来氟米特和甲氨喋呤治疗类风湿关节炎生命质量和临床疗？…

目的　对 II期随机对照临床试验中应用来氟米特 (L EF)和甲氨喋呤 (MTX)治疗的类风湿关节炎 (RA)患者的生命质量和临床疗效比较 ,旨在科学地评价 L EF在治疗 RA中的作用。方法　 5 0例活动性 RA病人按 1:1随机分入 L EF组(2 4例 )和 MTX组 (2 6例 ) ,分别服用 L EF2 0 mg/天 安慰剂 (C)和 MTX15 m g/每周 安慰剂 (B) 3个月。所有病人测定临床指标 ,并完成类风湿关节炎生命质量量表 [1 ] 和抑郁自评量表 (SDS)。结果　 L EF组病人主要生理指标除握力外均有明显改善 ,在统计学上均有意义 (P <0 .0 0 1) ,与 MTX组相比无明显差别 . L EF组显效率为 83.33% ,MTX组为 73.0 8%。 L EF组副反应发生率 8.3% ,较 MTX组低且轻微。 L EF组生命质量分均和 MTX组相近 ,统计学上无明显差别。 L EF组 35 %病人有抑郁临床表现 ,MTX组为 5 0 % (P =0 .2 3)。结论　 L EF治疗 RA病人 ,其疗效及生命质量和情绪抑郁改善方面与 MTX相似 ,且副反应更轻微。

Efficacy and quality of life in active rheumatoid arthritis treated by leflunomide in comparison with methotrexate:a double blind, randomized and controlled trial

Objective To assess clinical efficacy and quality of life(QOL) 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 and MTX groups respectively Patients in the former group received LEF 20mg/d and an identicalplacebo 6 tablets/w 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/d 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 83 33% and 73 08% 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 The rate of adverse effect events in the LEF group was 8 3% The score of QOL of the LEF treated patients at the end of study was similar to that of the MTX treated patients in the physical, social, emotional functions, self recognized health status and total QOL However, the self-depressive ratings (SDS scores) showed that about a half of MTX group have abnormal high scores while in LEF group only 35%of case (P=0 23) 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 , QOL and emotional and social functions, as well as a few and slight side effects