伞式设计与篮式设计在中医药循证评价中的应用  

Application of umbrella design and basket design in evidence-based research for traditional Chinese medicine

作　　者：郭晓慧[1] 黄仟 谢雁鸣[3] 温泽淮[1,4] GUO Xiao-hui;HUANG Qian;XIE Yan-ming;WEN Ze-huai(Key Unit of Methodology in Clinical Research,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China;the Second Clinical College,Guangzhou University of Chinese Medicine,Guangzhou 510120,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Science and Innovation Center of Guangzhou University of Chinese Medicine,Guangzhou 510405,China)

机构地区：[1]广东省中医院临床研究方法学重点研究室,广东广州510120 [2]广州中医药大学第二临床医学院,广东广州510120 [3]中国中医科学院中医临床基础医学研究所,北京100700 [4]广州中医药大学科创中心,广东广州510405

出　　处：《中国中药杂志》2021年第8期2010-2015,共6页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划“中医药现代化研究”重点专项(2018YFC1707400,2018YFC1707407)。

摘　　要：该文介绍了主方案、篮式设计、伞式设计、平台试验的基本定义、应用范围以及其优缺点,结合中医药特点、研究经验提出了中医药领域借鉴使用主方案设计、篮式设计、伞式设计进行临床研究的思路。笔者指出,作为一种高效的研究设计策略,主方案设计、篮式设计、伞式设计可用于中医领域同病异治、异病同治以及其病证结合的临床研究,特别是从中医证候分类入手进行探索,可以补充目前中医领域证候临床研究的空白;应用该类设计时,也应注意其潜在的缺点,在研究实施、管理和统计分析方面预先制定合理可行的措施以应对挑战。This paper introduced the basic definition, application scope, advantages and challenges of the master protocol, basket design, umbrella design and platform trial, and put forward the idea of using master protocol, basket design and umbrella design in Chinese medicine(CM) by considering the characteristics of CM and research experiences. The author pointed out that master protocol, basket design and umbrella design, as a high-efficiency research and design strategy, can be used in the clinical research on the treatment of the same disease with different therapies, the treatment of different diseases with the same therapy and the combination of diseases and CM syndromes. In particular, the exploration from the classification of CM syndromes can supplement the gaps in the cli-nical research on CM syndromes. In the application of such designs, it is also necessary to pay attention to their potential challenges and develop reasonable and feasible plans on research implementation, management and statistical analysis in advance to meet these challenges.

关 键 词：主方案设计 篮式设计 伞式设计 中医药 

分 类 号：R288[医药卫生—中药学]