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目的 研究来氟米特(LEF)治疗类风湿关节炎(RA)的疗效和安全性。 方法用随机双盲双模拟平行对照多中心临床试验,试验组70例患者每日口 服来氟米特(LEF)20 mg,1天1次;对照组69例患者口服氨甲喋呤(MTX)15 mg,1周1次,疗程12周,部分病例积累用药24周。结果治疗12,24周,试验 组与对照组有效率分别为44．28％(70例),79．36％(63例);49．27％(69例), 74．19％(62例),2组比较无显著性差异。2组均能改善RA患者临床症状、体 征和关节功能,降低血沉、C-反应蛋白和类风湿因子水平。2组药物不良反应 发生率分别为17．14％(12例)和31．88％(22例)(P<0．05)。结论来氟米 特治疗类风湿性关节炎疗效与耐受性均较氨甲喋呤好。
Objective To study the efficacy and safety of leflunomide (LEF) in the treatment of rheumatoid arthritis (RA). Methods A randomized, double-blind, double-dummy, parallel-controlled, multicenter trial of 70 patients in the experimental group received oral leflunomide (LEF) 20 mg once daily for 1 day. 69 patients in the control group received methotrexate (MTX) 15 mg orally, 1 week 1, treatment for 12 weeks, some cases accumulate medication for 24 weeks. Results The effective rates of treatment group and control group were 44.28% (70 cases), 79.36% (63 cases), 49.27% (69 cases) and 74.19% (62 cases) ), No significant difference between the two groups. Both groups could improve the clinical symptoms, signs and joint function of RA patients and reduce the levels of erythrocyte sedimentation rate, C-reactive protein and rheumatoid factor. Adverse drug reactions in the two groups were 17.14% (12 cases) and 31.88% (22 cases), respectively (P <0.05). Conclusion The efficacy and tolerability of leflunomide in the treatment of rheumatoid arthritis are better than that of methotrexate.