富集设计方法与中医临床研究  

Enrichment Design Method and Chinese Medicine Clinical Research

作　　者：闫世艳[1] 王彬[2] 马利[2] 何丽云[1] 刘保延[1] 

机构地区：[1]中国中医科学院 [2]湖北中医药大学信息工程学院

出　　处：《中医杂志》2017年第4期307-310,共4页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81303149);中央级公益性科研院所基本科研业务费(ZZ070818)

摘　　要：富集设计是动态设计的一种,是指通过找到治疗措施更为有效的靶人群,并以这个亚人群为研究对象进行后续的随机对照试验等验证性临床研究的方法。该方法可以提高临床研究的效率,同时也为后期更加准确地用药提供指导。在中医临床研究中,可以借鉴富集设计的思路和方法,提高中医临床研究的有效率,凸显中医的疗效优势和特点。在对富集设计的相关方法和类型进行详细介绍的基础上,结合中医辨证论治的特点,对中医临床研究中富集设计的应用方向和前景进行阐述,以期为中医临床研究提供新的思路和方法。Enrichment design,a kind of dynamic design,is a method that by finding the target population on whom the therapeutic measures are more effective,taking this sub-population as the subject,subsequent confirmatory clinical studies,such as randomized controlled trials,are carried out. This method could improve the effect of clinical research and provide guidance for late more accurate medication. In Chinese medicine clinical research,the thinking and methodology of enrichment design could be used for reference. The efficiency of Chinese medicine clinical research might be improved,and the therapeutic advantages and characteristics of Chinese medicine might be highlighted. Based on detailed introduction of related methods and types of enrichment design,combined with the characteristics of Chinese medicine syndrome differentiation and treatment,the authors explain the application direction and prospect of enrichment design in Chinese medicine clinical research to provide new idea and method.

关 键 词：中医临床研究 动态设计 富集设计 随机对照试验 

分 类 号：R24[医药卫生—中医临床基础]