Singh Gurkirpal, Fort John G, Goldstein Jay L, Levy Roger A, Hanrahan Patrick S, Bello Alfonso E, Andrade-Ortega Lilia, Wallemark Carl, Agrawal Naurang M, Eisen Glenn M, Stenson William F, Triadafilopoulos George
Department of Medicine, Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, Calif 94301, USA.
Am J Med. 2006 Mar;119(3):255-66. doi: 10.1016/j.amjmed.2005.09.054.
To evaluate the efficacy and upper gastrointestinal (UGI) safety of celecoxib, compared with nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs), among patients with osteoarthritis.
A total of 13274 osteoarthritis patients from 39 countries were randomly assigned to double-blind treatment with either celecoxib 100 mg twice daily (BID), celecoxib 200 mg BID, or nonselective NSAID therapy (diclofenac 50 mg BID or naproxen 500 mg BID) for 12 weeks. Standard validated measures were used to assess osteoarthritis efficacy. Serious UGI events were evaluated by 2 blinded, independent, gastrointestinal events committees.
Results from all primary efficacy assessments showed that both dosages of celecoxib were as effective as NSAIDs in treating osteoarthritis. Significantly more ulcer complications occurred within the nonselective NSAID group (0.8/100 patient-years) compared with the celecoxib group (0.1/100 patient-years) (odds ratio = 7.02; 95% confidence interval [CI], 1.46 to 33.80; P =.008). There were fewer ulcer complications in the celecoxib group compared with the NSAID group, both in patients taking concomitant aspirin and those not taking aspirin, but the difference reached statistical significance only in the latter comparison. The number of cardiovascular thromboembolic events was low and not statistically different between the groups (eg, myocardial infarction rates: celecoxib 10 events [0.55/100 patient-years] vs NSAIDs 1 event [0.11/100 patient-years], (P =.11), but the study was not powered to detect such differences.
In the treatment of osteoarthritis, celecoxib is as effective as the nonspecific NSAIDs naproxen and diclofenac, but has significantly fewer serious upper gastrointestinal events.
在骨关节炎患者中，评估塞来昔布与非特异性非甾体抗炎药（NSAIDs）相比的疗效及上消化道（UGI）安全性。
来自39个国家的13274例骨关节炎患者被随机分配至双盲治疗组，分别接受每日两次100毫克塞来昔布、每日两次200毫克塞来昔布或非选择性NSAID治疗（双氯芬酸每日两次50毫克或萘普生每日两次500毫克），为期12周。采用标准的验证性测量方法评估骨关节炎疗效。严重UGI事件由2个盲法、独立的胃肠道事件委员会进行评估。
所有主要疗效评估结果显示，两种剂量的塞来昔布在治疗骨关节炎方面与NSAIDs同样有效。与塞来昔布组（0.1/100患者年）相比，非选择性NSAID组（0.8/100患者年）发生溃疡并发症的显著更多（比值比 = 7.02；95%置信区间[CI]，1.46至33.80；P = 0.008）。在服用阿司匹林和未服用阿司匹林的患者中，塞来昔布组的溃疡并发症均少于NSAID组，但差异仅在后者比较中达到统计学显著性。心血管血栓栓塞事件的数量较低，且两组之间无统计学差异（例如，心肌梗死发生率：塞来昔布组10例[0.55/100患者年] vs NSAIDs组1例[0.11/100患者年]，（P = 0.11），但该研究无足够效能检测此类差异。
在骨关节炎治疗中，塞来昔布与非特异性NSAIDs萘普生和双氯芬酸同样有效，但严重上消化道事件显著更少。
