序贯分析法在评价具有显著个体变异临床指标中的应用  

A sequential analysis for efficacy evaluation of individual variable data of clinical trials

作　　者：李卫[1] 马宇超[2] 王杨[1] 成小如[1] 贾宣[1] 李一石[1] 

机构地区：[1]中国医学科学院 阜外心血管病医院卫生部心血管药物临床研究重点实验室,北京100037 [2]中科院数学与系统科学研究院应用数学所,北京100080

出　　处：《中国新药杂志》2006年第23期2065-2068,共4页Chinese Journal of New Drugs

摘　　要：目的:对国家Ⅰ类新药心肌肽素的心脏保护作用进行再评价。方法:采用成组序贯分析法中的三角形作图法,对心肌肽素Ⅲ期临床试验结果进行再分析。结果:496例行心脏瓣膜替换术和搭桥的患者随机进入试验。试验组322例,平均年龄(48．43±11．39)岁,服心肌肽素;对照组174例,平均年龄(50．44±11．47)岁,服极化液。成组序贯分析法结果显示,试验组疗效显著优于对照组。结论:对于具有较大变异的疗效指标,序贯分析法可能优于临床试验疗效分析常用的协方差分析法,同时还可大大节约样本量和试验时间。Objective： To re-evaluate the myocardial protection of cardiomyopeptidin-a type I state new drug of China. Methods： The triangular imaging process of the group sequential design was used to re-analyze the efficacy of cardiomyopeptidin phase III clinical trial. Results： Of 496 patients undergoing heart surgery and CABG who were recruited in this trial, 322 patients at age of （48.43 ± 11.39） years old and 174 patients at age of （50.44 ± 11.47） years old were randomized to enroll into cardiomyopeptidin and GIK group, respectively. The efficacy data by group sequential design showed the significant superiority of cardiomyopeptidin to GIK. Conclusion ： The group sequential process is a better statistical tool than ANOVA analyses for clinical outcomes with larger individual variation.

关 键 词：随机对照临床试验 成组序贯设计 Ⅰ类新药 心肌保护 

分 类 号：R95[医药卫生—药学]