荟萃分析对多样本临床试验结果重现率分析(英文)

探讨应用多样本临床试验荟萃分析进行药物和治疗方案有效性和安全性研究．方法：本文采用基本分析，一种非参数方法，评价临床试验结果的重现率，用于对充血性心脏衰竭（ＣＨＦ），ＣＨＦ伴心性死亡，ＣＨＦ伴其他原因死亡病例，对给予血管紧张素转化酶抑制剂（ＡＣＥ）治疗组和给安慰剂组各自的相对率和超常率的分析．结果：三组试验最后的结果分别为６９％，７４％，７６％，Ｐ＜０．０１，与给安慰剂组比较，ＡＣＥ治疗组减少３０／（１０００人·年），ＣＨＦ伴心性死亡组减少４０／（１０００人·年），Ｐ＜０．０１．结论：荟萃分析法是分析临床试验结果重现率的一种简单而有效的方法．

Recurrent events in meta-analysis of multiple clinical trials

AIM: To study the efficacy and safety of drug or therapy with recurrent events in meta-analysis of multiple clinical trials. METHODS: A nonparametric approach is Proposed to estimate the rates of recurrent events for meta-analysis of trails. The method was used in meta-analysis of angiotensin-converting enzyme (ACE) inhibitor clinical trials to analyze the relative rates and the excess rates between ACE inhibitor and placebo treatment groups for endpoints of hospitalizations for CHF, hospitalizations for CHF or cardiac death, and hospitalizations for CHF or any death, respectively. RESULTS: The estimates of those three endpoints were 69%, 74%, and 76% (P<0.01 ). Compared with placebo, ACE inhibitor reduced 30 cases of hospitalizations for CHF per 1000 person-years, or 40 cardiac deaths or hospitalizations for CHF per 1000 person-years (P<0.01). CONCLUSION: The method was a simple and efficient approach to conduct meta-analysis of clinical trials with recurrent events.