Calin A, Cawley M I, Pal B, Rosenberg J N, Silas A M, Williams P I
Royal National Hospital for Rheumatic Diseases, Bath.
Drugs. 1988;35 Suppl 1:57-63. doi: 10.2165/00003495-198800351-00013.
In a randomised double-blind, multicentre, crossover study, the short term efficacy and tolerance of a sustained action preparation of tiaprofenic acid 600 mg once daily was compared with sustained release indomethacin 75 mg once daily in 98 patients with osteoarthritis. After a minimum washout period of 3 days, patients were randomly allocated to receive each treatment in turn for a period of 4 weeks. There were no significant differences between the 2 treatments in the clinical assessments of pain level, duration of morning stiffness, articular index and functional impairment performed at the end of each treatment period. High pain levels on movement were reduced by both treatments, and reduction was also seen in night pain, where initial levels were lower. There was no significant difference between the number of patients who reported side effects on the 2 treatments. 37 patients (39%) reported 49 side effects while taking sustained release tiaprofenic acid, and 35 patients (37%) reported 53 side effects while taking sustained release indomethacin. Daily diary cards showed that both treatments provided improvements in duration of morning stiffness and in pain relief. Thus sustained action tiaprofenic acid and sustained release indomethacin were shown to be equally well tolerated and efficacious.
在一项随机双盲、多中心、交叉研究中,将98例骨关节炎患者每日一次服用600毫克噻洛芬酸缓释制剂的短期疗效和耐受性与每日一次服用75毫克吲哚美辛缓释制剂进行了比较。经过至少3天的洗脱期后,患者被随机分配依次接受每种治疗,为期4周。在每个治疗期结束时进行的疼痛程度、晨僵持续时间、关节指数和功能损害的临床评估中,两种治疗之间没有显著差异。两种治疗均能减轻运动时的高疼痛水平,对于初始水平较低的夜间疼痛也有减轻作用。报告两种治疗有副作用的患者数量没有显著差异。37例患者(39%)在服用噻洛芬酸缓释制剂时有49例副作用报告,35例患者(37%)在服用吲哚美辛缓释制剂时有53例副作用报告。每日日记卡显示,两种治疗在晨僵持续时间和疼痛缓解方面均有改善。因此,噻洛芬酸缓释制剂和吲哚美辛缓释制剂显示出同等良好的耐受性和疗效。