中成药上市后安全性综合评价研究探讨  

Discussion on the Study on Comprehensive Evaluation of the Safety of Post-Marketing Chinese Patent Medicines

作　　者：李春晓[1,2] 凌霄 李学林[1,2] 唐进法[1,2] 邢冬梅[1] 陈玉欢[1,2] 张辉[1] 张俊华[3] LI Chunxiao;LING Xiao;LI Xuelin;TANG Jinfa;XING Dongmei;CHEN Yuhuan;ZHANG Hui;ZHANG Junhua(The First Affiliated Hospital of Henan University of Chinese Medicine/Henan Province Engineering Laboratory For Clinical Evaluation Technology of Traditional Chinese Medicine,Zhengzhou,450000;Henan University of Chinese Medicine/Collaborative Innovation Center for Prevention and Treatment of Respiratory Diseases;Tianjin University of Traditional Chinese Medicine)

机构地区：[1]河南中医药大学第一附属医院/中药临床评价技术河南省工程实验室,450000 [2]河南中医药大学/呼吸疾病中医药防治省部共建协同创新中心 [3]天津中医药大学

出　　处：《中医杂志》2020年第12期1049-1053,共5页Journal of Traditional Chinese Medicine

基　　金：国家科技重大专项(2015ZX09501004);2020年度河南省重点研发与推广专项(202102310182);河南省中医药科学研究重点专项(2018ZY1007);河南省教育厅课题(19A360015)。

摘　　要：药品上市后的安全性再评价研究通常是通过自发呈报系统被动监测、主动监测或者Meta分析等多种途径发现不良反应(ADR),并在其基础上进行再评价。因此,药品上市后安全性研究是一个系统、动态的工程,难以通过单一的研究范式形成药品临床安全性结论,需要融合多元的方法客观、全面地进行综合性评价。由于各种定量研究方法获取的结果和定性研究结果的数据类型不同,导致各种单一结果难以整合形成综合性结果。混合方法研究(MMR)是定性研究及定量研究的补充,可以实现两种研究方法的强强联合,该研究模式与药品上市后安全性再评价的特点和需求高度吻合,因此可以借鉴MMR的设计,整合定量数据和定性资料,探索构建中成药上市后安全性综合评价的方法。Post-marketing safety re-evaluation research usually finds adverse drug reactions(ADR)through passive monitoring,active monitoring,or meta-analysis of the spontaneous reporting system,and re-evaluates was performed based on them.Therefore,post-marketing drug safety research is a systematic and dynamic project.It is difficult to form a drug clinical safety conclusion through a single research paradigm.It is necessary to integrate multiple methods to conduct an objective and comprehensive evaluation.Due to the different data types obtained by various quantitative research methods and qualitative research results,it is difficult to integrate various single results to form a comprehensive result.Mixed methods research(MMR)is a supplement to qualitative research and quantitative research.It can achieve a strong combination of the two research methods.This research model is highly consistent with the characteristics and needs of post-marketing safety reassessment.Therefore,MMR design can be used to integrate quantitative data and qualitative data,and explore ways to build a comprehensive evaluation of the safety of Chinese patent medicines after they are marketed.

关 键 词：中成药安全性 药品上市后再评价 混合方法研究 

分 类 号：R286[医药卫生—中药学]