Pfizer Inc, New York, NY, USA.
Int J Gen Med. 2014 May 16;7:227-35. doi: 10.2147/IJGM.S61297. eCollection 2014.
Celecoxib is an effective treatment for osteoarthritis (OA). However, information on its efficacy and safety profile in different racial/ethnic groups is limited. Noticeable differences among racial groups are found in other disease states, but a thorough investigation of OA is lacking. The objective of this study was to determine if celecoxib 200 mg once daily is as effective as naproxen 500 mg twice daily in the treatment of OA of the knee in Hispanic patients.
Hispanic patients aged ≥45 years with knee OA were randomized to receive celecoxib 200 mg once daily, naproxen 500 mg twice daily, or placebo for 6 weeks. The primary efficacy variable was the change in Patient's Assessment of Arthritis Pain at 6 weeks compared with baseline. Secondary variables were change in Patient's and Physician's Global Assessments of Arthritis from baseline to week 6/early termination, change in Western Ontario and McMaster Universities OA Index (WOMAC) from baseline to week 6/early termination, change in American Pain Society pain score, Pain Satisfaction Scale, Patient Health Questionnaire (PHQ-9), and measurements of upper gastrointestinal tolerability.
In total, 239 patients completed the trial (96 celecoxib, 96 naproxen, 47 placebo). Celecoxib was as effective as naproxen in reducing OA pain (least squares mean change from baseline [standard error] -39.7 [2.7] for celecoxib and -36.9 [2.6] for naproxen). Patient's and Physician's Global Assessments of Arthritis, WOMAC scores, upper gastrointestinal tolerability, Pain Satisfaction Scale, and PHQ-9 showed no statistically significant differences between the celecoxib and naproxen groups. The incidence of adverse events and treatment-related adverse events were similar among the treatment groups.
Celecoxib 200 mg once daily was as effective as naproxen 500 mg twice daily in the treatment of signs and symptoms of knee OA in Hispanic patients. Celecoxib was shown to be safe and well tolerated in this patient population.
塞来昔布是治疗骨关节炎（OA）的有效药物。然而，关于其在不同种族/民族群体中的疗效和安全性概况的信息有限。在其他疾病状态中，不同种族群体之间存在明显差异，但对 OA 的深入研究却很少。本研究的目的是确定塞来昔布 200mg 每日一次与萘普生 500mg 每日两次在治疗西班牙裔膝骨关节炎患者中的疗效是否相当。
≥45 岁的膝骨关节炎西班牙裔患者随机接受塞来昔布 200mg 每日一次、萘普生 500mg 每日两次或安慰剂治疗 6 周。主要疗效变量为与基线相比，6 周时患者对关节炎疼痛的评估变化。次要变量为从基线到第 6 周/提前终止时患者和医生对关节炎的总体评估变化、从基线到第 6 周/提前终止时西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC）的变化、美国疼痛学会疼痛评分、疼痛满意度量表、患者健康问卷（PHQ-9）以及上消化道耐受性的测量。
共有 239 例患者完成了试验（塞来昔布组 96 例、萘普生组 96 例、安慰剂组 47 例）。塞来昔布在减轻 OA 疼痛方面与萘普生同样有效（塞来昔布组自基线的最小平方均数变化[标准误差]为-39.7[2.7]，萘普生组为-36.9[2.6]）。患者和医生对关节炎的总体评估、WOMAC 评分、上消化道耐受性、疼痛满意度量表和 PHQ-9 在塞来昔布组和萘普生组之间无统计学显著差异。治疗组之间不良事件和治疗相关不良事件的发生率相似。
塞来昔布 200mg 每日一次与萘普生 500mg 每日两次在治疗西班牙裔膝骨关节炎患者的体征和症状方面同样有效。塞来昔布在该患者人群中显示出安全且耐受良好。
