Tian Lu, Cai Tianxi, Pfeffer Marc A, Piankov Nikita, Cremieux Pierre-Yves, Wei L J
Department of Preventive Medicine, Northwestern University, Chicago, IL 60611, USA.
Biostatistics. 2009 Apr;10(2):275-81. doi: 10.1093/biostatistics/kxn034. Epub 2008 Oct 14.
Recently, meta-analysis has been widely utilized to combine information across comparative clinical studies for evaluating drug efficacy or safety profile. When dealing with rather rare events, a substantial proportion of studies may not have any events of interest. Conventional methods either exclude such studies or add an arbitrary positive value to each cell of the corresponding 2 x 2 tables in the analysis. In this article, we present a simple, effective procedure to make valid inferences about the parameter of interest with all available data without artificial continuity corrections. We then use the procedure to analyze the data from 48 comparative trials involving rosiglitazone with respect to its possible cardiovascular toxicity.
最近，荟萃分析已被广泛用于整合比较临床研究中的信息，以评估药物疗效或安全性。在处理相当罕见的事件时，很大一部分研究可能没有任何感兴趣的事件。传统方法要么排除此类研究，要么在分析中给相应2×2表格的每个单元格添加一个任意的正值。在本文中，我们提出了一种简单有效的程序，可利用所有可用数据对感兴趣的参数进行有效推断，而无需人为的连续性校正。然后，我们使用该程序分析了48项涉及罗格列酮可能的心血管毒性的比较试验的数据。
