Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.
Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.
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DOI：
10.1056/nejm200011233432103
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发表时间：
2000-11-23
影响因子：
158.5
通讯作者：
Weaver, A
中科院分区：
文献类型：
--
作者：
Bombardier, C;Laine, L;Weaver, A
背景：每年有2% - 4%服用非选择性非甾体类抗炎药（NSAIDs）的患者出现临床上消化道事件。我们评估了在类风湿关节炎患者中，选择性环氧化酶-2抑制剂rofecoxib与非选择性非甾体抗炎药萘普生相比，是否与临床上重要的上消化道事件发生率较低相关。方法：我们随机分配8076例年龄≥50岁（或≥40岁且接受长期糖皮质激素治疗）且患有类风湿关节炎的患者，每天接受50mg罗非昔布或500mg萘普生，每天两次。主要终点为临床证实的上消化道事件（胃十二指肠穿孔或梗阻、上消化道出血和症状性胃十二指肠溃疡）。结果：罗非昔布与萘普生对类风湿关节炎疗效相近。在中位随访9.0个月期间，罗非昔布组每100患者年发生2.1例胃肠道事件，而萘普生组每100患者年发生4.5例胃肠道事件(相对危险度为0.5；95%可信区间为0.3 ~ 0.6；P
Background: Each year, clinical upper gastrointestinal events occur in 2 to 4 percent of patients who are taking nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2, would be associated with a lower incidence of clinically important upper gastrointestinal events than is the nonselective NSAID naproxen among patients with rheumatoid arthritis.Methods: We randomly assigned 8076 patients who were at least 50 years of age (or at least 40 years of age and receiving long-term glucocorticoid therapy) and who had rheumatoid arthritis to receive either 50 mg of rofecoxib daily or 500 mg of naproxen twice daily. The primary end point was confirmed clinical upper gastrointestinal events (gastroduodenal perforation or obstruction, upper gastrointestinal bleeding, and symptomatic gastroduodenal ulcers).Results: Rofecoxib and naproxen had similar efficacy against rheumatoid arthritis. During a median follow-up of 9.0 months, 2.1 confirmed gastrointestinal events per 100 patient-years occurred with rofecoxib, as compared with 4.5 per 100 patient-years with naproxen (relative risk, 0.5; 95 percent confidence interval, 0.3 to 0.6; P