Andrew A, Rodda B, Verhaest L, Van Winzum C
Br J Clin Pharmacol. 1977 Feb;4 Suppl 1(Suppl 1):45S-52S. doi: 10.1111/j.1365-2125.1977.tb04514.x.
The analgesic efficacy and tolerance of diflunisal in patients with osteoarthritis has been compared with ibuprofen and acetylsalicylic acid (ASA) in two clinical studies carried out double-blind for 12 weeks and then continued single-blind for a further 12 weeks. The studies involved 115 patients and 695 patients, respectively. Diflunisal was superior to ibuprofen in overall response, as assessed by both patients and investigators ( < 0.01), improvement in disease activity and by improvement in internal rotation of the hip ( < 0.05). Diflunisal was superior to ASA in overall response, as assessed by both patients and investigators, therapeutic index ( < 0.01), reduction in morning stiffness, and by improvement in performance of daily activities ( < 0.05). In the first study, the mean daily dose of diflunisal during the double-blind period was 702 mg and of ibuprofen 1 161 mg. In the second study, the mean daily dose of diflunisal was 612 mg and of ASA 2 461 mg. Diflunisal produced fewer gastrointestinal side-effects after 24 weeks of therapy than did ibuprofen ( < 0.01). Diflunisal produced fewer general side-effects and fewer gastrointestinal side-effects during the double-blind and the single-blind phases of the study ( < 0.01). Fewer patients discontinued therapy because of side-effects in the diflunisal group than in the ASA group ( < 0.05). Both ASA and diflunisal decreased serum uric acid, with diflunisal being more uricosuric than aspirin ( < 0.01).
在两项分别进行了12周双盲试验、然后又继续进行12周单盲试验的临床研究中,对双氯芬酸在骨关节炎患者中的镇痛效果及耐受性与布洛芬和乙酰水杨酸(ASA)进行了比较。这两项研究分别涉及115名患者和695名患者。在总体反应方面,经患者和研究人员评估,双氯芬酸均优于布洛芬(P<0.01),在疾病活动改善及髋关节内旋改善方面也优于布洛芬(P<0.05)。在总体反应方面,经患者和研究人员评估,双氯芬酸优于ASA,在治疗指数方面(P<0.01),在减轻晨僵及日常活动能力改善方面也优于ASA(P<0.05)。在第一项研究中,双氯芬酸在双盲期的平均日剂量为702毫克,布洛芬为1161毫克。在第二项研究中,双氯芬酸的平均日剂量为612毫克,ASA为2461毫克。治疗24周后,双氯芬酸产生的胃肠道副作用少于布洛芬(P<0.01)。在研究的双盲和单盲阶段,双氯芬酸产生的一般副作用和胃肠道副作用均较少(P<0.01)。因副作用而停止治疗的双氯芬酸组患者少于ASA组(P<0.05)。ASA和双氯芬酸均降低血清尿酸,双氯芬酸的促尿酸排泄作用比阿司匹林更强(P<0.01)。