实用性随机对照试验与其方法学特征思考.pdfVIP

31 1 2008 1 14 Journal of Beijing Un iversity ofT rad itional ChineseM ed icine Vo.l 31 No. 1 Jan. 2008 : 有鉴于国家 十一五期间中医药各类科研计划凸现了中医临床研究项目的重要性; 证论治具有原创思维与原创优势, 然其疗效评价系临床科研的瓶颈问题; 构建中医自身规律与循证 医学理念新旧结合的适用于中医复杂性干预的疗效评价方法, 积极探索被认可能推广立得住的 临床研究方法系统, 将是一件具有紧迫性与现实意义的工作本文重点研讨的实用性随机对照临 床试验方法, 将对中医药治疗重大疑难疾病, 常见病多发病的科研顶层设计与实验方案的优化产 生重要的影响, 具有一定的参考价值 实用性随机对照试验及其方法学特征思考* # 繄恭 刘保延 ( 中国中医科学院临床基础医学研究所 北京 100700) : 介绍了实用性随机对照试验的概念和背景, 以及它与解释性随机对照试验方法的区别, 并 针对国际上典型案例举例解析, 进一步探索实用性随机对照试验方法学的特征以期为根据中医 临床特点寻找合适的疗效评价方法提供帮助 : 随机对照试验; 实用性随机对照试验; 解释性随机对照试验; 方法学 : R2-03 Pragm atic random ized con trolled tria ls and its m ethodological features # Q ING Xue-me,i FANG Y i-gong, LIU Bao-yan , WANG Y ong-yan ( Ch inaA cademy of Ch ineseM edical Sciences, Beijing 100700) Abs tract: The concept and the background of pragmatic random ized controlled trials are introduced in th is article, and the d ifferences betw een pragmatic random ized controlled trials and explanatory random ized trials are also described. Themethodological features of pragm atic random ized controlled trials are further explored bym eans of som e typical cases study of pragmatic clin ical trials. K ey w ord s: random ized controlled trials; pragmatic random ized controlled trials; exp lanatory random ized controlled trials; methodology ( random ized controlled tria,l RCT) RCT , , RCT : ( ex- 1 planatory random ized controlled trials, exp lanatory RCT ( effectiveness) clinical trials) ( pragm atic , effectiveness, random ized controlled trials, pragmatic clin ical trials) , ; RCT RCT