Dreiser R L, Roche R, De Sahb R, Thomas F, Leutenegger E
Hôpitaux de Paris, France.
Eur J Rheumatol Inflamm. 1994;14(4):9-13.
One hundred and thirty-one male and female outpatients, aged 18-70 yr, with acute pain in the ankle joint caused by a post-traumatic sprain, entered a multicentre, randomised, double-blind, parallel-group, study. The patients were assigned to a 40 mg flurbiprofen patch (n = 65) or a non-medicated (but otherwise identical) control (n = 66), 12-hourly over 7 days, and were assessed at entry and after 3 and 7 days treatment. On day 7, spontaneous pain (the prime efficacy parameter), as evaluated by the patient on a visual analogue scale in the physician's office, showed significant improvement in the 40 mg flurbiprofen patch group compared to control (change from baseline) (p = 0.039), a result corroborated by the evaluation of the periarticular oedema: a reduction of 77.4% was observed in the 40 mg flurbiprofen patch group, compared with 63.8% in the control group (p = 0.025). The other selected efficacy criteria showed changes with a trend in favour of the 40 mg flurbiprofen patch but without statistical significance. Two mild and local adverse events were reported by two flurbiprofen patch patients, but neither patients discontinued the treatment prematurely. Physicians and patients found the flurbiprofen patch to be efficacious and well tolerated. Compliance was excellent in both groups. The efficacy and tolerability of the 40 mg flurbiprofen patch are therefore confirmed in the treatment of acute ankle sprains.
131名年龄在18至70岁之间、因创伤后扭伤导致踝关节急性疼痛的男女门诊患者，参与了一项多中心、随机、双盲、平行组研究。患者被分配至使用40毫克氟比洛芬贴剂组（n = 65）或非药物（但其他方面相同）对照组（n = 66），每12小时用药一次，持续7天，并在入组时以及治疗3天和7天后进行评估。在第7天，由患者在医生办公室使用视觉模拟量表评估的自发疼痛（主要疗效参数）显示，与对照组相比，40毫克氟比洛芬贴剂组有显著改善（相对于基线的变化）（p = 0.039），关节周围水肿的评估结果也证实了这一结果：40毫克氟比洛芬贴剂组观察到水肿减少了77.4%，而对照组为63.8%（p = 0.025）。其他选定的疗效标准显示有变化趋势，有利于40毫克氟比洛芬贴剂，但无统计学意义。两名使用氟比洛芬贴剂的患者报告了两例轻度局部不良事件，但两名患者均未过早停药。医生和患者均发现氟比洛芬贴剂有效且耐受性良好。两组的依从性都很好。因此，40毫克氟比洛芬贴剂在治疗急性踝关节扭伤中的疗效和耐受性得到了证实。
