来氟米特治疗类风湿关节炎疗效评价

目的：通过Ⅱ型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。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Wu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、据力、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，且除晨僵外两组间改善值和改善百分率比较明显差别。LEF组不良反应发生率为83%，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。

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

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.