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非萘普生非甾体抗炎药、COX-2抑制剂与老年人急性心肌梗死住院之间的关联:一项回顾性队列研究。

Association between nonnaproxen NSAIDs, COX-2 inhibitors and hospitalization for acute myocardial infarction among the elderly: a retrospective cohort study.

作者信息

Rahme Elham, Watson Douglas J, Kong Sheldon X, Toubouti Youssef, LeLorier Jacques

机构信息

Department of Medicine McGill University, and Research Institute, McGill University Health Center, Montreal, Canada.

出版信息

Pharmacoepidemiol Drug Saf. 2007 May;16(5):493-503. doi: 10.1002/pds.1339.

DOI:10.1002/pds.1339
PMID:17086567
Abstract

PURPOSE

To evaluate the association between rofecoxib, celecoxib, diclofenac, and ibuprofen and the risk of hospitalization for acute myocardial infarction (AMI) in an elderly population.

METHODS

We conducted a retrospective cohort study, using data from the government of Quebec health insurance agency databases, among patients 65-80 years of age who filled a prescription for any of the study drugs during 1999-2002. Cox regression models with time-dependent exposure were used to compare the incidence rates of hospitalization for AMI adjusting for patients' baseline characteristics. Analyses stratified by dose and number of supplied days were also conducted.

RESULTS

At the index date, a total of 91 062 patients were taking rofecoxib, 127 928 celecoxib, 49 193 diclofenac, and 15 601 ibuprofen. The adjusted hazard ratio (HR) (95%CI) of hospitalization for AMI were: celecoxib versus rofecoxib: 0.90 (0.79, 1.01); ibuprofen versus rofecoxib: 0.95 (0.65, 1.37); diclofenac versus rofecoxib: 1.01 (0.84, 1.22). In secondary analyses based on intended duration of use, neither COX-2 selective inhibitor was associated with a higher risk than ibuprofen or diclofenac. The unadjusted risk of AMI for all NSAIDs increased with dose. In the direct two way adjusted comparison of each NSAID stratified by dose, the only statistically significant difference was with rofecoxib >25 mg/day versus celecoxib >200 mg/day.

CONCLUSION

In this study there was no difference between AMI occurrence in elderly patients taking rofecoxib or celecoxib at recommended doses for chronic indications versus those taking ibuprofen/diclofenac. However, the risk of AMI was higher among patients using higher doses of rofecoxib (>25 mg/day) compared to patients using higher doses of celecoxib (>200 mg/day).

摘要

目的

评估罗非昔布、塞来昔布、双氯芬酸和布洛芬与老年人群急性心肌梗死(AMI)住院风险之间的关联。

方法

我们进行了一项回顾性队列研究,使用魁北克政府医疗保险机构数据库中的数据,研究对象为1999年至2002年期间开具过任何一种研究药物处方的65至80岁患者。采用具有时间依赖性暴露的Cox回归模型,比较调整了患者基线特征后的AMI住院发病率。还进行了按剂量和供应天数分层的分析。

结果

在索引日期,共有91062例患者服用罗非昔布,127928例服用塞来昔布,49193例服用双氯芬酸,15601例服用布洛芬。AMI住院的调整后风险比(HR)(95%CI)为:塞来昔布与罗非昔布相比:0.90(0.79,1.01);布洛芬与罗非昔布相比:0.95(0.65,1.37);双氯芬酸与罗非昔布相比:1.01(0.84,1.22)。在基于预期使用时长的二次分析中,两种COX - 2选择性抑制剂与布洛芬或双氯芬酸相比,均未显示出更高的风险。所有非甾体抗炎药(NSAIDs)未调整的AMI风险随剂量增加而升高。在按剂量分层的每种NSAID的直接双向调整比较中,唯一具有统计学显著差异的是罗非昔布>25毫克/天与塞来昔布>200毫克/天之间。

结论

在本研究中,服用罗非昔布或塞来昔布用于慢性适应证的推荐剂量的老年患者与服用布洛芬/双氯芬酸的患者相比,AMI发生率无差异。然而,与服用较高剂量塞来昔布(>200毫克/天)的患者相比,使用较高剂量罗非昔布(>25毫克/天)的患者发生AMI的风险更高。

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