来氟米特与甲氨蝶呤联合小剂量激素治疗类风湿关节炎的疗效观察

The efficacy of leflunomide and methotrexate combined with low-dose prednisone in the treatment of rheumatoid arthritis

目的比较来氟米特(LEF)及甲氨蝶呤(MTX)联合小剂量糖皮质激素与来氟米特联合甲氨蝶呤治疗类风湿关节炎的疗效和不良反应。方法将120例活动性类风湿关节炎患者按随机数字表法分为2组:试验组60例,口服强的松10mg,1次/d,LEF 20mg,1次/d,MTX 10mg,1次/周;对照组60例,口服LEF 20mg,1次/d,MTX 10mg,1次/周;观察评价关节肿胀压痛数,采用目视10cm模拟标尺法(VAS)由患者和医生评估病情的整体变化程度,C-反应蛋白(CRP)、血沉(ESR),类风湿因子(RF)等指标,同时监测患者肝肾功、血尿常规、血糖。结果在疗程第4周,两组总体疗效评价ACR50、ACR70比较差异已有统计学意义(P<0.05)。结论米氟米特及甲氨蝶呤联合小剂量糖皮质激素治疗类风湿关节炎疗效优于来氟米特与甲氨蝶呤两药联合。

Objective To compare the efficacy and safely of leflunomide （LEF） and methotrexate（MTX） combined with lowdose prednisone versus of LEF plus MTX in the treatment of active rheumatoid arthritis.Methods 120 patients were randomizedly divided into two groups,each one with 60 patients.The experiment group administrated prednisone 10mg po.qd.LEF 20mg po.qd and MTX 10ng po. qw for 48 weeks. The indexes of efficiency assessment included count of joint tenderness, count of joint swollen, patient＇ s and physician＇s global assesment with visual analogue seal,adverse events were registered at the same time.Results After 4 weeks treatment,significant differences has existed in ACR.50 and ACRT0 （ P 〈0.05） between the two groups,and the differences existed all the time till this clinical trial finished,which suggests that efficacy of experiment group is better than the control one.No significant difference exists in adverse evenis between the two groups. Conclusion The efficacy of LEF and MTX combined with low-dose prednlsone in the treatment-of rheumatoid arthritis is much better than LEF plus MTX.