Hochberg Marc C
Division of Rheumatology and Clinical Immunology, University of Maryland School of Medicine, 10 S. Pine St., MSTF 8-34, Baltimore, Maryland 21201, USA.
Curr Top Med Chem. 2005;5(5):443-8. doi: 10.2174/1568026054201695.
COX-2 selective inhibitors were developed in order to provide similar efficacy to traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) but with improved upper gastrointestinal safety. This paper presents an overview of randomized clinical trials demonstrating the efficacy of COX-2 selective inhibitors for the treatment of patients with arthritis, particularly osteoarthritis and rheumatoid arthritis. In osteoarthritis and rheumatoid arthritis, COX-2 selective inhibitors have been shown to be more effective than placebo and similarly effective as standard doses of nonselective NSAIDs. There are currently few randomized clinical trials comparing the efficacy of the 2 first-generation COX-2 selective inhibitors, celecoxib and rofecoxib, in osteoarthritis. Of 4 head-to-head studies comparing the 2 agents, 3 indicated similar efficacy, while the other demonstrated superiority of rofecoxib at a dose of 25 mg qd compared with celecoxib at a dose of 200 mg qd. There are no clinical trials comparing the efficacy of different agents for treatment of patients with rheumatoid arthritis. Some studies have also demonstrated efficacy for COX-2 selective inhibitors in patients with ankylosing spondylitis and gout. In aggregate, these data show that COX-2 selective inhibitors provide effective relief of pain in patients with osteoarthritis and rheumatoid arthritis, with efficacy that is similar to traditional NSAIDs. Cost-effectiveness and cost-utility studies suggest, however, that their use should be limited to patients at high risk of serious upper gastrointestinal side effects, including complicated ulcers.
COX-2选择性抑制剂的研发目的是提供与传统非选择性非甾体抗炎药(NSAIDs)相似的疗效,但提高上消化道安全性。本文概述了随机临床试验,这些试验证明了COX-2选择性抑制剂对关节炎患者,尤其是骨关节炎和类风湿关节炎患者的治疗效果。在骨关节炎和类风湿关节炎中,COX-2选择性抑制剂已被证明比安慰剂更有效,且与标准剂量的非选择性NSAIDs效果相似。目前,比较两种第一代COX-2选择性抑制剂塞来昔布和罗非昔布在骨关节炎中疗效的随机临床试验较少。在比较这两种药物的4项头对头研究中,3项表明疗效相似,而另一项显示,与每日剂量200mg的塞来昔布相比,每日剂量25mg的罗非昔布具有优越性。尚无比较不同药物治疗类风湿关节炎患者疗效的临床试验。一些研究还证明了COX-2选择性抑制剂对强直性脊柱炎和痛风患者的疗效。总体而言,这些数据表明,COX-2选择性抑制剂能有效缓解骨关节炎和类风湿关节炎患者的疼痛,其疗效与传统NSAIDs相似。然而,成本效益和成本效用研究表明,它们的使用应限于有严重上消化道副作用高风险的患者,包括复杂性溃疡患者。