Bernhard G C, Appelrouth D J, Bankhurst A D, Biundo J, Bockow B I, Brobyn R D, Brodsky A L, Burch F X, Chang R W, Cohen M H
Midwest Arthritis Treatment Center, Columbia Hospital, Milwaukee, Wisconsin 53211.
Am J Med. 1987 Oct 30;83(4B):44-9. doi: 10.1016/0002-9343(87)90593-6.
This report summarizes the results of a 17-investigator multicenter six-month randomized double-blind parallel group study. The safety and efficacy of nabumetone 1,000 mg taken at bedtime was compared with that of aspirin 900 mg four times daily in the treatment of adult patients with active class II or III classical or definite rheumatoid arthritis. Two hundred sixty-four patients were entered into the study. Two hundred fifty-seven (126 nabumetone and 131 aspirin) patients were evaluable for safety. Two hundred thirty-four (113 nabumetone and 121 aspirin) patients were evaluable for efficacy. There was significant improvement in each of six clinical measurements of efficacy in both treatment groups and little difference between groups. The somewhat greater improvement in articular index and duration of morning stiffness in the nabumetone-treated group did not reach statistical significance. There was an equal percentage of patient withdrawal for lack of efficacy in each group. Overall, the rate of patient withdrawal due to adverse experiences was greater (p = 0.01) for aspirin-treated patients. These experiences were usually dispepsia, abdominal pain, and tinnitus. It was concluded that nabumetone was an effective anti-inflammatory drug in the treatment of rheumatoid arthritis with less toxicity than aspirin.
本报告总结了一项由17名研究人员参与的多中心、为期6个月的随机双盲平行组研究结果。在治疗活动期II级或III级典型或确诊类风湿性关节炎的成年患者中，比较了睡前服用1000毫克萘丁美酮与每日4次服用900毫克阿司匹林的安全性和疗效。264名患者进入该研究。257名患者（126名服用萘丁美酮，131名服用阿司匹林）可进行安全性评估。234名患者（113名服用萘丁美酮，121名服用阿司匹林）可进行疗效评估。两个治疗组在六项疗效临床测量指标上均有显著改善，且组间差异不大。萘丁美酮治疗组在关节指数和晨僵持续时间方面的改善略大，但未达到统计学显著性。每组因疗效不佳而退出的患者比例相同。总体而言，阿司匹林治疗患者因不良事件而退出的比例更高（p = 0.01）。这些不良事件通常是消化不良、腹痛和耳鸣。得出的结论是，萘丁美酮是一种治疗类风湿性关节炎的有效抗炎药物，其毒性低于阿司匹林。
