2018 Fiscal Year Final Research Report
Identification and evaluation of risk factors for severe immune-mediated adverse drug reactions using Big Data
| Project/Area Number |
16K08433
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical pharmacy
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| Research Institution | National Institute of Health Sciences |
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Principal Investigator |
SAI Kimie 国立医薬品食品衛生研究所, 医薬安全科学部, 室長 (20195960)
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| Co-Investigator(Kenkyū-buntansha) |
今任 拓也 国立医薬品食品衛生研究所, 医薬安全科学部, 主任研究官 (20368989)
堀 雄史 浜松医科大学, 医学部附属病院, 薬剤師 (20436786)
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| Project Period (FY) |
2016-04-01 – 2019-03-31
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| Keywords | データベース / 重篤副作用 / リスク因子 / 免疫修飾因子 |
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| Outline of Final Research Achievements |
This study aimed to investigate the effects of immune modulating factors, such as infection, on development of three kinds of immune-mediated severe adverse drug reactions (ADRs), i.e., drug-induced anaphylaxis, severe cutaneous adverse reactions (SCAR) and drug-induced liver injury, using a global Individual Case Safety Report database and Japanese medical information databases. The reporting ratios of all three ADRs were significantly higher in patients with infection, especially for SCAR development by anti-inflammatory analgesics. Medical information database analysis also confirmed a major role of infection for development of these ADRs in the patients treated with anti-inflammatory analgesics. This study suggested a necessity of caution for a risk of development of immune-mediated ADRs when patients with infectious diseases are treated with a certain class of drugs.
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| Free Research Field |
臨床薬理学、薬剤疫学
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| Academic Significance and Societal Importance of the Research Achievements |
本研究から、特定の医薬品の治療に際して、治療前の免疫修飾要因、特に感染症や免疫系の異常を有する疾患を併発している際には、薬物アナフィラキシー、重症薬疹、肝障害の発症リスクへの注意喚起が必要となることが示唆された。また、免疫系への影響も考慮した適切な医薬品の選択によって、副作用の防止や軽減につながる可能性も考えられる。本結果が、今後の免疫関連副作用の発症機序の解明や予防のための研究につながる可能性が期待される。
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