摘要
判断两组药效在临床上是否等效，以“Ｐ＞０．０５”为依据是不妥的。应当先按临床专业要求，规定“新药在标准药的加减多少百分率之内，才认为等效”的标准，再以“双向单侧ｔ检验”进行判断。本文根据该检验的原理，提出“等效界值法”，数学上与之等质。计算结果完全一致，公式简明，计算方便。本法以Ｌ为等效界值，两组均数之差大于Ｌ时，则承认两药等效（Ｐ＜０．０５）。Ｌ的计算式如下：Ｌ＝Ｍｓ×Ｄ－Ｓｅ×Ｔ。Ｍｓ为标准药均数，Ｄ为等效标准的百分率，Ｓｅ为两组的共同标准误，Ｔ为单侧ｔ０．０５值．
It is inadequate to conclude the clinical equivalency of two drugs simply by“P>0.05”.Whereas a criterion should be set first according tothe rules of clinical specialty, which determines the maximum percentage of limit that a equivalent test drug may deviate from the standard drug. Then the two one-sidet test should be performed to draw the conclusion, Based on the principle of this test, in this paper we put forward an equivalency limit method, which is identical in its analysis result to the former one, but much simple in calculation.Let L denote the equivalent limit, and the equivalency can be concluded if the difference of two groups is significantly larger than L(P<0.05).The formula is as follows: L=Ms×D-Se×T where Ms is the mean of standard drug,D the percentage of clinic equivalency criterion, Se the common standard error of two groups,and T the t 0.05 value for one-sided test.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
1995年第2期116-118,共3页
The Chinese Journal of Clinical Pharmacology
关键词
等效性检验
T检验
临床统计
equivalency test
two one-sidet test
clinical statistics
