来氟米特治疗类风湿关节炎疗效评价  

Efficacy in Active Rheumatoid Arthritis Treated by Leflunomide in Comparison with Methotrexate: A Randomized and Controlled Trial

作　　者：姜林娣[1] 於强[1] 梅振武[1] 

机构地区：[1]复旦大学附属中山医院风湿科,上海200032

出　　处：《中国临床医学》2001年第2期157-158,160,共3页Chinese Journal of Clinical Medicine

摘　　要：目的 :通过II期随机对照临床试验比较研究药物来氟米特 (LEF)和阳性对照甲氨喋呤 (MTX)治疗类风湿关节炎 (RA)临床疗效和安全性 ,旨在科学地评价LEF在治疗RA中的作用。方法 :本试验为单盲随机对照临床研究。 5 0例活动性RA病人随机分入LEF组 (2 4例 )和MTX组 (2 6例 ) ,分别服用LEF2 0mg/d +安慰剂 (C)和MTX15mg/每周 +安慰剂 (B) 3个月。试验开始4周同时应用非甾体抗炎药丙嗪。所有病人在治疗前和试验结束后测定临床指标包括休息痛、晨僵、握力、关节压痛数 /指数、关节肿胀数 /指数、ESR、CRP、病人 /医师评价等。结果 :治疗 12周后 ,LEF组总有效率和显效率分别为 10 0 %和 83 .33% ,MTX组分别为 96 .15 %和 73.0 8% (P <0 .0 5 )。两组病人治疗 12周主要临床指标均较治疗前明显改善 ,且除晨僵外两组间改善值和改善百分率比较无明显差别。LEF组不良反应发生率为 83% ,MTX组为 2 3.0 8% (P =0 .0 12 )。病人对LEF耐受性好 ,两组病人对药物的耐受性有明显的差异 (P =0 .0 43)。结论 :LEF治疗RA病人 12周 ,其疗效与MTX相似 ,未发现不良反应 ,病人耐受性好。Objective: To assess clinical efficacy in rheumatoid arthritis (RA) patients with 3-month leflunomide (LEF) therapy, comparing with methotrexate (MTX). Methods: 50 consecutive patients with active rheumatoid arthritis had been randomly allocated into LEF ( n =24) and MTX ( n =26) groups respectively. Patients in the former group received LEF20mg daily and an identical placebo 6 tablets per week which was similar to MTX in shape, color and taste. Patients in the latter group received 15mg MTX per week and an identical placebo 2 tablets daily which was similar to LEF in shape, color and taste. All the patients had been followed up for 3 months. Results: The overall treatment response rates were 100% and 96.15% for LEF and MTX respectively, and no significant difference was found between the two groups. Both patients had much similar improvement in physical functions after treatment e.g. joint tenderness count/score, joint swelling count/score, ESR, CRP, RHF. The adverse effect in the LEF group was slight. Conclusion: LEF is an effective medication for treatment of RA, which is the same as MTX treatment in the improvement of clinical symptoms, and has a few and slight side effects.

关 键 词：来氟米特 甲氨喋呤 随机对照研究 类风湿性关节炎 药物治疗 

分 类 号：R593.22[医药卫生—内科学] R979.5[医药卫生—临床医学]