基于前瞻性队列的登记研究评价上市后经典名方治疗结局的设计要点思考——以安宫牛黄丸治疗急性缺血性脑卒中为例  

Key Points in the Design of Registry-based Prospective Cohort Study to Evaluate the Outcome of Post-marketing Classical Chinese Patent Medicines——Taking Angong Niuhuang Pills for Acute Ischemic Stroke as an Example

作　　者：艾艳珂[1] 刘佳[1] 赵天易 孟祥然 曹雪 王世华 李姗珊 李少红 吕晓颖[1] 李洪皎[1] 孙海舒[2] 李杨 赵贺 何丽云[1] 雒琳[1] AI Yanke;LIU Jia;ZHAO Tianyi;MENG Xiangran;CAO Xue;WANG Shihua;LI Shanshan;LI Shaohong;LYU Xiaoying;LI Hongjiao;SUN Haishu;LI Yang;ZHAO He;HE Liyun;LUO Lin(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Beijing Fengtai Youanmen Hospital,Beijing 100069,China;Beijing Tongrentang Commercial Investment Group Limited,Beijing 100035,China)

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]中国中医科学院中医药信息研究所,北京100700 [3]北京丰台右安门医院,北京100069 [4]北京同仁堂商业投资集团有限公司,北京100035

出　　处：《世界中医药》2022年第5期602-606,613,共6页World Chinese Medicine

基　　金：国家重点研发计划项目“中医药现代化研究”重点专项(2017YFC1703600);中国中医科学院科技创新工程项目(CI2021A00702-02)。

摘　　要：中医上市后经典名方虽然在国内被广泛应用,但缺乏高质量的循证证据支撑,影响其走出国门。设计良好的基于前瞻性队列的登记研究可更加真实地反映上市后经典名方在现实医疗环境下治疗与结局的因果效应关系。本文以安宫牛黄丸治疗急性缺血性脑卒中为例,从控制选择性偏倚、信息偏倚和混杂偏倚的角度,在临床设计、统计学考量和质量控制3个方面对基于前瞻性队列的登记研究设计要点进行论述。Post-marketing classical Chinese patent medicines(CPMs)have been widely used in China.However,lack of high-quality evidence-based data blocks its promoting abroad.A well-designed registry-based prospective cohort study can help better understand the causal relationship between treatment and outcome in a realistic medical environment.In this paper,we took Angong Niuhuang Pills for the treatment of acute ischemic stroke as an example to discuss the key points in clinical design,statistical considerations,and quality control in the design of registry-based cohort study from the perspective of controlling selection bias,information bias,and confounding bias.

关 键 词：登记研究 前瞻性队列研究 治疗结局评估 上市后经典名方 研究设计 

分 类 号：R21[医药卫生—中医学]