协方差分析在Ⅱ期临床研究中的应用  

Application of covariance analysis in phase Ⅱ clinical trials

作　　者：谢海棠[1] 孙华[1] 李娟[1] 童九翠[1] 江思艳[1] 李海刚[1] 潘行山[1] 贾元威[1] 孙瑞元[1] 

机构地区：[1]皖南医学院弋矶山医院临床药学部安徽省药物临床评价中心

出　　处：《中国临床药理学与治疗学》2010年第11期1240-1244,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：安徽省卫生厅重点项目(2010A0130)

摘　　要：目的:介绍协方差分析的统计方法及其在临床研究中的应用。方法:运用实例说明协方差分析的思路,并介绍一种用简单EXCEL函数实现协方差分析的方法。结果:实例分析表明,运用协方差分析,可得出新药组对矽肺的疗效优于老药组的结论,而不运用协方差分析时,新药组与老药组的疗效差异无统计学意义。结论:新药临床试验中常存在基线特征在处理组间不均衡从而影响对试验结果的正确评价,采用协方差分析可控制混杂因素的影响。AIM：Introduction of analysis of covariance（ANCOVA） and the application in clinical trials. METHODS：The method of ANCOVA was illustrated by a clinical case study.The implementation of ANCOVA by EXCEL software was also demonstrated and discussed.RESULTS：Once ANCOVA was employed,statistical significance was observed in the treatment effect on silicosis between new drug group and old drug group,whereas,the effects had no statistical significance when utilizing ordinary analysis.CONCLUSION：In clinical trials,the imbalance property of baseline among test groups may often affect the accurate evaluation to trial result.ANCOVA can be employed in this situation to adjust the baseline imbalance.

关 键 词：协方差分析 临床试验 

分 类 号：R969[医药卫生—药理学]