来氟米特治疗类风湿关节炎疗效评价  

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

作　　者：姜林娣[1] 於强[1] 梅振武 

机构地区：[1]复旦大学医学院附属中山医院风湿科,200032

出　　处：《中国临床医学》2000年第4期413-415,共3页Chinese Journal of Clinical Medicine

摘　　要：目的：通过Ⅱ期随机对照来氟米特（ＬＥＦ）和甲氨碟呤（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。５０例活动性ＲＡ病人随机分入ＬＥＦ组（２４例）和ＭＴＸ组（２６例），分别服用ＬＥＦ２０ｍｇ／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恶丙嗪。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１００％和８３．３３％，ＭＴＸ组分别为９６．１５％和７３．０８％（Ｐ＜０．０５）。两组病人治疗１２周主要临床指标均较治疗前明显改善，且除展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８．３％，ＭＴＸ组为２３．０８％（Ｐ＝０．０１２）。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＝０．０４３）。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). Method: 50 consecutive patients who suffered from 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 significantly difference was found between two groups. Both patients have much similar improvement in physical functions after treatment e. g. joint tenderness count/score, joint swelling count/score, ESR, CRP, RHF. The adverse effect events in the LEF group was slight. Conclusion: LEF is an effective medication for treatment of RA, which is the same as MTX treatment patients with active rheumatoid arthritis in the improvement of clinical symptoms, as well as a few and slight side effects.

关 键 词：来氟米特 甲氨喋呤 类风湿性关节炎 药物治疗 

分 类 号：R593.220.5[医药卫生—内科学]