacy scale, or skill for evaluating retrieved search results. However, at follow-up, the intervention group had improved more than the control group on both the eHEALS and skill for evaluating retrieved search results. Discussion: eHealth literacy improved after the e-learning, as evidenced by the change to the eHEALS scores and increased skill for evaluating retrieved search results. There was no significant effect of e-learning, which did not include content on healthy eating, on the Healthy Eating Literacy Scale scores. This indicates that scores did not increase much due to effects other than e-learning, as is sometimes seen with the Hawthorne effect. Although it was statistically significant, the effect size was small. Therefore, future research is necessary to verify the clinical implications. In sum, this study suggests that e-learning is an effective way to improve eHealth literacy.

DOI： 10.7717/peerj.5251

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Maternal working hours and early childhood overweight in Japan: a population-based study. Reviewed International journal

Toshiharu Mitsuhashi, Etsuji Suzuki, Soshi Takao, Hiroyuki Doi

Journal of occupational health   54 ( 1 )   25 - 33   2012

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Authorship：Lead author   Language：English   Publishing type：Research paper (scientific journal)   Publisher：JAPAN SOC OCCUPATIONAL HEALTH  

OBJECTIVES: There has been a growing concern that maternal employment could have adverse or beneficial effects on children's health. Although recent studies demonstrated that maternal employment was associated with a higher risk of childhood overweight, the evidence remains sparse in Asian countries. We sought to examine the relationship between maternal working hours and early childhood overweight in a rural town in Okayama Prefecture. METHODS: In February 2008, questionnaires were sent to parents of all preschool children aged ≥3 yr in the town to assess maternal working status (working hours and form of employment), children's body mass index, and potential confounders. Childhood overweight was defined following the age and sex-specific criteria of the International Obesity Task Force. Odds ratios (ORs) and 95% confidence intervals (CIs) for childhood overweight were estimated in a logistic regression. We used generalized estimating equations with an exchangeable correlation matrix, considering the correlation between siblings. RESULTS: We analyzed 364 preschool children. Adjusting for each child's characteristics (age, sex), mother's characteristics (age, obesity, educational attainment, smoking status, and social participation), and family's characteristics (number of siblings), children whose mothers work <8 h/day had a substantially lower risk for being overweight (OR: 0.28, 95% CI: 0.09, 0.93) compared with children of non-working mothers, whereas the relationship was less pronounced among children whose mothers work ≥8 h/day (OR: 0.71, 95% CI: 0.19, 2.68). We observed similar patterns in a stratified analysis by the form of maternal employment. CONCLUSION: Short maternal working hours are associated with a lower odds of early childhood overweight.

DOI： 10.1539/joh.11-0100-OA

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[Utilization, needs, and related factors for e-learning and its application to education and training in occupational safety and health among enterprises in Japan]. Reviewed

Toshiharu Mitsuhashi, Soshi Takao, Akizumi Tsutsumi, Norito Kawakami

Sangyo eiseigaku zasshi = Journal of occupational health   48 ( 5 )   183 - 91   2006.9

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Authorship：Lead author   Language：Japanese   Publisher：(公社)日本産業衛生学会  

In order to know utilization, needs, and related factors for e-learning and its application to education and training in occupational safety and health (OSH) among enterprises in Japan, a questionnaire survey was conducted of enterprises randomly selected from those with 1,000 or more employees and those with 999 or less (500 for each). Data from 134 (56 and 78, respectively) enterprises were analyzed (response rate, 13%). Among total enterprises, 19% had introduced and 16% planned to introduce e-learning. However, only 7% of larger enterprises and less than 3% of smaller enterprises used e-learning for education and training in OSH. On the other hand, 80-90% of enterprises responded positively to considering the use of e-learning for education and training on various OSH topics for various users. Highly rated merits of e-learning were "can use whenever", "can use anywhere"; and its highly rated obstacles were "cost", "individual PC not available", "insufficient information on efficacy". However, the merit "can monitor training" was significantly associated with the use/plan of e-learning. "Good contents not available" was more frequent among enterprises which used/planned e-learning. The study indicated a greater need for e-learning based OSH education and training, despite a currently low rate of its use. Improvement of e-learning platforms and contents, reduction of cost, and improvement of e-learning infrastructure at work may be needed to facilitate the use of e-learning in OSH.

DOI： 10.1539/sangyoeisei.48.183

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Elevated pulse pressure and risk of chronic kidney disease by hypertension status: A longitudinal study in Japanese adults

Yukari Okawa, Toshiharu Mitsuhashi

2025.3

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DOI： 10.1101/2025.03.27.25324763

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Comparison of Midazolam and Diazepam for Sedation in Patients Undergoing Double-Balloon Endoscopic Retrograde Cholangiopancreatography: A Propensity Score-Matched Analysis

Yuki Fujii, Kazuyuki Matsumoto, Akihiro Matsumi, Kazuya Miyamoto, Daisuke Uchida, Shigeru Horiguchi, Koichiro Tsutsumi, Toshiharu Mitsuhashi, Motoyuki Otsuka

Journal of Clinical Medicine   2025.3

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DOI： 10.3390/jcm14072287

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Acetic Acid-Indigo Carmine Chromocolonoscopy for Proximal Serrated Lesions: A Randomized, Three-Arm Colonoscopy Study. International journal

Hideaki Kinugasa, Sakiko Hiraoka, Sayo Kobayashi, Minoru Matsubara, Teruya Nagahara, Reiji Higashi, Kensuke Takei, Masayasu Ohmori, Takashi Nakamura, Takao Tsuzuki, Shouichi Tanaka, Ryosuke Hirai, Junki Toyosawa, Yuki Aoyama, Yasushi Yamasaki, Toshihiro Inokuchi, Masahiro Takahara, Takehiro Tanaka, Toshiharu Mitsuhashi, Motoyuki Otsuka

The American journal of gastroenterology   2025.3

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Language：English   Publishing type：Research paper (scientific journal)  

OBJECTIVES: Aggressive colorectal cancer (CRC) frequently originates from serrated lesions (SLs), particularly in the proximal colon, which are challenging to detect using standard screening colonoscopy. Although duplicate examinations or chromocolonoscopies are recommended for detecting proximal SLs, evidence from randomized trials is limited. We evaluated the effectiveness of tandem colonoscopy with an acetic acid-indigo carmine mixture (AIM) for detecting SLs in the proximal colon compared to white-light imaging (WLI) and indigo carmine (IC). METHODS: This three-arm, multicenter, randomized controlled trial involving nine institutions enrolled patients undergoing colonoscopy and assigned them randomly to the WLI, IC, or AIM group. The primary outcomes were the SL-detection rate (SDR) of proximal lesions during the second examination (SDR2nd) and SL additional rate (SAR). Secondary outcomes included the detection and additional rates of other polyps, factors contributing to SAR, and complications. RESULTS: Between 2021 and 2024, 1,319 participants with 1,267 polyps were included in the analysis. With AIM, the SDR2nd and SAR were significantly higher compared to WLI or IC (WLI vs. AIM: 2.7% vs. 14.0%, p<.001; IC vs. AIM: 7.9% vs. 14.0%, p=.002, and WLI vs. AIM: 22.4% vs. 69.3%, p<.001; IC vs. AIM: 45.8% vs. 69.3%, p=.001). AIM conferred a higher adenoma-detection rate (ADR)2nd than with WLI (10.5% vs. 24.7%; p<.001) and was an independent factor for SAR (odds ratio [95% confidence interval]: 7.79 [3.76-17.08]). No major adverse events were observed. CONCLUSIONS: AIM significantly improved proximal colon SDRs and outperformed WLI and IC. The relationship between SDR and CRC incidence warrants further investigation.

DOI： 10.14309/ajg.0000000000003411

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A randomized controlled trial of conventional GVHD prophylaxis with or without teprenone for the prevention of severe acute GVHD. International journal

Wataru Kitamura, Keiko Fujii, Mitsuru Tsuge, Toshiharu Mitsuhashi, Hiroki Kobayashi, Chihiro Kamoi, Akira Yamamoto, Takumi Kondo, Keisuke Seike, Hideaki Fujiwara, Noboru Asada, Daisuke Ennishi, Ken-Ichi Matsuoka, Nobuharu Fujii, Yoshinobu Maeda

Annals of hematology   2025.2

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Language：English   Publishing type：Research paper (scientific journal)  

Therapies that effectively suppress graft-versus-host disease (GVHD) without compromising graft-versus-leukemia/lymphoma (GVL) effects is important in allogeneic hematopoietic stem cell transplantation (allo-HSCT) for hematopoietic malignancies. Geranylgeranylacetone (GGA) is a main component of teprenone, a gastric mucosal protectant commonly used in clinical practice. In preclinical models, GGA suppresses proinflammatory cytokines, including interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α), which are associated with GVHD as well as induces thioredoxin-1 (Trx-1), which suppresses GVHD while maintaining GVL effects. Here, we investigated whether the addition of teprenone to standard GVHD prophylaxis could reduce the cumulative incidence of severe acute GVHD (aGVHD) without attenuating GVL effects. This open-label, randomized clinical trial enrolled 40 patients (21 control and 19 teprenone group) who received allo-HSCT between May 2022 and February 2023 in our institution. Patients in the teprenone group received 50 mg of teprenone orally thrice daily for 21 days from the initiation of the conditioning regimen. The cumulative incidence of severe aGVHD by day 100 after allo-HSCT was not significantly different in the two groups (27.9 vs. 16.1%, p = 0.25). The exploratory studies revealed no obvious changes in Trx-1 levels, but the alternations from baseline in IL-1β and TNF-α levels at day 28 after allo-HSCT tended to be lower in the teprenone group. In conclusion, we could not demonstrate that teprenone significantly prevented the development of severe aGVHD. Discrepancy with preclinical model suggests that appropriate dose of teprenone may be necessary to induce the expression of antioxidant enzymes that suppress severe aGVHD. Clinical Trial Registration number:jRCTs 061210072.

DOI： 10.1007/s00277-025-06269-2

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The Asia-Pacific Body Mass Index Classification and New-Onset Chronic Kidney Disease in Non-Diabetic Japanese Adults: A Community-Based Longitudinal Study from 1998 to 2023

Yukari Okawa, Toshiharu Mitsuhashi, Toshihide Tsuda

Biomedicines   2025.2

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Publishing type：Research paper (scientific journal)  

DOI： 10.3390/biomedicines13020373

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Association Between Dinner-to-Bed Time and Gastroesophageal Reflux-Related Diseases in Children. International journal

Kensuke Uraguchi, Naomi Matsumoto, Toshiharu Mitsuhashi, Soshi Takao, Seiichiro Makihara, Mizuo Ando, Takashi Yorifuji

Cureus   17 ( 1 )   e77709   2025.1

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Language：English   Publishing type：Research paper (scientific journal)  

INTRODUCTION: Gastroesophageal reflux disease (GERD) is characterized by esophageal mucosal injury due to the reflux of gastroduodenal contents. Typical symptoms include heartburn and acid regurgitation. In addition, gastroesophageal reflux (GER) can influence conditions such as otitis media, rhinitis, and asthma. This study aimed to examine the association between dinner-to-bed time and GER-related diseases, such as otitis media, allergic rhinitis, and asthma. METHODS: This was a longitudinal cohort study using secondary data. Data were collected from a large-scale birth cohort study conducted in Japan including babies born in 2001 and 2010. Dinner-to-bed time was categorized as "longer dinner-to-bed time" (>120 minutes), "shorter dinner-to-bed time" (≤120 minutes or less), and "irregular dinner-to-bed time." Modified Poisson regression with robust variance was used to estimate risk ratios (RRs). RESULTS: A total of 60,392 children were included in this study. Children with shorter dinner-to-bed time had a higher risk of asthma (adjusted RR (aRR) = 1.10; 95% confidence interval (CI), 1.03-1.18) than those with longer dinner-to-bed time. However, no significant association was observed between shorter dinner-to-bed time and otitis media or allergic rhinitis. Furthermore, supplementary analyses revealed that the risk of asthma was significantly higher in children born in 2001 (aRR = 1.13; 95% CI, 1.04-1.22). CONCLUSION: This study showed that dinner-to-bed time within 120 minutes after dinner increases the risk of developing asthma. This underscores the importance of considering lifestyle modifications, as certain pediatric asthma cases may be influenced by behaviors that promote GER.

DOI： 10.7759/cureus.77709

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Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trial

Masaya Abe, Keiko Fujii, Nobuharu Fujii, Toshiharu Mitsuhashi, Takuya Fukumi, Yuichi Sumii, Maiko Kimura, Tomohiro Urata, Takumi Kondo, Fumio Otsuka, Yoshinobu Maeda

Hematology, Transfusion and Cell Therapy   2024.12

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DOI： 10.1016/j.htct.2024.06.010

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Subjective global assessment for nutritional screening and its impact on surgical outcomes: A prospective study in older patients with colorectal cancer. International journal

Fuminori Teraishi, Yusuke Yoshida, Ryohei Shoji, Nobuhiko Kanaya, Yuki Matsumi, Kunitoshi Shigeyasu, Yoshitaka Kondo, Shunsuke Kagawa, Rie Tamura, Yoshikazu Matsuoka, Hiroshi Morimatsu, Toshiharu Mitsuhashi, Toshiyoshi Fujiwara

Langenbeck's archives of surgery   409 ( 1 )   356 - 356   2024.11

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Language：English   Publishing type：Research paper (scientific journal)  

PURPOSE: Our perioperative management center provides preoperative intervention and functional and nutritional assessments for colorectal cancer patients aged over 75 years. This study evaluated the associations of preoperative nutritional status with postoperative outcomes and prognosis in colorectal cancer patients aged 75 years or older. METHODS: This was a prospective, observational study of 71 colorectal cancer patients aged 75 years or older who underwent surgery between July 2020 and September 2022. The Subjective Global Assessment (SGA) was evaluated as a nutritional index. The patients were classified into three groups: SGA-A (well nourished), B (moderately malnourished), and C (severely malnourished), and the correlations with postoperative outcomes and prognosis were examined. RESULTS: The median age of the 71 patients (34 males, 37 females) was 78 (75-92) years, and their median body mass index (BMI) was 22.3 (13.4-31.9) kg/m2. Forty-eight patients had colon cancer, and 23 had rectal cancer. On the SGA, 28 patients were SGA-A, 25 SGA-B, and 18 SGA-C. The SGA-B/C group had significantly higher BMI (p < 0.01) and more ICU admissions (p = 0.02). The G8 score was significantly lower (p = 0.03) in the SGA-B/C group, suggesting coexisting functional decline. In terms of postoperative outcomes, the SGA-B/C group had a significantly longer postoperative hospital stay (p = 0.04). The 3-year OS rates for all stages were 100% in the SGA-A group and 49.7% in the SGA-B/C group (p = 0.03), while the 3-year OS rates for patients excluding Stage IV were 100% in the SGA-A group and 68.5% in the SGA-B/C group, not significantly different (p = 0.14). The 3-year RFS rate was 95.5% in the SGA-A group and 65.3% in the SGA-B/C group (p = 0.15). CONCLUSION: The SGA is a promising nutritional index associated with short-term outcomes in older patients undergoing colorectal cancer surgery. The SGA can be assessed in a few minutes during an outpatient visit, making it useful for routine clinical use.

DOI： 10.1007/s00423-024-03548-w

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The required experience of open pancreaticoduodenectomy before becoming a specialist in hepatobiliary and pancreatic surgeons: a multicenter, cohort study of 334 open pancreaticoduodenectomies. International journal

Tomokazu Fuji, Yuzo Umeda, Kosei Takagi, Masayoshi Hioki, Ryuichi Yoshida, Yoshikatsu Endo, Kazuya Yasui, Daisuke Nobuoka, Toshiharu Mitsuhashi, Toshiyoshi Fujiwara

BMC surgery   24 ( 1 )   366 - 366   2024.11

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Language：English   Publishing type：Research paper (scientific journal)  

BACKGROUND: Open pancreaticoduodenectomy (OPD) is an essential surgical procedure for expert hepato-biliary-pancreatic (HBP) surgeons. However, there is no standard for how many surgeries must be performed by a surgeon in training before they are considered to have enough experience to ensure surgical safety. METHODS: Cumulative Sum (CUSUM) analysis was performed using the surgical data of OPDs performed during the training period of board-certified expert surgeons of the Japanese Society of Hepato-Biliary-Pancreatic Surgery. RESULTS: Fourteen HBP surgeons participated in this study and performed 334 OPDs during their training period. The median (interquartile range) values for operative time, blood loss, and length of hospital stay were 455 (397-519) minutes, 450 (234--716) ml, and 28 (21-38) days, respectively. CUSUM analysis showed inflection points at 20 surgeries performed for operative time. After 20 procedures, operative time was significantly shorter (461 min vs. 425 min, p = 0.021) and blood loss was significantly lower (470 ml vs. 340 ml, p = 0.038). No significant differences between within 20 and after 21 procedures were found in the complication rate (53% vs. 48%, p = 0.424) and rate of in-hospital deaths (1.5% vs.1.4%. p = 0.945). Up to 20 surgeries, PDAC and another malignant tumor had longer operative time than benign/low malignant diseases (486 min vs. 472 min vs. 429 min, p < 0.001), and higher blood loss (500 ml vs. 502 ml vs. 355 ml, p < 0.001). Mortality rate was higher at PDAC cases (5% vs. 0% vs. 0%, p = 0.01). After the 21 procedures, these outcomes were improved and no differences in by primary disease were observed. Multivariable analysis showed that within 20 surgeries were independent risk factors of longer operative time (HR2.6, p = 0.013) and higher blood loss (HR2.0, p = 0.049). CONCLUSIONS: To stabilize the surgical outcome of OPD for malignant disease, at least 20 surgeries should be performed at a certified institution during surgeon training. TRIAL REGISTRATION: Clinical trial number: Not applicable.

DOI： 10.1186/s12893-024-02677-9

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In vitro fertilization and long-term child health and development: nationwide birth cohort study in Japan

Naomi Matsumoto, Takashi Mitsui, Tomoka Kadowaki, Toshiharu Mitsuhashi, Tomoya Hirota, Hisashi Masuyama, Takashi Yorifuji

European Journal of Pediatrics   184 ( 1 )   2024.11

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Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media LLC  

Abstract

The aim of this study is to compare long-term health outcomes between IVF-conceived children and non-IVF-conceived children in Japan, in the context of strong recommendation for single embryo transfer. Using data from a nationwide birth cohort linked with perinatal database, this study analyzed 2140 children born in Japan in May 2010. It compared child health and development outcomes up to 9 years of age between IVF-conceived and non-IVF-conceived children (binary exposure). A Poisson regression with robust variance to estimate the risk ratios for the association between IVF and various long-term child health and developmental outcomes. After adjusting for confounding factors, no significant differences were observed between IVF-conceived and naturally conceived children for most outcomes, including hospitalization, obesity, and developmental milestones. IVF-conceived children showed a slightly lower risk of attention problems at 8 years (adjusted Risk Ratio [aRR]: 0.73, 95% CI: 0.53–1.00). In subgroup analyses, IVF-conceived term children and singletons demonstrated reduced risk of cognitive delays at 5.5 years (aRR: 0.31, 95% CI: 0.10–0.96 and aRR: 0.37, 95% CI: 0.14–0.98, respectively).

Conclusion: In this Japanese cohort, IVF conception was not associated with adverse long-term health or developmental outcomes. These findings provide reassurance about the safety of IVF, particularly in the context of single embryo transfer policies. Further research is needed to explore specific IVF protocols and subgroups.

<table><tbody> <tr> <td colspan="2">What is known:• Long-term health and developmental outcomes of IVF-conceived children remain inconsistent across studies and populations, despite the widespread use of this technology.</td> </tr> <tr> <td colspan="2">What is new:• A nationwide population-based cohort study in Japan did not show adverse effects of IVF on long-term child health and development through age 9.• These findings provide reassurance about the safety of IVF, while indicating the need for careful monitoring in specific subgroups such as preterm and multiple births.</td> </tr> </tbody></table>

DOI： 10.1007/s00431-024-05883-y

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Other Link： https://link.springer.com/article/10.1007/s00431-024-05883-y/fulltext.html

Dyslipidemia and development of chronic kidney disease in non-diabetic Japanese adults: a 26-year, community-based, longitudinal study

Yukari Okawa, Toshiharu Mitsuhashi

2024.10

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Publisher：Cold Spring Harbor Laboratory  

Follow-up studies evaluating the relationship between dyslipidemia and chronic kidney disease (CKD) in non-diabetic populations are limited. This longitudinal study (1998–2024) examined whether the prevalence of dyslipidemia is associated with the subsequent development of CKD in non-diabetic Japanese adult citizens of Zentsuji, Kagawa Prefecture, Japan. Dyslipidemia was defined as low-density lipoprotein cholesterol concentrations ≥140 mg/dL, high-density lipoprotein cholesterol concentrations &lt;40 mg/dL, and/or triglyceride concentrations ≥150 mg/dL. Participants were considered to have developed CKD if their estimated glomerular filtration rate was &lt;60 mL/min/1.73 m². The proportional hazard assumptions were violated. Therefore, the Weibull accelerated failure-time model was selected using the Akaike and Bayesian information criteria. The final cohort included 5970 participants, 41.6% of whom were men. The mean follow-up was 7.09 years. After the follow-up, 1890 (31.7%) participants developed CKD. Participants with dyslipidemia had a 5% shorter survival time (95% confidence interval: 3%–7%) to incident CKD compared with those without dyslipidemia in the full model. High-density lipoprotein cholesterol concentrations &lt;40 mg/dL and triglyceride concentrations ≥150 mg/dL also reduced the survival time to CKD onset by 5%–6%. Our results provide further evidence that controlling the lipid profile to an appropriate range may prevent the future onset of CKD.

DOI： 10.1101/2024.10.25.24315968

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Kinetics of SARS-CoV-2 antibody titers after booster vaccinations during an Omicron surge in Japan

Naomi Matsumoto, Ayako Sasaki, Tomoka Kadowaki, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

Vaccine   42 ( 21 )   126156 - 126156   2024.8

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Publishing type：Research paper (scientific journal)   Publisher：Elsevier BV  

DOI： 10.1016/j.vaccine.2024.126156

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Increased Oxidative Stress and Decreased Citrulline in Blood Associated with Severe Novel Coronavirus Pneumonia in Adult Patients. International journal

Mitsuru Tsuge, Eiki Ichihara, Kou Hasegawa, Kenichiro Kudo, Yasushi Tanimoto, Kazuhiro Nouso, Naohiro Oda, Sho Mitsumune, Goro Kimura, Haruto Yamada, Ichiro Takata, Toshiharu Mitsuhashi, Akihiko Taniguchi, Kohei Tsukahara, Toshiyuki Aokage, Hideharu Hagiya, Shinichi Toyooka, Hirokazu Tsukahara, Yoshinobu Maeda

International journal of molecular sciences   25 ( 15 )   2024.7

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This study investigated the correlation between oxidative stress and blood amino acids associated with nitric oxide metabolism in adult patients with coronavirus disease (COVID-19) pneumonia. Clinical data and serum samples were prospectively collected from 100 adult patients hospitalized for COVID-19 between July 2020 and August 2021. Patients with COVID-19 were categorized into three groups for analysis based on lung infiltrates, oxygen inhalation upon admission, and the initiation of oxygen therapy after admission. Blood data, oxidative stress-related biomarkers, and serum amino acid levels upon admission were compared in these groups. Patients with lung infiltrations requiring oxygen therapy upon admission or starting oxygen post-admission exhibited higher serum levels of hydroperoxides and lower levels of citrulline compared to the control group. No remarkable differences were observed in nitrite/nitrate, asymmetric dimethylarginine, and arginine levels. Serum citrulline levels correlated significantly with serum lactate dehydrogenase and C-reactive protein levels. A significant negative correlation was found between serum levels of citrulline and hydroperoxides. Levels of hydroperoxides decreased, and citrulline levels increased during the recovery period compared to admission. Patients with COVID-19 with extensive pneumonia or poor oxygenation showed increased oxidative stress and reduced citrulline levels in the blood compared to those with fewer pulmonary complications. These findings suggest that combined oxidative stress and abnormal citrulline metabolism may play a role in the pathogenesis of COVID-19 pneumonia.

DOI： 10.3390/ijms25158370

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Comprehensive geriatric assessment as an indicator of postoperative recovery in older patients with colorectal cancer. International journal

Fuminori Teraishi, Ryohei Shoji, Yoshitaka Kondo, Shunsuke Kagawa, Rie Tamura, Yoshikazu Matsuoka, Hiroshi Morimatsu, Toshiharu Mitsuhashi, Toshiyoshi Fujiwara

Journal of geriatric oncology   101837 - 101837   2024.7

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DOI： 10.1016/j.jgo.2024.101837

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Risk factors and treatment strategies for cholecystitis after metallic stent placement for malignant biliary obstruction: a multicenter retrospective study. International journal

Akihiro Matsumi, Hironari Kato, Taiji Ogawa, Toru Ueki, Masaki Wato, Masakuni Fujii, Tatsuya Toyokawa, Ryo Harada, Yuki Ishihara, Masahiro Takatani, Hirofumi Tsugeno, Naoko Yunoki, Takeshi Tomoda, Toshiharu Mitsuhashi, Motoyuki Otsuka

Gastrointestinal endoscopy   100 ( 1 )   76 - 84   2024.7

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BACKGROUND AND AIMS: Cholecystitis can occur after self-expandable metallic stent (SEMS) placement for malignant biliary obstruction (MBO), but the best treatment option for cholecystitis has not been determined. Here, we aimed to identify the risk factors of cholecystitis after SEMS placement and determine the best treatment option. METHODS: Incidence, treatments, and predictive factors of cholecystitis were retrospectively evaluated in 1084 patients with distal MBO (DMBO) and 353 patients with hilar MBO (HMBO) who underwent SEMS placement at 12 institutions from January 2012 to March 2021. RESULTS: Cholecystitis occurred in 7.5% of patients with DMBO and 5.9% of patients with HMBO. The recurrence rate was significantly lower (P = .043) and the recurrence-free period significantly longer (P = .039) in endoscopic procedures than in percutaneous procedures for cholecystitis treatment. EUS-guided gallbladder drainage (EUS-GBD) was better in terms of technical success, procedure time, and recurrence-free period than endoscopic transpapillary gallbladder drainage. Obstruction across the cystic duct orifice by tumor (P = .015) and by stent (P = .037) were independent risk factors for cholecystitis in DMBO. Cases with multiple SEMS placements (odds ratio [OR], 11; 95% confidence interval [CI], 0.68-190; P = .091) and with gallbladder stones (OR, 2.3; 95% CI ,0.92-5.6; P = .075) had a higher risk for cholecystitis in HMBO. CONCLUSIONS: The incidences of cholecystitis after SEMS placement for DMBO and HMBO were similar. EUS-GBD is the optimal treatment option for patients with cholecystitis after SEMS placement for MBO.

DOI： 10.1016/j.gie.2024.02.019

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Phase <scp>I/II</scp> clinical trial of brentuximab vedotin for pretreated Japanese patients with <scp>CD30</scp>‐positive cutaneous T‐cell lymphoma

Yoji Hirai, Jun Sakurai, Shiho Yoshida, Takashi Kikuchi, Toshiharu Mitsuhashi, Tomoko Miyake, Taku Fujimura, Riichiro Abe, Hiroki Fujikawa, Hikari Boki, Hiraku Suga, Sayaka Shibata, Tomomitsu Miyagaki, Takatoshi Shimauchi, Eiji Kiyohara, Yoshio Kawakami, Shin Morizane

The Journal of Dermatology   2024.6

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Abstract

Brentuximab vedotin (BV), a conjugate of anti‐CD30 antibody and monomethyl auristatin E, has emerged as a promising treatment option for refractory CD30+ mycosis fungoides (MF) and primary cutaneous anaplastic large‐cell lymphoma (pcALCL). BV has been shown to be safe and effective in treating Hodgkin's lymphoma and peripheral T‐cell lymphoma. This multicenter, prospective, single‐arm phase I/II study evaluated the efficacy of BV in Japanese patients with CD30+ cutaneous lymphomas, namely CD30+ cutaneous T‐cell lymphoma. Participants were divided into two groups: those with CD30+ MF or pcALCL (cohort 1, n = 13) and those with CD30+ lymphoproliferative disorders other than those in cohort 1 (cohort 2, n = 3). The studied population included the full analysis set (FAS), modified FAS (mFAS), and safety analysis set (SAF). These sets were identified in cohorts 1 and 1 + 2 and labeled FAS1 and FAS2, mFAS1 and mFAS2, and SAF1 and SAF2, respectively. Each treatment cycle lasted 3 weeks, and BV was continued for up to 16 cycles after the third cycle based on treatment response. The primary endpoint was the 4‐month objective response rate (ORR4) determined by the Independent Review Forum (IRF). ORR4 was 69.2% for FAS1 and 62.5% for FAS2 (P &lt; 0.0001). Secondary endpoints of ORR, assessed using the global response score (53.8% in FAS1) and modified severity‐weighted assessment tool (62.5% in FAS1), using the IRF, provided results comparable to the primary findings. The incidence of ≥grade 3 adverse events (≥15%) in SAF1 was peripheral neuropathy in three patients (23%) and fever and eosinophilia in two patients (15%). In conclusion, BV showed favorable efficacy, tolerability, and safety profile in Japanese patients with relapsed or refractory CD30+ primary cutaneous T‐cell lymphoma. The trial was registered with University Hospital Medical Information Network Clinical Trials Registry, Japan (protocol ID: UMIN000034205).

DOI： 10.1111/1346-8138.17324

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Aspartate/alanine aminotransferase ratio and development of chronic kidney disease in non-diabetic Japanese men and women

Yukari Okawa, Toshiharu Mitsuhashi, Etsuji Suzuki

2024.5

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AimThe objective of this study was to explore the relationship between serum aspartate/alanine aminotransferase ratio (AST/ALT) and subsequent development of chronic kidney disease (CKD) in non-diabetic Japanese men and women in a 25-year follow-up study.MethodsThe study included all middle-aged and older non-diabetic Japanese citizens who received health check-ups in Zentsuji, Kagawa, Japan (1998–2023). AST/ALT was classified into three categories: &lt;1.0 (reference), 1.0–&lt;1.5, and ≥1.5. Participant characteristics were compared by AST/ALT categories. The Weibull accelerated failure time model was used to examine the association between AST/ALT categories and subsequent CKD onset because the proportional hazards assumption was violated.ResultsOf 6309 men and 9192 women, 2966 men and 4395 women remained in the final cohort. After a mean follow-up of 7.50 years for men and 8.34 years for women, 33.7% of men and 34.0% of women developed CKD. Women had higher AST/ALT than men. In women, a dose-response relationship was observed, with a 9% shorter survival time to CKD onset for AST/ALT ≥1.5 compared with AST/ALT &lt;1.0. In contrast, men had a shorter survival time to CKD onset by point estimates, but the 95% confidence intervals crossed 1 in all models.ConclusionsIn this study comparing the risks of CKD development in non-diabetic men and women by AST/ALT levels, a dose-response relationship was only observed in women. Differences in the distribution of AST/ALT by sex may have affected the results. Therefore, in non-diabetic Japanese women, AST/ALT may be used as an indicator of future CKD development.

DOI： 10.1101/2024.05.20.24307032

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Pediatric otitis media in Japan: A nationwide longitudinal study of the pre- and post-pneumococcal conjugate vaccine eras born in 2001 and 2010. International journal

Kensuke Uraguchi, Naomi Matsumoto, Toshiharu Mitsuhashi, Soshi Takao, Seiichiro Makihara, Mizuo Ando, Takashi Yorifuji

Vaccine   2024.5

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BACKGROUND: Otitis media (OM) is a prevalent respiratory disease in children and poses significant public health challenges due to its impact on child health and economic burdens. However, there have no nationwide epidemiological studies conducted in Japan. This study investigates the epidemiological trends of OM in Japan, taking into account the impact of the 7-valent pneumococcal conjugate vaccine (PCV7) introduction. METHOD: This study was retrospective cohort study using secondary data on the nationwide longitudinal birth cohort. This survey followed two cohorts born in 2001 (pre-PCV era) and 2010 (post-PCV era) until the age of 9. Every year, parents were surveyed about their children's health status, including occurrences of OM. The annual period prevalence and cumulative incidence of OM were assessed in this study, and the two cohorts were compared using a modified Poisson regression model adjusted environmental factors with the 2001 cohort as reference. RESULT: The study included 47,015 children from the 2001 cohort and 38,554 from the 2010 cohort. Peak annual period prevalence of OM varied by era. Cumulative incidence was 13.8 % for the 2001 cohort and 18.5 % for the 2010 cohort by 1.5 years of age and 28.9 % and 33.3 %, respectively, by 3.5 years of age. In particular, from the fourth survey onward, covering ages 2.5-3.5 years, a shift was observed from an increased risk to a decreased risk of OM. CONCLUSION: This nationwide longitudinal study emphasizes variations in OM epidemiology across Japan over time, with changes potentially influenced by the introduction of PCV7. In this study, due to the absence of individual PCV7 vaccination data, the effect of PCV7 was estimated based on the vaccination rate at the population level. The results suggest a notable decrease in the incidence of OM in later years, aligning with the increased uptake of PCV7.

DOI： 10.1016/j.vaccine.2024.05.020

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A multi-center, prospective, clinical study to evaluate the anti-reflux efficacy of laparoscopic double-flap technique (lD-FLAP Study).

Shinji Kuroda, Michihiro Ishida, Yasuhiro Choda, Atsushi Muraoka, Shinji Hato, Tetsuya Kagawa, Norimitsu Tanaka, Toshiharu Mitsuhashi, Yoshihiko Kakiuchi, Satoru Kikuchi, Masahiko Nishizaki, Shunsuke Kagawa, Toshiyoshi Fujiwara

Annals of gastroenterological surgery   8 ( 3 )   374 - 382   2024.5

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BACKGROUND: Double-flap technique (DFT) is a reconstruction procedure after proximal gastrectomy (PG). We previously reported a multi-center, retrospective study in which the incidence of reflux esophagitis (RE) (Los Angeles Classification ≥Grade B [LA-B]) 1 year after surgery was 6.0%. There have been many reports, but all of them were retrospective. Thus, a multi-center, prospective study was conducted. METHODS: Laparoscopic PG + DFT was performed for cT1N0 upper gastric cancer patients. The primary endpoint was the incidence of RE (≥LA-B) 1 year after surgery. The planned sample size was 40, based on an estimated incidence of 6.0% and an upper threshold of 20%. RESULTS: Forty patients were recruited, and 39, excluding one with conversion to total gastrectomy, received protocol treatment. Anastomotic leakage (Clavien-Dindo ≥Grade III) was observed in one patient (2.6%). In 38 patients, excluding one case of postoperative mortality, RE (≥LA-B) was observed in two patients (5.3%) 1 year after surgery, and the upper limit of the 95% confidence interval was 17.3%, lower than the 20% threshold. Anastomotic stricture requiring dilatation was observed in two patients (5.3%). One year after surgery, body weight change was 88.9 ± 7.0%, and PNI <40 and CONUT ≥5, indicating malnutrition, were observed in only one patient (2.6%) each. In the quality of life survey using the PGSAS-45 questionnaire, the esophageal reflux subscale score was 1.4 ± 0.6, significantly better than the public data (2.0 ± 1.0; p = 0.001). CONCLUSION: Laparoscopic DFT showed anti-reflux efficacy. Taken together with the acceptable incidence of anastomotic stricture, DFT can be an option for reconstruction procedure after PG.

DOI： 10.1002/ags3.12783

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Antibody titers and the risk of infection during the SARS-CoV-2 Omicron phase in Bizen City, Japan. International journal

Tomoka Kadowaki, Ayako Sasaki, Naomi Matsumoto, Toshiharu Mitsuhashi, Hideharu Hagiya, Soshi Takao, Takashi Yorifuji

The Journal of infectious diseases   2024.4

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BACKGROUND: Understanding the association between the immune response and the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has implications for forthcoming prevention strategies. We evaluated the association between antibody titers and the risk of infection for the general population during the Omicron-dominant phase. METHODS: This was a prospective cohort study of residents or people affiliated with institutions in Bizen City, which included 1,899 participants. We measured the titers of antibodies against SARS-CoV-2 repeatedly every 2 months from June 2022 to March 2023. Infection status was obtained from self-reported questionnaires and the official registry. We estimated risk ratios (RRs) for infection within 2 months of the date of each antibody measurement with 95% confidence intervals (CIs) based on antibody titer categories and spline functions. RESULTS: Compared with the <2,500 arbitrary unit (AU)/mL category, the 2,500-5,000, 5,000-10,000, and ≥10,000 AU/mL categories had adjusted RRs (95% CI) of 0.81 (0.61-1.08), 0.51 (0.36-0.72), and 0.41 (0.31-0.54), respectively. The spline function showed a non-linear relationship between antibody titer and risk. CONCLUSIONS: Higher antibody titers were associated with a lower risk. We demonstrate the usefulness of measuring an antibody titers to determine the appropriate timing for future vaccination.

DOI： 10.1093/infdis/jiae207

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Impact of amyloid and tau positivity on longitudinal brain atrophy in cognitively normal individuals

Motonobu Fujishima, Yohei Kawasaki, Toshiharu Mitsuhashi, Hiroshi Matsuda

Alzheimer's Research & Therapy   2024.4

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DOI： 10.1186/s13195-024-01450-7

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Photon-Counting Detector CT: Potential for 75% Reduction in Contrast Medium Amount: A Phantom Study.

Fumiyo Higaki, Yusuke Morimitsu, Toshihiro Iguchi, Hayato Saito, Haruhiko Takaki, Ayako Nakagoshi, Maki Wada, Mayu Uka, Noriaki Akagi, Toshiharu Mitsuhashi, Yusuke Matsui, Takao Hiraki

Acta medica Okayama   78 ( 2 )   135 - 142   2024.4

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This study aimed to evaluate the potential reduction in contrast medium utilization using photon-counting detector computed tomography (PCD-CT). One PCD-CT scan (CT1) and three conventional (non-PCD-CT) CT scans (CT2-CT4) were performed using a multi-energy CT phantom that contained eight rods with different iodine concentrations (0.2, 0.5, 1, 2, 5, 10, 15, and 20 mg/ml). The CT values of the seven groups (CT1 for 40, 50, 60, and 70 keV; and CT2-4) were measured. Noise and contrast-to-noise ratio (CNR) were assessed for the eight rods at various iodine concentrations. CT2 and CT1 (40 keV) respectively required 20 mg/ml and 5 mg/ml of iodine, indicating that a comparable contrast effect could be obtained with approximately one-fourth of the contrast medium amount. The standard deviation values increased at lower energy levels irrespective of the iodine concentration. The CNR exhibited a decreasing trend with lower iodine concentrations, while it remained relatively stable across all iodine levels (40-70 keV). This study demonstrated that virtual monochromatic 40 keV images offer a similar contrast effect with a reduced contrast medium amount when compared to conventional CT systems at 120 kV.

DOI： 10.18926/AMO/66916

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Longitudinal antibody dynamics after COVID-19 vaccine boosters based on prior infection status and booster doses

Naomi Matsumoto, Ayako Sasaki, Tomoka Kadowaki, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

Scientific Reports   14 ( 1 )   2024.2

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Abstract

Global concern over COVID-19 vaccine distribution disparities highlights the need for strategic booster shots. We explored longitudinal antibody responses post-booster during the Omicron wave in a Japanese cohort, emphasizing prior infection and booster doses. This prospective cohort study included 1763 participants aged 18 years and older with at least three vaccine doses (7376 datapoints). Antibody levels were measured every 2 months. We modeled temporal declines in antibody levels after COVID-19 vaccine boosters according to prior infection status and booster doses using a Bayesian linear mixed-effects interval-censored model, considering age, sex, underlying conditions, and lifestyle. Prior infection enhanced post-booster immunity (posterior median 0.346, 95% credible interval [CrI] 0.335–0.355), maintaining antibody levels (posterior median 0.021; 95% CrI 0.019–0.023) over 1 year, in contrast to uninfected individuals whose levels had waned by 8 months post-vaccination. Each additional booster was correlated with higher baseline antibody levels and slower declines, comparing after the third dose. Female sex, older age, immunosuppressive status, and smoking history were associated with lower baseline post-vaccination antibodies, but not associated with decline rates except for older age in the main model. Prior infection status and tailored, efficient, personalized booster strategies are crucial, considering sex, age, health conditions, and lifestyle.

DOI： 10.1038/s41598-024-55245-9

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Other Link： https://www.nature.com/articles/s41598-024-55245-9

Treatment interruption in hypertensive patients during the <scp>COVID</scp>‐19 pandemic: An interrupted time series analysis using prescription data in Okayama, Japan

Naoko Nakamura, Toshiharu Mitsuhashi, Naomi Matsumoto, Shunsaku Hayase, Takashi Yorifuji

Journal of General and Family Medicine   25 ( 2 )   102 - 109   2024.2

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Abstract

Background

The COVID‐19 pandemic has impacted healthcare behaviors, leading to fewer pediatric visits in Japan and potentially fewer visits by adult patients. However, existing Japanese studies on treatment interruptions have generally relied on questionnaire‐based methods. In this study, we assessed the impact of the pandemic on antihypertensive treatment interruption using real‐world prescription data.

Methods

We conducted an interrupted time series analysis using the National Health Insurance Database in Okayama Prefecture, Japan. Participants included individuals aged 40–69 years with at least one antihypertensive prescription between 2018 and 2020. Treatment interruption was defined as a 3‐month or longer gap in prescriptions after medication depletion. We used segmented Poisson regression with models unadjusted and adjusted for seasonality and over‐dispersion to assess monthly treatment interruptions before and after Japan's April 2020 emergency.

Results

During the study period, 23.0% of 55,431 participants experienced treatment interruptions. Cyclical fluctuations in interruptions were observed. The crude analysis indicated a 1.2‐fold increase in treatment interruptions following the pandemic; however, the adjusted models showed no significant changes. Even among higher‐risk groups, such as women, younger adults, and those with shorter prescriptions, no significant alterations were observed.

Conclusion

We found no significant impact of the COVID‐19 pandemic on antihypertensive treatment interruption in Okayama Prefecture. The less severe outbreak in the area or increased use of telemedicine and extended prescriptions may have contributed to treatment continuity. Further research is needed using a more stable and comprehensive database, broader regional data, and detailed prescription records to validate and extend our findings.

DOI： 10.1002/jgf2.678

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Plasma concentrations of histidine-rich glycoprotein in primary graft dysfunction after lung transplantation. International journal

Toshio Shiotani, Seiichiro Sugimoto, Yasuaki Tomioka, Shin Tanaka, Toshiharu Mitsuhashi, Ken Suzawa, Kazuhiko Shien, Kentaroh Miyoshi, Hiromasa Yamamoto, Mikio Okazaki, Shinichi Toyooka

Interdisciplinary cardiovascular and thoracic surgery   38 ( 2 )   2024.2

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OBJECTIVES: Histidine-rich glycoprotein has been reported as an anti-inflammatory glycoprotein that inhibits acute lung injury in mice with sepsis and as a prognostic biomarker in patients with sepsis. We investigated the relationship between plasma concentrations of histidine-rich glycoprotein and the risk of occurrence of primary graft dysfunction. METHODS: According to the primary graft dysfunction grade at post-transplant 72 h, patients who underwent lung transplantation were divided into three groups: non-primary graft dysfunction group (grade 0-1), moderate primary graft dysfunction group (grade 2), and severe primary graft dysfunction group (grade 3). The plasma concentrations of histidine-rich glycoprotein measured daily during the first post-transplant 7 days were compared among the three groups. Appropriate cutoff values of the concentrations were set for survival analyses after lung transplantation. RESULTS: A total of 68 patients were included. The plasma histidine-rich glycoprotein concentration at post-transplant 72 h was significantly lower in the severe primary graft dysfunction group (n = 7) than in the other two groups [non-primary graft dysfunction group (n = 43), P = 0.042; moderate primary graft dysfunction group (n = 18), P = 0.040]. Patients with plasma histidine-rich glycoprotein concentration ≥34.4 µg/ml at post-transplant 72 h had significantly better chronic lung allograft dysfunction-free survival (P = 0.012) and overall survival (P = 0.037) than those with the concentration <34.4 µg/ml. CONCLUSIONS: Plasma histidine-rich glycoprotein concentrations at post-transplant 72 h might be associated with the risk of development of primary graft dysfunction.

DOI： 10.1093/icvts/ivae021

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Longitudinal changes in antibody titers in a nursing home in which COVID-19 clusters occurred

Tomoka Kadowaki, Ayako Sasaki, Naomi Matsumoto, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

American Journal of Infection Control   2024.2

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DOI： 10.1016/j.ajic.2024.02.006

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Is obesity in the Asia-Pacific body mass index classification associated with the development of chronic kidney disease in non-diabetic Japanese men and women?

Yukari Okawa, Toshiharu Mitsuhashi, Toshihide Tsuda

2024.1

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Abstract

Objective

Obesity is a risk factor for the development of chronic kidney disease (CKD). However, little is known about the relationship between the Asia-Pacific body mass index classification (Asia-Pacific classification) and the development of CKD in non-diabetic Asian men and women.

Methods

Body mass index (BMI) was categorized in accordance with the Asia-Pacific classification: underweight (&lt;18.5 kg/m²), normal weight (18.5–22.9 kg/m²), overweight (23.0–24.9 kg/m²), obesity class I (25.0–29.9 kg/m²), and obesity class II (≥30.0 kg/m²). Using administrative checkup data for non-diabetic Japanese adults (1998–2023), we assessed the relationship between the Asia-Pacific classification and the development of CKD by sex. The Weibull accelerated failure time model was selected because the proportional hazards assumption was violated.

Results

In total, 34.2% of 3098 men and 34.8% of 4391 women had developed CKD. The mean follow-up time was 7.41 years for men and 8.25 years for women. Compared with normal weight, obesity class I was associated with a 6% (95% confidence interval [CI]: 2%–10%) shorter time to CKD development in men and a 6% (95% CI: 2%–9%) shorter time to CKD development in women. Obesity class II was associated with the shortest survival to the development of CKD by point estimate in men but had an almost null value in women (i.e., 95% CIs crossed 1 in all of the models).

Conclusions

Among non-diabetic Japanese men and women, obesity class I in the Asia-Pacific classification was associated with a shorter survival time to CKD onset than normal weight. Low point estimates for obesity class II suggested a dose-response relationship in men but a less clear relationship in women. The conventional cutoff value for obesity, BMI ≥30.0 kg/m², may be too high a risk factor for the development of CKD in non-diabetic Asians, regardless of sex.

DOI： 10.1101/2024.01.06.23300566

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Epidural versus patient-controlled intravenous analgesia on pain relief and recovery after laparoscopic gastrectomy for gastric cancer: randomized clinical trial. International journal

Satoru Kikuchi, Takashi Matsusaki, Toshiharu Mitsuhashi, Shinji Kuroda, Hajime Kashima, Nobuo Takata, Ema Mitsui, Yoshihiko Kakiuchi, Kazuhiro Noma, Yuzo Umeda, Hiroshi Morimatsu, Toshiyoshi Fujiwara

BJS open   8 ( 1 )   2024.1

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BACKGROUND: Epidural analgesia (EDA) is a main modality for postoperative pain relief in major open abdominal surgery within the Enhanced Recovery After Surgery protocol. However, it remains unclear whether EDA is an imperative modality in laparoscopic gastrectomy (LG). This study examined non-inferiority of patient-controlled intravenous analgesia (PCIA) to EDA in terms of postoperative pain and recovery in patients who underwent LG. METHODS: In this open-label, non-inferiority, parallel, individually randomized clinical trial, patients who underwent elective LG for gastric cancer were randomized 1:1 to receive either EDA or PCIA after surgery. The primary endpoint was pain score using the Numerical Rating Scale at rest 24 h after surgery, analysed both according to the intention-to-treat (ITT) principle and per protocol. The non-inferiority margin for pain score was set at 1. Secondary outcomes were postoperative parameters related to recovery and adverse events related to analgesia. RESULTS: Between 3 July 2017 and 29 September 2020, 132 patients were randomized to receive either EDA (n = 66) or PCIA (n = 66). After exclusions, 64 patients were included in the EDA group and 65 patients in the PCIA group for the ITT analysis. Pain score at rest 24 h after surgery was 1.94 (s.d. 2.07) in the EDA group and 2.63 (s.d. 1.76) in the PCIA group (P = 0.043). PCIA was not non-inferior to EDA for the primary endpoint (difference 0.69, one side 95% c.i. 1.25, P = 0.184) in ITT analysis. Postoperative parameters related to recovery were similar between groups. More EDA patients (21 (32.8%) versus 1 (1.5%), P < 0.001) developed postoperative hypotension as an adverse event. CONCLUSIONS: PCIA was not non-inferior to EDA in terms of early-phase pain relief after LG.Registration number: UMIN000027643 (https://www.umin.ac.jp/ctr/index-j.htm).

DOI： 10.1093/bjsopen/zrad161

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Antibody levels and the risk of SARS-CoV-2 infection during the Omicron surge

Ayako Sasaki, Tomoka Kadowaki, Naomi Matsumoto, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

GHM Open   2024

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DOI： 10.35772/ghmo.2023.01018

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Association Between Clinical Remission of Infantile-Onset Allergic Rhinitis During the School-Age Period and the Type of Housing: A Longitudinal Population-Based Japanese Study. International journal

Kensuke Uraguchi, Naomi Matsumoto, Toshiharu Mitsuhashi, Soshi Takao, Seiichiro Makihara, Mizuo Ando, Takashi Yorifuji

Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners   2023.12

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This study investigated the association between housing type and clinical remission of infantile-onset allergic rhinitis (AR) in 53,575 children born in 2001 in Japan. Infantile-onset AR was defined as the presence of AR symptoms reported between ages 1.5 and 4.5 years, and remission was assessed between ages 10 and 12. The type of housing was categorized into detached houses and multi-unit residential buildings with 1-2, 3-5, or ≥6 floors. Among the 4,352 infantile-onset AR, 42.9% experienced remission. Notably, living in multi-unit residential buildings, particularly those with 1-2 and ≥6 floors, was positively associated with AR remission.

DOI： 10.1016/j.pedhc.2023.11.011

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Association between blood pressure and new onset of chronic kidney disease in non-diabetic Japanese adults: a population-based longitudinal study from 1998 to 2023

Yukari Okawa, Toshiharu Mitsuhashi

2023.12

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Abstract

Background and Aims

Hypertension is a risk factor for developing chronic kidney disease (CKD). Studies of adult participants in the USA reported that hypertension increased the risk of developing CKD even in the non-diabetic population. However, studies in non-diabetic populations are limited and additional studies in other races are required. This study aimed to examine the relationship between hypertension and the development of CKD in non-diabetic Asian adults.

Methods and Results

In this longitudinal study, non-diabetic Japanese adults who took annual checkups from 1998 to 2023 were included. CKD was defined as &lt;60 mL/min/1.73 m², and hypertension was classified into four levels according to the guidelines of the American College of Cardiology/American Heart Association. The Weibull accelerated failure time model was selected because the proportional hazards assumption was violated. Of the 7 363 (men: 40.3%) people in the final cohort, 2 498 (men: 40.1%) developed CKD after a mean follow-up of 7.99 years. Elevated blood pressure (BP) and hypertension stage 2 had a 9% (95% confidence interval [CI]: 1%–16%) and 11% (95% CI: 5%–17%) shorter survival time to CKD onset, respectively, than normal BP. Hypertension stage 1 also had a shorter survival to CKD onset by point estimate, but all 95% CIs crossed 1 in all models.

Conclusions

In a relatively healthy Asian population without diabetes, controlling BP to an appropriate range reduces the risk of developing CKD.

DOI： 10.1101/2023.12.06.23299067

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Review of a Series of Surveys on Adverse Reactions to the COVID-19 mRNA-1273 Vaccine at Okayama University.

Naomi Matsumoto, Chigusa Higuchi, Chikara Miyaji, Toshiharu Mitsuhashi, Hideharu Hagiya, Soshi Takao, Takashi Yorifuji

Acta medica Okayama   77 ( 6 )   567 - 575   2023.12

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This paper presents the results of a series of surveys conducted from July 2021 to March 2023 to investigate the post-vaccination adverse reactions to the mRNA-1273 (Moderna) vaccine among faculty, staff, and students at Okayama University. These studies complement the official surveys conducted by the Ministry of Health, Labour and Welfare (MHLW) and provide a more representative picture of adverse reactions in the general population including large numbers of healthy young people. Pain, swelling, redness at the injection site, fever, headache, and malaise were the main adverse reactions reported. The proportion of adverse reactions was generally higher after the second vaccination and decreased with each additional vaccination. No statistically significant differences in the adverse reactions were found for males and females and those with/without a history of allergy, but a lower proportion of fever was observed in older participants and those with underlying medical conditions. We also evaluated the association between adverse reactions and antibody titers after the third vaccination and found no significant differences in antibody levels one month after vaccination. This series of studies highlights the importance of conducting surveys in diverse populations to provide a more representative picture of post-vaccination adverse reactions during a pandemic.

DOI： 10.18926/AMO/66148

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Fine particulate matter and diabetes prevalence in Okayama, Japan Reviewed International journal

Tani Y, Kashima S, Mitsuhashi T, Suzuki E, Takao S, Yorifuji T

Acta Medica Okayama   77 ( 6 )   607 - 612   2023.12

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Many studies have shown an association between long-term exposure to particulate matter having an aerodynamic diameter of 2.5 μm or less (PM2.5) and diabetes mellitus (DM), but few studies have focused on Asian subjects. We thus examined the association between long-term exposure to PM2.5 and DM prevalence in Okayama City, Japan. We included 76,591 participants who had received basic health checkups in 2006 and 2007. We assigned the census-level modeled PM2.5 data from 2006 and 2007 to each participant and defined DM using treatment status and the blood testing. PM2.5 was associated with DM prevalence, and the prevalence ratio (95% confidence interval) was 1.10 (1.00-1.20) following each interquartile range increase (2.1 μg/m3) in PM2.5. This finding is consistent with previous results and suggests that long-term exposure to PM2.5 is associated with an increased prevalence of DM in Okayama City, Japan, where the PM2.5 level is lower than in other cities in Asian countries.

DOI： 10.18926/AMO/66152

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COVID-19 pandemic and language development in children at 18 months: a repeated cross-sectional study over a 6-year period in Japan

Rumi Matsuo, Naomi Matsumoto, Toshiharu Mitsuhashi, Takashi Yorifuji

Archives of Disease in Childhood   archdischild - 2023   2023.11

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Objective

To evaluate the impact of the COVID-19 pandemic experience on language development among children, we compared language development at 18 months of age, before and during the pandemic in Japan, where strict control measures continued over a long period.

Methods

This was a repeated cross-sectional study and we included children who attended the 18-month health check-up provided by the Okayama City Public Health Center between January 2017 and December 2022 (n=33 484). We compared indicators of language development before (from January 2017 to February 2020) and during (from March 2020 to December 2022) the pandemic. Our primary outcome was the proportion of children who required follow-up for language development by the Public Health Center. The secondary outcome was the proportion of children who could not say three or more meaningful words. We estimated risk ratios (RRs) and their 95% CIs, adjusted for potential confounders.

Results

The prevalence of the primary outcome was 33.5% before the pandemic and 36% during the pandemic. Compared with before the pandemic, increased RRs for the primary and secondary outcomes were observed during the pandemic, with RRs (95% CIs) of 1.09 (1.06–1.13) for the primary outcome and 1.11 (1.05–1.17) for the secondary outcome. Although the statistical interactions were not significant, the RRs were higher for children cared for at home than those in nursery schools and with ≤3 family members than those with ≥4 family members.

Conclusions

The COVID-19 pandemic was associated with an increased risk of impaired language development in children at 18 months. More extensive support is needed for higher risk families, as well as follow-up of long-term language development in children affected by the COVID-19 pandemic.

DOI： 10.1136/archdischild-2023-325926

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Factors associated with survival in patients with clear cell sarcoma. International journal

Tomohiro Fujiwara, Toshiyuki Kunisada, Eiji Nakata, Toshiharu Mitsuhashi, Toshifumi Ozaki, Akira Kawai

The bone & joint journal   105-B ( 11 )   1216 - 1225   2023.11

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AIMS: Clear cell sarcoma (CCS) of soft-tissue is a rare melanocytic subtype of mesenchymal malignancy. The aim of this study was to investigate the clinical and therapeutic factors associated with increased survival, stratified by clinical stage, in order to determine the optimal treatment. METHODS: The study was a retrospective analysis involving 117 patients with histologically confirmed CCS, between July 2016 and November 2017, who were enrolled in the Bone and Soft Tissue Tumour Registry in Japan. RESULTS: The five- and ten-year survival rates were 41% (95% confidence interval (CI) 29 to 52) and 37% (95% CI 25 to 49), respectively. On multivariable analysis, the size of the tumour of > 10 cm (p = 0.006), lymph node metastasis at the time of diagnosis (p < 0.001), distant metastases at the time of diagnosis (p < 0.001), and no surgery for the primary tumour (p = 0.019) were independently associated with a poor survival. For N0M0 CCS (n = 68), the development of distant metastases was an independent prognostic factor for survival (early (< 12 months), hazard ratio (HR) 116.78 (95% CI 11.69 to 1,166.50); p < 0.001; late (> 12 months), HR 14.79 (95% CI 1.66 to 131.63); p = 0.016); neoadjuvant/adjuvant chemotherapy (p = 0.895) and/or radiotherapy (p = 0.216) were not significantly associated with survival. The five-year cumulative incidence of local recurrence was 19% (95% CI 8 to 35) and the size of the tumour was significantly associated with an increased rate of local recurrence (p = 0.012). For N1M0 CCS (n = 18), the risk of mortality was significantly lower in patients who underwent surgery for both the primary tumour and lymph node metastases (HR 0.03 (95% CI 0.00 to 0.56); p = 0.020). For M1 CCS (n = 31), excision of the primary tumour was independently associated with better survival (HR 0.26 (95% CI 0.09 to 0.76); p = 0.013). There was no significant difference in survival between the different types of systemic treatment (p = 0.523). CONCLUSION: Complete excision of the primary tumour and lymph nodes is associated with a better survival in patients with CCS. Systemic treatment appears to provide limited benefits, demonstrating a pressing need for novel systemic agents.

DOI： 10.1302/0301-620X.105B11.BJJ-2022-0743.R3

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Effectiveness of the Original COVID-19 Vaccine against COVID-19 Exacerbations during the Omicron Wave: A Population-based Study in Okayama, Japan.

Naomi Matsumoto, Toshiharu Mitsuhashi, Rumi Matsuo, Tomoka Kadowaki, Soshi Takao, Takashi Yorifuji

JMA journal   6 ( 4 )   463 - 469   2023.10

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INTRODUCTION: In Japan, approximately 97 million individuals have received their primary two doses of coronavirus disease 2019 (COVID-19) vaccine at the end of 2022. In this study, we aim to examine the effectiveness of the primary vaccines and compare its efficacy to booster vaccine shots in terms of preventing COVID-19 exacerbations during the Omicron-predominant period in Japan. METHODS: For this analysis, we have collected all the confirmed COVID-19-positive cases from different medical institutions in Okayama City and have also utilized the information from the public Vaccination Record System. Taking the number of vaccinations into consideration, we then conducted a population-based study to assess the effectiveness of the two primary vaccine doses in preventing COVID-19 exacerbations during the Omicron waves. Our primary and secondary outcomes were COVID-19 exacerbations with respiratory failure (i.e., oxygen saturation on room air ≤ 93%, requiring supplemental oxygen), intensive care unit admission and/or mechanical ventilator requirement, or death, in accordance with the Japanese COVID-19 guidelines, and pneumonia during the course of COVID-19 infection, respectively. RESULTS: In total, 95,329 COVID-19-positive individuals, aged 5 years and above, were included in this analysis (study period from January 1 to September 10, 2022). As per our findings, the effectiveness of the primary two doses against COVID-19 exacerbations compared with those who had never been vaccinated was 55.5% (95% confidential interval [CI]: 32.6-71.7), whereas it was higher after the third dose (76.9%; 95% CI: 66.7-84.0) and the fourth dose (75.7%; 95% CI: 58.8-85.7). Effectiveness was sustained for ≥ 5 months after the third vaccination, and preventive effectiveness was observed in individuals aged ≥ 65 years. CONCLUSIONS: As per the results of this study, we can conclude that the efficacy of the primary two doses of SARS-CoV-2 vaccine can be further strengthened in terms of preventing COVID-19 exacerbations by administering third and fourth booster vaccine shots. The additional bivalent vaccine is anticipated to further increase its efficacy against the Omicron strain, suggesting that individuals who have not received their booster shots yet should consider getting them to prevent COVID-19 exacerbations.

DOI： 10.31662/jmaj.2023-0019

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Effectiveness of the original COVID-19 vaccine in preventing COVID-19 exacerbations during the Omicron wave: A population-based study in Okayama, Japan. Reviewed

Matsumoto N, Mitsuhashi T, Matsuo R, Kadowaki T, Takao S, Yorifuji T

JMA J.   6 ( 4 )   463 - 46   2023.10

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DOI： 10.31662/jmaj.2023-0019.

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Prospective evaluation of core number of biopsy for renal tumor: are multiple cores preferable?

Toshihiro Iguchi, Yusuke Matsui, Tomohiro Toji, Jun Sakurai, Koji Tomita, Mayu Uka, Noriyuki Umakoshi, Takahiro Kawabata, Kazuaki Munetomo, Toshiharu Mitsuhashi, Takao Hiraki

Japanese journal of radiology   2023.10

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PURPOSE: This single-center, single-arm, prospective, open-label study was conducted to evaluate the optimal number of cores (single or multiple) in renal tumor biopsy. MATERIALS AND METHODS: Forty-four biopsies of 44 tumors (mean diameter, 2.7 ± 1.0 cm; range, 1.6-5.0 cm) were included. Biopsy was performed under ultrasound or computed tomography fluoroscopy guidance using an 18-gauge cutting needle and the co-axial method. Two or more specimens were obtained, which were divided into first and subsequent specimens. "First specimen" and "all specimens" were histologically evaluated (i.e., appropriateness of specimen, histological diagnosis, subtype, and Fuhrman grade of renal cell carcinoma [RCC]) blindly and independently by two board-certified pathologists. RESULTS: Multiple specimens were successfully and safely obtained in all the biopsies. All tumors were histologically diagnosed; 40 malignancies included 39 RCCs and 1 solitary fibrous tumor, and 4 benign lesions included 2 angiomyolipomas, 1 oncocytoma, and 1 capillary hemangioma. In all RCCs, the subtype could be determined (32 clear cell RCCs, 4 chromophobe RCCs, and 3 papillary RCCs), and the Furman grade was determined in 38 RCCs. When only the first specimen was evaluated, 22.7% of the specimens were inappropriate for diagnosis, and 34 (77.3%) were histologically diagnosed. The diagnostic yield was significantly lower than that of all specimens (P = 0.0044). Univariate analysis revealed that smaller lesions were a significant predictor of diagnostic failure (P = 0.020). CONCLUSION: Biopsy with multiple cores significantly improved diagnostic yield. Thus, operators should obtain multiple cores during renal tumor biopsy.

DOI： 10.1007/s11604-023-01496-x

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Antibody Titers After a Third and Fourth SARS-CoV-2 Vaccine Dose in Bizen City, Japan

Tomoka Kadowaki, Ayako Sasaki, Naomi Matsumoto, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

Journal of Epidemiology   33 ( 9 )   484 - 486   2023.9

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DOI： 10.2188/jea.je20230034

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A population-based longitudinal study on glycated hemoglobin levels and new-onset chronic kidney disease among non-diabetic Japanese adults. International journal

Yukari Okawa, Etsuji Suzuki, Toshiharu Mitsuhashi, Toshihide Tsuda, Takashi Yorifuji

Scientific reports   13 ( 1 )   13770 - 13770   2023.8

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Chronic kidney disease (CKD) is a major global public health problem. Recent studies reported that diabetes and prediabetes are risk factors for developing CKD; however, the exact glycated hemoglobin (HbA1c) cut-off value for prediabetes remains controversial. In this study, we aimed to examine the relationship between HbA1c levels and subsequent CKD development in greater detail than previous studies. Longitudinal data of annual checkups of 7176 Japanese non-diabetic people (male: 40.4%) from 1998 to 2022 was analyzed. HbA1c values were categorized into < 5.0%, 5.0-5.4%, 5.5-5.9%, and 6.0-6.4%. CKD was defined as an estimated glomerular filtration rate < 60 ml/min/1.73 m2. The descriptive statistics at study entry showed that higher HbA1c values were associated with male, older, overweight or obese, hypertensive, or dyslipidemic people. During a mean follow-up of 7.75 person-years, 2374 participants (male: 40.0%) developed CKD. The Weibull accelerated failure time model was selected because the proportional hazards assumption was violated. The adjusted time ratios of developing CKD for HbA1c levels of 5.5-5.9% and 6.0-6.4% compared with 5.0-5.4% were 0.97 (95% confidence interval: 0.92-1.03) and 1.01 (95% confidence interval: 0.90-1.13), respectively. There was no association between HbA1c in the prediabetic range and subsequent CKD development.

DOI： 10.1038/s41598-023-40300-8

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Obesity, overweight, and severe prognosis in COVID-19 patients in Japan

Tomoka Kadowaki, Naomi Matsumoto, Rumi Matsuo, Toshiharu Mitsuhashi, Ayako Sasaki, Soshi Takao, Takashi Yorifuji

Journal of Infection and Chemotherapy   2023.8

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DOI： 10.1016/j.jiac.2023.08.004

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Effect of 2-week postpartum check-ups on screening positive for postpartum depression: a population-based cohort study using instrumental variable estimation in Japan

Naoko Nakamura, Toshiharu Mitsuhashi, Yasuko Nakashima, Naomi Matsumoto, Takashi Yorifuji

Family Practice   2023.7

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Abstract

Background

Postpartum depression is experienced by approximately 10% of women and affects the health and development of their children. Although it is recommended that all mothers have the opportunity for early detection and intervention for postpartum depression, it is unclear whether early postpartum check-ups help to reduce postpartum depression.

Objective

The aim of this study was to assess the effect of 2-week postpartum check-ups on screening positive for postpartum depression in Japan.

Methods

This was a population-based cohort study that used the administrative database of Tsuyama, Japan. Participants were women who received postpartum home visits from a public health nurse in Tsuyama during the fiscal years 2017–2019. Data were obtained on participant’s attendance at a 2-week postpartum check-up and their responses on the Edinburgh Postpartum Depression Scale. Owing to the initiation of a publicly funded postpartum check-up programme, participants were pseudo-randomly assigned to receive/not receive a 2-week postpartum check-up. We conducted instrumental variable estimation to assess the causal effects of the check-up on screening positive for postpartum depression.

Results

The characteristics of the 1,382 participants did not differ by fiscal year of childbirth. We found a 6.7% (95% confidence interval 2.2–11.2) reduction in the prevalence of screening positive for postpartum depression as an effect of 2-week postpartum check-ups among women received 1-month postpartum home visits.

Conclusion

The results suggest that 2-week postpartum check-ups are effective in reducing the prevalence of screening positive for postpartum depression among 1-month postpartum women. Despite some limitations, early postpartum care could reduce postpartum depression.

DOI： 10.1093/fampra/cmad074

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Association between handwashing and gargling education for children and prevention of respiratory tract infections: a longitudinal Japanese children population-based study

Kensuke Uraguchi, Toshiharu Mitsuhashi, Naomi Matsumoto, Soshi Takao, Seiichiro Makihara, Mizuo Ando, Takashi Yorifuji

European Journal of Pediatrics   2023.7

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DOI： 10.1007/s00431-023-05062-5

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Complementary and Alternative Medicine Use, Cancer Screening, and Medical Checkups in Japan from 2001 to 2013: A Repeated Cross-Sectional Study. International journal

Nobuyoshi Matsuki, Etsuji Suzuki, Toshiharu Mitsuhashi, S V Subramanian, Soshi Takao, Takashi Yorifuji

Journal of integrative and complementary medicine   2023.6

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Introduction: The association between complementary and alternative medicine (CAM) use and other health-related behaviors is an important issue. A previous study reported that complementary medicine use is related to greater use of cancer screening, whereas alternative medicine use is related to lower use of cancer screening. Given the sparse evidence from Japan, we aimed to examine the association of CAM use with cancer screening and medical checkups. We used a repeated cross-sectional survey of a nationally representative sample of Japanese people and conducted age-period-cohort analysis. Methods: The study population was 68,217 of 83,827 individuals observed from 2001 to 2013 who received cancer screening. CAM users were defined as individuals who received acupuncture, moxibustion, anma/massage/shiatsu, or judo therapy for their most worrisome symptom. The outcomes of interest were receiving stomach, lung, colorectal, uterine, and breast cancer screenings and medical checkups. Using crossclassified multilevel logistic regression models, we estimated odds ratios (ORs) and 95% credible intervals (CIs) for cancer screening and medical checkups. Results: For CAM users of complementary medicine, the adjusted ORs for stomach, lung, and colorectal cancer screening were 1.40 (95% CI: 1.35-1.44), 1.37 (95% CI: 1.34-1.40), and 1.52 (95% CI: 1.49-1.54), respectively. We found similar results for uterine and breast cancer screening, and medical checkups. Conclusions: Irrespective of whether they use CAM, CAM users in Japan tend to receive a variety of cancer screenings and medical checkups.

DOI： 10.1089/jicm.2023.0077

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Endoscopic evaluation by the Kyoto classification of gastritis combined with serum anti-Helicobacter pylori antibody testing reliably risk-stratifies subjects in a population-based gastric cancer screening program.

Ryosuke Hirai, Mami Hirai, Motoyuki Otsuka, Toshiharu Mitsuhashi, Yuichi Shimodate, Hirokazu Mouri, Kazuhiro Matsueda, Hiroshi Yamamoto, Motowo Mizuno

Journal of gastroenterology   58 ( 9 )   848 - 855   2023.6

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BACKGROUND: We previously demonstrated that the Kyoto classification of gastritis was useful for judging the status of Helicobacter pylori infection in a population-based screening program, and that adding H. pylori antibody test improved its accuracy (UMIN000028629). Here, we tested whether our endoscopic diagnosis of H. pylori infection status reliably estimated gastric cancer risk in the program. METHODS: Data were collected from1345 subjects who underwent endoscopic follow-up 4 years after the end of the registration. We analyzed the association of three diagnostic methods of H. pylori infection with gastric cancer detection: (1) endoscopic diagnosis based on the Kyoto classification of gastritis; (2) serum diagnosis according to the ABC method (H. pylori antibody and pepsinogen I and II); and (3) endoscopic diagnosis together with H. pylori antibody test. RESULTS: During the follow-up, 19 cases of gastric cancer were detected. By Kaplan-Meier analysis, the detection rates of cancer were significantly higher in the past or current H. pylori infection groups than in the never-infected group with all 3 methods. By the Cox proportional hazards model, the hazard ratio for cancer detection was highest in evaluation with the combined endoscopic diagnosis and the antibody test (method 3; hazard ratio 22.6, 95% confidence interval 2.99-171) among the three methods (the endoscopic diagnosis (method 1); 11.3, 2.58-49.8, and the ABC method (method 2); 7.52, 2.49-22.7). CONCLUSIONS: Endoscopic evaluation of H. pylori status with the Kyoto classification of gastritis, especially combined with serum anti-Helicobacter pylori antibody testing, reliably risk-stratified subjects in a population-based gastric cancer screening program.

DOI： 10.1007/s00535-023-02010-w

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Correction: Characteristics of synchronous and metachronous duodenal tumors and association with colorectal cancer: a supplementary analysis.

Yasushi Yamasaki, Motohiko Kato, Yoji Takeuchi, Shu Hoteya, Tsuneo Oyama, Satoru Nonaka, Shoichi Yoshimizu, Masao Yoshida, Ken Ohata, Yoshimasa Miura, Yuko Hara, Shigetsugu Tsuji, Osamu Dohi, Hiroya Ueyama, Koichi Kurahara, Tomoaki Tashima, Nobutsugu Abe, Toshiharu Mitsuhashi, Atsushi Nakayama, Ichiro Oda, Naohisa Yahagi

Journal of gastroenterology   58 ( 5 )   470 - 471   2023.5

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DOI： 10.1007/s00535-023-01984-x

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新型コロナウイルスワクチン接種歴と抗体価との関連

門脇 知花, 佐々木 綾子, 松本 尚美, 三橋 利晴, 高尾 総司, 頼藤 貴志

日本衛生学雑誌   78 ( Suppl. )   S194 - S194   2023.3

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Language：Japanese   Publisher：(一社)日本衛生学会  

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Characteristics of synchronous and metachronous duodenal tumors and association with colorectal cancer: a supplementary analysis.

Yasushi Yamasaki, Motohiko Kato, Yoji Takeuchi, Shu Hoteya, Tsuneo Oyama, Satoru Nonaka, Shoichi Yoshimizu, Masao Yoshida, Ken Ohata, Yoshimasa Miura, Yuko Hara, Shigetsugu Tsuji, Osamu Dohi, Hiroya Ueyama, Koichi Kurahara, Tomoaki Tashima, Nobutsugu Abe, Toshiharu Mitsuhashi, Atsushi Nakayama, Ichiro Oda, Naohisa Yahagi

Journal of gastroenterology   58 ( 5 )   459 - 469   2023.2

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BACKGROUND: We previously reported outcomes of endoscopic resection for duodenal tumors in a large cohort. This study investigated the frequency and characteristics of synchronous and metachronous lesions, and their association with colorectal advanced adenoma (CAA) and colorectal cancer (CRC). METHODS: Patients underwent duodenal endoscopic resection during January 2008 to December 2018. Background and characteristics, incidence of synchronous and metachronous lesions, and incidence of CAA and CRC were investigated. Patients without synchronous lesions were classified as the single group, and those with synchronous lesions as the synchronous group. Patients were also classified as the metachronous and non-metachronous groups. The characteristics among the groups were compared. RESULTS: We included 2658 patients with 2881 duodenal tumors: 2472 (93.0%) patients had single, 186 (7.0%) had synchronous, and 54 (2.0%) had metachronous lesions. The 5-year cumulative incidence of metachronous lesions was 4.1%. In total, 208 (7.8%) had CAA and 127 (4.8%) patients had CRC, and colonoscopy was performed in 936 (35.2%) patients. The incidence of CAA in the synchronous groups tended to be higher compared with that in the single groups (11.8% vs 7.5%, adjusted risk ratio 1.56), and the incidence of CRC in the metachronous groups tended to be higher compared with that in the non-metachronous groups (13.0% vs 4.6%, adjusted risk ratio 2.75), but there was no difference after adjusting for colonoscopy. CONCLUSIONS: This study showed the incidence of synchronous and metachronous duodenal lesions. There was no significant difference in incidence of CAA and CRC among each group, but further studies are warranted.

DOI： 10.1007/s00535-023-01964-1

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Protocol for a randomised, placebo-controlled, double-blinded clinical trial on the effect of oestrogen replacement on physical performance to muscle resistance exercise for older women with osteoarthritis of knee joint: the EPOK trial

Tomohiro Mitoma, Jota Maki, Hikaru Ooba, Eriko Eto, Kasumi Takahashi, Tsunemasa Kondo, Tomohiro Ikeda, Yoko Sakamoto, Toshiharu Mitsuhashi, Hisashi Masuyama

BMC Geriatrics   23 ( 1 )   2023.2

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Abstract

Background

Knee osteoarthritis (KOA) is highly prevalent in older women, and previous studies suggest the involvement of hormonal factors play a role in the pathogenesis of osteoarthritis. KOA causes musculoskeletal impairment, resulting in decreased physical activity, muscle mass, and strength, which leads to sarcopenia and further increases the burden on healthcare systems. Oestrogen replacement therapy (ERT) improves joint pain and muscle performance in early menopausal women. Muscle resistance exercise (MRE) is a non-pharmacological method that preserves the physical functions of patients with KOA. However, data on short-term oestrogen administration combined with MRE in postmenopausal women, especially in those aged &gt; 65 years, are limited. Therefore, this study presents a protocol of a trial aimed to examine the synergistic effect of ERT and MRE on lower-limb physical performance in older women with KOA.

Methods

We will conduct a double-blinded, randomised placebo-controlled trial in 80 Japanese women aged &gt; 65 years living independently with knee pain. The participants will be randomly categorised into two groups: (1) 12-week MRE programme with transdermal oestrogen gel containing 0.54 mg oestradiol per push and (2) 12-week MRE programme with placebo gel. The primary outcome measured using the 30-s chair stand test, and secondary outcomes (body composition, lower-limb muscle strength, physical performance, self-reported measure of knee pain, and quality of life) will be measured at baseline, 3 months, and 12 months, and these outcomes will be analysed based on the intention-to-treat.

Discussion

The EPOK trial is the first study to focus on the efficacy of ERT on MRE among women aged &gt; 65 years with KOA. This trial will provide an effective MRE to prevent KOA-induced lower-limb muscle weakness, confirming the benefit of short-term oestrogen administration.

Trial registration

Japan Registry of Clinical Trials: jRCTs061210062. Registered 17th December 2021, https://jrct.niph.go.jp/en-latest-detail/jRCTs061210062.

DOI： 10.1186/s12877-023-03828-y

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21世紀出生児縦断調査を用いた小児の手洗い・うがい教育の感染予防効果について

浦口 健介, 三橋 利晴, 松本 尚美, 頼藤 貴志

Journal of Epidemiology   33 ( Suppl.1 )   110 - 110   2023.2

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A randomized controlled trial of teprenone in terms of preventing worsening of COVID-19 infection. International journal

Eiki Ichihara, Kou Hasegawa, Kenichiro Kudo, Yasushi Tanimoto, Kazuhiro Nouso, Naohiro Oda, Sho Mitsumune, Haruto Yamada, Ichiro Takata, Hideharu Hagiya, Toshiharu Mitsuhashi, Akihiko Taniguchi, Shinichi Toyooka, Kohei Tsukahara, Toshiyuki Aokage, Hirokazu Tsukahara, Katsuyuki Kiura, Yoshinobu Maeda

PloS one   18 ( 10 )   e0287501   2023

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BACKGROUND: Some COVID-19 patients develop life-threatening disease accompanied by severe pneumonitis. Teprenone induces expression of heat-shock proteins (HSPs) that protect against interstitial pneumonia in preclinical models. We explored whether teprenone prevented worsening of COVID-19 infections. METHODS: This open-label, randomized, pilot phase 2 clinical trial was conducted at five institutions in Japan. We randomized patients hospitalized for COVID-19 with fever to teprenone or no-teprenone groups in a 1:1 ratio. We stratified patients by sex, age < and ≥ 70 years and the existence (or not) of complications (hypertension, diabetes, ischemic heart disease, chronic pulmonary disease and active cancer). No limitation was imposed on other COVID-19 treatments. The primary endpoint was the intubation rate. RESULTS: One hundred patients were included, 51 in the teprenone and 49 in the no- teprenone groups. The intubation rate did not differ significantly between the two groups: 9.8% (5/51) vs. 2.0% (1/49) (sub-hazard ratio [SHR] 4.99, 95% confidence interval [CI]: 0.59-42.1; p = 0.140). The rates of intra-hospital mortality and intensive care unit (ICU) admission did not differ significantly between the two groups: intra-hospital mortality 3.9% (2/51) vs. 4.1% (2/49) (hazard ratio [HR] 0.78, 95%CI: 0.11-5.62; p = 0.809); ICU admission 11.8% (6/51) vs. 6.1% (3/49) (SHR 1.99, 95%CI: 0.51-7.80; p = 0.325). CONCLUSION: Teprenone afforded no clinical benefit. TRIAL REGISTRATION: Japan Registry of Clinical Trials jRCTs061200002 (registered on 20/May/2020).

DOI： 10.1371/journal.pone.0287501

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Frailty and all-cause and cause-specific mortality in Japan. Reviewed International journal

Rumi Matsuo, Naomi Matsumoto, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

Archives of gerontology and geriatrics   107   104906 - 104906   2022.12

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BACKGROUND: In aging societies, there is an increasing focus on the concept of frailty. However, there is no consistent means to assess this concept. We assessed frailty using the Kihon Checklist (KCL), which is widely used in Japan, and examined the association between frailty and all-cause and cause-specific mortality in Japan, the most aged society in the world. METHODS: This was a retrospective cohort study, and we analyzed 43,312 participants aged ≥ 65 years who were enrolled in basic health checkups in Okayama City, Japan. We defined the frailty status of the participants using the KCL. To assess the association of frailty status with all-cause and cause-specific mortality, we used cause-specific Cox proportional hazard models to estimate hazard ratios (HRs), adjusting for individual potential confounders. Mean follow-up time was 9.3 years. RESULTS: The fully adjusted HR for all-cause mortality was 1.34 (95% confidence interval [CI]: 1.27-1.41) for the prefrail group and 2.22 (95% CI: 2.11-2.33) for the frail group. A similar pattern was observed for cardiovascular disease, respiratory disease, and cancer mortality. Younger people (65-74 years) and women tended to have higher effect estimates than older people (≥ 75 years) and men. CONCLUSION: Prefrailty and frailty can increase the risk of both all-cause and cause-specific mortality. Our study suggests that to support frail patients, it could be effective to focus on the prevention and management of cardiovascular and respiratory disease, and that the KCL may be useful as a method of screening for frailty.

DOI： 10.1016/j.archger.2022.104906

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Correction to: Correlation between renal ablation zone in contrast‑enhanced CT and non‑enhanced MRI during the early period following percutaneous cryoablation. Reviewed

Noriyuki Umakoshi, Toshihiro Iguchi, Takao Hiraki, Yusuke Matsui, Koji Tomita, Mayu Uka, Soichiro Kajita, Motoo Araki, Toshiharu Mitsuhashi, Hideo Gobara, Susumu Kanazawa

Japanese journal of radiology   40 ( 12 )   1316 - 1316   2022.12

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DOI： 10.1007/s11604-022-01337-3

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岡山市の新型コロナウイルス感染症の各流行期における症状及び重症度の比較に関する記述分析研究

松尾 瑠美, 松本 尚美, 門脇 知花, 三橋 利晴, 高尾 総司, 頼藤 貴志

岡山医学会雑誌   134 ( 3 )   160 - 165   2022.12

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Language：Japanese   Publisher：岡山医学会  

2020年2月1日から2022年3月31日までに岡山市保健所にCOVID-19の発生届があった患者31037名を対象とし、流行期別に第3波～第6波に分け、症状、重症度、死亡割合などについて分析した。結果、症状のうち発熱の割合は各流行期とも約55%前後であった。デルタ株が流行した第5波では、それまでの流行期に比べて発熱や全身倦怠感、関節・筋肉痛、頭痛などの症状が強く、下痢などの消化器症状が比較的多くみられた。オミクロン株が流行した第6波では咽頭痛が50%と多かった。嗅覚・味覚障害は第3波では約7%で、その後は1～3%と低下傾向にあった。各流行期における中等症II以上の割合を年齢層別にみると、第4波までは60～70代で30%以上、80代以上で40%以上と高かったが、その後は低下傾向にあった。60～70代の死亡割合は第3波が最も高く2.1%で、その後は低下傾向にあった。80代以上の死亡割合は、第3・4波に12%前後と高く、第5波に2.3%と低下し、第6波に4.2%とやや上昇していた。

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Other Link： https://search.jamas.or.jp/default/link?pub_year=2022&ichushi_jid=J00175&link_issn=&doc_id=20221208190003&doc_link_id=10.4044%2Fjoma.134.160&url=https%3A%2F%2Fdoi.org%2F10.4044%2Fjoma.134.160&type=J-STAGE&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00007_2.gif

Do Complementary and Alternative Medicine Users Also Use Conventional Medicine? A Repeated Cross-Sectional Study in Japan from 1995 to 2013 Reviewed

Nobuyoshi Matsuki, Etsuji Suzuki, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

Journal of Integrative and Complementary Medicine   29 ( 2 )   119 - 126   2022.11

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：Mary Ann Liebert Inc  

DOI： 10.1089/jicm.2022.0631

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Other Link： https://www.liebertpub.com/doi/pdf/10.1089/jicm.2022.0631

Bilateral verses bilateral with tri-segmental endoscopic drainage using metal stents for high-grade malignant hilar biliary obstructions: A multicenter, randomized controlled trial: BRAVE study (BRAVE study). International journal

Kazuyuki Matsumoto, Toshiharu Mitsuhashi, Hirofumi Kawamoto, Etsuji Ishida, Masakuni Fujii, Yutaka Akimoto, Hiroyuki Seki, Yuki Ishihara, Taiji Ogawa, Tatsuhiro Yamazaki, Yuki Fujii, Hironari Kato

Medicine   101 ( 40 )   e30857   2022.10

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INTRODUCTION: Bilateral endoscopic drainage with self-expanding metallic stent (SEMS) can be used to manage hilar malignant biliary obstruction (HMBO) more effectively in comparison to unilateral drainage. An increased drainage area is predicted to prolong stent patency and patient survival. However, few reports have described the utility of trisegmental drainage and the benefits of using trisegmental drainage remain unknown. Thus, we launched a randomized clinical trial (RCT) to compare the clinical outcomes between bilateral and trisegmental drainage using SEMSs in patients with high-grade HMBO. METHODS AND ANALYSIS: This study was conducted as a multicenter randomized control trial (RCT) in 8 high-volume medical centers in Japan, and will prove the non-inferiority of bilateral drainage to trisegmental drainage. Patients with unresectable HMBO with Bismuth type IIIa or IV who pass the inclusion and exclusion criteria will be randomized to receive bilateral or trisegmental drainage at a 1:1 ratio. At each center, the on-site study investigators will obtain informed consent from the candidates, and will use an electronic data capture system (REDCap) to input necessary information, and register candidates with the registration secretariat. The primary endpoint is the rate of non-recurrent biliary obstruction (RBO) at 180 days after SEMSs placement. A -10% non-inferiority margin is assumed in the statistical analysis of the primary endpoint. Secondary endpoints include the rate of technical and clinical success, time to recurrent biliary obstruction (TRBO), causes of RBO, procedure-related adverse events (AEs), procedure time, TRBO with or without endoscopic sphincterotomy, overall survival, and the technical and clinical success rates at reintervention. DISCUSSION: If the non-inferiority of bilateral drainage is demonstrated, it is predicted that the procedure time will be shortened and the medical cost will be reduced, which will be beneficial to the patient and the medical economy. TRIAL REGISTRATION: Registered in Japan Registry of Clinical Trial-Registration (trial number. jRCTs062220038). This version number 1. Protocol dated Jun 23, 2022.

DOI： 10.1097/MD.0000000000030857

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Breastfeeding at 6 months of age had a positive impact on overweight and obesity in Japanese adolescents at 15 years of age

Tomoka Kadowaki, Naomi Matsumoto, Etsuji Suzuki, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

Acta Paediatrica   112 ( 1 )   106 - 114   2022.9

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DOI： 10.1111/apa.16551

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Examining the association between vaccine reactogenicity and antibody titer dynamics after the third dose of BNT162b2 vaccine using a mixed-effects model

Naomi Matsumoto, Hideharu Hagiya, Masanori Nakayama, Masanori Furukawa, Toshiharu Mitsuhashi, Soshi Takao, Fumio Otsuka, Takashi Yorifuji

Journal of Infection and Chemotherapy   2022.9

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Publishing type：Research paper (scientific journal)   Publisher：Elsevier BV  

DOI： 10.1016/j.jiac.2022.09.012

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Effects of Tanden Breathing on Constipation: A Randomized Controlled Trial.

Hiroshi Habu, Toshiharu Mitsuhashi, Akiko Tokinobu, Takashi Yorifuji, Soshi Takao

Acta medica Okayama   76 ( 4 )   391 - 398   2022.8

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Tanden breathing, an ancient health technique, involves expiratory abdominal pressure breathing is practiced in Japan. In this study we examined the ability of Tanden breathing to relieve constipation. The study was designed as a stratified-block randomized controlled trial enrolling 20 participants. Nineteen were female and one was male, none were elderly. During the 6-week intervention period, the participants performed video-guided Tanden breathing about 10 min once day. We evaluated constipation using the Constipation Assessment Scale (CAS). There were significant differences in the mean CAS score between time points (baseline, 3 weeks after baseline, 6 weeks after baseline), groups (intervention and control), and their interaction (time×group) using repeated-measures analysis of variance. The control group showed no change in the mean CAS score; the mean CAS scores of the intervention group changed from 7.2 at baseline to 3.9 at 3 weeks and 3.1 at 6 weeks after baseline. A regression analysis of the difference in the mean CAS between baseline and 6 weeks later showed that the CAS of the intervention group was 4.3 points lower than that of the control group (95% confidence interval, 2.5-6.1). The results suggested that Tanden breathing is effective in relieving constipation among young women.

DOI： 10.18926/AMO/63893

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Early enlarging cavitation after percutaneous radiofrequency ablation of lung tumors: Incidence, risk factors and outcome. International journal

Koji Tomita, Toshihiro Iguchi, Yusuke Matsui, Mayu Uka, Noriyuki Umakoshi, Toshiharu Mitsuhashi, Jun Sakurai, Hideo Gobara, Susumu Kanazawa, Takao Hiraki

Diagnostic and interventional imaging   103 ( 10 )   464 - 471   2022.5

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PURPOSE: The purpose of this study was to retrospectively determine the incidence of early enlarging cavitation after percutaneous radiofrequency ablation (RFA) of lung tumor and identify risk factors associated with their occurrence. PATIENTS AND METHODS: A total of 245 patients (140 men, 105 women; mean age, 62.7 ± 11.8 [SD] years; age range: 31-87 years) with 605 lung tumors who were treated using 401 RFA sessions from April 2010 to March 2020 were included. Of which, 31 patients with 38 early enlarging cavitation and control group (151 patients with 228 tumors) were analyzed. Early enlarging cavitation was defined as cavities with an enlarged size (>3 cm) occurring on ablated lesions within seven days after RFA. Incidence of cavitation, risk and post-procedural factors of occurrence, major adverse events (AEs) that occurred in RFA sessions with cavitation, and course of cavitation were evaluated. AEs were classified using the CIRSE classification system for complications. RESULTS: Thirty-eight cavities (6.3%, 38/605 tumors) in 31 patients occurred in an average of 3.1 ± 1.7 days (range, 1-7 days) after 32 RFA sessions. Distance from pleura ≥ 20 mm, contact with vessel ≥ 3 mm, multitined expandable electrode ≥ 3 cm, and bronchus ≥ 2 mm encompassed in the ablation zone were independent risk factors of occurrence. Fever ≥ 38.5 °C, white blood cell count ≥ 10,000/μl one day after RFA, and steroid therapy were independent post-procedural factors of occurrence. Twenty-four Grade 3 and two Grade 6 AEs occurred. Twenty-nine cavities disappeared within a mean duration of 111.9 ± 64.9 (SD) days (range: 44-274 days) and four remained with a mean follow-up of 279.2 ± 174 (SD) days; five patients were lost to follow-up. CONCLUSIONS: Early enlarging cavitation occurs in 6.3% of lung tumors treated with RFA and are associated with 26 major AEs in 32 sessions. Aforementioned procedural factors and post-procedural inflammation were significant risk factors of occurrence.

DOI： 10.1016/j.diii.2022.05.004

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Correlation between renal ablation zone in contrast-enhanced CT and non-enhanced MRI during the early period following percutaneous cryoablation.

Noriyuki Umakoshi, Toshihiro Iguchi, Takao Hiraki, Yusuke Matsui, Koji Tomita, Mayu Uka, Soichiro Kajita, Motoo Araki, Toshiharu Mitsuhashi, Hideo Gobara, Susumu Kanazawa

Japanese journal of radiology   40 ( 10 )   1087 - 1095   2022.5

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PURPOSE: To retrospectively evaluate and correlate the contrast-enhanced computed tomography (CECT) and non-enhanced magnetic resonance imaging (MRI) during the early period following renal cryoablation. MATERIALS AND METHODS: Both dynamic CECT and non-enhanced MRI were performed within 4 days following cryoablation in 34 renal tumors in 33 patients. The renal volumes of the unenhanced regions on dynamic CECT (nephrogenic phase, 4 mm thickness) and the regions with signal intensity changes on non-enhanced MRI (fat-suppressed T2-weighted image, 4 mm thickness) were evaluated. Fusion images of the axial, coronal, and sagittal sections of CECT and MRI images were created from the maximum cross-section of the renal tumor, and the match score of each image was visually evaluated on a 5-point scale. RESULTS: The mean renal volume of the unenhanced regions on CECT and those with signal intensity changes on non-enhanced MRI following cryoablation were 29.5 ± 19.9 cm3 (range, 4.3-97.4 cm3) and 30.7 ± 19.8 cm3 (range, 6.7-94.0 cm3), respectively; the difference between them was -1.17 cm3 (95% confidence interval [CI] -2.74, 0.40, P = 0.139). The Pearson's product-moment correlation coefficient (r = 0.975; 95% CI, 0.951, 0.988; P < 0.0001) showed a strong correlation between the volumes. The average match score between CECT and non-enhanced MRI was as high as 4.5 ± 0.5 points (radiologist 1, 4.3 ± 0.5; radiologist 2, 4.7 ± 0.5). Local tumor control rate was 94.1% (32/34 tumors) and recurrence-free survival rate was 82.0% (95% CI: 64.2%, 91.5%) at 5 years. CONCLUSIONS: The region with signal intensity changes on non-enhanced MRI was strongly correlated with the unenhanced region on CECT during the early period following renal cryoablation.

DOI： 10.1007/s11604-022-01285-y

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Resection depth for small colorectal polyps comparing cold snare polypectomy, hot snare polypectomy and underwater endoscopic mucosal resection. International journal

Junki Toyosawa, Yasushi Yamasaki, Tsuyoshi Fujimoto, Shouichi Tanaka, Takehiro Tanaka, Toshiharu Mitsuhashi, Hiroyuki Okada

Endoscopy international open   10 ( 5 )   E602-E608   2022.5

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Background and study aims  Small colorectal polyps are removed by various methods, including cold snare polypectomy (CSP), hot snare polypectomy (HSP), and underwater endoscopic mucosal resection (UEMR), but the indications for using these methods are unclear. We retrospectively assessed the efficacy of CSP, HSP, and UEMR for small polyps, focusing on the depth of the resected specimens. Patients and methods  Outpatients with non-pedunculated small polyps (endoscopically diagnosed as 6 to 9 mm), resected by two endoscopists between July 2019 and September 2020, were enrolled. We histologically evaluated the specimens resected via CSP, HSP, and UEMR. The main outcome was the containment rate of the muscularis mucosa (MM) and submucosa (SM) tissues. Results  Forty polyps resected via CSP (n = 14), HSP (n = 12), or UEMR (n = 14) were enrolled after excluding 13 polyps with resection depths that were difficult to determine. The rates of specimens containing MM and SM tissue differed significantly (57 % and 29 % for CSP, 92 % and 83 % for HSP, and 100 % and 100 % for UEMR, respectively ( P  = 0.005 for MM and P  < 0.001 for SM tissue). Multiple logistic regression analysis showed UEMR was an independent factor relating to the containment of SM tissue. The thickness of SM tissue by CSP, HSP, and UEMR were 52 μm, 623 μm, and 1119 μm, respectively ( P  < 0.001). The thickness by CSP was significantly less than those by HSP and UEMR ( P  < 0.001, Bonferroni correction). Conclusions  UEMR could be the best method to contain SM tissue without injection. Further studies are needed to evaluate the indication of UEMR for small polyps.

DOI： 10.1055/a-1785-8616

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Nonrecurrence Rate of Underwater EMR for ≤20-mm Nonampullary Duodenal Adenomas: A Multicenter Prospective Study (D-UEMR Study)

Yasushi Yamasaki, Noriya Uedo, Takuji Akamatsu, Tomo Kagawa, Reiji Higashi, Osamu Dohi, Masanori Furukawa, Yu Takahashi, Takuya Inoue, Shouichi Tanaka, Ryuta Takenaka, Mikitaka Iguchi, Takuji Kawamura, Takao Tsuzuki, Tomoaki Yamasaki, Takeshi Yamashina, Junichiro Nasu, Tomohiko Mannami, Atsushi Yamauchi, Kazuhiro Matsueda, Shigeyuki Aizawa, Toshiharu Mitsuhashi, Hiroyuki Okada, Hiromitsu Kanzaki, Shuntaro Inoue, Muneaki Miyake, Masayasu Ohmori, Yoji Takeuchi, Yasuhiro Tani, Nobuyuki Harada, Nobukazu Agatsuma, Keijirou Okada, Maiko Ikenouchi, Yasuki Nakatani, Yoshito Uenoyama, Yukitaka Yamashita, Shigenao Ishikawa, Tomoki Inaba, Koji Miyahara, Yuki Moritou, Masahiro Nakagawa, Hiroaki Kitae, Tsugitaka Ishida, Yuji Naito, Akiyoshi Nishio, Masaaki Shimatani, Ryo Kato, Shinya Taki, Koichiro Mandai, Kasumi Sanada, Kojiro Nakase, Hiroko Nebiki, Shunsuke Saito, Toshiyuki Wakatsuki, Naoyuki Nishimura

Clinical Gastroenterology and Hepatology   20 ( 5 )   1010 - 1018.e3   2022.5

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Background and aims: Endoscopic resection of nonampullary duodenal adenoma is often challenging, and its technique has not yet been standardized. To overcome the practical difficulty of conventional endoscopic mucosal resection, underwater endoscopic mucosal resection (UEMR) was recently developed; therefore, we investigated the effectiveness and safety of UEMR for nonampullary duodenal adenoma. Methods: A multicenter, prospective cohort study was conducted at 21 institutions in Japan. We enrolled patients with no more than 2 nonampullary duodenal adenomas ≤20 mm in size, who were planned to undergo UEMR. After UEMR, follow-up endoscopies were scheduled at 2 and 12 months after the procedure, and biopsy specimens were taken from the post-UEMR scars. The primary endpoint was the proportion of patients with histologically proven nonrecurrence at follow-up endoscopy and biopsy. Results: A total of 155 patients with 166 lesions underwent UEMR. One patient with a non-neoplastic lesion in the resected specimen and 10 patients with 10 lesions who were lost to follow-up were excluded. Finally, 144 patients with 155 lesions who received all follow-up endoscopies were analyzed for the primary endpoint. The proportion of patients with proven nonrecurrence was 97.2% (n = 140 of 144; 95% confidence interval, 92.8%–99.1%) which exceeded the predefined threshold value (92%). Two cases of delayed bleeding (1.2%) occurred and they were successfully managed by clips. All recurrences were successfully treated by additional endoscopic treatment. Conclusions: This multicenter, prospective cohort study demonstrated effectiveness and safety of UEMR for nonampullary duodenal adenomas ≤20 mm in size. (University Hospital Medical Network Clinical Trials Registry, Number: UMIN000030414).

DOI： 10.1016/j.cgh.2021.06.043

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Report on adverse reactions to novel coronavirus vaccines

Matsumoto Naomi, Higuchi Chigusa, Mitsuhashi Toshiharu, Hagiya Hideharu, Takao Soshi, Yorifuji Takashi

Okayama Igakkai Zasshi (Journal of Okayama Medical Association)   134 ( 1 )   35 - 42   2022.4

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Language：Japanese   Publisher：Okayama Medical Association  

DOI： 10.4044/joma.134.35

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Effect of mRNA Vaccines in Preventing COVID-19 Severe Pneumonia Among COVID-19 Patients in Japan

Rumi Matsuo, Naomi Matsumoto, Tomoka Kadowaki, Toshiharu Mitsuhashi, Soshi Takao, Takashi Yorifuji

Journal of Epidemiology   32 ( 3 )   151 - 152   2022.3

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Publishing type：Research paper (scientific journal)   Publisher：Japan Epidemiological Association  

DOI： 10.2188/jea.je20210487

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Causal Effect of the Tokyo 2020 Olympic and Paralympic Games on the Number of COVID-19 Cases under COVID-19 Pandemic: An Ecological Study Using the Synthetic Control Method Reviewed

Norio Yamamoto, Toshiharu Mitsuhashi, Yuuki Tsuchihashi, Takashi Yorifuji

Journal of Personalized Medicine   12 ( 2 )   209 - 209   2022.2

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：MDPI AG  

Previous studies have not assessed the causal effect of the Olympic Games on the spread of pandemics. Using the synthetic control method and the national public city data in Japan recorded from February to September 2021, we estimated the causal effects of the Tokyo 2020 Olympic and Paralympic Games on the number of coronavirus disease 2019 (COVID-19) cases. The difference between the number of COVID-19 cases in Tokyo and a counterfactual “synthetic Tokyo” (created using synthetic control method) after the opening of the Tokyo 2020 Games (23 July 2021) widened gradually and then considerably over time. It was predicted that the Tokyo 2020 Games increased the number of COVID-19 cases in Tokyo by approximately 469.4 per 100,000 population from the opening of the event to 30 September. However, sensitivity analysis of the ratio of the pre- and post-game root mean square prediction errors using regression weights did not suggest robustness. Our results showed that the Tokyo 2020 Games probably increased the number of COVID-19 cases even under preventive regulations; however, the extent of this increase was difficult to estimate clearly due to an overlap with the fifth wave associated with the Delta variant.

DOI： 10.3390/jpm12020209

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In Vivo Microwave Ablation of Normal Swine Lung at High-power, Short-duration Settings.

Toshihiro Iguchi, Takao Hiraki, Yusuke Matsui, Tomohiro Toji, Mayu Uka, Koji Tomita, Toshiyuki Komaki, Noriyuki Umakoshi, Toshiharu Mitsuhashi, Susumu Kanazawa

Acta medica Okayama   76 ( 1 )   57 - 62   2022.2

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To evaluate the volume and heat-sink effects of microwave ablation (MWA) in the ablation zone of the normal swine lung. MWA at 100 W was performed for 1, 2, and 3 min in 7, 5, and 5 lung zones, respectively. We assessed the histopathology in the ablation zones and other outcome measures: namely, length of the longest long and short axes, sphericity, ellipsoid area, and ellipsoid volume. The mean long- and short-axis diameters were 22.0 and 14.1 mm in the 1-min ablation zone, 27.6 and 20.2 mm in the 2-min ablation zone; and 29.2 and 21.2 mm in the 3-min ablation zone, respectively. All measures, except sphericity, were significantly less with 1-min ablation than with either 2- or 3-min ablation. There were no significant differences between the 2- and 3-min ablation zones, but all measures except sphericity were larger with 3-min ablation. Although there were no blood vessels that resulted in a heat-sink effect within the ablation zones, the presence of bronchi nearby in 5 lung ablation zones resulted in reduced ablation size. In high-power, short-duration MWA, the lung ablation volume was affected by ablation time. Some ablations showed that a heat-sink effect by a neighboring bronchus might occur.

DOI： 10.18926/AMO/63212

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Adverse reactions and attitudes toward vaccines among young populations one month after receiving a second dose of mRNA-1273 in Japan

Naomi Matsumoto, Chigusa Higuchi, Toshiharu Mitsuhashi, Hideharu Hagiya, Soshi Takao, Takashi Yorifuji

Global Health &amp; Medicine   4 ( 2 )   141 - 143   2022

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Publishing type：Research paper (scientific journal)   Publisher：National Center for Global Health and Medicine (JST)  

DOI： 10.35772/ghm.2021.01125

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Effects of Tanden Breathing on Constipation: A Randomized Controlled Trial

Hiroshi Habu, Toshiharu Mitsuhashi, Akiko Tokinobu, Takashi Yorifuji, Soshi Takao

Acta Medica Okayama   76 ( 4 )   391 - 398   2022

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Publishing type：Research paper (scientific journal)  

Tanden breathing, an ancient health technique, involves expiratory abdominal pressure breathing is practiced in Japan. In this study we examined the ability of Tanden breathing to relieve constipation. The study was designed as a stratified-block randomized controlled trial enrolling 20 participants. Nineteen were female and one was male, none were elderly. During the 6-week intervention period, the participants performed video-guided Tanden breathing about 10 min once day. We evaluated constipation using the Constipation Assessment Scale (CAS). There were significant differences in the mean CAS score between time points (baseline, 3 weeks after baseline, 6 weeks after baseline), groups (intervention and control), and their interaction (time×group) using repeated-measures analysis of variance. The control group showed no change in the mean CAS score; the mean CAS scores of the intervention group changed from 7.2 at baseline to 3.9 at 3 weeks and 3.1 at 6 weeks after baseline. A regression analysis of the difference in the mean CAS between baseline and 6 weeks later showed that the CAS of the intervention group was 4.3 points lower than that of the control group (95% confidence interval, 2.5-6.1). The results suggested that Tanden breathing is effective in relieving constipation among young women.

DOI： 10.18926/AMO/63893

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A single-center, single-arm, prospective, open-label trial to evaluate the efficacy and safety of percutaneous sclerotherapy with polidocanol for painful venous malformations (SCIRO-2001): study protocol Reviewed

Mayu Uka, Jun Sakurai, Yusuke Matsui, Toshihiro Iguchi, Koji Tomita, Noriyuki Umakoshi, Kazuaki Munetomo, Toshiharu Mitsuhashi, Hideo Gobara, Takao Hiraki

Nagoya J. Med. Sci. 84. 746–751, 2022   2021.12

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DOI： 10.18999/nagjms.84.4.746

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Trajectory of body mass index and height changes from childhood to adolescence: a nationwide birth cohort in Japan. International journal

Naomi Matsumoto, Toshihide Kubo, Kazue Nakamura, Toshiharu Mitsuhashi, Akihito Takeuchi, Hirokazu Tsukahara, Takashi Yorifuji

Scientific reports   11 ( 1 )   23004 - 23004   2021.11

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To investigate the dynamics of body mass index (BMI) and height changes in childhood leading to obesity in adolescents. BMI Z-scores were calculated using the LMS (lambda-mu-sigma) method based on yearly height and weight information (age 1.5-15 years) from a nationwide Japanese birth cohort that started in 2001 (n = 26,711). We delineated the trajectories of BMI and height changes leading to obesity at age 15 years using mixed effect models. Children who became obese at the age of 15 years kept relatively high BMI z-scores through childhood for both genders, and had an increasing trend over time as opposed to the normal weight group, with an increasing slope during puberty. Early adiposity rebound was associated with overweight or obesity at the age of 15 years. Age at peak height velocity (APHV) occurred earlier in the obese/overweight group at age 15 years than in the normal weight group, and occurred later in the underweight group. Obese adolescents experienced early adiposity rebound timing and maintained a serial BMI z-score increase throughout childhood, with a greater slope at puberty. An earlier peak in height gain during puberty may have contributed to the observed patterns of BMI change.

DOI： 10.1038/s41598-021-02464-z

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The Impact of KRAS Mutation in Patients With Sporadic Nonampullary Duodenal Epithelial Tumors. International journal

Hideaki Kinugasa, Hiromitsu Kanzaki, Takehiro Tanaka, Shumpei Yamamoto, Yasushi Yamasaki, Kazuhiro Nouso, Kouichi Ichimura, Masahiro Nakagawa, Toshiharu Mitsuhashi, Hiroyuki Okada

Clinical and translational gastroenterology   12 ( 11 )   e00424   2021.11

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INTRODUCTION: The genomic characterization of primary nonampullary duodenal adenocarcinoma indicates a genetic resemblance to gastric and colorectal cancers. However, a correlation between the clinical and molecular characteristics of these cancers has not been established. This study aimed to elucidate the clinicopathological features of sporadic nonampullary duodenal epithelial tumors, including their molecular characteristics and prognostic factors. METHODS: One hundred forty-eight patients with sporadic nonampullary duodenal epithelial tumors were examined in this study. Patient sex, age, TNM stage, tumor location, treatment methods, histology, KRAS mutation, BRAF mutation, Fusobacterium nucleatum, mucin phenotype, and programmed death-ligand 1 (PD-L1) status were evaluated. KRAS and BRAF mutations, Fusobacterium nucleatum, mucin phenotype, and PD-L1 status were analyzed by direct sequencing, quantitative polymerase chain reaction, and immunochemical staining. RESULTS: The median follow-up duration was 119.4 months. There were no deaths from duodenal adenoma (the primary disease). Kaplan-Meier analysis for duodenal adenocarcinoma showed a significant effect of TNM stage (P < 0.01). In univariate analysis of primary deaths from duodenal adenocarcinoma, TNM stage II or higher, undifferentiated, KRAS mutations, gastric phenotype, intestinal phenotype, and PD-L1 status were significant factors. In multivariate analysis, TNM stage II or higher (hazard ratio: 1.63 × 1010, 95% confidence interval: 18.66-6.69 × 1036) and KRAS mutation (hazard ratio: 3.49, confidence interval: 1.52-7.91) were significant factors. DISCUSSION: Only KRAS mutation was a significant prognostic factor in primary sporadic nonampullary duodenal adenocarcinoma in cases in which TNM stage was considered.

DOI： 10.14309/ctg.0000000000000424

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COVID-19に対応した看護師の不安・看護上の課題の計量テキスト分析による探索

三橋 利晴, 坂本 陽子

日本公衆衛生学会総会抄録集   80回   306 - 306   2021.11

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Impact of lymph node dissection on clinical outcomes of intrahepatic cholangiocarcinoma: inverse probability of treatment weighting with survival analysis.

Yuzo Umeda, Toshiharu Mitsuhashi, Toru Kojima, Daisuke Satoh, Kenta Sui, Yoshikatsu Endo, Masaru Inagaki, Masahiro Oishi, Takahito Yagi, Toshiyoshi Fujiwara

Journal of hepato-biliary-pancreatic sciences   2021.9

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BACKGROUND: Lymph node metastasis (LNM) has been established as a critical risk factor for prognosis in intrahepatic cholangiocarcinoma (ICC). The clinical implications of lymph-node dissection (LND) have been debated. This study aimed to clarify the prognostic impact of LND by multicenter-retrospective analysis. METHODS: A total of 310 ICC patients who had undergone curative resection between 2000 and 2016 were retrospectively analyzed. The prognostic impact of LND was estimated under an inverse probability of treatment weighting (IPTW) approach using propensity scores. RESULTS: LND was performed for 224 patients (72%), with LNM pathologically confirmed in 90 patients (40%). Prognosis was poorer for patients with LNM (median survival, 16.9 months) than for those without (57.2 months; p<0.0001). One-, 3-, and 5-year overall survival rates (OS) were comparable among the LND+ (81.6%, 48.0%, and 37.5%, respectively) and the LND- groups (81.6%, 55.4%, and 44.6%, respectively). However, advanced tumor, as characterized by larger tumor, multinodular lesions, and serosal invasion, was significantly more frequent in the LND+ group than in the LND- group. After IPTW adjusting for imbalances, 1-, 3-, and 5-year OS were better in the LND+ group (83.5%, 52.2%, and 42.8%, respectively) than in the LND- group (71.9%, 32.4%, and 23.4%, respectively; p=0.046). LND thus showed significant prognostic impact (hazard ratio = 0.58, 95%CI = |0.39|-|0.84|, p=0.005). Especially in hilar ICC, LND showed significant prognostic impact. However, peripheral ICC displayed no therapeutic benefit from LND. CONCLUSIONS: LND could have significant role to improve oncologic outcomes. Therapeutic LND should be implemented on the basis of tumor location and tumor advancement.

DOI： 10.1002/jhbp.1038

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Early childhood exposure to maternal smoking and behavioral development. Reviewed International journal

Makiko Ariyoshi, Toshiharu Mitsuhashi, Naomi Matsumoto, Kazue Nakamura, Takashi Yorifuji

Archives of environmental & occupational health   1 - 8   2021.8

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We examined the association between early childhood exposure to maternal smoking and behavioral issues at 8 years old using a large nationwide population-based longitudinal survey in Japan that began in 2001. We included 46,737 children with information about maternal smoking taken from the 6-month survey. We used logistic regression analysis to examine the hypothesis. Early childhood exposure to maternal smoking increased the risk of behavioral problems related to attention and aggressive or disruptive behavior. The adjusted odds ratios (95% confidence intervals) were 1.37 (1.22-1.54) for inability to wait their turn during play and 1.40 (1.27-1.55) for destroying toys and, compared with children of nonsmoking mothers. Children of mothers who were heavy smokers were more likely to develop behavioral problems than others. Stopping early childhood exposure to maternal exposure can protect children's neurodevelopment.

DOI： 10.1080/19338244.2021.1972278

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Effectiveness of supplemental oral calcium drink in preventing citrate-related adverse effects in peripheral blood progenitor cell collection. International journal

Keiko Fujii, Nobuharu Fujii, Takumi Kondo, Toshiharu Mitsuhashi, Makoto Nakamura, Keisuke Seike, Yasuhisa Sando, Maiko Kimura, Masayuki Matsuda, Shuntaro Ikegawa, Hiroyuki Sugiura, Fumio Otsuka, Yoshinobu Maeda

Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis   60 ( 4 )   103147 - 103147   2021.8

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：PERGAMON-ELSEVIER SCIENCE LTD  

Peripheral blood progenitor cells (PBPCs) are a predominant graft source in allogeneic hematopoietic cell transplantation. Citrate-induced hypocalcemia remains the most frequent side effect of PBPC apheresis. Although the method for preventing severe adverse events is established, more efficient prophylaxis is required so that volunteer donors can donate PBPCs without pain and anxiety. We studied 80 healthy donors who underwent PBPC harvest between February 2014 and June 2020. Of these, 23 donors who underwent apheresis between February 2014 and December 2015 received only the standard prophylaxis of intravenous calcium gluconate. Oral calcium drinks were provided to 57 donors who underwent apheresis from January 2016 to June 2020 to supplement intravenous calcium gluconate prophylaxis. The ionized calcium (ICa) levels at multiple time intervals and the hypocalcemic symptoms were evaluated. Oral supplementation with a calcium drink maintained significantly higher ICa levels. Analysis using the inverse probability weighted regression adjustment method suggested that calcium drinks reduced the frequency of citrate-related reactions by 39.2 %. Administering a prophylactic oral calcium drink before apheresis with intravenous administration of calcium gluconate is promising to further reduce citrate-induced hypocalcemia in volunteer donors.

DOI： 10.1016/j.transci.2021.103147

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Randomized trial comparing the 25G and 22G Franseen needles in endoscopic ultrasound‐guided tissue acquisition from solid pancreatic masses for adequate histological assessment

Takeshi Tomoda, Hironari Kato, Yuuki Fujii, Tatsuhiro Yamazaki, Kazuyuki Matsumoto, Shigeru Horiguchi, Koichiro Tsutsumi, Hirofumi Inoue, Takehiro Tanaka, Toshiharu Mitsuhashi, Hiroyuki Okada

Digestive Endoscopy   2021.7

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DOI： 10.1111/den.14079

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Alcohol Consumption and Age-related Macular Degeneration: A Systematic Review and Dose-response Meta-analysis. International journal

Jingjing Zhang, Toshiharu Mitsuhashi, Toshihiko Matsuo, Takashi Yorifuji, Jun Hamada, Yangyang Liu

Current eye research   1 - 8   2021.6

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Purpose: To perform a systematic review on the association between alcohol consumption and risk of age-related macular degeneration (AMD) using a meta-analytical approach.Method: Systematic literature research was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Both categorical and dose-response meta-analysis was performed separately for early and late AMD. A fixed-effect model was used to calculate pooled effect estimates with 95% confidence interval (CI).Result: Seven studies were included in the analysis with 4,566 and 440 cases of early and late AMD, respectively. Compared to the nondrinkers or occasional drinkers, the pooled effect estimates for early AMD with moderate (1.19, 95% CI [1.03-1.37]) and heavy (1.24, [1.10-1.39]) alcohol consumption, but not light (0.95, [0.90-1.06]) alcohol consumption, were statistically significant. However, the pooled effect estimates for late AMD with light (1.03, [0.79-1.33]), moderate (1.13, [0.83-1.55]), and heavy (0.98, [0.63-1.53]) alcohol consumption were found to be insignificant. A linear dose-response relationship was established (P < .05) between alcohol consumption and risk of early AMD, and the pooled effect estimate for an increase in alcohol consumption of 10 g/day was 1.14 (1.08-1.21).Conclusion: Moderate and heavy alcohol consumption could increase the risk of early AMD, but not late AMD, with a linear dose-response relationship.

DOI： 10.1080/02713683.2021.1942070

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Accreditation as a qualified surgeon improves surgical outcomes in laparoscopic distal gastrectomy.

Satoru Kikuchi, Tetsuya Kagawa, Shinji Kuroda, Masahiko Nishizaki, Nobuo Takata, Kazuya Kuwada, Ryohei Shoji, Yoshihiko Kakiuchi, Toshiharu Mitsuhashi, Yuzo Umeda, Kazuhiro Noma, Shunsuke Kagawa, Toshiyoshi Fujiwara

Surgery today   51 ( 12 )   1978 - 1984   2021.5

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PURPOSE: The Endoscopic Surgical Skill Quantification System for qualified surgeons (QSs) was introduced in Japan to improve surgical outcomes. This study reviewed the surgical outcomes after initial experience performing laparoscopic distal gastrectomy (LDG) and evaluated the improvement in surgical outcomes following accreditation as a QS. METHODS: Eighty-seven consecutive patients who underwent LDG for gastric cancer by a single surgeon were enrolled in this study. The cumulative sum method was used to analyze the learning curve for LDG. The surgical outcomes were evaluated according to the two phases of the learning curve (learning period vs. mastery period) and accreditation (non-QS period vs. QS period). RESULTS: The learning period for LDG was 48 cases. Accreditation was approved at the 67th case. The operation time and estimated blood loss were significantly reduced in the QS period compared to the non-QS period (230 vs. 270 min, p < 0.001; 20.5 vs. 59.8 ml, p = 0.024, respectively). Furthermore, the major complication rate was significantly lower in the QS period than in the non-QS period (0 vs. 10.6%, p = 0.044). CONCLUSIONS: Experience performing approximately 50 cases is required to reach proficiency in LDG. After receiving accreditation as a QS, the surgical outcomes, including the complication rate, were improved.

DOI： 10.1007/s00595-021-02309-2

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Leucine-rich alpha-2 glycoprotein as a marker of mucosal healing in inflammatory bowel disease. International journal

Eriko Yasutomi, Toshihiro Inokuchi, Sakiko Hiraoka, Kensuke Takei, Shoko Igawa, Shumpei Yamamoto, Masayasu Ohmori, Shohei Oka, Yasushi Yamasaki, Hideaki Kinugasa, Masahiro Takahara, Keita Harada, Masaki Furukawa, Kouichi Itoshima, Ken Okada, Fumio Otsuka, Takehiro Tanaka, Toshiharu Mitsuhashi, Jun Kato, Hiroyuki Okada

Scientific reports   11 ( 1 )   11086 - 11086   2021.5

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：NATURE RESEARCH  

Leucine-rich alpha-2 glycoprotein (LRG) may be a novel serum biomarker for patients with inflammatory bowel disease. The association of LRG with the endoscopic activity and predictability of mucosal healing (MH) was determined and compared with those of C-reactive protein (CRP) and fecal markers (fecal immunochemical test [FIT] and fecal calprotectin [Fcal]) in 166 ulcerative colitis (UC) and 56 Crohn's disease (CD) patients. In UC, LRG was correlated with the endoscopic activity and could predict MH, but the performance was not superior to that of fecal markers (areas under the curve [AUCs] for predicting MH: LRG: 0.61, CRP: 0.59, FIT: 0.75, and Fcal: 0.72). In CD, the performance of LRG was equivalent to that of CRP and Fcal (AUCs for predicting MH: LRG: 0.82, CRP: 0.82, FIT: 0.70, and Fcal: 0.88). LRG was able to discriminate patients with MH from those with endoscopic activity among UC and CD patients with normal CRP levels. LRG was associated with endoscopic activity and could predict MH in both UC and CD patients. It may be particularly useful in CD.

DOI： 10.1038/s41598-021-90441-x

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The Effect of Peer Instruction Lectures on Learning Attitudes in Epidemiology Education.

Toshiharu Mitsuhashi

Acta medica Okayama   75 ( 5 )   601 - 609   2021

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Research suggests that the fundamental concepts of epidemiology cannot be sufficiently learned in traditional lectures, and interactive learning is necessary. However, few studies have investigated interactive epidemiology education in general, or peer instruction (PI) in particular. This study investigated the effect of PI. Study par-ticipants were fourth-year medical students. The attitude of participants in regard to PI learning was examined in a non-PI and a PI group. The Survey of Attitudes Toward Statistics (SATS) (containing six sub-categories) was conducted as a learning-attitudes index. The pre- and post-lecture scores were compared between the non-PI and PI groups using double robust (DR) estimation. The non-PI and PI groups consisted of 20 and 121 student participants, respectively. In DR estimation, affect exhibited the lowest SATS score changes, at -0.51 (95% confidence interval -0.78 to -0.24; p-value < 0.001), whereas effort exhibited the highest score changes of 0.01 (95% confidence interval -0.30 to 0.32; p-value = 0.952). The epidemiology lecture with PI did not increase the SATS scores. This might be due to issues related to the experimental design. Further research investigating the effects of interactive epidemiology education, it will be necessary to develop tools for assessing the learning of epidemiological concepts and to improve the research design.

DOI： 10.18926/AMO/62773

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Evaluation of complete cold forceps polypectomy resection rate for 3- to 5-mm colorectal polyps. International journal

Yasushi Yamasaki, Keita Harada, Shumpei Yamamoto, Eriko Yasutomi, Mami Hirai, Masayasu Ohmori, Shohei Oka, Toshihiro Inokuchi, Hideaki Kinugasa, Yuusaku Sugihara, Masahiro Takahara, Sakiko Hiraoka, Takehiro Tanaka, Toshiharu Mitsuhashi, Hiroyuki Okada

Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society   2020.11

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BACKGROUND AND STUDY AIMS: The propriety of cold forceps polypectomy (CFP) using jumbo biopsy forceps for diminutive polyps remains controversial. We conducted a prospective study to evaluate the complete CFP resection rate of 3-5-mm polyps using additional endoscopic mucosal resection (EMR) specimens following CFP. PATIENTS AND METHODS: Patients with 3-5-mm protruded or flat elevated colorectal polyps diagnosed endoscopically as adenomas or serrated lesions were prospectively enrolled. CFP using jumbo biopsy forceps was used to remove the eligible polyps and repeated until the absence of residuals were confirmed via image-enhanced endoscopy or chromoendoscopy. After CFP, saline was injected at the defect, and the marginal specimen of the defect was resected using EMR to histologically evaluate the residue. The primary outcome was the complete CFP resection rate, which was defined as no residue at the EMR site. Other outcomes were the number of CFP bites and the complete resection rate by lesion size. RESULTS: Eighty patients with 120 polyps were enrolled. The mean polyp size was 4.1 ± 0.7 mm. The overall complete resection rate was 96.7% (95% confidence interval [CI], 91.7-98.7), and the rates for 3-, 4- and 5-mm polyps were 100% (95% CI, 86.7-100), 96.0% (95% CI, 86.5-98.9) and 95.5% (95% CI, 85.1-98.8), respectively. The one-bite CFP rates were 92%, 60% and 31% for the 3-, 4- and 5-mm polyps, respectively. CONCLUSIONS: The complete CFP resection rate for 3-5-mm polyps was acceptable, although the one-bite clearance rate decreased as the polyp size increased (UMIN000028841).

DOI： 10.1111/den.13895

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Survival Outcomes of Treatment with Radiofrequency Ablation, Stereotactic Body Radiotherapy, or Sublobar Resection for Patients with Clinical Stage I Non-Small-Cell Lung Cancer: A Single-Center Evaluation. Reviewed International journal

Toshihiro Iguchi, Takao Hiraki, Yusuke Matsui, Toshiharu Mitsuhashi, Norihisa Katayama, Kuniaki Katsui, Junichi Soh, Jun Sakurai, Hideo Gobara, Shinichi Toyooka, Susumu Kanazawa

Journal of vascular and interventional radiology : JVIR   31 ( 7 )   1044 - 1051   2020.7

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PURPOSE: To retrospectively compare the outcomes of radiofrequency (RF) ablation, stereotactic body radiotherapy (SBRT), and sublobar resection (SLR) in patients with stage I non-small-cell lung cancer (NSCLC) at a single center. MATERIALS AND METHODS: Overall, 289 patients (38 RF ablation, 58 SBRT, and 193 SLR) were included. Kaplan-Meier curves were generated, multiple propensity score was estimated using a multinomial logistic regression model, and relationships between treatments and outcomes were assessed using a Cox proportional hazard model. Hazard ratios (HRs) for death from any cause and disease progression or death from any cause were examined by a crude model, an inverse probability of treatment weighting (IPTW) model, and an IPTW model adjusted for missing variables. RESULTS: The 5-year overall and progression-free survival rates were 58.9% and 39.9%, respectively, for RF ablation; 42.0% and 34.9%, respectively, for SBRT; and 85.5% and 75.9%, respectively, for SLR. Significantly longer survival time and lower HR were observed for SLR than other treatments. However, after statistical adjustment, these relationships were not significant except for reduced HR of disease progression or death from any cause of SLR compared to RF ablation in the IPTW model. The median hospital stays for RF ablation, SBRT, and SLR were 6.5, 6, and 16 days, respectively. Adverse events of grade 3 or higher occurred only in 11 SLR cases. CONCLUSIONS: SLR achieved the longest survival. However, after statistical adjustment, there were no significant outcome differences among RF ablation, SBRT, and SLR, except for 1 model. RF ablation or SBRT may be alternative treatments for selected patients with early-stage NSCLC.

DOI： 10.1016/j.jvir.2019.11.035

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Difference in specimen weights with semi-automatic cutting biopsy needles. Reviewed

Toshihiro Iguchi, Takao Hiraki, Yusuke Matsui, Toshiharu Mitsuhashi, Toshiyuki Komaki, Soichiro Okamoto, Shogo Fukuma, Koji Tomita, Mayu Uka, Susumu Kanazawa

Japanese journal of radiology   38 ( 6 )   579 - 586   2020.6

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PURPOSE: To assess specimen weight difference of six types of semi-automatic cutting biopsy needles. MATERIALS AND METHODS: We compared 18- and 20-gauge needles, one aspiration-type (STARCUT® aspiration-type, TSK Laboratory, Tochigi, Japan) and five non-aspiration-type (MISSION®, BARD, AZ; SuperCore™, Argon Medical Devices, TX; Temno Evolution®, Care Fusion, IL; FINE CORE®, Toray Medical, Tokyo, Japan; Quick-Core®, Cook, IN) needles. Four biopsies were performed with each needle with the longest throw length on an excised bovine liver. The biopsies were repeated with new needles, four times with four different livers. STARCUT® was used both with and without aspiration. RESULTS: Sixteen specimens were obtained with each needle. In needles of gauges, STARCUT® with aspiration provided the heaviest specimen and significantly heavier specimens were obtained with STARCUT® with aspiration (P < 0.05) than five non-aspiration-type needles. The specimen weight differed significantly (P < 0.001) among all 18- and 20-gauge needles. The specimen weights did not differ significantly between aspiration and non-aspiration biopsies with STARCUT® (6.32 vs. 5.97 mg with 18-gauge needle, P = 0.342; 1.95 vs. 1.92 mg with 20-gauge needle, P = 0.886). CONCLUSION: Although STARCUT® with aspiration provided the heaviest specimen, specimen weights were not significantly different between aspiration and non-aspiration biopsies. We assessed the specimen weight difference of six types of semi-automatic cutting biopsy needles. Significantly heavier specimens were obtained with STARCUT® with aspiration than the other needles. The specimen weight differed significantly among all 18- and 20-gauge needles but did not differ significantly between aspiration and non-aspiration biopsies with STARCUT®.

DOI： 10.1007/s11604-020-00935-3

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Robotic CT-guided out-of-plane needle insertion: comparison of angle accuracy with manual insertion in phantom and measurement of distance accuracy in animals. Reviewed International journal

Toshiyuki Komaki, Takao Hiraki, Tetsushi Kamegawa, Takayuki Matsuno, Jun Sakurai, Ryutaro Matsuura, Takuya Yamaguchi, Takanori Sasaki, Toshiharu Mitsuhashi, Soichiro Okamoto, Mayu Uka, Yusuke Matsui, Toshihiro Iguchi, Hideo Gobara, Susumu Kanazawa

European radiology   30 ( 3 )   1342 - 1349   2020.3

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OBJECTIVES: To evaluate the accuracy of robotic CT-guided out-of-plane needle insertion in phantom and animal experiments. METHODS: A robotic system (Zerobot), developed at our institution, was used for needle insertion. In the phantom experiment, 12 robotic needle insertions into a phantom at various angles in the XY and YZ planes were performed, and the same insertions were manually performed freehand, as well as guided by a smartphone application (SmartPuncture). Angle errors were compared between the robotic and smartphone-guided manual insertions using Student's t test. In the animal experiment, 6 robotic out-of-plane needle insertions toward targets of 1.0 mm in diameter placed in the kidneys and hip muscles of swine were performed, each with and without adjustment of needle orientation based on reconstructed CT images during insertion. Distance accuracy was calculated as the distance between the needle tip and the target center. RESULTS: In the phantom experiment, the mean angle errors of the robotic, freehand manual, and smartphone-guided manual insertions were 0.4°, 7.0°, and 3.7° in the XY plane and 0.6°, 6.3°, and 0.6° in the YZ plane, respectively. Robotic insertions in the XY plane were significantly (p < 0.001) more accurate than smartphone-guided insertions. In the animal experiment, the overall mean distance accuracy of robotic insertions with and without adjustment of needle orientation was 2.5 mm and 5.0 mm, respectively. CONCLUSION: Robotic CT-guided out-of-plane needle insertions were more accurate than smartphone-guided manual insertions in the phantom and were also accurate in the in vivo procedure, particularly with adjustment during insertion. KEY POINTS: • Out-of-plane needle insertions performed using our robot were more accurate than smartphone-guided manual insertions in the phantom experiment and were also accurate in the in vivo procedure. • In the phantom experiment, the mean angle errors of the robotic and smartphone-guided manual out-of-plane needle insertions were 0.4° and 3.7° in the XY plane (p < 0.001) and 0.6° and 0.6° in the YZ plane (p = 0.65), respectively. • In the animal experiment, the overall mean distance accuracies of the robotic out-of-plane needle insertions with and without adjustments of needle orientation during insertion were 2.5 mm and 5.0 mm, respectively.

DOI： 10.1007/s00330-019-06477-1

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Correction to: Risk of gastric cancer in the second decade of follow-up after Helicobacter pylori eradication. Reviewed

Susumu Take, Motowo Mizuno, Kuniharu Ishiki, Chiaki Kusumoto, Takayuki Imada, Fumihiro Hamada, Tomowo Yoshida, Kenji Yokota, Toshiharu Mitsuhashi, Hiroyuki Okada

Journal of gastroenterology   55 ( 3 )   289 - 290   2020.3

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In the original publication of the article, the figure 3 was published with errors. The corrected figure 3 should appear as in this correction.

DOI： 10.1007/s00535-019-01654-x

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Risk of gastric cancer in the second decade of follow-up after Helicobacter pylori eradication. Reviewed

Susumu Take, Motowo Mizuno, Kuniharu Ishiki, Chiaki Kusumoto, Takayuki Imada, Fumihiro Hamada, Tomowo Yoshida, Kenji Yokota, Toshiharu Mitsuhashi, Hiroyuki Okada

Journal of gastroenterology   55 ( 3 )   281 - 288   2020.3

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BACKGROUND AND AIMS: Eradication of Helicobacter pylori reduces the risk of gastric cancer. In this study, we investigated the risk beyond 10 years after eradication of H. pylori. METHODS: We conducted a retrospective cohort study of 2737 patients who had yearly endoscopic follow-up after cure of H. pylori infection. For comparison of gastric cancer risk in the second decade of follow-up with that in the first decade, we calculated standardized incidence ratios (SIRs) by dividing the number of observed cases of gastric cancer in the second decade of follow-up by that of expected cases which was estimated using the incidence rate ratio of age in the first decade. RESULTS: During the follow-up for as long as 21.4 years (mean 7.1 years), gastric cancer developed in 68 patients (0.35% per year). The SIRs for diffuse-type gastric cancer was infinity (0 expected case and 4 observed cases) in patients with mild gastric mucosal atrophy and 10.9 (95% confidence interval 4.53-26.1) with moderate atrophy, whereas no significant increase of SIRs was observed in intestinal-type cancer regardless of the grade of baseline gastric atrophy or in diffuse-type cancer in patients with severe atrophy even though who had the highest risk. CONCLUSIONS: The longer the follow-up, the greater the risk of developing diffuse-type gastric cancer becomes in patients with mild-to-moderate gastric atrophy at baseline. Endoscopic surveillance should be continued beyond 10 years after cure of H. pylori irrespective of the severity of gastric atrophy.

DOI： 10.1007/s00535-019-01639-w

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Physical activity and incident dementia in older Japanese adults: The Okayama study. Reviewed International journal

Yangyang Liu, Toshiharu Mitsuhashi, Michiyo Yamakawa, Megumi Sasai, Toshihide Tsuda, Hiroyuki Doi, Jun Hamada

International journal of geriatric psychiatry   34 ( 10 )   1429 - 1437   2019.10

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OBJECTIVE: To evaluate the association between regular physical activity and the risk of incident dementia in older Japanese adults. METHODS: This was a retrospective cohort study performed in Okayama City, Japan. Overall, 51 477 older Japanese adults were followed from 2008 to 2014. A health checkup questionnaire was used to assess regular physical activity. The Dementia Scale of long-term care insurance was used as a measure of incident dementia. Cox proportional hazard models were used to calculate adjusted hazard ratios, with their 95% confidence intervals, for the incidence of dementia across the categories of physical activity. RESULTS: During a 7-year follow-up, 13 816 subjects were considered as having incident dementia. Compared with participants who performed physical activity less than or equal to one time per week, the multivariate adjusted hazard ratio values (95% confidence intervals) for participants who performed physical activity greater than or equal to two times per week but not every day and those who performed physical activity every day were 0.79 (0.75-0.84) and 0.94 (0.89-0.98), respectively. The interaction of physical activity and sex was statistically significant (P < .01). In subgroup analysis, the multivariate-adjusted hazard ratio values (95% confidence intervals) remained low, at 0.76 (0.70-0.84) in males and 0.81 (0.76-0.87) in females who performed physical activity greater than or equal to two times per week but not every day; they were 0.82 (0.76-0.89) in males and 1.01 (0.95-1.07) in females who performed physical activity every day. CONCLUSIONS: Regular physical activity could reduce the risk of incident dementia in older Japanese adults, except females who performed physical activity every day.

DOI： 10.1002/gps.5135

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Risk Factors for Low Bone Mineral Density Determined in Patients in a General Practice Setting. Reviewed

Akemi Ando, Toshiharu Mitsuhashi, Mitsugi Honda, Yoshihisa Hanayama, Kou Hasegawa, Mikako Obika, Hitomi Kataoka, Fumio Otsuka

Acta medica Okayama   73 ( 5 )   403 - 411   2019.10

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Osteoporosis increases the risk of bone fractures. It is diagnosed based on an individual's bone mineral density (BMD) or a fracture without trauma. BMD is usually measured by the dual energy X-ray absorptiometry (DXA) method. Here we investigated factors for the earliest possible prediction of decreased BMD by examining the relationships between patients' BMD values and changes in the patients' physical and laboratory values. We retrospectively reviewed the medical records of 149 patients who visited our department in 2014-2015 for a variety of reasons and underwent an area BMD examination by DXA. We analyzed the relationships between decreasing BMD and the patients' gender, age, body mass index (BMI), medical background, hemoglobin, electrolytes, and thyroid function. Thirty-nine of the patients were diagnosed with osteoporosis based on their T-scores. An adjusted analysis showed that female gender, aging, and increased serum calcium level were significantly related to decreasing femoral BMD, whereas high BMI was associated with an increase in femoral BMD. Collectively the results indicate that for the early detection of low BMD, it is important for general-practice physicians to consider conducting a BMD checkup when treating female and elderly patients with a low BMI and/or elevated serum calcium level.

DOI： 10.18926/AMO/57370

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Alcohol consumption and incident dementia in older Japanese adults: The Okayama Study. Reviewed

Yangyang Liu, Toshiharu Mitsuhashi, Michiyo Yamakawa, Megumi Sasai, Toshihide Tsuda, Hiroyuki Doi, Jun Hamada

Geriatrics & gerontology international   19 ( 8 )   740 - 746   2019.8

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AIM: To evaluate the association between the amount and frequency of alcohol consumption and incident dementia in older Japanese adults using large sample size data over a long follow-up period. METHODS: This was a retrospective cohort study carried out in Japan. A total of 53 311 older adults were followed from 2008 to 2014. A health checkup questionnaire was used to assess the amount and frequency of alcohol consumption. The Dementia Scale of long-term care insurance was used as a measure of incident dementia. Cox proportional hazards models were used to calculate adjusted hazard ratios, with their 95% confidence intervals, for the incidence of dementia across the categories of alcohol consumption by sex. RESULTS: During a 7-year follow-up period, 14 479 participants were regarded as having incident dementia. Compared with non-drinkers, the multivariate adjusted hazard ratios for participants with alcohol consumption ≤2 units per day, occasionally (0.88, 95% CI 0.81-0.96 in men and 0.84, 95% 0.79-0.90 in women) and daily (0.79, 95% 0.73-0.85 in men and 0.87, 95% 0.78-0.97 in women) were statistically significant, and the difference between occasional and daily consumption was only statistically significant in men; however, for participants with alcohol consumption >2 units per day, occasionally (0.91, 95% 0.71-1.16 in men and 1.09, 95% 0.72-1.67 in women) and daily (0.89, 95% 0.81-1.00 in men and 1.16, 95% 0.84-1.81 in women) were not significant. CONCLUSIONS: Alcohol consumption of ≤2 units per day, occasionally or daily, could reduce the risk of incident dementia, with greater benefit for men with such daily consumption. Geriatr Gerontol Int 2019; 19: 740-746.

DOI： 10.1111/ggi.13694

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Simultaneous Integrated Boost Volumetric Modulated Arc Therapy for Middle or Lower Esophageal Cancer Using Elective Nodal Irradiation: Comparison with 3D Conformal Radiotherapy. Reviewed

Kotaro Yoshio, Akihisa Wakita, Toshiharu Mitsuhashi, Takahiro Kitayama, Kento Hisazumi, Daisaku Inoue, Nobuhisa Tajiri, Tsuyoki Shiode, Shiro Akaki, Susumu Kanazawa

Acta medica Okayama   73 ( 3 )   247 - 257   2019.6

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We investigated the feasibility of simultaneous integrated boost (SIB) volumetric modulated arc therapy (VMAT) using elective nodal irradiation (ENI) for middle or lower esophageal cancer and compared it with three-dimensional conformal radiotherapy (3D-CRT). The study included 15 patients. The prescribed doses included a standard dose (50.4 Gy) and a high dose (60 Gy) for the planning target volume (PTV) of the involved lesions. The objective of the whole lung volume receiving ≥ 20 Gy (V20Gy) was < 30%, and the mean lung dose (MLD) was < 20 Gy. The volumes of the lung receiving 5 Gy (V5Gy) and the heart receiving 30-50 Gy (V30-50Gy) were kept as low as reasonably achievable. As a result, SIB-VMAT showed superior dose conformity for the PTV (p<0.001). Although the lung V5Gy was significantly increased (p<0.001), the V20Gy and MLD showed no significant increase. The heart V30-50Gy showed a > 20% reduction in the mean against 3D-CRTs. Our results demonstrate the feasibility of SIB-VMAT for the treatment of middle or lower esophageal cancer with ENI. Although attention should be paid to the low-dose area of the lungs, SIB-VMAT would be a promising treatment option with improved outcomes for esophageal cancer.

DOI： 10.18926/AMO/56868

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Combined effects of body mass index and unhealthy behaviors on disability in older Japanese adults: the Okayama study. Reviewed International journal

Yangyang Liu, Toshiharu Mitsuhashi, Michiyo Yamakawa, Megumi Sasai, Toshihide Tsuda, Hiroyuki Doi, Jun Hamada

PeerJ   7   e8146   2019

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Background: Body mass index (BMI) is a significant predictor of functional disability in older adults. However, when evaluated, the association between BMI and incident functional disability, considering behaviors only as covariates or not, may not be appropriate. The primary purpose of the study was to investigate the combined effects of BMI and unhealthy behaviors on the risk of incident functional disability. Methods: This was a retrospective cohort study that took place in Okayama City, Japan. Data on BMI and unhealthy behaviors were obtained using the health check-up questionnaire. The certification of Long-Term Care Insurance was used to measure functional disability. Cox proportional hazard models were used; adjusted hazard ratios (HRs) with 95% confidence interval (CI) were calculated for incidence of functional disability across categories of BMI and number of unhealthy behaviors. Results: The relationship between BMI and incident functional disability was U-shaped (HR = 1.18, 95% CI [1.11-1.25], among the underweight range; and 1.26 [1.19-1.34] among the obesity range), and its risk was significantly higher within the normal-to-overweight range of BMI values with co-occurring unhealthy behaviors (with normal weight range and one, 1.17 [1.01-1.21]; two, 1.29 [1.18-1.41]; and three or four unhealthy behaviors 1.38 [1.24-1.54]; as well as among overweight range and one, 1.16 [1.05-1.27]; two, 1.26 [1.15-1.38]; and three or four unhealthy behaviors, 1.47 [1.31-1.64]). In each BMI category, the risk of incident functional disability increased with increasing number of unhealthy behaviors (p < 0.05 for linear tread), with the highest risk (1.87 [1.58-2.20]) occurring in combination with at least three unhealthy behaviors with BMI ≥ 27.5, for both sexes (2.20 [1.64-2.92] in men and 1.66 [1.35-2.04] in women). Conclusion: It is necessary to consider the combined effects of BMI and behaviors on incident functional disability. Furthermore, interventions targeting multiple behaviors should be considered as such interventions may offer greater benefits than simple interventions.

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Randomized Controlled Trial of Epidural versus Patient-controlled Intravenous Analgesia for Postoperative Pain Control after Laparoscopic Gastrectomy. Reviewed

Satoru Kikuchi, Shinji Kuroda, Masahiko Nishizaki, Takashi Matsusaki, Toshiharu Mitsuhashi, Kazuya Kuwada, Shunsuke Kagawa, Hiroshi Morimatsu, Toshiyoshi Fujiwara

Acta medica Okayama   72 ( 1 )   95 - 98   2018.2

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Although epidural analgesia (EDA) is considered standard postoperative analgesia for open gastrectomy, it has been unclear whether EDA has benefits in laparoscopic gastrectomy (LG) because postoperative pain after a laparoscopic procedure is significantly reduced. We are conducting a two-arm, single-center, prospective randomized non-inferiority trial to evaluate the postoperative pain relief of patient-controlled intravenous analgesia (PCIA) compared to EDA. A total of 132 patients undergoing LG will be randomized to EDA and PCIA groups (n=64 each) for postoperative pain control. The primary endpoint is postoperative pain at 24 h after surgery. This study will clarify the optimal pain management after LG.

DOI： 10.18926/AMO/55671

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Plan quality comparison between 4-arc and 6-arc noncoplanar volumetric modulated arc stereotactic radiotherapy for the treatment of multiple brain metastases. Reviewed

Yoshio K, Mitsuhashi T, Wakita A, Kitayama T, Hisazumi K, Inoue D, Shiode T, Akaki S, Kanazawa S

Medical dosimetry : official journal of the American Association of Medical Dosimetrists   43 ( 4 )   358 - 362   2018.1

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DOI： 10.1016/j.meddos.2017.11.007

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Robotically Driven CT-guided Needle Insertion: Preliminary Results in Phantom and Animal Experiments. Reviewed International journal

Takao Hiraki, Tetsushi Kamegawa, Takayuki Matsuno, Jun Sakurai, Yasuzo Kirita, Ryutaro Matsuura, Takuya Yamaguchi, Takanori Sasaki, Toshiharu Mitsuhashi, Toshiyuki Komaki, Yoshihisa Masaoka, Yusuke Matsui, Hiroyasu Fujiwara, Toshihiro Iguchi, Hideo Gobara, Susumu Kanazawa

Radiology   285 ( 2 )   454 - 461   2017.11

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Purpose To evaluate the accuracy of the remote-controlled robotic computed tomography (CT)-guided needle insertion in phantom and animal experiments. Materials and Methods In a phantom experiment, 18 robotic and manual insertions each were performed with 19-gauge needles by using CT fluoroscopic guidance for the evaluation of the equivalence of accuracy of insertion between the two groups with a 1.0-mm margin. Needle insertion time, CT fluoroscopy time, and radiation exposure were compared by using the Student t test. The animal experiments were approved by the institutional animal care and use committee. In the animal experiment, five robotic insertions each were attempted toward targets in the liver, kidneys, lungs, and hip muscle of three swine by using 19-gauge or 17-gauge needles and by using conventional CT guidance. The feasibility, safety, and accuracy of robotic insertion were evaluated. Results The mean accuracies of robotic and manual insertion in phantoms were 1.6 and 1.4 mm, respectively. The 95% confidence interval of the mean difference was -0.3 to 0.6 mm. There were no significant differences in needle insertion time, CT fluoroscopy time, or radiation exposure to the phantom between the two methods. Effective dose to the physician during robotic insertion was always 0 μSv, while that during manual insertion was 5.7 μSv on average (P < .001). Robotic insertion was feasible in the animals, with an overall mean accuracy of 3.2 mm and three minor procedure-related complications. Conclusion Robotic insertion exhibited equivalent accuracy as manual insertion in phantoms, without radiation exposure to the physician. It was also found to be accurate in an in vivo procedure in animals. © RSNA, 2017 Online supplemental material is available for this article.

DOI： 10.1148/radiol.2017162856

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Radiofrequency ablation of pulmonary tumors near the diaphragm Reviewed

T. Iguchi, T. Hiraki, H. Gobara, H. Fujiwara, J. Sakurai, Y. Matsui, T. Mitsuhashi, S. Toyooka, S. Kanazawa

Diagnostic and Interventional Imaging   98 ( 7-8 )   535 - 541   2017.7

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：Elsevier Masson SAS  

Purpose To retrospectively evaluate the feasibility, safety, and efficacy of radiofrequency ablation (RFA) of lung tumors located near the diaphragm. Materials and methods A total of 26 patients (15 men, 11 women
mean age, 61.5 years ± 13.0 [SD]) with a total of 29 lung tumors near the diaphragm (i.e., distance &lt
 10 mm) were included. Mean tumor diameter was 11.0 mm ± 5.3 (SD) (range, 2–23 mm). Efficacy of RFA, number of adverse events and number of adverse events with a grade ≥ 3, based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0, were compared between patients with lung tumors near the diaphragm and a control group of patients with more distally located lung tumors (i.e., distance ≥ 10 mm). Results RFA was technically feasible for all tumors near the diaphragm. Four grade 3 adverse events (1 pneumothorax requiring pleurodesis and 3 phrenic nerve injuries) were observed. No grade ≥ 4 adverse events were reported. The median follow-up period for tumors near the diaphragm was 18.3 months. Local progression was observed 3.3 months after RFA in 1 tumor. The technique efficacy rates were 96.2% at 1 year and 96.2% at 2 years and were not different, from those observed in control subjects (186 tumors
P = 0.839). Shoulder pain (P &lt
 0.001) and grade 1 pleural effusion (P &lt
 0.001) were more frequently observed in patients with lung tumor near the diaphragm. The rates of grade ≥ 3 adverse events did not significantly differ between tumors near the diaphragm (4/26 sessions) and the controls (7/133 sessions) (P = 0.083). Conclusion RFA is a feasible and effective therapeutic option for lung tumors located near the diaphragm. However, it conveys a higher rate of shoulder pain and asymptomatic pleural effusion by comparison with more distant lung tumors.

DOI： 10.1016/j.diii.2017.01.008

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Lesion Size on Ultrasonography Predicts Potential Invasion in Ductal Carcinoma in situ Preoperatively Diagnosed by Breast Needle Biopsy. Reviewed

Kyoko Shimoyama, Tomo Osako, Toshiharu Mitsuhashi, Futoshi Akiyama, Takuji Iwase

Acta medica Okayama   71 ( 3 )   233 - 240   2017.6

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：OKAYAMA UNIV MED SCHOOL  

Ductal carcinoma in situ (DCIS) of the breast has no potential to metastasize, but over 20% of cases preoperatively diagnosed as DCIS are upstaged on final pathology. The rates of upstaging and the predictors for invasion on final pathology were evaluated. For 240 primary breast cancers, radiological findings on mammography, ultrasonography, and magnetic resonance imaging were investigated along with pathological and clinical information. Univariate and multivariate analyses were performed to identify predictors of potential invasion. Of the 240 breast cancers, 68 (28.3%) showed invasion on final pathology, and 5 (2.5%) had sentinel node metastasis. The multivariate analysis identified five independent predictors: non-mass lesions >2.4 cm on ultrasonography (odds ratio [OR] 2.84, 95% confidence interval [CI] 1.02-7.95, p=0.047), comedo-type histology (OR 6.89, 95% CI 1.89-25.08, p<0.01), solid-type histology (OR 7.97, 95% CI 2.08-30.49, p<0.01), palpable mass (OR 2.63, 95% CI 1.05-6.64, p=0.04), and bloody nipple discharge (OR 4.61, 95% CI 1.20-17.66, p=0.02). These five predictors were associated with invasion on final pathology and may help select candidates for sentinel node biopsy.

DOI： 10.18926/AMO/55206

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Disappearance of Renal Cysts Included in Ice Ball During Cryoablation of Renal-Cell Carcinoma: A Potential Therapy for Symptomatic Renal Cysts? Reviewed International journal

Mitsuko Yodoya, Takao Hiraki, Toshihiro Iguchi, Hiroyasu Fujiwara, Yusuke Matsui, Yoshihisa Masaoka, Jun Sakurai, Toshiharu Mitsuhashi, Hideo Gobara, Susumu Kanazawa

Journal of vascular and interventional radiology : JVIR   28 ( 6 )   869 - 876   2017.6

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PURPOSE: To retrospectively evaluate the effect of cryoablation of renal-cell carcinoma on nearby renal cysts with the goal to investigate the potential for an alternative therapy to treat symptomatic renal cysts. MATERIALS AND METHODS: The study population comprised 46 cysts (mean size, 12 mm; range, 5-43 mm) that were within or near the ice ball during cryoablation in 22 patients. Size change of each cyst was evaluated via enhanced CT or MR imaging before and 1, 3, 6, and 12 months after cryoablation. Forty-one cysts were also followed after 12 months. Variables including positional relationship between the cyst and the ice ball were evaluated via linear regression analysis using generalized estimating equation models to determine which factors affected cyst shrinkage rate at 12 months. RESULTS: Fifteen, 12, and 19 cysts were completely included in, partially included in, or excluded from the ice ball, respectively. The overall shrinkage rate was 62%, and 57% of cysts (26 of 46) had disappeared at 12 months. Only the relationship between the cyst and the ice ball was significantly (P < .001) associated with cyst shrinkage rate. Cyst disappearance rates at 12 months were 100% (15 of 15), 67% (8 of 12), and 16% (3 of 19) for cysts completely included, partially included, and excluded from the ice ball, respectively. Among the 22 cysts that disappeared at 12 months and continued to be followed, none recurred after 12 months. CONCLUSIONS: All renal cysts that were completely included in the ice ball disappeared after cryoablation, demonstrating the potential utility of cryoablation as an alternative therapy for symptomatic renal cysts.

DOI： 10.1016/j.jvir.2017.02.027

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One-year outcomes of a treat-and-extend regimen of intravitreal aflibercept for polypoidal choroidal vasculopathy. Reviewed

Mio Hosokawa, Yuki Morizane, Masayuki Hirano, Shuhei Kimura, Fumiaki Kumase, Yusuke Shiode, Shinichiro Doi, Shinji Toshima, Mika Hosogi, Atsushi Fujiwara, Toshiharu Mitsuhashi, Fumio Shiraga

Japanese journal of ophthalmology   61 ( 2 )   150 - 158   2017.3

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PURPOSE: To evaluate the 1-year treatment outcomes of intravitreal aflibercept injections (IVA) using a treat-and-extend regimen for polypoidal choroidal vasculopathy (PCV). METHODS: Thirty-seven eyes with treatment-naive PCV treated with IVA using a treat-and-extend regimen for 1 year were reviewed retrospectively. The main outcome measures were changes in the best-corrected visual acuity (BCVA) and central retinal thickness (CRT), and the treatment interval at 1 year. The predictive factors for patients who could not continue to extend the treatment interval because of poor response to IVA or recurrence were analyzed. RESULTS: The mean logarithm of the minimum angle of resolution BCVA improved from 0.37 at baseline to 0.21 at 1 year (P < 0.001). The mean CRT decreased from 342.3 μm at baseline to 196.6 μm at 1 year (P < 0.001). The mean treatment interval was 9.7 weeks at 1 year (4 weeks in 11 eyes [29.7%], 6 weeks in 1 eye [2.7%], 8 weeks in 2 eyes [5.4%], 10 weeks in 1 eye [2.7%], and 12 weeks in 22 eyes [59.5%]). A larger number of polypoidal lesions at baseline was predictive for patients who could not continue to extend the treatment interval. CONCLUSIONS: IVA using a treat-and-extend regimen is effective for improving BCVA and CRT in eyes with PCV.

DOI： 10.1007/s10384-016-0492-7

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Interfractional Seminal Vesicle Motion Relative to the Prostate Gland for Image-guided Radiotherapy for Prostate Cancer with/without Androgen Deprivation Therapy: A Retrospective Cohort Study. Reviewed

Takahiro Waki, Kuniaki Katsui, Toshiharu Mitsuhashi, Takeshi Ogata, Norihisa Katayama, Mitsuhiro Takemoto, Yasutomo Nasu, Hiromi Kumon, Susumu Kanazawa

Acta medica Okayama   71 ( 1 )   31 - 39   2017.2

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We investigated differences in seminal vesicle (SV) length and interfractional SV motion relative to the prostate gland in prostate cancer patients. We compared 32 patients who received androgen deprivation therapy (ADT) before radiotherapy with 12 patients receiving radiotherapy alone at Okayama University Hospital in August 2008-July 2011. We examined the right and left SVs' length and motion by computed tomography (CT) to determine the ADT's effects and analyzed 347 CT scans in a multiple linear regression model. The ADT patients' SV length was significantly shorter than the non-ADT patients'. The differences in right and left SV lengths between the ADT and non-ADT patients were 6.8 mm (95% CI 2.0-11.7 mm) and 7.2 mm (95% CI 3.1- 11.3 mm) respectively in an adjusted regression model. SV motion did not differ between the ADT and non- ADT patients in terms of interfractional motion of the SV tips and the SVs' center relative to the prostate gland. The ADT patients had significantly shorter SVs compared to the non-ADT patients, but no difference in SV motion was observed. SV interfractional motion should thus be compensated using the same planning margins, regardless of whether ADT is used.

DOI： 10.18926/AMO/54823

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Clinical Epidemiology and Treatment of Febrile and Afebrile Convulsions With Mild Gastroenteritis: A Multicenter Study. Reviewed International journal

Yousuke Higuchi, Toshihide Kubo, Toshiharu Mitsuhashi, Naoko Nakamura, Ichiro Yokota, Osamu Komiyama, Isamu Kamimaki, Shigenori Yamamoto, Yasushi Uchida, Kyoko Watanabe, Hironori Yamashita, Shigeki Tanaka, Kosei Iguchi, Ryouji Ichimi, Shinichiro Miyagawa, Toshimitsu Takayanagi, Hiroshi Koga, Akinori Shukuya, Akiko Saito, Keizo Horibe

Pediatric neurology   67   78 - 84   2017.2

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BACKGROUND: We investigated features and responses to treatment in patients with febrile and afebrile convulsions with mild gastroenteritis and characterized convulsions with rotavirus and norovirus gastroenteritis. METHODS: We conducted a prospective, observational study to evaluate patients with febrile and afebrile convulsions with mild gastroenteritis who were hospitalized between November 2011 and March 2014 at 13 facilities in the National Hospital Organization. We classified the patients into two groups: presence or absence of fever. We investigated the background, clinical and laboratory characteristics, viral antigen in stool, and efficacy of anticonvulsant drugs. RESULTS: Of 126 patients enrolled in this study, 50 were febrile (Fc group) and 76 were afebrile (aFc group). A family history of febrile seizures was significantly more frequent in the Fc group than in the aFc group (28.0% vs 9.2%, P = 0.005). Clinical characteristics were similar between the rotavirus and norovirus groups, but fever was significantly more frequent in the rotavirus group (46.2% vs 8.3%, P < 0.001). Serum sodium levels were significantly negatively related to the number of seizures in the aFc group (β = -0.13; 95% confidence interval, -0.24, -0.03; P = 0.01). Carbamazepine was significantly more efficacious than diazepam suppositories in the aFc group (odds ratio = 49.3, 95% confidence interval, 2.35, 1037; P = 0.01). CONCLUSION: Febrile convulsions with mild gastroenteritis show characteristics of both febrile seizures and convulsions with mild gastroenteritis. Carbamazepine is optimal for convulsions with mild gastroenteritis. Clinical features of convulsions with rotavirus and norovirus gastroenteritis are similar, except for fever. Serum sodium levels may play a major role in the onset of convulsions with mild gastroenteritis.

DOI： 10.1016/j.pediatrneurol.2016.05.011

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Radiofrequency ablation of pulmonary metastases from sarcoma: single-center retrospective evaluation of 46 patients. Reviewed

Takuya Sato, Toshihiro Iguchi, Takao Hiraki, Hideo Gobara, Hiroyasu Fujiwara, Jun Sakurai, Yusuke Matsui, Toshiharu Mitsuhashi, Junichi Soh, Shinichi Toyooka, Susumu Kanazawa

Japanese journal of radiology   35 ( 2 )   61 - 67   2017.2

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：SPRINGER  

PURPOSE: This retrospective, single-center study evaluated radiofrequency (RF) ablation for pulmonary metastases of sarcoma. MATERIALS AND METHODS: Forty-six patients with sarcoma (144 pulmonary metastases) underwent 88 RF ablation sessions. Data regarding local tumor progression, efficacy, procedural adverse events (AEs; National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0), overall survival (OS), and OS-associated prognostic factors were retrospectively evaluated using univariate analyses. RESULTS: Local progression occurred in 22 of 144 tumors (15.3%). Primary and secondary efficacy rates were 83.5 and 90.0% at 1 year and 76.3 and 81.4% at 2 years, respectively. Seventy-three grade 1 AEs, 33 grade 2 AEs, and no grade ≥ 3 AEs were observed. Twenty-eight patients (60.9%) remained alive and 18 died, yielding 1-, 2-, and 3-year OS rates of 80.6, 70.1, and 47.1% (median survival time, 31.7 months). Univariate analysis revealed extrapulmonary metastasis (P = 0.005), noncurative RF ablation (P = 0.009), and a post-RF ablation disease-free interval of ≤12 months (P = 0.015) as significant negative prognostic factors. CONCLUSION: RF ablation is safe, offers good local control, and may be a viable treatment option for pulmonary metastasis of sarcoma.

DOI： 10.1007/s11604-016-0601-z

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A typology of four notions of confounding in epidemiology. Reviewed

Etsuji Suzuki, Toshiharu Mitsuhashi, Toshihide Tsuda, Eiji Yamamoto

Journal of epidemiology   27 ( 2 )   49 - 55   2017.2

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Confounding is a major concern in epidemiology. Despite its significance, the different notions of confounding have not been fully appreciated in the literature, leading to confusion of causal concepts in epidemiology. In this article, we aim to highlight the importance of differentiating between the subtly different notions of confounding from the perspective of counterfactual reasoning. By using a simple example, we illustrate the significance of considering the distribution of response types to distinguish causation from association, highlighting that confounding depends not only on the population chosen as the target of inference, but also on the notions of confounding in distribution and confounding in measure. This point has been relatively underappreciated, partly because some literature on the concept of confounding has only used the exposed and unexposed groups as the target populations, while it would be helpful to use the total population as the target population. Moreover, to clarify a further distinction between confounding "in expectation" and "realized" confounding, we illustrate the usefulness of examining the distribution of exposure status in the target population. To grasp the explicit distinction between confounding in expectation and realized confounding, we need to understand the mechanism that generates exposure events, not the product of that mechanism. Finally, we graphically illustrate this point, highlighting the usefulness of directed acyclic graphs in examining the presence of confounding in distribution, in the notion of confounding in expectation.

DOI： 10.1016/j.je.2016.09.003

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Impact of Cushing's sign in the prehospital setting on predicting the need for immediate neurosurgical intervention in trauma patients: a nationwide retrospective observational study. Reviewed International journal

Tetsuya Yumoto, Toshiharu Mitsuhashi, Yasuaki Yamakawa, Atsuyoshi Iida, Nobuyuki Nosaka, Kohei Tsukahara, Hiromichi Naito, Atsunori Nakao

Scandinavian journal of trauma, resuscitation and emergency medicine   24 ( 1 )   147 - 147   2016.12

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BACKGROUND: Cushing's reflex usually results from intracranial hypertension. Although Cushing's sign can implicate severe traumatic brain injury (TBI) in injured patients, no major investigations have been made. The purpose of this study was to assess the predictability of life-threatening brain injury requiring immediate neurosurgical intervention (LT-BI) among trauma patients with Cushing's sign in the prehospital setting. METHODS: This was a retrospective study using data from the Japan Trauma Data Bank from the period of 2010 to 2014. Patients 16 years old or older with blunt mechanisms of injury who were transported directly from the scene and Glasgow Coma Scale for eye opening of one in the prehospital setting were included. LT-BI was defined as patients requiring burr hole evacuation or craniotomy within 24 h of hospital arrival and patients who were non-survivors due to isolated severe TBI. Prehospital systolic blood pressure (pSBP) and heart rate (pHR) were assessed using area under the receiver operating characteristic curve (AUROC) and multiple logistic regression analysis to predict LT-BI. RESULTS: Of 6332 eligible patients, 1859 (29%) exhibited LT-BI. AUROC of LT-BI using pSBP and pHR was 0.666 (95% confidence interval (CI); 0.652-0.681, P < 0.001), and 0.578 (95% CI; 0.563-0.594, P < 0.001), respectively. AUROC of pSBP was the highest among the 60 ≤ pHR ≤ 99 subgroup, of which AUROC was 0.680 (95% CI; 0.662-0.699, P < 0.001). Multiple logistic regression analysis showed that the higher the pSBP and the lower the pHR, the more likely that the patients had LT-BI. In a group with pSBP ≥ 180 mmHg and pHR ≤ 59 beats/min, the odds ratio and 95% CI of LT-BI after adjusting for age, sex, and severity of injuries to other body regions was 4.77 (2.85-7.97), P < 0.001 was compared with the reference group, which was defined as patients with normal vital signs. DISCUSSION: Our study has found that the combination of hypertension and bradycardia, which are the components of Cushing's sign without eye opening in the prehospital setting was a weak but a significant predictor of LT-BI, or death due to possible isolated severe TBI. CONCLUSIONS: Prehospital Cushing's sign with disturbed level of consciousness in trauma patients was a weak but significant predictor of the need for immediate neurosurgical intervention.

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Fracture of totally implanted central venous access devices: a propensity-score-matched comparison of risks for Groshong silicone versus polyurethane catheters. Reviewed International journal

Soichi Kojima, Takao Hiraki, Hideo Gobara, Toshihiro Iguchi, Hiroyasu Fujiwara, Yusuke Matsui, Toshiharu Mitsuhashi, Susumu Kanazawa

The journal of vascular access   17 ( 6 )   535 - 541   2016.11

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PURPOSE: To evaluate retrospectively the fracture risk of totally implanted venous access devices connected to Groshong silicone (SC) versus polyurethane (PU) catheters, inserted via the internal jugular vein. MATERIALS AND METHODS: The study population comprised 384 SC and 221 PU central venous catheters implanted via the internal jugular vein. The presence of catheter fracture was evaluated. Variables possibly related to catheter fracture were evaluated. First, in order to determine the factors associated with fracture, fracture rates were compared with the log-rank test between the two groups divided by each of the variables. Then, in order to adjust for potential confounders, propensity-score matching of the variables was employed in the two catheter groups. Finally, the rates of fracture were compared between the two propensity-score-matched catheter groups. RESULTS: There were 16 cases of catheter fracture, for an overall fracture percentage of 2.6% (16/605). All 16 cases of fracture occurred in the SC catheter group. Smaller patient body mass index (p = 0.039), deeper catheter tip position (p = 0.022), and SC catheters (p = 0.019) were significantly associated with fracture. With the propensity-score-matching method, 180 cases were selected in each catheter group. Comparison of the two propensity-score-matched groups showed that fracture rates for SC catheters remained significantly (p = 0.018) higher than those for PU catheters. CONCLUSIONS: Ports connected to Groshong SC catheters - when implanted via the internal jugular vein - posed a higher risk of fracture than did ports connected to PU catheters.

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Errors in causal inference: an organizational schema for systematic error and random error. Reviewed International journal

Etsuji Suzuki, Toshihide Tsuda, Toshiharu Mitsuhashi, Mohammad Ali Mansournia, Eiji Yamamoto

Annals of epidemiology   26 ( 11 )   788 - 793   2016.11

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PURPOSE: To provide an organizational schema for systematic error and random error in estimating causal measures, aimed at clarifying the concept of errors from the perspective of causal inference. METHODS: We propose to divide systematic error into structural error and analytic error. With regard to random error, our schema shows its four major sources: nondeterministic counterfactuals, sampling variability, a mechanism that generates exposure events and measurement variability. RESULTS: Structural error is defined from the perspective of counterfactual reasoning and divided into nonexchangeability bias (which comprises confounding bias and selection bias) and measurement bias. Directed acyclic graphs are useful to illustrate this kind of error. Nonexchangeability bias implies a lack of "exchangeability" between the selected exposed and unexposed groups. A lack of exchangeability is not a primary concern of measurement bias, justifying its separation from confounding bias and selection bias. Many forms of analytic errors result from the small-sample properties of the estimator used and vanish asymptotically. Analytic error also results from wrong (misspecified) statistical models and inappropriate statistical methods. CONCLUSIONS: Our organizational schema is helpful for understanding the relationship between systematic error and random error from a previously less investigated aspect, enabling us to better understand the relationship between accuracy, validity, and precision.

DOI： 10.1016/j.annepidem.2016.09.008

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Single Center Prospective Phase II Trial of CT-guided Radiofrequency Ablation for Pulmonary Metastases from Colorectal Cancer (SCIRO-1401). Reviewed

Jun Sakurai, Yusuke Matsui, Takao Hiraki, Toshihiro Iguchi, Hiroyasu Fujiwara, Hideo Gobara, Toshiharu Mitsuhashi, Takeshi Nagasaka, Susumu Kanazawa

Acta medica Okayama   70 ( 4 )   317 - 21   2016.8

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The present single center prospective phase II clinical trial is designed to evaluate the efficacy and safety of percutaneous radiofrequency (RF) ablation for colorectal lung metastases. Patients who have colorectal lung metastases without extrapulmonary metastases are included in this study. The primary endpoint is 3-year overall survival (OS) after RF ablation. The secondary endpoints are the prevalence of adverse events within 4 weeks, local tumor progression rate, 1- and 5-year OS, cause-specific survival, and relapse-free survival. The recruitment of patients commenced in July 2014, and the enrolment of 45 patients is intended over the 3 years of study period.

DOI： 10.18926/AMO/54512

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A phase 1, dose-finding and pharmacokinetic study of gemcitabine with nab-paclitaxel in patients with metastatic breast cancer. Reviewed International journal

Seiji Yoshitomi, Naruto Taira, Hiroyoshi Doihara, Taeko Mizoo, Tomohiro Nogami, Takayuki Iwamoto, Takayuki Motoki, Tadahiko Shien, Yutaka Ogasawara, Junji Matsuoka, Hisashi Tsuji, Toshiharu Mitsuhashi

Cancer chemotherapy and pharmacology   78 ( 2 )   289 - 94   2016.8

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PURPOSE: Gemcitabine (Gem) with paclitaxel (Pac) is used for patients with metastatic breast cancer who require cytoreduction with manageable toxicities. Nanoparticle albumin-bound (nab)-Pac exhibits better efficacy and reduces the risk of hypersensitivity reactions associated with solvent-based Pac. Therefore, Gem plus nab-Pac (GA) therapy may be effective for metastatic breast cancer. The purpose of this study was to determine the maximum tolerated dose for GA therapy. METHODS: The subjects were patients with metastatic breast cancer with performance status 0 or 1 and normal hepatic, renal and marrow function. Leukopenia, neutropenia or thrombocytopenia of grade 4, neutropenic fever, or non-hematological toxicity of grade 3 or higher during the 1st cycle, and chemotherapy-induced peripheral neurotoxicity of grade 2 or higher at the end of the 1st cycle were defined as dose-limiting toxicities (DLTs). Gem (1250 mg/m(2)) was administered on days 1 and 8. nab-Pac was administered at a starting dose of 180 mg/m(2) (cohort 1) and escalated to 220 mg/m(2) (cohort 2) and 260 mg/m(2) (cohort 3) on day 1 of the 21-day cycle, using a 3 + 3 design. RESULTS: Nine patients (n = 3, 3, and 3 in cohorts 1, 2, and 3, respectively) were included in the study (median age 56 years; range 43-75 years). DLTs did not occur in any cohorts. CONCLUSIONS: The initial recommend dose in GA therapy is 1250 mg/m(2) Gem and 260 mg/m(2) nab-Pac. It is well known that nab-Pac has cumulative toxicities, and thus the efficacy and safety of GA therapy require validation in a phase 2 study.

DOI： 10.1007/s00280-016-3091-x

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Chronic interstitial pneumonia in young patients undergoing lung transplantation or autopsy: clinico-radiologic-pathologic observations from a single institution. Reviewed

Mayu Uka, Toshihiro Iguchi, Katsuya Kato, Hidehiro Hayashi, Ichiro Yamadori, Toshiharu Mitsuhashi, Takahiro Oto, Shuhei Sato, Susumu Kanazawa

Japanese journal of radiology   34 ( 7 )   515 - 22   2016.7

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PURPOSE: To retrospectively evaluate high-resolution computed tomography (HRCT) findings and clinical diagnoses of chronic interstitial pneumonia (IP) with a poor prognosis in young patients (≤50 years). MATERIALS AND METHODS: HRCT images of 8 men and 7 women (mean age 34.8 years) obtained before lung transplantation or autopsy were reviewed. After reviewing whole lung specimens and pathologic diagnoses, all patients were clinically diagnosed according to the 2010 idiopathic pulmonary fibrosis/usual interstitial pneumonia (IPF/UIP) consensus statement. RESULTS: HRCT images revealed intralobular reticular opacity, air cysts, ground glass opacity, traction bronchiectasis, and interlobular septal thickening. Intralobular reticular opacity was the most extensive finding. Abnormal findings existed predominantly in both the peripheral and lower lung zones in only 1 patient. Classifications of HRCT patterns were "UIP" (n = 2), "inconsistent with UIP" (n = 11), and "indeterminate UIP" (n = 2). Multidisciplinary diagnoses were "IPF/UIP" (n = 1), "possible IPF/UIP" (n = 1), "IP with connective tissue disease" (n = 7), "fibrotic nonspecific IP" (n = 1), and "unclassified IP" (n = 5). CONCLUSION: The most extensive HRCT finding was intralobular reticular opacity. Most HRCT images differed from typical IPF/UIP, and IPF/UIP was uncommon in young patients with chronic IP with a poor prognosis.

DOI： 10.1007/s11604-016-0551-5

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Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes. Reviewed International journal

Shinji Sakamoto, Manabu Takaki, Yuko Okahisa, Yutaka Mizuki, Masatoshi Inagaki, Hiroshi Ujike, Toshiharu Mitsuhashi, Soshi Takao, Masashi Ikeda, Yosuke Uchitomi, Nakao Iwata, Norihito Yamada

Journal of human genetics   61 ( 4 )   329 - 34   2016.4

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Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study.

DOI： 10.1038/jhg.2015.153

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Radiofrequency Ablation of Lung Tumors Using a Multitined Expandable Electrode: Impact of the Electrode Array Diameter on Local Tumor Progression. Reviewed International journal

Hiroki Ihara, Hideo Gobara, Takao Hiraki, Toshiharu Mitsuhashi, Toshihiro Iguchi, Hiroyasu Fujiwara, Yusuke Matsui, Junichi Soh, Shinichi Toyooka, Susumu Kanazawa

Journal of vascular and interventional radiology : JVIR   27 ( 1 )   87 - 95   2016.1

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PURPOSE: To retrospectively investigate the impact of the electrode array diameter on local tumor progression after lung radiofrequency ablation. MATERIALS AND METHODS: This study included 651 lung tumors treated using multitined expandable electrodes and followed for ≥ 6 months. The mean long-axis tumor diameter was 12 mm ± 7 (range, 2-42 mm). The difference between electrode array diameter and tumor diameter (DAT) was used to investigate the impact of the electrode array diameter. All tumors were classified into 2 groups according to various variables including DAT (≥ 10 mm or < 10 mm). The primary technique efficacy rates were calculated using Kaplan-Meier analysis and compared between the 2 groups of each variable using the log-rank test. In addition, crude and multivariate multilevel survival analyses were performed by sequentially including DAT and the other variables in 5 models. RESULTS: The median DAT for 651 tumors was 12 mm (range, -15 to 24 mm). The technique efficacy rate was significantly lower in the < 10 mm DAT group than in the ≥ 10 mm group (P < .001). In the crude and multivariate multilevel survival analyses, < 10 mm DAT was a significant risk factor for local progression in all models except model 5 (P = .067). In the ≥ 10 mm group, the technique efficacy rates were not significantly different between the 2 ≥ 10 mm DAT subgroups (10 to <15 mm DAT vs ≥ 15 mm DAT). CONCLUSIONS: DAT is an important risk factor for local progression. We recommend an electrode that is ≥ 10 mm larger than the tumor diameter.

DOI： 10.1016/j.jvir.2015.07.025

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Predicting pleural invasion using HRCT and 18F-FDG PET/CT in lung adenocarcinoma with pleural contact. Reviewed

Takashi Tanaka, Takayoshi Shinya, Shuhei Sato, Toshiharu Mitsuhashi, Koichi Ichimura, Junichi Soh, Shinichi Toyooka, Mitsumasa Kaji, Shinichiro Miyoshi, Susumu Kanazawa

Annals of nuclear medicine   29 ( 9 )   757 - 65   2015.11

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OBJECTIVE: To evaluate the relevance of high-resolution computed tomography (HRCT) findings and fluorine-18-fluorodeoxyglucose ((18)F-FDG) uptake for risk stratification of visceral pleural invasion by lung adenocarcinoma. METHODS: The HRCT findings and (18)F-FDG uptake for lung adenocarcinomas with pleural contact on CT were retrospectively analyzed in 208 consecutive patients (94 females and 114 males; median age, 69.0 years) between January 2009 and December 2013, with institutional review board approval. The HRCT findings and maximum standardized uptake value (SUV max) were recorded for each patient. Multivariate logistic regression was used for statistical analysis, and subgroup analysis stratified for whole tumor size ≤ 3 cm was also performed. RESULTS: Multivariate analysis showed that SUV max [odds ratio (OR) 1.09, 95 % confidence interval (CI) 1.02-1.16, P = 0.014] and obtuse angle (OR 4.14, 95 % CI 1.97-8.74, P < 0.001) were significant independent predictors for visceral pleural invasion. Receiver operating characteristic (ROC) analysis showed that, compared with the multivariate models [area under the curve (Az) 0.819-0.829], SUV max alone (Az 0.815) was useful in predicting visceral pleural invasion. In the subgroup analysis, multivariate analysis showed that SUV max (OR 1.29, 95 % CI 1.12-1.50, P = 0.001) and contact length with the pleura (OR 1.13, 95 % CI 1.05-1.22, P = 0.001) were significant independent predictors for visceral pleural invasion. ROC analysis showed that SUV max alone (Az 0.844) showed similar diagnostic performance to the multivariate models (Az 0.845-0.857). CONCLUSIONS: SUV max alone and multivariate models including SUV max are useful for the prediction of visceral pleural invasion by lung adenocarcinoma.

DOI： 10.1007/s12149-015-0999-x

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Risk factors for systemic air embolism as a complication of percutaneous CT-guided lung biopsy: multicenter case-control study. Reviewed International journal

Hiroaki Ishii, Takao Hiraki, Hideo Gobara, Hiroyasu Fujiwara, Hidefumi Mimura, Kotaro Yasui, Tetsuya Doke, Takashi Mukai, Hironori Kurokawa, Yoshitomo Ando, Soichiro Hase, Toshihiro Iguchi, Takayuki Yabuki, Kenichi Omae, Nobuhisa Tajiri, Toshiharu Mitsuhashi, Susumu Kanazawa

Cardiovascular and interventional radiology   37 ( 5 )   1312 - 20   2014.10

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PURPOSE: To determine risk factors for systemic air embolism by percutaneous computed tomography (CT)-guided lung biopsy. METHODS: This case-control study used data from 2216 percutaneous lung biopsy procedures performed over 11 years at 12 institutions in Japan. Systemic air embolism was identified by retrospective review of CT images obtained during and immediately after the procedures. To fulfill our objective, multiple variables were compared between cases and controls with univariate analyses by using Student's t test and Fisher's exact test for numerical and categorical values, respectively. Multivariate logistic regression analysis was then performed using selected variables. RESULTS: Ten cases of systemic air embolism and 2,206 controls were identified. Univariate analyses showed that the lesions in the lower lobe (P = 0.025) and occurrence of parenchymal hemorrhage (P = 0.019) were significant risk factors. Multivariate analysis showed that the use of a larger biopsy needle was a significant risk factor (P = 0.014). CONCLUSION: Parenchymal hemorrhage during the procedure, lesions in the lower lobe, and the use of larger biopsy needles may be risk factors for systemic air embolism by percutaneous CT-guided lung biopsy. Our findings may provide clues toward minimizing the risk of this complication.

DOI： 10.1007/s00270-013-0808-7

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A simple example as a pedagogical device? Reviewed International journal

Etsuji Suzuki, Toshiharu Mitsuhashi, Toshihide Tsuda, Eiji Yamamoto

Annals of epidemiology   24 ( 7 )   560 - 1   2014.7

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DOI： 10.1016/j.annepidem.2014.04.003

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Alternative definitions of "proportion eliminated". Reviewed International journal

Etsuji Suzuki, Toshiharu Mitsuhashi, Toshihide Tsuda, Eiji Yamamoto

Epidemiology (Cambridge, Mass.)   25 ( 2 )   308 - 9   2014.3

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Language：English   Publisher：LIPPINCOTT WILLIAMS & WILKINS  

DOI： 10.1097/EDE.0000000000000050

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A counterfactual approach to bias and effect modification in terms of response types. Reviewed International journal

Etsuji Suzuki, Toshiharu Mitsuhashi, Toshihide Tsuda, Eiji Yamamoto

BMC medical research methodology   13   101 - 101   2013.7

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BACKGROUND: The counterfactual approach provides a clear and coherent framework to think about a variety of important concepts related to causation. Meanwhile, directed acyclic graphs have been used as causal diagrams in epidemiologic research to visually summarize hypothetical relations among variables of interest, providing a clear understanding of underlying causal structures of bias and effect modification. In this study, the authors aim to further clarify the concepts of bias (confounding bias and selection bias) and effect modification in the counterfactual framework. METHODS: The authors show how theoretical data frequencies can be described by using unobservable response types both in observational studies and in randomized controlled trials. By using the descriptions of data frequencies, the authors show epidemiologic measures in terms of response types, demonstrating significant distinctions between association measures and effect measures. These descriptions also demonstrate sufficient conditions to estimate effect measures in observational studies. To illustrate the ideas, the authors show how directed acyclic graphs can be extended by integrating response types and observed variables. RESULTS: This study shows a hitherto unrecognized sufficient condition to estimate effect measures in observational studies by adjusting for confounding bias. The present findings would provide a further understanding of the assumption of conditional exchangeability, clarifying the link between the assumptions for making causal inferences in observational studies and the counterfactual approach. The extension of directed acyclic graphs using response types maintains the integrity of the original directed acyclic graphs, which allows one to understand the underlying causal structure discussed in this study. CONCLUSIONS: The present findings highlight that analytic adjustment for confounders in observational studies has consequences quite different from those of physical control in randomized controlled trials. In particular, the present findings would be of great use when demonstrating the inherent distinctions between observational studies and randomized controlled trials.

DOI： 10.1186/1471-2288-13-101

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Shift work and diabetes mellitus among male workers in Japan: does the intensity of shift work matter? Reviewed

Katsuhiko Ika, Etsuji Suzuki, Toshiharu Mitsuhashi, Soshi Takao, Hiroyuki Doi

Acta medica Okayama   67 ( 1 )   25 - 33   2013

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：OKAYAMA UNIV MED SCHOOL  

The purpose of this study was to examine the association between shift work and diabetes mellitus by separating shift workers according to the intensity of their shift work (seasonal shift work and continuous shift work). Between May and October 2009, we collected data from annual health checkups and questionnaires at a manufacturing company in Shizuoka, Japan. Questionnaires were returned by 1,601 workers (response rate: 96.2%, men/women = 1,314/287). Diabetes mellitus was defined as hemoglobin A1c ≥ 6.5% and fasting blood sugar ≥ 126 mg/dl. After exclusions, which included all the women and clerical workers because they did not work in shifts, we analyzed 475 skilled male workers. After adjusting for age, smoking status, frequency of alcohol consumption, and cohabitation status, odds ratios for diabetes mellitus were 0.98 (95% confidence interval [CI]: 0.28-4.81) and 2.10 (95% CI: 0.77-5.71) among seasonal shift workers and continuous shift workers, respectively, compared with non-shift workers. In an age-stratified analysis (<45 years vs. ≥45 years), the association between continuous shift work and diabetes mellitus was more pronounced among older participants. Compared with non-shift workers, the risk of diabetes mellitus was increased among continuous shift workers, whereas its effect is limited among seasonal shift workers.

DOI： 10.18926/AMO/49254

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Influence of radiofrequency ablation of lung cancer on pulmonary function. Reviewed International journal

Akihiro Tada, Takao Hiraki, Toshihiro Iguchi, Hideo Gobara, Hidefumi Mimura, Shinichi Toyooka, Katsuyuki Kiura, Toshihide Tsuda, Toshiharu Mitsuhashi, Susumu Kanazawa

Cardiovascular and interventional radiology   35 ( 4 )   860 - 7   2012.8

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PURPOSE: The purpose of this study was to evaluate altered pulmonary function retrospectively after RFA. METHODS: This retrospective study comprised 41 ablation sessions for 39 patients (22 men and 17 women; mean age, 64.8 years). Vital capacity (VC) and forced expiratory volume in 1 s (FEV(1)) at 1 and 3 months after RFA were compared with the baseline (i.e., values before RFA). To evaluate the factors that influenced impaired pulmonary function, univariate analysis was performed by using multiple variables. If two or more variables were indicated as statistically significant by univariate analysis, these variables were subjected to multivariate analysis to identify independent factors. RESULTS: The mean VC and FEV(1) before RFA and 1 and 3 months after RFA were 3.04 and 2.24 l, 2.79 and 2.11 l, and 2.85 and 2.13 l, respectively. The values at 1 and 3 months were significantly lower than the baseline. Severe pleuritis after RFA was identified as the independent factor influencing impaired VC at 1 month (P = 0.003). For impaired FEV(1) at 1 month, only severe pleuritis (P = 0.01) was statistically significant by univariate analysis. At 3 months, severe pleuritis (VC, P = 0.019; FEV(1), P = 0.003) and an ablated parenchymal volume ≥20 cm(3) (VC, P = 0.047; FEV(1), P = 0.038) were independent factors for impaired VC and FEV(1). CONCLUSIONS: Pulmonary function decreased after RFA. RFA-induced severe pleuritis and ablation of a large volume of marginal parenchyma were associated with impaired pulmonary function.

DOI： 10.1007/s00270-011-0221-z

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Phrenic nerve injury after radiofrequency ablation of lung tumors: retrospective evaluation of the incidence and risk factors. Reviewed International journal

Yusuke Matsui, Takao Hiraki, Hideo Gobara, Mayu Uka, Yoshihisa Masaoka, Akihiro Tada, Shinichi Toyooka, Toshiharu Mitsuhashi, Hidefumi Mimura, Susumu Kanazawa

Journal of vascular and interventional radiology : JVIR   23 ( 6 )   780 - 5   2012.6

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PURPOSE: To retrospectively investigate the incidence of and risk factors for phrenic nerve injury after radiofrequency (RF) ablation of lung tumors. MATERIALS AND METHODS: The study included 814 RF ablation procedures of lung tumors. To evaluate the development of phrenic nerve injury, chest radiographs obtained before and after the procedure were examined. Phrenic nerve injury was assumed to have developed if the diaphragmatic level was elevated after the procedure. To identify risk factors for phrenic nerve injury, multiple variables were compared between cases of phrenic nerve injury and randomly selected controls by using univariate analyses. Multivariate analysis was then performed to identify independent risk factors. RESULTS: Evaluation of phrenic nerve injury from chest radiographs was possible after 786 procedures. Evidence of phrenic nerve injury developed after 10 cases (1.3%). Univariate analysis revealed that larger tumor size (≥ 20 mm; P = .014), proximity of the phrenic nerve to the tumor (< 10 mm; P < .001), the use of larger electrodes (array diameter or noninsulated tip length ≥ 3 cm; P = .001), and higher maximum power applied during ablation (≥ 100 W; P < .001) were significantly associated with the development of phrenic nerve injury. Multivariate analysis demonstrated that the proximity of the phrenic nerve to the tumor (< 10 mm; P < .001) was a significant independent risk factor. CONCLUSIONS: The incidence of phrenic nerve injury after RF ablation was 1.3%. The proximity of the phrenic nerve to the tumor was an independent risk factor for phrenic nerve injury.

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Preoperative graft volume assessment with 3D-CT volumetry in living-donor lobar lung transplantations. Reviewed

Katsuhide Kojima, Katsuya Kato, Takahiro Oto, Toshiharu Mitsuhashi, Takayoshi Shinya, Tetsuro Sei, Yoshihiro Okumura, Shuhei Sato, Shinichiro Miyoshi, Susumu Kanazawa

Acta medica Okayama   65 ( 4 )   265 - 8   2011.8

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：OKAYAMA UNIV MED SCHOOL  

To determine the effectiveness of living-donor lobar lung transplantation (LDLLT), it is necessary to predict the recipient's postoperative lung function. Traditionally, Date's formula, also called the segmental ratio, has used the number of lung segments to estimate the forced vital capacity (FVC) of grafts in LDLLT. To provide a more precise estimate of graft FVC, we calculated the volumes of the lower lobe and total lung using three-dimensional computed tomography (3D-CT) and the volume ratio between them. We calculated the volume ratio in 52 donors and tested the difference between the segmental volume ratios with a one-tailed t-test. We also calculated the predicted graft FVC in 21 LDLLTs using the segmental ratio pFVC(c) and the volume ratio pFVC(v), and then found the Pearson's correlation coefficients for both pFVC(c) and pFVC(v) with the recipients' actual FVC (rFVC) measured spirometrically 6 months after surgery. Significant differences were found between the segmental ratio and the average volume ratio for both sides (right, p＝0.03;left, p＝0.0003). Both pFVC(c) and pFVC(v) correlated significantly with rFVC at 6 months after surgery (p＝0.007 and 0.006). Both the conventional and the volumetric methods provided FVC predictions that correlated significantly with measured postoperative FVC.

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Evaluation of an internet-based self-help program for better quality of sleep among Japanese workers: a randomized controlled trial. Reviewed International journal

Etsuji Suzuki, Masao Tsuchiya, Kumi Hirokawa, Toshiyo Taniguchi, Toshiharu Mitsuhashi, Norito Kawakami

Journal of occupational health   50 ( 5 )   387 - 99   2008

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Language：English   Publishing type：Research paper (scientific journal)   Publisher：JAPAN SOC OCCUPATIONAL HEALTH  

The effectiveness of Internet-based self-help programs for insomnia is still unclear. A randomized controlled trial was conducted to evaluate the effect of an Internet-based self-help program for better quality of sleep among adult workers. Forty-three volunteers were recruited and randomly assigned to either an intervention group (n=21) or a waiting-list group (n=22). The intervention group participated in a two-week Internet-based program, including selecting and daily practicing sleep-related target behaviors and monitoring those behaviors along with sleep quality. At the same time, each participant received automatically generated, personalized messages and reports both daily and weekly. A total of 12 intervention group participants and 18 waiting-list group participants completed questionnaires at baseline, post-intervention, and at a 3-wk follow-up. Subjective sleep quality was measured by a self-reported questionnaire developed for this study. The sleep quality score increased in the intervention group at post-intervention, with a significant interaction effect [F(1,28)=5.19, p=0.031]. Sleep-related behaviors also greatly increased in the intervention group at post-intervention, with a significant interaction effect [F(1,28)=7.14, p=0.012]. Sleep-onset latency reduced in the intervention group at follow-up, with a marginally significant effect [F(1,28)=3.52, p=0.071]. The Internet-based self-help program improves subjective sleep quality and sleep-onset latency among adult workers.

DOI： 10.1539/joh.L7154

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