Essex M N, Bhadra P, Sands G H
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA.
J Int Med Res. 2012;40(4):1357-70. doi: 10.1177/147323001204000414.
To assess the efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis (OA) of the knee.
This 6-month, randomized, double-blind, double-dummy trial was conducted at 47 centres in the USA. Patients with OA of the knee were randomized to receive 200 mg celecoxib orally once daily or 500 mg naproxen orally twice daily. The primary endpoint was defined as a 20% improvement from baseline to 6 months in Western Ontario and McMaster Universities (WOMAC) OA total score.
A total of 586 out of 589 randomized patients received at least one dose of celecoxib (n=294) or naproxen (n=292). The primary endpoint (6-month response rate) was achieved by 52.7% and 49.7% of patients in the celecoxib and naproxen treatment groups, respectively. Significantly fewer discontinuations due to gastrointestinal adverse events occurred in patients receiving celecoxib than in those receiving naproxen (4.1% versus 15.1%, respectively).
Over the 6month study period, celecoxib provided similar improvements in OA symptoms to naproxen. In addition, celecoxib provided better upper gastrointestinal tolerability than naproxen.
评估塞来昔布与萘普生对膝骨关节炎（OA）患者的疗效和耐受性。
这项为期6个月的随机、双盲、双模拟试验在美国47个中心进行。膝骨关节炎患者被随机分为两组，分别口服200毫克塞来昔布，每日一次，或口服500毫克萘普生，每日两次。主要终点定义为从基线到6个月时，西安大略和麦克马斯特大学（WOMAC）OA总分改善20%。
589名随机分组患者中，共有586名接受了至少一剂塞来昔布（n = 294）或萘普生（n = 292）。塞来昔布和萘普生治疗组分别有52.7%和49.7%的患者达到主要终点（6个月缓解率）。接受塞来昔布治疗的患者因胃肠道不良事件停药的人数明显少于接受萘普生治疗的患者（分别为4.1%和15.1%）。
在为期6个月的研究期间，塞来昔布在OA症状改善方面与萘普生相似。此外，塞来昔布在上消化道耐受性方面优于萘普生。
