针灸临床试验的样本量估计  

Sample size estimation in acupuncture and moxibustion clinical trials

作　　者：胡晶 李博 张会娜 刘卫红 冯硕 HU Jing;LI Bo;ZHANG Hui-na;LIU Wei-hong;FENG Shuo(Evidence-Based Medicine Center,Beijing Hospital of TCM,Capital Medical University,Beijing Institute of TCM,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院/北京市中医研究所循证医学中心,北京100010

出　　处：《中国针灸》2021年第10期1147-1152,共6页Chinese Acupuncture & Moxibustion

基　　金：国家自然科学基金面上项目:81973694、81774146。

摘　　要：确定合适的样本量是临床试验研究设计的关键步骤,而未报告样本量估计或估计不合理在目前发表的针灸临床试验中仍是一个比较突出的问题。目前临床试验假设检验类型的优效性试验、非劣效性试验和等效性试验已普遍应用于针灸临床试验中,本文针对这3种类型的适用情况、计算方法和PASS11软件的操作进行介绍。并针对针灸临床试验样本量估计时存在的问题,从参数设定、组间比例确定、多个比较组方面,对针灸领域样本量估计的特殊性进行总结,以期指导针灸临床研究者在进行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.

关 键 词：针灸 优效性试验 非劣效性试验 等效性试验 样本量估计 

分 类 号：R33[医药卫生—人体生理学]