罗非昔布撤市时代的非选择性 NSAIDs、昔布类和胃保护剂处方 - 一项涉及 617400 名患者的研究。

Prescription of nonselective NSAIDs, coxibs and gastroprotective agents in the era of rofecoxib withdrawal - a 617,400-patient study.

机构信息

Department of Medical Informatics, Erasmus University Medical Centre, Rotterdam, the Netherlands.

出版信息

Aliment Pharmacol Ther. 2012 Oct;36(8):790-9. doi: 10.1111/apt.12028. Epub 2012 Aug 28.

DOI:10.1111/apt.12028

PMID:22928490

Abstract

BACKGROUND

Gastroprotective strategies are recommended for nonsteroidal anti-inflammatory drug (NSAID) users at risk of upper gastrointestinal (UGI) complications.

AIM

To compare the use of gastroprotective strategies in NSAID users in three countries, and the subsequent impact of rofecoxib withdrawal.

METHODS

We conducted a population-based cohort study in three general practice (GP) databases: (i) United Kingdom's (UK) GP Research Database (1998-2008); (ii) Italy's (IT) Health Search/CSD Longitudinal Patient Database (2000-2007); and (iii) the Dutch (NL) Integrated Primary Care Information database (1996-2006). Study cohorts comprised incident NSAID users ≥50 years. Preventive strategies included: (i) co-prescription of gastroprotective agents; or (ii) cyclooxygenase-2-selective inhibitor use. Under-use was defined as no gastroprotection in patients with ≥1 UGI risk factor (history of UGI event, age ≥65 years, concomitant use of anticoagulants, antiplatelets or glucocorticoids). Interrupted time-series analysis was performed to assess the impact of rofecoxib withdrawal on preventive strategies.

RESULTS

The study populations consisted of 384 649 UK, 177 747 IT and 55 004 NL NSAID users. In UK, under-use of preventive strategies fell from 91% to 71% [linear trend (lt) P = 0.001], in NL from 92% to 58% (lt P < 0.001) and in IT from 90% to 76% (lt P = 0.38) in high-risk NSAID users. In 2000 and 2006, under-use was significantly lower in NL compared with UK and IT (P < 0.001) in high-risk users. After rofecoxib's withdrawal, under-use increased significantly in UK and NL.

CONCLUSIONS

The prescription of gastropreventive strategies followed a similar pattern across countries. Despite a temporary negative effect of rofecoxib withdrawal on under-use, improvement of gastroprotection with nonsteroidal anti-inflammatory drugs was observed.

摘要

背景

建议对有上消化道（UGI）并发症风险的非甾体抗炎药（NSAID）使用者采用胃保护策略。

目的

比较三个国家 NSAID 使用者中胃保护策略的使用情况，以及随后罗非昔布撤市的影响。

方法

我们在三个全科医生（GP）数据库中进行了一项基于人群的队列研究：（i）英国（UK）GP 研究数据库（1998-2008 年）；（ii）意大利（IT）健康搜索/CSD 纵向患者数据库（2000-2007 年）；和（iii）荷兰（NL）综合初级保健信息数据库（1996-2006 年）。研究队列包括新发生的≥50 岁 NSAID 使用者。预防策略包括：（i）同时开具胃保护剂；或（ii）使用环氧化酶-2 选择性抑制剂。如果患者有≥1 个 UGI 危险因素（UGI 事件史、年龄≥65 岁、同时使用抗凝剂、抗血小板或糖皮质激素），则定义为未使用胃保护。使用中断时间序列分析来评估罗非昔布撤市对预防策略的影响。

结果

研究人群包括 384649 名英国、177747 名意大利和 55004 名荷兰 NSAID 使用者。在英国，高危 NSAID 使用者中预防策略的未使用率从 91%降至 71%（线性趋势（lt）P=0.001），在荷兰从 92%降至 58%（lt P<0.001），在意大利从 90%降至 76%（lt P=0.38）。在 2000 年和 2006 年，高危使用者中荷兰的未使用率明显低于英国和意大利（P<0.001）。罗非昔布撤市后，英国和荷兰的未使用率显著增加。