以证统病干预性临床研究方法学框架的实施建议  

Explanation for the Methodological Framework for Interventional Clinical Research of Chinese Medicine under the Research Mode of Syndrome Dominating Disease

作　　者：黄仟 周莉 禤美玲 郭晓慧 邱幸莹 刘冰清 曹文聪 温泽淮 HUANG Qian;ZHOU Li;XUAN Meiling;GUO Xiaohui;QIU Xingying;LIU Bingqing;CAO Wencong;WEN Zehuai(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine,Guangzhou,510120;The Second Clinical Medical College of Guangzhou University of Chinese Medicine)

机构地区：[1]广州中医药大学第二附属医院/广东省中医院,广东省广州市510120 [2]广州中医药大学第二临床医学院

出　　处：《中医杂志》2024年第13期1328-1333,共6页Journal of Traditional Chinese Medicine

基　　金：国家重点研发计划(2018YFC1707407)。

摘　　要：以证统病干预性临床研究方法学框架旨在为以证统病模式下的中医药异病同治临床疗效评价研究提供方案设计、评价和实施的技术参考。该方法学框架包括一般原则、研究切入点、研究设计要点3个主干内容,共25个条目。从研究的规范与原则、选题切入角度,以及研究对象选择、干预措施与对照设置、结局测量、疗程和随访时间、样本方向、设计形式与类型等方面提出实施要求与建议。并结合具体研究实例对该方法学框架的条目内容进行阐释,以期为研究人员提供实践指引和建议。The methodological framework for interventional clinical research of Chinese medicine(CM)under the research mode of syndrome dominating disease provides a set of technical principles and methods to design,evalu⁃ate,and implement of this kind.It consists of three main parts including general principles,research points and key design elements,with a total of 25 items.This methodological framework proposes implementing requirements and recommendations in a variety of aspects,including basic norms to be followed in relevant studies,perspectives for se⁃lecting research topics,as well as the technological details on study population(P),intervention(I)and comparison(C),outcome measurement(O),time frame(T)of treatment and follow-up,sample orientation(prospective versus retrospective),study design(S)format and type.To provide practical guidance for future studies,this article clearly explains each items of the methodological framework through some supportive cases.

关 键 词：证候 异病同治 干预性研究 临床研究方法学 疗效评价 以证统病 

分 类 号：R2-03[医药卫生—中医学]