研究者詳細 - 座間味　義人

論文 - 座間味　義人

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Population-Based Observational Study of Adverse Drug Event-Related Mortality in the Super-Aged Society of Japan. 国際誌

Tomoko Funahashi, Toshihiro Koyama, Hideharu Hagiya, Ko Harada, Syunya Iinuma, Soichiro Ushio, Yoshito Zamami, Takahiro Niimura, Kazuaki Shinomiya, Keisuke Ishizawa, Toshiaki Sendo, Shiro Hinotsu, Mitsunobu R Kano

Drug safety 44 ( 5 ) 531 - 539 2021年5月

記述言語：英語掲載種別：研究論文（学術雑誌）

INTRODUCTION: Adverse drug events (ADEs) are a major cause of mortality. OBJECTIVE: We examined long-term trends for ADE-related deaths in Japan. METHODS: This observational study was conducted using the Japanese Vital Statistics from 1999 to 2016. Data for all ADE-related deaths were extracted using International Classification of Diseases, Tenth Revision codes. We analysed ADE-related deaths by age and sex and calculated crude and age-standardised mortality rates (ASMR) per 100,000 people. We used Joinpoint regression analysis to identify significant changing points in mortality trends and to estimate annual percentage change (APC). RESULTS: In total, 16,417 ADE-related deaths were identified. The crude mortality rate for individuals aged ≥ 65 years was higher than that of young individuals. The ASMR per 100,000 people increased from 0.44 in 1999 to 0.64 in 2016. The crude mortality rate increased from 0.44 in 1999 to 1.01 in 2016. The APC of ASMR increased at a rate of 2.8% (95% confidence interval [CI] 1.4-4.2) throughout the study period. In addition, crude mortality increased at a rate of 5.7% (95% CI 4.2-7.3) annually from 1999 to 2016. The ADE-related mortality rate was higher for men than for women during the study period. CONCLUSIONS: The number of and trend in ADE-related deaths increased in Japan from 1999 to 2016, particularly in the older population.

DOI： 10.1007/s40264-020-01037-9

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Trends in hepatitis C virus-associated mortality rates in Japan, 1998-2017. 国際誌

Hideharu Hagiya, Toshihiro Koyama, Matsuo Deguchi, Yusuke Minato, Satomi Miura, Tomoko Funahashi, Yusuke Teratani, Yoshito Zamami, Kazuaki Shinomiya, Yoshihisa Kitamura, Toshiaki Sendo, Shiro Hinotsu, Mitsunobu Kano

Journal of gastroenterology and hepatology 36 ( 9 ) 2486 - 2492 2021年4月

記述言語：英語掲載種別：研究論文（学術雑誌）

BACKGROUND AND AIM: The current prevalence of hepatitis C virus infection and hepatitis C virus-associated mortality in Japan falls short of the World Health Organization goal of viral hepatitis elimination by 2030. We aimed to evaluate the trends in hepatitis C virus-associated mortality in Japan. METHODS: This nationwide observational study used the Japanese Vital Statistics from 1998 to 2017 and included all Japanese hepatitis C virus-associated deaths (84 936) of adults aged ≥ 40 years. We calculated the crude and age-standardized mortality rates per 100 000 persons by age and sex. Joinpoint regression analysis was used to identify significant changing points in trends and to estimate the annual percentage changes and the average annual percentage changes for the entire study period. RESULTS: The crude mortality rate per 100 000 persons (annual death number) increased from 5.5 (3548) in 1998 to 7.0 (4843) in 2005 and decreased to 4.0 (3095) in 2017. By 2017, the crude mortality rates per 100 000 persons among men and women had dropped to 3.6 and 4.3, respectively. The age-standardized mortality rate was higher in women than in men. The average annual percentage change was -3.8% (95% confidence interval: -5.0 to -2.5). The declining trend was more rapid in men (-4.5%, 95% confidence interval: -5.3 to -3.6) than in women (-2.7%, 95% confidence interval: -3.8 to -1.6). CONCLUSIONS: Trends in hepatitis C virus-associated mortality rates have declined in an accelerating manner in Japan, especially among men.

DOI： 10.1111/jgh.15517

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薬剤誘発性大動脈解離易発症モデルマウスを用いた薬効評価

石澤有紀, 合田光寛, 相澤風花, 座間味義人, 濱野裕章, 八木健太, 池田康将, 石澤啓介, 玉置俊晃

四国医学雑誌 77 ( 1-2 ) 57 - 62 2021年4月

オキサリプラチン誘発末梢神経障害に対するHMG-CoA還元酵素阻害剤の影響

相澤風花, 座間味義人, 濱野裕章, 石澤啓介, 梶本春奈, 森山大嗣, 新村貴博, 合田光寛, 八木健太, 石澤有紀

四国医学雑誌 77 ( 1-2 ) 109 - 109 2021年4月

A comparison of the safety and effectiveness of prasugrel and clopidogrel in younger population undergoing percutaneous coronary intervention: A retrospective study using a Japanese claims database. 国際誌

Hiromi Hagiwara, Hidekatsu Fukuta, Hiroya Hashimoto, Takahiro Niimura, Yoshito Zamami, Keisuke Ishizawa, Takeshi Kamiya, Nobuyuki Ohte

Journal of cardiology 77 ( 3 ) 285 - 291 2021年3月

記述言語：英語掲載種別：研究論文（学術雑誌）

BACKGROUND: Prasugrel inhibits platelet aggregation more potently than clopidogrel. In the global phase III trial, prasugrel [loading dose/maintenance dose (LD/MD), 60/10 mg] reduced the incidence of ischemic events but involved a higher risk of hemorrhage than clopidogrel in patients with acute coronary syndromes who were scheduled to undergo percutaneous coronary intervention (PCI). In the Japanese phase III trial for similar patients wherein the prasugrel dose regimen was adjusted (LD/MD, 20/3.75 mg), the efficacy of prasugrel and clopidogrel were comparable to that in the global trial; however, the safety could not be determined due to limited power. Given the strict enrollment criteria, the results of the Japanese phase III trial may not be applicable to routine clinical practice. We compared the safety and effectiveness of prasugrel and clopidogrel in the real-world setting in Japanese patients. METHODS: With an analysis of a large claims database prepared during the post-marketing stages in Japan, we identified patients undergoing PCI and compared the incidence of bleeding and ischemic coronary events between patients who received prasugrel and those receiving clopidogrel. RESULTS: Between January 1, 2014 and December 31, 2018, we identified 1977 patients who were scheduled to undergo urgent PCI (urgent PCI cohort) and 1922 who were scheduled to undergo elective PCI (elective PCI cohort). After propensity-score matching, there were no significant differences in the baseline clinical characteristics of the prasugrel and clopidogrel groups in the urgent (n = 1080) and elective PCI (n = 1626) cohorts. In Cox proportional hazard analyses, there were no significant differences in the incidence of bleeding or ischemic coronary events during the median 8-month follow-up in both cohorts. CONCLUSIONS: The safety and effectiveness of prasugrel was comparable to that of clopidogrel in real-world Japanese patients scheduled to undergo PCI.

DOI： 10.1016/j.jjcc.2020.10.001

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【抗菌薬供給トラブルもし入手困難になったら、そのときどうする】主要な抗菌薬が供給不足になったときに考慮する代替薬セファゾリン、セファレキシン

岡田直人, 座間味義人, 石澤啓介

薬局 72 ( 3 ) 422 - 426 2021年3月

記述言語：日本語出版者・発行元：(株)南山堂

＜Key Points＞◎セファゾリンやセファレキシンは黄色ブドウ球菌やレンサ球菌、大腸菌・クレブシエラ属・プロテウス属、ペプトストレプトコッカス属に抗菌活性を示す。◎セファゾリンは他のセファロスポリン系抗菌薬やバンコマイシンと比較してメチシリン感性黄色ブドウ球菌(MSSA)菌血症における治療失敗率が有意に低い。◎無菌検体からMSSAが検出された感染症の場合は、セファゾリンを優先的に使用できるようなスキームの構築が必要である。◎MSSAをターゲットにした手術部位感染の予防の場合は、施設のアンチバイオグラムを参考に、良好な抗菌活性を示す狭域スペクトルの抗菌薬を用いる。◎セファゾリンやセファレキシンの代替薬を考える場合、抗菌スペクトルの「大は小を兼ねる」理論は適さない場合があることに留意する。(著者抄録)

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第5回病院薬剤師が実践するリバーストランスレーショナルリサーチの最前線〜臨床情報を突破口とした創薬・育薬研究〜大規模医療情報データベースを活用した抗がん剤副作用予防のためのリバーストランスレーショナルリサーチ

合田光寛, 座間味義人, 新村貴博, 萱野純史, 濱野裕章, 岡田直人, 相澤風花, 八木健太, 石澤有紀, 桐野靖, 中村敏己, 石澤啓介

日本薬学会年会要旨集 141年会 S21 - 3 2021年3月

COVID-19感染拡大に伴うオンライン型薬学実務実習の導入

相澤風花, 座間味義人, 濱野裕章, 岡田直人, 林明希, 八木健太, 合田光寛, 桐野靖, 中村敏己, 石澤啓介

日本薬学会年会要旨集 141年会 28P01 - 257 2021年3月

大規模医療情報データベースを活用したバンコマイシン関連腎障害に対する薬剤性腎障害原因薬剤の多剤併用における影響

坂東貴司, 中馬真幸, 新村貴博, 座間味義人, 石澤有紀, 合田光寛, 八木健太, 濱野裕章, 岡田直人, 泉侑希, 桐野靖, 中村敏己, 石澤啓介

日本薬学会年会要旨集 141年会 27V11 - pm01 2021年3月

次世代の若手研究者が切り開く薬学研究の発展と医療への貢献大規模医療情報データベースを用いたドキソルビシン誘発心筋症に対する予防薬の探索

阪本淑華, 座間味義人, 新村貴博, 相澤風花, 八木健太, 合田光寛, 石澤有紀, 石澤啓介

日本薬学会年会要旨集 141年会 GS04 - 6 2021年3月

大規模医療情報データベースを活用したバンコマイシン関連腎障害に対する薬剤性腎障害原因薬剤の多剤併用における影響

坂東貴司, 中馬真幸, 新村貴博, 座間味義人, 石澤有紀, 合田光寛, 八木健太, 濱野裕章, 岡田直人, 泉侑希, 桐野靖, 中村敏己, 石澤啓介

日本薬学会年会要旨集 141年会 27V11 - pm01 2021年3月

基礎研究と臨床研究の融合による薬剤性末梢神経障害に対する予防薬探索

新村貴博, 座間味義人, 川尻雄大, 合田光寛, 相澤風花, 八木健太, 石澤有紀, 石澤啓介

日本薬学会年会要旨集 141年会 27P02 - 198S 2021年3月

COVID-19感染拡大に伴うオンライン型薬学実務実習の導入

相澤風花, 座間味義人, 濱野裕章, 岡田直人, 林明希, 八木健太, 合田光寛, 桐野靖, 中村敏己, 石澤啓介

日本薬学会年会要旨集 141年会 28P01 - 257 2021年3月

合田光寛, 座間味義人, 新村貴博, 萱野純史, 濱野裕章, 岡田直人, 相澤風花, 八木健太, 石澤有紀, 桐野靖, 中村敏己, 石澤啓介

日本薬学会年会要旨集 141年会 S21 - 3 2021年3月

次世代の若手研究者が切り開く薬学研究の発展と医療への貢献レニン・アンジオテンシン・アルドステロン系阻害薬はオキサリプラチン誘発末梢神経障害の発症を抑制する

内田真美, 牛尾聡一郎, 新村貴博, 飛鷹範明, 田中亮裕, 北村佳久, 千堂年昭, 座間味義人, 石澤啓介, 武智研志, 柴田和彦, 難波弘行, 川崎博己, 高取真吾

日本薬学会年会要旨集 141年会 GS04 - 5 2021年3月

Concomitant Use of Acetaminophen and Aspirin Increases Risk of Kidney Injury: Analysis of the Japanese Adverse Drug Event Report Database. 国際誌

Satoru Mitsuboshi, Takahiro Niimura, Yoshito Zamami

Journal of clinical pharmacology 61 ( 2 ) 269 - 270 2021年2月

The Risk Factors Associated with Immune Checkpoint Inhibitor-Related Pneumonitis. 国際誌

Mizuho Asada, Takahisa Mikami, Takahiro Niimura, Yoshito Zamami, Yoshihiro Uesawa, Masayuki Chuma, Keisuke Ishizawa

Oncology 99 ( 4 ) 1 - 4 2021年1月

記述言語：英語

BACKGROUND: Pneumonitis is a serious adverse event in patients treated with immune checkpoint inhibitors (ICIs), with a mortality rate of up to 20%. The risk factors for ICI-related pneumonitis remain unclear due to the scarce data and infrequent event rate of 0-10% for all grades in patients using ICIs. OBJECTIVES: This study evaluated the risk factors for ICI-related pneumonitis using the United States Food and Drug Administration (US FDA) Adverse Event Reporting System (FAERS) database. METHOD: To investigate the association between pneumonitis and ICIs, the FAERS database, which contains spontaneous adverse event reports submitted to the US FDA, was utilized. Data between January 2014 and December 2019 were collected. Univariate logistic regression analysis with covariates, including age, sex, and ICI use, was performed to assess the risk of ICI-related pneumonitis. The relative risk of pneumonitis was estimated using by the odds ratio. RESULTS: We identified 4,248,808 reports, including 51,166 cases of those who received eight different ICIs. Nivolumab was the most common ICI (n = 27,273 of 51,166 [53.3%] patients). Reporting rates of pneumonitis were significantly high in ICI users (odds ratio 29.48; 95% confidence interval [CI], 27.49-31.62). Univariate logistic regression analysis showed that pneumonitis risk was significantly associated with age. Age ≤60 years old was associated with an increase in the reported frequency of pneumonitis. CONCLUSIONS: Our data suggest that the risk of ICI-related pneumonitis may increase in certain populations, including younger age (age <60 years) and ICIs users. These patients require careful monitoring.

DOI： 10.1159/000512633

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Neuroimmunological adverse events associated with immune checkpoint inhibitor: a retrospective, pharmacovigilance study using FAERS database. 国際誌

Takahisa Mikami, Bobby Liaw, Mizuho Asada, Takahiro Niimura, Yoshito Zamami, Deborah Green-LaRoche, Lori Pai, Michael Levy, Suriya Jeyapalan

Journal of neuro-oncology 152 ( 1 ) 135 - 144 2021年1月

記述言語：英語掲載種別：研究論文（学術雑誌）

PURPOSE: To investigate the characteristics and risk factors for neurologic adverse events (AEs) induced by immune checkpoint inhibitors (ICIs). METHODS: An observational, retrospective, and pharmacovigilance study based on the FAERS database collected between January 2014 and December 2019 was conducted. ICI-related AEs were defined as adverse reactions in patients using anti-PD-1 (nivolumab and pembrolizumab), anti-PD-L1 (atezolizumab, avelumab, and durvalumab), and anti-CTLA-4 (ipilimumab and tremelimumab). Neurologic AEs previously reported to be associated with ICI were evaluated in the disproportionality analysis using the reporting odds ratio (ROR). RESULTS: Among 50,406 ICI-related reports, 3619 (7.2%) neurological case was found: 1985 with anti-PD-1, 372 with anti-PD-L1, 366 with anti-CTLA-4, and 896 with the combination of ICIs. In comparison to non-ICI drug use, ICI use demonstrated higher risk for neurologic complication, including hypophysitis/hypopituitarism, myasthenia gravis, encephalitis/myelitis, meningitis, Guillain-Barre syndrome, vasculitis, and neuropathy. The risk of neurologic AEs associated with ICI combination therapy was as high as or even higher than ICI monotherapy, most significantly in hypophysitis/hypopituitarism. The proportion of serious neurological events and death related to combination therapy has been decreasing in recent years. Older age, male and female sex, and metastasis were not significant risk factors for the incidence of neurologic ICI-related AEs. Patients at older age, with melanoma or non-small cell lung cancer, or on dual ICI therapy may be at higher risk of fatal neurologic AEs. CONCLUSION: ICI use is associated with a higher risk of neurological complications, with dual ICI therapy posing a higher risk, while older age, sex, or metastasis were not. Patients at older age, with certain cancer types, or on dual ICI therapy may be at higher risk of fatal neurologic AEs.

DOI： 10.1007/s11060-020-03687-2

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Investigation of drugs affecting hypertension in bevacizumab-treated patients and examination of the impact on the therapeutic effect. 国際誌

Kenta Yagi, Marin Mitstui, Yoshito Zamami, Takahiro Niimura, Yuki Izawa-Ishizawa, Mitsuhiro Goda, Masayuki Chuma, Kimiko Fukunaga, Takahiro Shibata, Shunsuke Ishida, Takumi Sakurada, Naoto Okada, Hirofumi Hamano, Yuya Horinouchi, Yasumasa Ikeda, Hiroaki Yanagawa, Keisuke Ishizawa

Cancer medicine 10 ( 1 ) 164 - 172 2021年1月

記述言語：英語掲載種別：研究論文（学術雑誌）

BACKGROUND: In patients treated with bevacizumab, hypertension may be a biomarker of therapeutic efficacy. However, it is not clear whether drugs that control blood pressure influence bevacizumab's efficacy. In this study, we investigated drugs that may affect hypertension in bevacizumab-treated patients and examined the impact on the therapeutic effect. PATIENTS AND METHODS: We analyzed 3,724,555 reports from the third quarter of 2010 to the second quarter of 2015. All data were obtained from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) analysis. In this retrospective cohort study, we investigated a total of 58 patients diagnosed with colorectal cancer and treated for the first time with bevacizumab containing XELOX or mFOLFOX6 at The University of Tokushima Hospital between January 2010 and December 2015. The effect of the treatment was evaluated according to Response Evaluation Criteria in Solid Tumors version 1.0. Thereafter, the effect was confirmed using Gene Expression Omnibus (GEO) and cultured cells. RESULTS: There are few reports in FAERS of hypertension in patients treated with omeprazole on bevacizumab. Based on the chart review, patients who used proton pump inhibitors (PPI) had a lower response to treatment than those who did not (response rate: 25% vs 50%). Furthermore, experiments on GEO and cell lines suggested that induction of vascular endothelial growth factor (VEGF) gene expression by PPIs is the cause of the reduced therapeutic effect. CONCLUSION: PPIs prevent hypertension in bevacizumab-treated patients but may reduce bevacizumab's anti-tumoral effects by inducing VEGF expression.

DOI： 10.1002/cam4.3587

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Advanced Life Support vs. Basic Life Support for Patients With Trauma in Prehospital Settings: A Systematic Review and Meta-Analysis. 国際誌

Yutaka Kondo, Tatsuma Fukuda, Ryo Uchimido, Masahiro Kashiura, Soichiro Kato, Hiroshi Sekiguchi, Yoshito Zamami, Toru Hifumi, Kei Hayashida

Frontiers in medicine 8 660367 - 660367 2021年

記述言語：英語

Background: Advanced Life Support (ALS) is regarded to be associated with improved survival in pre-hospital trauma care when compared to Basic Life Support (BLS) irrespective of lack of evidence. The aim of this study is to ascertain ALS improves survival for trauma in prehospital settings when compared to BLS. Methods: We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for published controlled trials (CTs), and observational studies that were published until Aug 2017. The population of interest were adults (>18 years old) trauma patients who were transported by ground transportation and required resuscitation in prehospital settings. We compared outcomes between the ALS and BLS groups. The primary outcome was in-hospital mortality and secondary outcomes were neurological outcome and time spent on scene. Results: We identified 2,502 studies from various databases and 10 studies were included in the analysis (two CTs, and eight observational studies). The outcomes were not statistically significant between the ALS and BLS groups (pooled OR 1.14; 95% CI 0.95 to 1.36 for mortality, pooled OR 1.12; 95% CI 0.88 to 1.42 for good neurological outcomes, pooled mean difference -0.96; 95% CI-6.64 to 4.72 for on-scene time) in CTs. In observational studies, ALS prolonged on-scene time and increased mortality (pooled OR 1.56; 95% CI: 1.31 to 1.86 for mortality, and pooled mean difference, 1.26; 95% CI: 0.07 to 2.45 for on-scene time). Conclusions: In prehospital settings, the present study showed no advantages of ALS on the outcomes in patients with trauma compared to BLS.

DOI： 10.3389/fmed.2021.660367

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