Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: A randomized controlled trial
Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: A randomized controlled trial
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DOI：
10.4065/74.11.1095
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发表时间：
1999-11-01
影响因子：
8.9
通讯作者：
Geis, GS
中科院分区：
文献类型：
--
作者：
Bensen, WG;Fiechtner, JJ;Geis, GS
目的：比较塞来昔布（一种环氧合酶-2（考克斯-2）抑制剂）与奈洛芬（一种非甾体抗炎药）和安慰剂治疗膝关节骨关节炎的疗效和安全性。方法：在这项多中心、随机、双盲、安慰剂对照试验中，1003例有症状的膝关节骨关节炎患者被随机分配接受塞来昔布治疗，剂量为50，100或200毫克，每天两次;萘普生，500毫克，每天两次;或安慰剂12周。患者进行了评价与标准措施的疗效2至7天后，停止以前的NSAID或镇痛治疗，并在2，6，和12周的治疗与研究drug.Results：塞来昔布治疗导致显着改善骨关节炎的体征和症状，确定所有的疗效措施。在治疗开始后2天内出现显著疼痛缓解，在2周内明显的最大抗炎和镇痛活性在整个12周研究中持续存在。与安慰剂相比，所有塞来昔布剂量均有效，尽管50 mg每日两次给药方案的有效性最低。较高剂量的塞来昔布（100和200 mg，每日两次）的有效性相似，这些给药方案观察到的改善幅度与500 mg，每日两次的那普利相当。所有剂量的塞来昔布和萘普生均耐受良好。结论：塞来昔布抑制考克斯-2是治疗骨关节炎的有效方法，临床体征和症状改善与萘普生治疗相当。
Objective: To compare the efficacy and safety of celecoxib, a cyclooxygenase-2 (COX-2) inhibitor, with those of naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and placebo in the treatment of osteoarthritis of the knee.Methods: In this multicenter, randomized, double blind, placebo-controlled trial, 1003 patients with symptomatic osteoarthritis of the knee were randomly assigned to receive celecoxib at doses of 50, 100, or 200 mg twice a day; naproxen, 500 mg twice a day; or placebo for 12 weeks. Patients were evaluated with standard measures of efficacy 2 to 7 days after discontinuing previous NSAID or analgesic therapy and after 2, 6, and 12 weeks of treatment with the study drug.Results: Celecoxib treatment led to significant improvement in the signs and symptoms of osteoarthritis as determined by all efficacy measures. Significant pain relief occurred within 2 days of the initiation of treatment, and maximum anti-inflammatory and analgesic activity, evident within 2 weeks, was sustained throughout the 12-week study. All celecoxib doses were efficacious compared with placebo, although the 50-mg twice-daily dosage regimen was minimally effective. The higher doses of celecoxib (100 and 200 mg twice a day) were similarly efficacious, and the magnitude of improvement observed with these dosing regimens was comparable to that seen with naproxen at a dose of 500 mg twice a day. All doses of celecoxib and naproxen were well tolerated,Conclusion: COX-2 inhibition with celecoxib is an effective approach for the treatment of osteoarthritis, as seen by clinical improvement in signs and symptoms comparable to treatment with naproxen.