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氟比洛芬与萘普生治疗类风湿性关节炎的对比研究

Flurbiprofen versus naproxen in the treatment of rheumatoid arthritis.

作者信息

Brown B L, Johnson J H, Stiger T R

出版信息

Am J Med. 1986 Mar 24;80(3A):105-9. doi: 10.1016/0002-9343(86)90124-5.

Abstract

The efficacy and safety of flurbiprofen (Ansaid, Upjohn), 100 mg twice daily, were compared with those of naproxen, 250 mg twice daily, in a six-week, double-blind, randomized study involving 133 patients with rheumatoid arthritis. Patients completing the six-week treatment phase were then treated with flurbiprofen, 100 mg twice daily, during a six-week open-label phase. In the double-blind phase, both treatment groups showed improvement from baseline and, in general, the arthritic condition of all patients was significantly less severe while receiving treatment. In the open-label phase, the patients in whom therapy was switched from naproxen to flurbiprofen reported greater improvement compared with baseline than they did at the end of the double-blind phase. Statistically significant differences between medication groups were few. At weeks four and six, grip strength for the naproxen group increased from baseline by a marginal amount compared with the flurbiprofen group. Global evaluations of disease improvement by patients and physicians and proximal interphalangeal joint size showed trends in favor of flurbiprofen. In the double-blind phase, 29.4 percent of flurbiprofen-treated patients (n = 20) and 23.1 percent of naproxen-treated patients (n = 15) experienced side effects, most of which were gastrointestinal in origin. In the open-label phase, 81.0 percent of the patients (n = 87) satisfactorily completed the six weeks of flurbiprofen treatment. Based on this study, 100 mg of flurbiprofen administered twice daily was as effective as 250 mg of naproxen twice daily in the treatment of rheumatoid arthritis.

摘要

在一项为期六周的双盲随机研究中,将每日两次、每次100毫克氟比洛芬(安赛蜜,优普强公司生产)的疗效和安全性与每日两次、每次250毫克萘普生的疗效和安全性进行了比较,该研究涉及133名类风湿性关节炎患者。完成六周治疗阶段的患者随后在为期六周的开放标签阶段接受每日两次、每次100毫克氟比洛芬的治疗。在双盲阶段,两个治疗组均较基线有所改善,总体而言,所有患者在接受治疗期间的关节炎病情均明显减轻。在开放标签阶段,从萘普生换用氟比洛芬治疗的患者报告称,与基线相比,其改善程度大于双盲阶段结束时。药物组之间的统计学显著差异很少。在第四周和第六周,萘普生组的握力较基线相比略有增加,而氟比洛芬组则不然。患者和医生对疾病改善的总体评估以及近端指间关节大小显示出有利于氟比洛芬的趋势。在双盲阶段,接受氟比洛芬治疗的患者中有29.4%(n = 20)出现副作用,接受萘普生治疗的患者中有23.1%(n = 15)出现副作用,大多数副作用源于胃肠道。在开放标签阶段,81.0%的患者(n = 87)顺利完成了六周的氟比洛芬治疗。基于这项研究,每日两次服用100毫克氟比洛芬在治疗类风湿性关节炎方面与每日两次服用250毫克萘普生效果相当。

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