The Incidence of Gastrointestinal Perforations Among Rheumatoid Arthritis Patients
The Incidence of Gastrointestinal Perforations Among Rheumatoid Arthritis Patients
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DOI：
10.1002/art.30107
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发表时间：
2011-02-01
影响因子：
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通讯作者：
Delzell, Elizabeth
中科院分区：
文献类型：
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作者：
Curtis, Jeffrey R.;Xie, Fenglong;Delzell, Elizabeth
客观的。胃肠道（GI）穿孔已成为与用于治疗类风湿性关节炎（RA）的药物相关的新的安全问题。本研究旨在描述 RA 患者胃肠道穿孔的发生率和危险因素。方法。利用美国大型健康计划的管理数据库，我们确定了接受生物制剂、甲氨蝶呤 (MTX)、口服糖皮质激素和非甾体抗炎药 (NSAID) 治疗的 RA 患者。我们评估的其他危险因素包括憩室炎。使用经过验证的算法来识别胃肠道穿孔住院情况。使用 Cox 比例风险模型评估发病率和风险因素。结果。在 40,841 名 RA 患者中，发现 37 名因胃肠道穿孔住院。目前正在接受生物制剂治疗且同时接受口服糖皮质激素治疗的患者的胃肠道穿孔率（1.12/1,000人年[95%置信区间 (95% CI) 0.50-2.49]）高于正在接受生物制剂治疗但未接受糖皮质激素治疗的患者（0.47/1,000人年[95% CI]） 0.22-0.98]）或接受 MTX 治疗同时接受糖皮质激素治疗的患者（0.87 每 1,000 人年 [95% CI 0.36-2.10]）。与目前使用糖皮质激素和 NSAID 一起治疗（风险比 4.7 [95% CI 1.9-12.0]）或单独使用糖皮质激素（风险比 2.8 [95% CI 1.3-6.1]）相比，生物制剂和 MTX 均未与胃肠道穿孔显着相关。憩室炎也是一个很强的危险因素（风险比 9.1 [95% CI 3.1-26.4]）。 70% 的胃肠道穿孔患者接受了糖皮质激素治疗，或患有憩室炎，或两者兼而有之。结论。胃肠道穿孔是 RA 患者中罕见但严重的不良事件。由于大多数胃肠道穿孔患者正在接受糖皮质激素治疗或之前患有憩室炎，因此这些人应被视为具有较高的风险。
Objective. Gastrointestinal (GI) perforation has emerged as a novel safety concern in relation to medications used to treat rheumatoid arthritis (RA). This study was undertaken to characterize the incidence and risk factors for GI perforation in RA patients.Methods. Using administrative databases of a large US health plan, we identified RA patients treated with biologic agents, methotrexate (MTX), oral glucocorticoids, and nonsteroidal antiinflammatory drugs (NSAIDs). Additional risk factors we evaluated included diverticulitis. Hospitalization with GI perforation was identified using a validated algorithm. Incidence rates and risk factors were evaluated using Cox proportional hazards models.Results. Among 40,841 RA patients, 37 hospitalizations with GI perforation were identified. The rate of GI perforation among patients currently being treated with biologic agents who were also receiving oral glucocorticoids was higher (1.12 per 1,000 person-years [95% confidence interval (95% CI) 0.50-2.49]) than for patients being treated with biologic agents who were not also receiving glucocorticoids (0.47 per 1,000 person-years [95% CI 0.22-0.98]) or for patients being treated with MTX who were also receiving glucocorticoids (0.87 per 1,000 person-years [95% CI 0.36-2.10]). Neither biologic agents nor MTX was significantly associated with GI perforation, in contrast to current treatment with glucocorticoids and NSAIDs together (hazard ratio 4.7 [95% CI 1.9-12.0]) or glucocorticoids alone (hazard ratio 2.8 [95% CI 1.3-6.1]). Diverticulitis also was a strong risk factor (hazard ratio 9.1 [95% CI 3.1-26.4]). Seventy percent of patients with GI perforation received glucocorticoids, had antecedent diverticulitis, or both.Conclusion. GI perforation is an uncommon but serious adverse event among RA patients. Because a majority of patients with GI perforation were being treated with glucocorticoids or had previously experienced diverticulitis, these individuals should be considered at higher risk.