临床两组药物等效的判断方法及其辨析

Determination of equivalence of two drugs in clinical trial

临床两组药效比较 ,最严谨的方法是等效性检验。而用把握度进行例数估算 ,若出现P >0 .0 5 ,则难下结论 ,既不表示按估算的例数进行试验 ,就可做出两组药效基本相同的结论 ,也不能认为只要例数足够多 ,P >0 .0 5也能说明两组基本等效。一般t检验不宜作“两组药效基本相同”

The best method is the bioequivalence test in order to determine whether two drugs give rise to the same or similar efficacy, and it should be the basis of procedures for estimating the sample size needed to detect an equivalence. The power of test can not conclude an equivalence at P> 0.05 even in a larger sample size.