Reginster J Y, Malmstrom K, Mehta A, Bergman G, Ko A T, Curtis S P, Reicin A S
Services de Medecine de l'Appareil Locomoteur, Polycliniques Universitaires L Brull, Liege, Belgium.
Ann Rheum Dis. 2007 Jul;66(7):945-51. doi: 10.1136/ard.2006.059162. Epub 2006 Dec 1.
To assess the efficacy and safety of etoricoxib 60 mg once daily and naproxen 500 mg twice daily over a 138-week treatment period in patients with osteoarthritis (OA).
Two 1-year randomised, double blind, parallel group two-part base studies (part I 12 weeks; part II 40 weeks), followed by an 86-week extension, in patients with OA (hip or knee) were conducted at 80 clinical centres (19 countries). The studies had identical designs. Patients taking placebo in part I received etoricoxib or naproxen (1:1 ratio) in part II and the extension; patients taking etoricoxib or naproxen in part I continued to receive the same treatment throughout the entire length of the studies. Co-primary efficacy end points were patient global assessment of disease status, and WOMAC questionnaire pain subscale and physical function subscale (100 mm VAS). Efficacy over 138 weeks was assessed by graphical analysis. Safety was assessed by observation of adverse experiences and laboratory and physical evaluations.
997 patients entered (615 completed) the base studies. Of these patients, 463 patients entered the extensions. A total of 161 and 152 patients in the etoricoxib and naproxen groups, respectively, completed 138 treatment weeks. Etoricoxib and naproxen showed similar efficacy throughout the 138 weeks of treatment. For etoricoxib and naproxen, respectively, WOMAC pain assessments were 67 and 67 mm (baseline); 28 and 29 mm (1 year), and 34 and 33 mm (138 weeks). Results for the other efficacy end points were similar to those seen with the WOMAC pain assessments. Both etoricoxib and naproxen were generally well tolerated.
Both etoricoxib and naproxen demonstrated long-term clinical efficacy for the treatment of OA. Etoricoxib and naproxen were generally well tolerated.
评估依托考昔60毫克每日一次和萘普生500毫克每日两次在138周治疗期内对骨关节炎（OA）患者的疗效和安全性。
在80个临床中心（19个国家）对OA（髋或膝）患者进行了两项为期1年的随机、双盲、平行组两部分基础研究（第一部分12周；第二部分40周），随后进行86周的延长期研究。两项研究设计相同。在第一部分服用安慰剂的患者在第二部分和延长期接受依托考昔或萘普生（1:1比例）；在第一部分服用依托考昔或萘普生的患者在整个研究期间继续接受相同治疗。共同主要疗效终点为患者对疾病状态的整体评估，以及WOMAC问卷疼痛子量表和身体功能子量表（100毫米视觉模拟评分）。通过图形分析评估138周的疗效。通过观察不良事件以及实验室和体格检查评估安全性。
997例患者进入基础研究（615例完成）。在这些患者中，463例患者进入延长期。依托考昔组和萘普生组分别有161例和152例患者完成了138周的治疗。在138周的治疗期间，依托考昔和萘普生显示出相似的疗效。依托考昔和萘普生的WOMAC疼痛评估分别为67毫米和67毫米（基线）；28毫米和29毫米（1年），以及34毫米和33毫米（138周）。其他疗效终点的结果与WOMAC疼痛评估结果相似。依托考昔和萘普生总体耐受性良好。
依托考昔和萘普生均显示出治疗OA的长期临床疗效。依托考昔和萘普生总体耐受性良好。
