基于真实世界的中药注射剂疗效评价的研究概述  

An Overview of the Research on the Evaluation of the Therapeutic Effect of Traditional Chinese Medicine Injections based on the Real-w orld Study

作　　者：李宁[1] 韩瑞婷[1] 王宗耀[1] 郑晓娜[1] 余海滨[2] LINing HAN Ruiting WANG Zongyao ZHENG Xiaona YU Haibin(Grade 2014 Graduate, Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China Grade 2015 Graduate, Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China Department of Scientific Research, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China)

机构地区：[1]河南中医药大学,郑州450000 [2]河南中医学院第一附属医院科研部,郑州450000

出　　处：《中国中医药现代远程教育》2016年第19期140-142,共3页Chinese Medicine Modern Distance Education of China

基　　金：“十二五”国家科技支撑计划项目(No:2013BAI02B10)

摘　　要：回顾目前中药注射剂(TCMIs)疗效评价研究的不同方法,比较真实世界研究(RWS)与随机对照研究(RCT)的不同,根据中医研究自身特点,指出真实世界研究适用于中药注射剂上市后研究,通过对已有的中药注射剂在真实世界研究的分析,归纳出真实世界的中药注射剂疗效评价研究存在关于安全性研究较多而有效性研究较少,且评价指标过于简单等不足,探讨构建真实世界中药注射剂疗效评价的研究重点,以期为"真实世界"的中药注射剂疗效评价研究提供思路。The current different methods of TCMIs efficacy evaluation study were reviewed, and the differences of RWS and RCT were compared. According to Chinese medicine research＇s characteristics, RWS applies for TCMIs -marketing studies were pointed out. Through the analysis of the existing TCMIs in the RWS, the insufficients were summarized, such as the safety of more research and less effectiveness research, too simple evaluation and other issues. From exploring on building real world efficacy evaluation of TCMIs research priorities, we can provide ideas for the evaluation of the efficacy of TCMIs in the RWS

关 键 词：中药注射剂 真实世界研究 疗效评价 概述 

分 类 号：R286[医药卫生—中药学]