生存研究样本量设计表及其使用方法  

Design tables of the required sample sizes for survival studies and their appliocations

作　　者：赵国龙[1] 孙爱民[1] 魏金星[2] 汲振余[1] 陈洪涛[1] 王月平 刘欣[1] 

机构地区：[1]河南省医学科学研究所,河南郑州450052 [2]郑州大学第一附属院,河南郑州450052 [3]北京武警总队医院内科,北京100027

出　　处：《河南医学研究》2001年第4期297-300,共4页Henan Medical Research

摘　　要：目的 :本文就两样本生存研究所需样本量用广义渐近正态法设计出 15 30个方案 ,制成设计表供临床使用。方法 :利用C语言编制程序 ,按通用格式打印设计表。结果 :常用方案查表可得。这些与两样本生存率检验相匹配 ,具有还原性 ,摆脱了比例危险的假设 ,在常见临床条件下观测功效符合预定功效。结论 :这些设计表适用于两样本癌症临床研究的设计 。Objective: Design tables of the required sample sizes for survival studies including 1,530 projects were made out based on the generalized asymptotic normal procedure for clinical applications. Methods: The procedure was programmed in the C language and the output was printed in the destgn tables with usual form. Results: Common projects can be found in the tables. They are matched with the test on two survival rates, reducible when there is no censoring, free from the assumption of proportional hazards, The observed power coinccides with the prescribed power in usual clinical situations. Conclusion: The tables are appropriate with planning clinical cancer studies, especially useful for clinicians or the relevant investigators.

关 键 词：渐近正态法 终检 试验设计 样本量 生存率 

分 类 号：R195.1[医药卫生—卫生统计学]