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法国国家索赔数据库样本中布洛芬与对乙酰氨基酚配药后冠心病事件的倾向评分匹配队列研究。

Coronary Events After Dispensing of Ibuprofen: A Propensity Score-Matched Cohort Study Versus Paracetamol in the French Nationwide Claims Database Sample.

机构信息

Bordeaux PharmacoEpi, INSERM CIC1401, University of Bordeaux, CHU de Bordeaux, 146 rue Leo Saignat, 33076, Bordeaux, France.

INSERM U1219, 33076, Bordeaux, France.

出版信息

Drug Saf. 2018 Nov;41(11):1049-1058. doi: 10.1007/s40264-018-0686-7.

Abstract

INTRODUCTION

Non-steroidal anti-inflammatory drugs are associated with a dose and duration-dependent coronary risk. There is little information concerning analgesic-dose ibuprofen, among the most widely used drugs worldwide.

OBJECTIVE

Our objective was to measure the risks of acute coronary syndrome (ACS) after dispensing of ibuprofen, versus paracetamol.

METHODS

Propensity score 1:2-matched cohorts of ibuprofen or paracetamol treatment episodes (TEs) in Echantillon Généraliste de Bénéficiaires (EGB), the 1/97 sample of Système National des Données de Santé (SNDS), the French nationwide claims database, from 2009 to 2014, were compared. Outcomes were hospital admissions for ACS during the 3 months after the dispensing of ibuprofen or paracetamol. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated overall and stratified on low-dose aspirin dispensing.

RESULTS

A total of 315,269 ibuprofen TEs in 168,400 persons were matched to 630,457 paracetamol TEs in 395,952 patients. Event rates were 50-100 times higher in low-dose aspirin users (27 vs 0.28 per 1000 patient years). Overall there was no difference in risk of ACS at 3 months (HR 0.94, 95% CI 0.74-1.20) despite a transient increase in the first 2 weeks in ibuprofen users (HR 1.70, 95% CI 1.11-2.59). In the stratified analysis, this short-term risk was only found in aspirin users (5% of population, HR 1.84, 95% CI 1.24-3.24), but not in non-aspirin users (HR 1.09, 95% CI 0.40-2.94).

CONCLUSIONS

There was no evidence for an increased risk of ACS in patients dispensed ibuprofen compared to paracetamol.

摘要

介绍

非甾体抗炎药与剂量和时间相关的冠状动脉风险有关。关于全球应用最广泛的药物之一——镇痛剂量的布洛芬,相关信息很少。

目的

我们的目的是测量与扑热息痛相比,开具布洛芬后的急性冠状动脉综合征(ACS)风险。

方法

2009 年至 2014 年,在法国全国性索赔数据库——Echantillon Généraliste de Bénéficiaires(EGB)和 Système National des Données de Santé(SNDS)的 1/97 样本中,对倾向评分 1:2 匹配的布洛芬或扑热息痛治疗期(TE)队列进行比较。结果是在开具布洛芬或扑热息痛后的 3 个月内因 ACS 住院的情况。总体计算和低剂量阿司匹林给药分层的危险比(HR)和 95%置信区间(CI)。

结果

共匹配了 168400 人开具的 315269 次布洛芬 TE 和 395952 名患者的 630457 次扑热息痛 TE。低剂量阿司匹林使用者的事件发生率高 50-100 倍(27 与 0.28/1000 患者年)。尽管布洛芬使用者在头 2 周内风险短暂增加(HR 1.70,95%CI 1.11-2.59),但在 3 个月时,ACS 风险无差异(HR 0.94,95%CI 0.74-1.20)。在分层分析中,这种短期风险仅见于阿司匹林使用者(人群中的 5%,HR 1.84,95%CI 1.24-3.24),而非阿司匹林使用者则没有(HR 1.09,95%CI 0.40-2.94)。

结论

与扑热息痛相比,开具布洛芬的患者发生 ACS 的风险没有增加的证据。

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