Faculty Profiles - MITSUHASHI Toshiharu

Papers - MITSUHASHI Toshiharu

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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

Publishing type：Research paper (scientific journal) Publisher：Wiley

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 < 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

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

Publisher：Cold Spring Harbor Laboratory

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: <1.0 (reference), 1.0–<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 <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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Publishing type：Research paper (scientific journal) Publisher：Wiley

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

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

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

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

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

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

Publisher：Cold Spring Harbor Laboratory

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 (<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

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

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

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

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

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

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

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

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

Publisher：Cold Spring Harbor Laboratory

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 <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

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

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

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

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

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

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

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

Publishing type：Research paper (scientific journal) Publisher：BMJ

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

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

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

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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