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冠状动脉搭桥手术后使用非甾体抗炎药:尽管有黑框警告,使用率仍居高不下。

Non-steroidal anti-inflammatory drug administration after coronary artery bypass surgery: utilization persists despite the boxed warning.

作者信息

Kulik Alexander, Bykov Katsiaryna, Choudhry Niteesh K, Bateman Brian T

机构信息

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital, and Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2015 Jun;24(6):647-53. doi: 10.1002/pds.3788. Epub 2015 Apr 22.

Abstract

PURPOSE

In 2005, the US Food and Drug Administration (FDA) issued a boxed warning against the administration of non-steroidal anti-inflammatory drugs (NSAIDs) after coronary artery bypass graft (CABG) surgery because of cardiovascular safety concerns. We assessed utilization rates before and after the advisory and evaluated predictors of NSAID administration following CABG.

METHODS

We assembled a cohort of 277,576 patients who underwent CABG from 2004 to 2010. Temporal trends in NSAID exposure were evaluated, and predictors of postoperative NSAID use were identified using generalized estimating equations.

RESULTS

Over the study period, 92,938 CABG patients (33.5%) received NSAIDs following surgery. The frequency of NSAID administration declined steadily over time, from a peak of 38.9% in 2004 to a low of 29.0% in 2010 (p < 0.0007). Ketorolac was the most frequent NSAID prescribed, commonly on the first postoperative day. Surgery performed after the boxed warning was independently associated with a 20% lower odds of NSAID administration [odds ratio (OR): 0.80; p = 0.0003]. Other factors that predicted a lower odds of NSAID use following surgery included a history of renal disease (OR: 0.33; p < 0.0001) and liver disease (OR: 0.66; p < 0.0001), and the need for concurrent valve surgery (OR: 0.78; p < 0.0001). A mammary graft at the time of surgery increased the odds of NSAID administration (OR: 1.23; p < 0.0001).

CONCLUSIONS

The frequency of NSAID administration after CABG has declined since the FDA advisory, yet many patients continue to receive them in recent years. Our data highlight the need for future research initiatives to further define the risks associated with NSAID use in this population.

摘要

目的

2005年,美国食品药品监督管理局(FDA)因心血管安全问题发布了关于冠状动脉旁路移植术(CABG)后禁用非甾体抗炎药(NSAIDs)的黑框警告。我们评估了该警告发布前后NSAIDs的使用率,并对CABG术后使用NSAIDs的预测因素进行了评估。

方法

我们纳入了一组2004年至2010年接受CABG手术的277,576例患者。评估了NSAIDs暴露的时间趋势,并使用广义估计方程确定了术后使用NSAIDs的预测因素。

结果

在研究期间,92,938例CABG患者(33.5%)术后接受了NSAIDs治疗。NSAIDs的使用频率随时间稳步下降,从2004年的峰值38.9%降至2010年的低点29.0%(p < 0.0007)。酮咯酸是最常处方的NSAIDs,通常在术后第一天使用。黑框警告发布后进行的手术与NSAIDs使用几率降低20%独立相关[比值比(OR):0.80;p = 0.0003]。其他预测术后NSAIDs使用几率较低的因素包括肾病病史(OR:0.33;p < 0.0001)、肝病病史(OR:0.66;p < 0.0001)以及同期进行瓣膜手术的必要性(OR:0.78;p < 0.0001)。手术时使用乳腺移植物会增加NSAIDs使用的几率(OR:1.23;p < 0.0001)。

结论

自FDA发布警告以来,CABG术后NSAIDs的使用频率有所下降,但近年来仍有许多患者继续使用。我们的数据凸显了未来研究计划的必要性,以进一步明确该人群中使用NSAIDs相关的风险。

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