Perez-Ruiz F, Alonso-Ruiz A, Ansoleaga J J
Rheumatology Section, Hospital de Cruces, Vizcaya, Spain.
Clin Rheumatol. 1996 Sep;15(5):473-7. doi: 10.1007/BF02229644.
To compare the efficacy and safety of aceclofenac (AC) and tenoxicam (TX) in the treatment of rheumatoid arthritis (RA), a multicentric parallel, randomized, double-blind trial of three months duration was performed in 292 patients: 145 were randomized to the AC treatment group and 147 to the TX treatment group. The trial was completed by 237 (81.1%) patients. Both treatment groups showed amelioration of clinical parameters monitored at 15 days, and this improvement continued until the end of the trial, no statistically significant differences being observed between AC and TX. Twenty-four patients (8.2%, 12 AC and 12 TX) did not complete the trial because of inefficacy, and 15 because of side effects (5.1%, 6 AC and 9 TX), in 7 of them due to gastrointestinal intolerance (2,4%, 1 AC, 6 TX, p = 0.052). These data demonstrate that AC shows similar efficacy to TX in the treatment of rheumatoid arthritis and better safety profile than TX, mainly regarding gastrointestinal tolerability.
为比较醋氯芬酸（AC）和替诺昔康（TX）治疗类风湿关节炎（RA）的疗效和安全性，对292例患者进行了一项为期三个月的多中心平行、随机、双盲试验：145例随机分为AC治疗组，147例随机分为TX治疗组。237例（81.1%）患者完成了试验。两个治疗组在15天时监测的临床参数均有改善，且这种改善持续到试验结束，AC和TX之间未观察到统计学显著差异。24例患者（8.2%，AC组12例，TX组12例）因无效未完成试验，15例（5.1%，AC组6例，TX组9例）因副作用未完成试验，其中7例（2.4%，AC组1例，TX组6例，p = 0.052）因胃肠道不耐受。这些数据表明，AC在治疗类风湿关节炎方面显示出与TX相似的疗效，且安全性优于TX，主要体现在胃肠道耐受性方面。
