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Construction of novel MHC-class II based strategy and evaluation method for drug-induced myopathy.

Research Project

Project/Area Number 15K15009
Research Category

Grant-in-Aid for Challenging Exploratory Research

Allocation TypeMulti-year Fund
Research Field Medical pharmacy
Research InstitutionNational Institute of Health Sciences

Principal Investigator

Saito Yoshiro  国立医薬品食品衛生研究所, 医薬安全科学部, 部長 (50215571)

Co-Investigator(Kenkyū-buntansha) 児玉 進  岡山大学, 医歯薬学総合研究科, 准教授 (20621460)
中村 亮介  国立医薬品食品衛生研究所, 医薬安全科学部, 室長 (50333357)
Project Period (FY) 2015-04-01 – 2019-03-31
Project Status Completed (Fiscal Year 2018)
Budget Amount *help
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2016: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Keywords副作用 / 機序 / HLA / ゲノム / 薬剤反応性 / トランスレーショナルリサーチ
Outline of Final Research Achievements

Drug-induced myopathy, including rhabdomyolysis, is a severe adverse reaction that may result in renal failure and death in severe cases. We found a human leukocyte antigen HLA-DRB1 type that was significantly associated with statin-related myopathy by a genome analysis of Japanese patients who developed drug-induced myopathy. In this study, we confirmed the situation of statins in suspected drugs among the reported rhabdomyolysis cases in Japan and evaluated the interaction between HLA-DRB1 protein and suspected drugs.

Academic Significance and Societal Importance of the Research Achievements

本研究結果は、HLA-DRB1と医薬品との相互作用の可能性を示唆したものであり、重篤副作用の発現機序の理解に一定の意義があると考えられる。またその過程で行った、医薬品医療機器総合機構に「横紋筋融解症」として報告された数の医薬品別の集計結果は、本副作用の安全対策に貢献しうる情報と考えられる。

Report

(5 results)
  • 2018 Annual Research Report   Final Research Report ( PDF )
  • 2017 Research-status Report
  • 2016 Research-status Report
  • 2015 Research-status Report
  • Research Products

    (17 results)

All 2019 2018 2017 2016 2015 Other

All Int'l Joint Research (1 results) Journal Article (6 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 5 results,  Open Access: 1 results,  Acknowledgement Compliant: 1 results) Presentation (10 results) (of which Int'l Joint Research: 1 results,  Invited: 8 results)

  • [Int'l Joint Research] The University of Liverpool(英国)

    • Related Report
      2017 Research-status Report
  • [Journal Article] Conference report: pharmacogenomics in special populations at WCP20182019

    • Author(s)
      Suarez‐Kurtz Guilherme、Aklillu Eleni、Saito Yoshiro、Somogyi Andrew A.
    • Journal Title

      British Journal of Clinical Pharmacology

      Volume: 85 Issue: 3 Pages: 467-475

    • DOI

      10.1111/bcp.13828

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Points-to-consider documents: Scientific information on the evaluation of genetic polymorphisms during non-clinical studies and phase I clinical trials in the Japanese population2018

    • Author(s)
      Hiratsuka Masahiro、Hirasawa Noriyasu、Oshima Yoshiteru、Kodama Susumu、Miyata Toshio、Dan Takashi、Takatoku Hiroyuki、Kuribayashi Hideaki、Nakamura Ryosuke、Saito Yoshiro
    • Journal Title

      Drug Metabolism and Pharmacokinetics

      Volume: 33 Issue: 3 Pages: 141

    • DOI

      10.1016/j.dmpk.2018.01.005

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Pharmacogenomic information in the Warning section of drug labels: A comparison between labels in the United States and those in five other countries/regions.2018

    • Author(s)
      Imatoh T, Sai K, Saito Y
    • Journal Title

      J Clin Pharm Ther.

      Volume: 43 Issue: 4 Pages: 493-499

    • DOI

      10.1111/jcpt.12691

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Pharmacogenomic information in the Warning section of drug labels: A comparison between labels in the United States and those in five other countries/regions.2018

    • Author(s)
      Imatoh T, Sai K, Saito Y
    • Journal Title

      J Clin Pharm Ther.

      Volume: 43

    • Related Report
      2017 Research-status Report
    • Peer Reviewed
  • [Journal Article] Diurnal glycemic fluctuation is associated with severity of coronary artery disease in prediabetic patients: Possible role of nitrotyrosine and glyceraldehyde-derived advanced glycation end products2017

    • Author(s)
      Watanabe M. Kawai Y, Kitayama M, Akao H, Motoyama A, Wakasa M, Saito R, Aoki H, Fujibayashi K, Tsuchiya T, Nakanishi H, Saito K, Takeuchi M, Kajinami K.
    • Journal Title

      Journal of Cardiology

      Volume: 69 Issue: 6 Pages: 625-631

    • DOI

      10.1016/j.dmpk.2016.09.002

    • Related Report
      2016 Research-status Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant
  • [Journal Article] 臨床における重症薬疹とゲノムマーカー.2015

    • Author(s)
      岡本(内田)好海, 児玉進, 中村亮介, 斎藤嘉朗
    • Journal Title

      毒性質問箱

      Volume: 17 Pages: 18-23

    • Related Report
      2015 Research-status Report
  • [Presentation] Pharmacogenomic research and its implementation in Asian region2018

    • Author(s)
      Saito Y
    • Organizer
      18th World Congress of Basic and Clinical Pharmacology
    • Related Report
      2018 Annual Research Report
    • Invited
  • [Presentation] 副作用回避へのバイオマーカー情報の応用と課題2017

    • Author(s)
      斎藤嘉朗
    • Organizer
      第55回日本癌治療学会学術集会
    • Related Report
      2017 Research-status Report
    • Invited
  • [Presentation] オミックス解析による副作用バイオマーカー開発の進展2017

    • Author(s)
      斎藤嘉朗
    • Organizer
      第38回日本臨床薬理学会学術集会
    • Related Report
      2017 Research-status Report
    • Invited
  • [Presentation] 副作用予測のためのゲノムバイオマーカー探索とそのin vitro 評価2016

    • Author(s)
      斎藤嘉朗、前川京子、中村亮介
    • Organizer
      第29回 日本動物実験代替法学会
    • Place of Presentation
      福岡
    • Year and Date
      2016-11-17
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] Use of PGx information for prediction of severe adverse drug reactions: Current status and future perspectives2016

    • Author(s)
      Yoshiro Saito, Keiko Maekawa, Ryosuke Nakamura
    • Organizer
      第14回日本臨床腫瘍学会学術年会
    • Place of Presentation
      神戸
    • Year and Date
      2016-07-28
    • Related Report
      2016 Research-status Report
    • Invited
  • [Presentation] Prediction of severe adverse drug reactions using pharmacogenomic biomarkers: Current status and future prospects in Japan2016

    • Author(s)
      Yoshiro Saito, Keiko Maekawa and Ryosuke Nakamura
    • Organizer
      International Conference on Human Genetics
    • Place of Presentation
      Kyoto
    • Year and Date
      2016-04-06
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] 日本人におけるスタチン誘因性筋障害発症と関連するHLA遺伝子型2015

    • Author(s)
      佐井君江,梶波康二,赤尾浩慶,今任拓也,松澤由美子,前川京子,日本 PGxデータサイエンスコソーシアム,斎藤嘉朗
    • Organizer
      第22回日本免疫毒性学会学術年会
    • Place of Presentation
      京都
    • Year and Date
      2015-09-11
    • Related Report
      2015 Research-status Report
  • [Presentation] 国内の動向:臨床試料を用いた安全性バイオマーカー探索と検証2015

    • Author(s)
      斎藤嘉朗, 前川京子, 齊藤公亮, 中村亮介, 熊谷雄治
    • Organizer
      第42回日本毒性学会学術年会
    • Place of Presentation
      金沢
    • Year and Date
      2015-06-30
    • Related Report
      2015 Research-status Report
    • Invited
  • [Presentation] ゲノム薬理学とTDMへの応用2015

    • Author(s)
      斎藤嘉朗
    • Organizer
      第32回日本TDM学会学術大会
    • Place of Presentation
      松本
    • Year and Date
      2015-05-22
    • Related Report
      2015 Research-status Report
    • Invited
  • [Presentation] Genetic background of stain-related myopathy in Japanese2015

    • Author(s)
      Kajinami K, Akao H, Sai K, Maekawa K, Japanese Pharmacogenomics Data Science Consortium, Saito Y
    • Organizer
      第79回日本循環器学会学術集会
    • Place of Presentation
      大阪
    • Year and Date
      2015-04-26
    • Related Report
      2015 Research-status Report

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Published: 2015-04-16   Modified: 2022-02-22  

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