Poul J, West J, Buchanan N, Grahame R
United Medical School, Guy's Hospital, London.
Br J Rheumatol. 1993 Nov;32(11):1000-3. doi: 10.1093/rheumatology/32.11.1000.
The objective of the present study was to establish the efficacy and tolerability of local action transcutaneous flurbiprofen (flurbiprofen LAT) in the treatment of soft tissue lesions. A randomized, double-blind, parallel-group placebo-controlled study was carried out in two hospital outpatient rheumatology clinics. One hundred and four patients aged 18-75 yr were randomized to receive a non-woven polyester-backed patch supporting a formulation containing 40 mg flurbiprofen 12-hourly over 14 days; or a non-medicated (but otherwise identical) control. Statistically significant differences in favour of the active preparation were seen at both days 7 (P = 0.02) and 14 (P = 0.009) for the investigator's overall opinion of severity of the condition, and at day 7 for the investigator's assessment of pain severity (P = 0.04 intention-to-treat; P = 0.052 N.S. eligible data). The need for further treatment in the form of steroid injections after the trial was greater in the controls (29/44, 66%) than in the flurbiprofen LAT group (17/46, 37%) (chi 2 = 7.54 on 1 d.o.f., P = 0.006). Plasma flurbiprofen levels in 11 patients ranged from 13.4 to 338.7 ng/ml (mean 116; median 57.9). Eight out of 53 (15%) patients receiving flurbiprofen LAT reported a total of 10 adverse events, compared with three out of 51 (6%) reporting seven events among controls. Patients found the patch convenient and soothing. We conclude that flurbiprofen LAT is an effective and acceptable treatment for soft tissue lesions, and should be considered as an alternative therapy to local steroid injection.
本研究的目的是确定局部作用的透皮氟比洛芬(氟比洛芬LAT)治疗软组织损伤的疗效和耐受性。在两家医院的门诊风湿病诊所进行了一项随机、双盲、平行组安慰剂对照研究。104例年龄在18 - 75岁的患者被随机分为两组,一组接受一种非织造聚酯背衬贴片,该贴片含有40mg氟比洛芬,每12小时给药一次,持续14天;另一组接受非药物(但其他方面相同)对照。在第7天(P = 0.02)和第14天(P = 0.009),研究者对病情严重程度的总体评价显示,活性制剂组有统计学意义的显著差异;在第7天,研究者对疼痛严重程度的评估也显示有显著差异(意向性分析P = 0.04;符合条件的数据P = 0.052,无统计学意义)。试验后,对照组中需要以类固醇注射形式进行进一步治疗的比例(29/44,66%)高于氟比洛芬LAT组(17/46,37%)(自由度为1时,卡方值 = 7.54,P = 0.006)。11例患者的血浆氟比洛芬水平在13.4至338.7 ng/ml之间(平均116;中位数57.9)。接受氟比洛芬LAT治疗的53例患者中有8例(15%)共报告了10起不良事件,而对照组51例中有3例(6%)报告了7起不良事件。患者认为贴片使用方便且能缓解症状。我们得出结论,氟比洛芬LAT是治疗软组织损伤的一种有效且可接受的治疗方法,应被视为局部类固醇注射的替代疗法。