中药上市后临床再评价研究思路探讨  

Discussion on research ideas of post-marketing clinical re-evaluation of traditional Chinese medicine

作　　者：陈玉欢[1] 凌霄 李春晓[2] 王盼盼[1] 刘淑钰 马志欢 李学林[2] CHEN Yu-huan;LING Xiao;LI Chun-xiao;WANG Pan-pan;LIU Shu-yu;MA Zhi-huan;LI Xue-lin(Henan University of Chinese Medicine,Zhengzhou 450046,China;Henan Province Engineering Laboratory for Clinical Evaluation Technology of Chinese Medicine,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学,郑州450046 [2]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,郑州450000

出　　处：《中国新药杂志》2021年第24期2262-2267,共6页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2015ZX09501004-001-007)。

摘　　要：国内外西药再评价体系已初步形成,明确了药品上市后再评价需针对药物最新研究资料,根据不同主体的需求确定再评价目的,选取合适的方法开展再评价研究。中药上市后再评价研究虽取得了一定进展,但中西药理论体系的差异和上市前研究的不足,中药上市后临床再评价研究仍存在较多问题。本文通过梳理汇总中药上市后临床研究现状,剖析中药上市后临床再评价研究存在的问题,并分别针对中成药上市后临床再评价研究和中药饮片临床再评价研究提出关键技术完善方法,基于多层次、多来源、多方法的研究数据与结果,形成基于真实世界研究的高水平中药上市后临床再评价综合体系,为中药合理应用和药品政策制订提供依据。The re-evaluation system of western medicines at home and abroad has been preliminarily formed.It is clear that the post-marketing re-evaluation of drugs must be based on the latest research data of the drugs,the purpose of the re-evaluation should be determined according to the needs of different subjects,and appropriate methods should be selected to carry out the re-evaluation research.Although the post-marketing re-evaluation research of traditional Chinese medicine has made some progress,there are still many problems in this field due to the differences in the theoretical systems of Chinese and Western medicine and the deficiencies of pre-marketing research.This article summarized the status of post-marketing clinical re-evaluation research of traditional Chinese medicine,analyzed the problems,and proposed key technology improvement methods for the post-marketing clinical re-evaluation research of Chinese patent medicines and Chinese herbal medicine pieces.It is hoped that a high-level comprehensive post-marketing clinical re-evaluation system for traditional Chinese medicines based on real world study would be formed based on multi-level,multi-source,multi-method research data and results,which will provide a basis for the rational use of traditional Chinese medicine and the formulation of national drug policies.

关 键 词：中药上市后临床再评价 临床研究 中药饮片 中成药 真实世界研究 综合评价体系 

分 类 号：R95[医药卫生—药学]