中药不良反应报告表的设计要点和方法  

Key Point and Methods of Designing Spontaneous Adverse Drug Reaction Reporting System Form of Chinese Medicine

作　　者：黎元元[1] 张承绪[2] 谢雁鸣[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中药新药与临床药理》2010年第5期555-558,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家十一五科技支撑计划"中药上市后安全性监测与再评价标准规范的研究"(2006BA121B11);中国中医科学院自主选题项目"基于中医证候的上市中药注射剂免疫毒理学评价指标的筛选及其示范研究"(Z02101)

摘　　要：药品不良反应(ADR)报告表是开展上市后的药物警戒及安全性监测的重要工具。目前,国内的ADR报告表不能完全满足中药上市后ADR报告的需要。作者在借鉴国外对中草药/天然药的管理以及不良反应报告表的基础上,分析中药发生ADR的原因和特点,并对其科学性和可行性进行验证,设计制定符合中药特点的自发报告系统中药ADR报告表。这对开展中药上市后的药物警戒及安全性监测具有重要意义。Adverse Drug Reaction（ADR）form has been used as an important tool to report the reaction of post-market pharmacovigilance and security monitoring.The current ADR form can not satisfactorily meet the needs of the ADR report after Chinese Medicine going on the market.Based on the foreign management of herbal medicine and on the conformations of foreign ADR forms,we defined the reasons and the characteristics of ADR of Chinese medicine,and then designed the spontaneous ADR reporting system form of Chinese Medicine.Finally we verified the feasibility of the scientific highlights of the spontaneous ADR reporting system form of Chinese Medicine.The construction of the spontaneous ADR reporting system form of Chinese Medicine will have great significance to the post-marketing Chinese medicine pharmacovigilance and security monitoring.

关 键 词：中药 不良反应 报告表 临床设计 

分 类 号：R285.6[医药卫生—中药学]