多临床终点的等效性检验方法探讨

目的　探讨多临床终点的等效性检验方法。方法　应用改进的HotellingT2 检验对两组均数向量进行等效性检验 ,通过扣除变量间相关性的方法获得各变量是否等效的具体信息 ;并结合实例进行分析 ,以± 2 %为等效界值的上下界 ,对“A、B两药治疗绝经后骨质疏松症”的四个疗效指标分别进行单变量和多变量等效性检验 ,比较其结果。结果　当HotellingT2 检验的统计量对应的P >α时 ,可认为所有变量不等效 ;若P≤α时 ,应进行不等效变量的筛选 ,经筛选无不等效变量可认为其等效 ,若经筛选有不等效变量 ,则认为该变量不等效 ,该方法克服了重复单变量等效性检验的缺点。结论　应用改进的HotellingT2 检验并结合不等效变量的筛选方法 ,可以对多个临床终点同时进行等效性检验 ,该方法合理且可操作

Statistical test on multivariate in therapautical equivalence analysis

OBJECTIVE: To explore the way for testing of multivariate in therapeutical equivalence. METHODS: By improved Hotelling T(2) test, the mean vector of two groups was tested. The information of each variable could then be obtained by deducting the their correlations. "Clinical Equivalence of Drug A and Drug B for Postmenopausal Bone Looseness" was used in this research. The primary measure of efficacy was regarded as the improvement rate of four variables with predefined limit of equivalence (2%) with the results of univariate test and multivariate test compared. RESULTS: Under P > alpha, all the variables were nonequivalent. Under P