Single objective performance criteria and its application in evaluation of non-drug therapy in TCM

HAN Mei; CAO Hui-juan; ZHANG Ying; LIU Zhao-lan; LI Xun; BU Fan-long; LIU Jian-ping

doi:10.16025/j.1674-1307.2020.05.027

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Single objective performance criteria and its application in evaluation of non-drug therapy in TCM

更新时间：2023-04-11

- Single objective performance criteria and its application in evaluation of non-drug therapy in TCM
- Beijing Journal of Traditional Chinese Medicine Vol. 39, Issue 5, Pages: 499-503(2020)
- 作者机构：
  
  1. 北京中医药大学循证医学中心
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2020.05.027
  CLC：
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[1]韩梅,曹卉娟,张颖,刘兆兰,李迅,卜繁龙,刘建平.单组试验目标值法及其在中医非药物疗法评价中的应用[J].北京中医药,2020,39(05):499-503.

HAN Mei, CAO Hui-juan, ZHANG Ying, et al. Single objective performance criteria and its application in evaluation of non-drug therapy in TCM. [J]. Beijing Journal of Traditional Chinese Medicine 39(5):499-503(2020)
[1]韩梅,曹卉娟,张颖,刘兆兰,李迅,卜繁龙,刘建平.单组试验目标值法及其在中医非药物疗法评价中的应用[J].北京中医药,2020,39(05):499-503. DOI： 10.16025/j.1674-1307.2020.05.027.

HAN Mei, CAO Hui-juan, ZHANG Ying, et al. Single objective performance criteria and its application in evaluation of non-drug therapy in TCM. [J]. Beijing Journal of Traditional Chinese Medicine 39(5):499-503(2020) DOI： 10.16025/j.1674-1307.2020.05.027.

摘要

中医非药物疗法在我国的医疗干预措施中占有重要地位,随机对照试验是目前国际公认的循证临床实践的金标准,但有的研究因患者的选择意愿、伦理、经济等原因使得随机分组并设置同期平行对照难以实施,此时可考虑采用单组临床试验来评价干预措施的疗效。本研究介绍了设置目标值的单组临床试验的发展及其在国内外的应用情况,分析了该方法在中医非药物疗法疗效评价中应用的可行性,重点介绍了单组试验目标值法的设计要点,包括结局指标的选择、建立目标值的方法、样本量计算以及统计分析方法,并以实例说明研究设计与分析的过程,提出该方法在中医药非药物疗法疗效评价使用中的注意事项,为广大中医药临床研究者提供新的研究思路和方法。

Abstract

关键词

单组试验目标值法中医非药物疗法疗效评价

Keywords

单组试验目标值法中医非药物疗法疗效评价

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