Hochberg Marc C
Department of Medicine and Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Semin Arthritis Rheum. 2002 Dec;32(3 Suppl 1):4-14. doi: 10.1053/sarh.2002.37215.
The cyclooxygenase (COX)-2-selective nonsteroidal anti-inflammatory drugs (NSAIDs; coxibs) were developed in order to reduce upper gastrointestinal (GI) side effects associated with traditional nonselective NSAIDs. This article presents an overview of clinical trials showing the efficacy of coxibs for the treatment of patients with arthritis. In osteoarthritis trials, coxibs were more effective than placebo and similarly effective compared with standard doses of traditional NSAIDs. Some studies lasted up to a year and showed effectiveness of coxibs for long-term treatment of patients with osteoarthritis. There are currently few adequately powered trials comparing the efficacy of the 2 first-generation coxibs, celecoxib and rofecoxib. Of 2 head-to-head studies comparing the 2 agents, 1 indicated similar efficacy, whereas the other showed the superiority of rofecoxib at a dose of 25 mg daily compared with celecoxib at a dose of 200 mg daily. In studies enrolling patients with rheumatoid arthritis, coxibs also have shown efficacy superior to that of placebo and similar to that of traditional NSAIDs. There are no clinical trials comparing the efficacy of different coxibs for treatment of patients with rheumatoid arthritis. In endoscopic studies, the GI safety and tolerability profile of coxibs has been consistently superior to that of traditional NSAIDs. In large clinical outcome trials, at least 1 of the coxibs, rofecoxib, significantly reduced the risk of confirmed complicated upper GI events compared with the conventional NSAID naproxen. Both rofecoxib and celecoxib reduced the risk of confirmed clinical upper GI events compared with the nonselective NSAIDs naproxen and ibuprofen in patients with osteoarthritis and rheumatoid arthritis not taking low-dose aspirin. Therefore, coxibs provide effective relief of pain from osteoarthritis and rheumatoid arthritis, with efficacy that is comparable to traditional NSAIDs, but with a significantly lower incidence of GI complications.
环氧化酶(COX)-2选择性非甾体抗炎药(NSAIDs;昔布类药物)的研发旨在减少与传统非选择性NSAIDs相关的上消化道(GI)副作用。本文概述了显示昔布类药物治疗关节炎患者疗效的临床试验。在骨关节炎试验中,昔布类药物比安慰剂更有效,与标准剂量的传统NSAIDs效果相似。一些研究持续长达一年,显示昔布类药物对骨关节炎患者的长期治疗有效。目前,比较两种第一代昔布类药物塞来昔布和罗非昔布疗效的充分有力试验较少。在两项比较这两种药物的直接对比研究中,一项显示疗效相似,而另一项显示,与每日剂量200mg的塞来昔布相比,每日剂量25mg的罗非昔布更具优势。在纳入类风湿关节炎患者的研究中,昔布类药物也显示出优于安慰剂且与传统NSAIDs相似的疗效。没有临床试验比较不同昔布类药物治疗类风湿关节炎患者的疗效。在内镜研究中,昔布类药物的GI安全性和耐受性始终优于传统NSAIDs。在大型临床结局试验中,与传统NSAIDs萘普生相比,至少一种昔布类药物罗非昔布显著降低了确诊的复杂性上消化道事件的风险。与未服用低剂量阿司匹林的骨关节炎和类风湿关节炎患者使用的非选择性NSAIDs萘普生和布洛芬相比,罗非昔布和塞来昔布均降低了确诊的临床消化道事件的风险。因此,昔布类药物能有效缓解骨关节炎和类风湿关节炎引起的疼痛,疗效与传统NSAIDs相当,但胃肠道并发症的发生率显著降低。