Turner R A, Shackleford R W, Whipple J P
Clin Ther. 1986;9 Suppl C:37-46.
A multicenter, open-label clinical trial evaluated the efficacy and tolerability of diflunisal given twice daily and aspirin given four times daily in the long-term treatment of patients with rheumatoid arthritis. Patients who successfully completed a 12-week, double-blind, parallel study comparing diflunisal (500 to 750 mg daily) with aspirin (2.6 to 3.9 gm daily) continued on the same medication in a 40-week, open-label segment of the study. The dosage of diflunisal could be increased to a maximum of 1 gm daily during the open-label phase. Both regimens were effective during the 40-week study. Diflunisal was better tolerated than aspirin as judged by the overall incidence of clinical adverse experiences. Patients treated with diflunisal had significantly fewer adverse experiences involving the digestive system and organs of special sense than did those treated with aspirin.
一项多中心、开放标签的临床试验评估了每日两次服用双氯芬酸和每日四次服用阿司匹林对类风湿性关节炎患者的长期治疗效果及耐受性。成功完成一项为期12周的双盲、平行研究(该研究比较了每日服用500至750毫克双氯芬酸与每日服用2.6至3.9克阿司匹林的效果)的患者,在该研究为期40周的开放标签阶段继续服用相同药物。在开放标签阶段,双氯芬酸的剂量可增加至每日最大1克。在为期40周的研究中,两种治疗方案均有效。根据临床不良事件的总体发生率判断,双氯芬酸的耐受性优于阿司匹林。与服用阿司匹林的患者相比,服用双氯芬酸的患者涉及消化系统和特殊感觉器官的不良事件明显更少。