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老年骨关节炎患者使用非甾体抗炎药和胃保护剂的胃肠道风险:一项全国性回顾性队列研究

Gastrointestinal risk of non-steroidal anti-inflammatory drugs and gastroprotective agents used in the treatment of osteoarthritis in elderly patients: A nationwide retrospective cohort study
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作者信息

Han Mi Hye, Nam Jin Hyun, Noh Eunsun, Lee Eui-Kyung

出版信息

Int J Clin Pharmacol Ther. 2019 Nov;57(11):531-541. doi: 10.5414/CP203377.

Abstract

OBJECTIVE

Osteoarthritis is highly prevalent in older adults and often treated with nonsteroidal anti-inflammatory drugs (NSAIDs). COX-2-selective NSAIDs have been shown to offer better gastrointestinal (GI) safety benefits than non-selective NSAIDs (ns-NSAIDs). However, most COX-2-selective NSAIDs have not been comprehensively evaluated for use in combination with gastroprotective agents (GPAs). This study compared the risk of adverse GI events in patients treated with COX-2-selective NSAIDs and ns-NSAIDs alone, or in combination with GPAs.

MATERIALS AND METHODS

We utilized National Health Insurance Claim Data collected from 2012 to 2015. Newly diagnosed patients with osteoarthritis (60 years or older) were included in this study. The study population was divided into two groups: 1) COX-2-selective NSAID treatment and 2) ns-NSAIDs treatment. Patients were followed-up for up to 6 months to determine whether GI events occurred. The Cox proportional hazards model was used to identify differences in risk. Subgroup analyses were conducted for monotherapies and combination treatments with GPAs.

RESULTS

The number of subjects prescribed COX-2-selective NSAID and ns-NSAIDs were 20,868 (5.6%) and 353,494 (94.4%), respectively. After adjustment for confounding factors, COX-2-selective NSAID were safer than ns-NSAIDs (adjusted hazard ratio (aHR) = 0.80, 95% confidence interval (CI): 0.77 - 0.82). Use of GPAs with COX-2-selective NSAID was associated with a lower risk of GI events than use of ns-NSAIDs (aHR = 0.92, 95% CI: 0.87 - 0.97).

CONCLUSION: Use of COX-2-selective NSAID was associated with a lower risk of GI adverse events than use of ns-NSAIDs as a monotherapy. Furthermore, COX-2-selective NSAID were safer than ns-NSAIDs in combination with GPAs.
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摘要

目的

骨关节炎在老年人中非常普遍,通常使用非甾体抗炎药(NSAIDs)进行治疗。与非选择性NSAIDs(ns-NSAIDs)相比,COX-2选择性NSAIDs已被证明具有更好的胃肠道(GI)安全性。然而,大多数COX-2选择性NSAIDs尚未与胃保护剂(GPA)联合使用进行全面评估。本研究比较了单独使用COX-2选择性NSAIDs和ns-NSAIDs,或与GPA联合使用的患者发生胃肠道不良事件的风险。

材料与方法

我们利用了2012年至2015年收集的国民健康保险理赔数据。本研究纳入了新诊断的骨关节炎患者(60岁及以上)。研究人群分为两组:1)COX-2选择性NSAID治疗组和2)ns-NSAIDs治疗组。对患者进行长达6个月的随访,以确定是否发生胃肠道事件。使用Cox比例风险模型来识别风险差异。对单一疗法和与GPA联合治疗进行了亚组分析。

结果

开具COX-2选择性NSAID和ns-NSAIDs的受试者数量分别为20,868(5.6%)和353,494(94.4%)。在对混杂因素进行调整后,COX-2选择性NSAID比ns-NSAIDs更安全(调整后的风险比(aHR)=0.80,95%置信区间(CI):0.77 - 0.82)。与使用ns-NSAIDs相比,COX-2选择性NSAID与GPA联合使用时发生胃肠道事件的风险较低(aHR = 0.92,95% CI:0.87 - 0.97)。

结论

与单独使用ns-NSAIDs相比,使用COX-2选择性NSAID发生胃肠道不良事件的风险较低。此外,在与GPA联合使用时,COX-2选择性NSAID比ns-NSAIDs更安全。

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