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中国临床药理学与治疗学 ›› 2005, Vol. 10 ›› Issue (11): 1315-1317.

• 设计·统计·分析 • 上一篇    下一篇

单病例随机对照试验在中医药临床研究中的应用与思考

许卫华   

  1. 广州中医药大学 DME 中心,广州 510405,广东
  • 收稿日期:2005-09-02 修回日期:2005-10-17 出版日期:2005-11-26 发布日期:2020-11-12

Some thoughts on use of randomized controlled in individual patients in TCM researches

XU Wei-hua   

  1. DME Center,Guangzhou University of TCM,Guangzhou 510405,Guandong,China
  • Received:2005-09-02 Revised:2005-10-17 Online:2005-11-26 Published:2020-11-12

摘要: 本文介绍单病例随机对照试验的设计模式和应用条件。提出应用单病例随机对照设计方法进行中医药临床研究时应着重考虑的问题:盲法的实施、对照药的选择、洗脱期的确定、效应指标的选择及结论的外推。

关键词: 随机对照试验, 试验设计, 个体化治疗, 临床研究

Abstract: This paperdescribed the design model of randomized controlled trial in individual patients(N of 1 RCTs)and the conditions of conducting this study de-sign,and also pointed out the key points to be considered in conducting an N of 1 RCTs in clinical trial of TCM,i.e.the implementation of blindness,selection of the con-trolled drug and effect indices,setting uPof wash-out pe-riod and the generalization of the study findings.

Key words: randomized controlled trial, clinical tri-al, traditional Chinese medicine, individualized treatment

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