CAJ | 학술논문

临床试验重复性原则要求恰当的样本量估算，达到统计学要求的把握度。同样，在系统综述或Meta分析中，当纳入的试验数目较少或纳入试验总的样本量较小时，往往会因为随机误差的影响而夸大干预措施的疗效。通过实例简要介绍一种系统综述或Meta分析样本量估算的软件和方法，通过应用试验序贯分析（TSA）来调整随机误差，并估算系统综述或Meta分析所需的样本量。
림상시험중복성원칙요구흡당적양본량고산，체도통계학요구적파악도。동양，재계통종술혹Meta분석중，당납입적시험수목교소혹납입시험총적양본량교소시，왕왕회인위수궤오차적영향이과대간예조시적료효。통과실례간요개소일충계통종술혹Meta분석양본량고산적연건화방법，통과응용시험서관분석（TSA）래조정수궤오차，병고산계통종술혹Meta분석소수적양본량。
The estimation of sample size is required by the repeatability principle of clinical trials aiming at the study power in statistics. Similarly, in systematic review and Meta-analysis, when the number of included trials or the total sample size was too small, the curative effect will be exaggerated due to random errors. The paper briefly introduces a method for estimating sample size, which can adjust random errors and calculate the sample size needed by systematic review and Meta-analysis through applying trial sequential analysis (TSA).