不良反应因果关系判定方法对上市后中成药安全性评价的指导意义  

Causality Assessment of Adverse Drug Reactions and Its Guiding Significance for Post-evaluation of Chinese Patent Medicine

作　　者：陈诗琪[1] 郑蕊 李幼平[2] 邝心颖[2] 商洪才[1] Chen Shiqi;Zheng Rui;Li Youping;Joey S.W.Kwong;Shang Hongcai(Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100700,China;Cochrane China, Chinese Evidence-Based Medicine Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]四川大学华西医院中国Cochrane中心/中国循证医学中心,成都610041

出　　处：《世界科学技术-中医药现代化》2018年第10期1729-1733,共5页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：中共中央组织部第二批国家"万人计划"(2016)经费资助项目(W02020052);第二批国家高层次人才特殊支持计划领军人才;负责人:商洪才

摘　　要：本文介绍了5种国内外常见的不良反应因果关系判定方法,依据我国卫生部评定法相关要求,系统阐明了上市后中成药不良反应关联性分析要点。在该判定方法的指导下,对有关不良反应报告内容进行完善,借以挖掘有效的中成药安全性预警信号,通过深入探索中成药临床应用中的不良反应机制,进一步补充不良反应资料。This study introduces 5 methods of causality assessment of adverse drug reactions(ADRs) domestic and overseas. According to the assessment of ministry of public health of China, the key points about the relevance analysis have been illuminated for the post-evaluation of Chinese patent medicine. Under the guidance of the causality assessment, we should describe the ADR reports in detail and further detect the accurate ADR warning signals. In order to supplement the ADR information, more researches concerning the ADR mechanism should be fully explored.

关 键 词：不良反应 因果关系判定 关联性分析 中成药 安全性评价 

分 类 号：R2-031[医药卫生—中西医结合]