多中心两组临床试验所需样本量的测定.pdfVIP

中国医院统计　2003 年 3 月第 10 卷第 1 期 ·27 · 多中心两组临床试验所需样本量的测定 赵国龙 　王曙炎 　　【摘要】　目的 　提出用于多中心两组临床试验的样本量测定方法。方法 　由 Cochran 检验或 MantelHaenszel 检验反推得出所需总样本量 ,按层样本分数和组样本分数进行样本量的分配。结果 　如此获得的样本量测定方法 与检验方法一一匹配。该方法具有同质性 ,当只有一层时还原为同质假设下的简化正态法或同质假设下的简化正 态法加 1 。针对Cochran 检验的设计可为等层或非等层设计 ,而针对 MantelHaenszel 检验的只能是等层设计。结论 　该方法可用于多中心两组临床试验方案的设计。附有工作实例描述设计过程。 【关键词】　Cochran 检验 　临床试验 　MantelHaenszel 检验 　样本量 ( ) 中图分类号:R195 1 　文献标识码 :A 　文章编号 2003 The Determination of the Required Sample Size for MultiCenter TwoGroup Clinical Trials 　Zhao Guolong , W ang S huyan , Henan Medical U niversity , Zhengz hou , 450052 【Abstract 】　Objective 　This paper concerns the determination of the required sample size for multicenter two group clinical trials Methods 　The required total sample size is derived inversely from the Cochran test or the Mantel Haenszel test and allocated into each stratum and each group in the light of the relevant sample fractions Results 　The procedures are certainly matched with the tests respectively They possess the property of homogeneity and reduce to the procedure of simple normal assuming homogeneity or that plus one when there is only one stratum The procedure derived from the Cochran test can be used for the designs with equalor unequalsized strata but the procedure derived from the MantelHaenszel test only for the designs with equalsized strata Conclusion 　The procedures proposed can be applied to planning multicenter twogroup clinical trials A worked example illustrates the planning process 【Key words】