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选择性环氧化酶-2抑制剂与心肌梗死风险:随机对照试验的荟萃分析

Risk of myocardial infarction associated with selective COX-2 inhibitors: meta-analysis of randomised controlled trials.

作者信息

Chen Li-Chia, Ashcroft Darren M

机构信息

School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Oxford Road, Manchester, UK.

出版信息

Pharmacoepidemiol Drug Saf. 2007 Jul;16(7):762-72. doi: 10.1002/pds.1409.

Abstract

PURPOSE

To evaluate the risk of myocardial infarction (MI) associated with the use of selective cyclooxygenase-2 (COX-2) inhibitors (coxibs).

METHODS

Systematic review and meta-analysis of randomised controlled trials (RCTs) using a fixed-effect model to estimate the odds ratios (ORs) for risk of MI associated with coxibs compared against placebo, non-steroidal anti-inflammatory drugs (NSAIDs) and other coxibs.

RESULTS

Fifty-five trials (99 087 patients) were included in the meta-analysis. The overall pooled OR for MI risk for any coxib compared against placebo was 1.46 (95%CI: 1.02, 2.09). We found celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib were associated with higher MI risks compared against placebo. The pooled OR for any coxib compared against other NSAIDs was 1.45 (95%CI: 1.09, 1.93). Rofecoxib had a significantly higher risk of MI than naproxen (OR: 5.39; 95%: 2.08, 14.02) and valdecoxib had lower MI risk than diclofenac (OR: 0.14, 95%CI: 0.03, 0.73). There were no significant differences identified in the risk of MI from the available head-to-head comparisons of coxibs.

CONCLUSIONS

Coxibs were associated with increased risks of MI when compared against placebo or non-selective NSAIDs. Differences in MI risk were also apparent between comparisons of individual NSAIDs. Future work should consider using individual patient data (IPD) meta-analysis to explore differences in MI risk between different subgroups of patients.

摘要

目的

评估使用选择性环氧化酶-2(COX-2)抑制剂(昔布类药物)与心肌梗死(MI)相关的风险。

方法

对随机对照试验(RCT)进行系统评价和荟萃分析,采用固定效应模型估计与安慰剂、非甾体抗炎药(NSAIDs)及其他昔布类药物相比,昔布类药物导致MI风险的比值比(OR)。

结果

荟萃分析纳入了55项试验(99087例患者)。与安慰剂相比,任何昔布类药物导致MI风险的总体合并OR为1.46(95%置信区间:1.02,2.09)。我们发现,与安慰剂相比,塞来昔布、罗非昔布、依托考昔、伐地昔布和卢米昔布与更高的MI风险相关。与其他NSAIDs相比,任何昔布类药物导致MI风险的合并OR为1.45(95%置信区间:1.09,1.93)。罗非昔布的MI风险显著高于萘普生(OR:5.39;95%:2.08,14.02),伐地昔布的MI风险低于双氯芬酸(OR:0.14,95%置信区间:0.03,0.73)。在昔布类药物之间进行的现有直接比较中未发现MI风险存在显著差异。

结论

与安慰剂或非选择性NSAIDs相比,昔布类药物与MI风险增加相关联个体NSAIDs之间的MI风险差异也很明显。未来研究应考虑采用个体患者数据(IPD)荟萃分析来探究不同患者亚组之间MI风险的差异。

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