Bellamy N, Buchanan W W, Chalmers A, Ford P M, Kean W F, Kraag G R, Gerecz-Simon E, Campbell J
Department of Medicine, University of Western Ontario, London, Canada.
J Rheumatol. 1993 Jun;20(6):999-1004.
To conduct the first Canadian study of the comparative efficacy and safety of tenoxicam and diclofenac in patients with primary osteoarthritis (OA) of the knee.
Tenoxicam 20 mg per os once daily (po od) was compared to diclofenac (Voltaren) 50 mg per os 3 times a day (po tid) in a 12-week, double blind, randomized, controlled, multicenter, parallel trial. The primary outcome measure was the pain dimension of the WOMAC OA Index. Following an initial screening visit and a 3 to 7 day NSAID-free washout period (i.e., baseline), patients were assessed at Weeks 2, 4 and 12; assessments including some 15 efficacy variables and safety variables.
Ninety-eight patients [tenoxicam (n = 48), diclofenac (n = 50)] participated in the trial. Statistically significant (p < or = 0.05) improvements in all 3 dimensions of the WOMAC OA Index and six efficacy variables were noted in both treatment groups. No significant between drug differences were noted on any efficacy variable. Significantly fewer patients reported adverse events in the tenoxicam group (21 vs 33, p = 0.03).
Tenoxicam is efficacious and well tolerated in patients with OA of the knee. In this group of patients it was similar in efficacy and superior in tolerability to diclofenac 150 mg/day (50 mg tid). Thus the benefit/risk ratio of tenoxicam was superior to that of diclofenac in this study.
开展加拿大首项关于替诺昔康和双氯芬酸治疗膝关节原发性骨关节炎（OA）患者的疗效及安全性比较研究。
在一项为期12周的双盲、随机、对照、多中心、平行试验中，将替诺昔康20毫克每日口服一次（po od）与双氯芬酸（扶他林）50毫克每日口服3次（po tid）进行比较。主要疗效指标是WOMAC骨关节炎指数的疼痛维度。在首次筛查访视和3至7天的无非甾体抗炎药洗脱期（即基线期）后，于第2、4和12周对患者进行评估；评估包括约15项疗效变量和安全性变量。
98名患者[替诺昔康组（n = 48），双氯芬酸组（n = 50）]参与了试验。两个治疗组在WOMAC骨关节炎指数的所有3个维度和6项疗效变量方面均有统计学意义的显著改善（p≤0.05）。在任何疗效变量上均未发现药物间的显著差异。替诺昔康组报告不良事件的患者明显较少（21例对33例，p = 0.03）。
替诺昔康对膝关节OA患者有效且耐受性良好。在该组患者中，其疗效与每日150毫克（50毫克 tid）的双氯芬酸相似，但耐受性更佳。因此，在本研究中替诺昔康的效益/风险比优于双氯芬酸。
