摘要
对两组平均水平差异的差异性检验得出不拒绝零假设的结论时,此结果常常被误解为两治疗方案疗效等价。本文从等效性检验的方法实现、样本量要求、等效界限的选择等几个方面阐述了两组疗效比较的临床试验应如何判定疗效等价,以期引起广大医务工作者、临床治疗用药物研制者的注意,正确地给出对试验结果的诠释。
When null hypothesis is not rejected for significance test between two averages, sometimes the result is wrongly interpreted as an indication of equivalence between two clinical treatments. In this article, the proper implement of equivalence test, estimation of sample size, determination of equivalence margins are discussed. It is supposed to help clinical workers and medical researchers to correctly carry out statistical hypothesis test so as to find the possible equivalence between two treatment effects in clinical trials, to avoid wrong explanation to raw data.
出处
《循证医学》
CSCD
2008年第4期228-230,共3页
The Journal of Evidence-Based Medicine
基金
中山大学本科教学课程建设项目(编号:中大教务[2007]34号-2-20)
关键词
等效性检验
临床试验
equivalence test
clinical trial
