中国临床药理学杂志2024，Vol.40Issue(2)：299-304,6.DOI:10.13699/j.cnki.1001-6821.2024.02.031
药物不良事件因果关系评估方法及实施步骤讨论
Discussion of the methodology and implementation steps for assessing the causality of adverse event
房虹 1王书航 1俞悦 1崔丹丹 1唐玉 1李宁 1温泽淮 2贾硕鹏 1王海学 3裴小静 3刘敏 3于安琪 1周凌云 4石方芳 5卢淑杰6
作者信息
- 1. 国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京 100021
- 2. 广东省中医院临床研究方法学重点研究室,广州广东 510120
- 3. 国家药品监督管理局药品审评中心,北京 100022
- 4. 赛诺菲中国投资有限公司,北京 100022
- 5. 辉瑞中国投资有限公司,上海 201210
- 6. 信达生物制药有限公司,江苏苏州 215000
- 折叠
摘要
Abstract
The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.关键词
不良事件/个例评价/因果关系评估/评价方法/药物警戒Key words
adverse event/case evaluation/causality assessment/evaluation methods/pharmacovigilance分类
医药卫生引用本文复制引用
房虹,王书航,俞悦,崔丹丹,唐玉,李宁,温泽淮,贾硕鹏,王海学,裴小静,刘敏,于安琪,周凌云,石方芳,卢淑杰..药物不良事件因果关系评估方法及实施步骤讨论[J].中国临床药理学杂志,2024,40(2):299-304,6.
