来氟米特治疗类风湿关节炎随机双盲平行对照临床试验  

Randomized double - blind controlled clinical trial of leflunomide in the treatment of rheumatoid arthritis

作　　者：张玲玲[1] 丁长海[1] 梁朝朝 魏伟[1] 徐建华[2] 李向培[3] 鲍春德[4] 徐叔云[1] 

机构地区：[1]安徽医科大学临床药理研究所,安徽合肥230032 [2]安徽医科大学附属医院,安徽合肥230022 [3]安徽省立医院,安徽合肥230065 [4]上海第二医科大学仁济医院,上海200001

出　　处：《中国临床药理学杂志》2005年第5期341-344,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：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 efficacy and salty of leflunomide （LEF） and methotrexate （MTX） in the treatment of rheumatoid arthritis （RA）. Methods In this random, double- blind, double- dummy, controlled, multicentric clinical trial, 70 patients with RA were allocated to received LEF （20 mg·d^-1, once a day）, 69 patients received MTX （15 mg · week^-1, once a week） . Period of treatment is 12 weeks, part of cases may administrate drug for 24 weeks. Results The effective ratios of 12 weeks and 24 weeks in LEF group were 44. 28% （n =70）and 79. 36% （n =63） , respectively, the effective ratios of 12 and 24 weeks in MTX group were 49.27% （ n = 69 ） , 74.19% （ n = 62 ）, respectively. Through riddit analysis, the difference of curative effect between LEF and MTX had no significancy. Symptom , sign and join function of RA patients received LEF and MTX were ameliorated distinctly, the lever of ESR, CRP and RF were reduced. The ratio of adverse reactions of LEF and MTX were 17. 14% （ n = 12 ） and 31.88 % （ n = 22 ）, respectively （ P 〈 0.05 ）. Conclusion Leflunomide is an effective and safe drug in treatment of RA.

关 键 词：类风湿关节炎 来氟米特片 氨甲喋呤片 

分 类 号：R684[医药卫生—骨科学] R982[医药卫生—外科学]