[Sample size estimation in acupuncture and moxibustion clinical trials].
[Sample size estimation in acupuncture and moxibustion clinical trials].
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DOI：
10.13703/j.0255-2930.20201020-0002
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发表时间：
2021-10-12
期刊：
影响因子：
--
通讯作者：
Feng, Shuo
中科院分区：
文献类型：
--
作者：
Hu, Jing;Li, Bo;Feng, Shuo
在临床试验设计中，样本量的合理估计是非常重要的。然而，目前已发表的针灸临床试验中，样本量估计不足或不恰当仍是一个突出问题。目前针灸临床试验中广泛采用优效性检验、非劣效性检验和等效性检验。本文重点介绍这三种假设检验类型的应用、计算方法以及PASS11软件的使用。针对针灸临床试验中样本量估计存在的问题，从参数设置、干预组与对照组比例、多组比较等方面总结针灸临床试验样本量估计的特殊性，以指导针灸临床研究者在开展临床试验时正确估计样本量。
The appropriate sample size estimation is very important in the design of clinical trials. However, insufficient or inappropriate sample size estimation is still a prominent problem in the currently published acupuncture and moxibustion clinical trials. At present, the superiority test, non-inferiority test and equivalence test have been widely used in acupuncture and moxibustion clinical trials. This article focuses on the application, calculation methods and PASS11 software using of these three hypothesis test types. In view of the problems in the estimation of sample size in acupuncture and moxibustion clinical trials, the particularity of sample size estimation in acupuncture and moxibustion is summarized from the aspects of parameter setting, ratio of intervention group and control group, and multi-group comparison, in order to guide acupuncture clinical researchers to correctly estimate sample size when conducting clinical trials.