来氟米特治疗类风湿关节炎的临床疗效评价

Observation of the efficacy of leflunomide and methotrexate in the treatment of rheumatoid arthritis

目的 :观察来氟米特 (leflunomide,LEF)治疗类风湿关节炎 (RA)的临床疗效和安全性 ,并以氨甲蝶吟 (methotrexate,MTX)作为对照。方法 :5 0例活动性RA患者随机分为两组 :一组口服LEF首始剂量 5 0mg/d连用 3天 ,继以 2 0mg/d维持 ,另一组口服小剂量MTX 7.5～ 10mg/周 ,监测治疗前、1月后和 3月后关节晨僵时间、关节肿胀数、关节疼痛数、ESR、CRP、RF和不良反应。结果 :观察显示LEF组服药 2～ 3周后临床症状逐渐缓解 ,MTX组服药 5～ 6周后临床症状逐渐缓解。治疗 1月后 ,LEF组总有效率为 73.34% ,MTX组为 4 0 .0 0 % (P <0 .0 5 ) ;两组患者各项临床及生化指标相比差异有显著性 (P <0 .0 5 )。治疗 3月后 ,LEF组总有效率为 90 .0 0 % ,MTX组为 85 .0 0 % (P >0 .0 5 ) ;两组患者各项临床及生化指标与治疗前比较差异有显著性 (P <0 .0 0 1) ;LEF组与MTX组相比各项临床及生化指标差异无显著性 (P >0 .0 5 )。两组不良反应发生率相比差异无显著性 (P >0 .0 5 ) ,但LEF组不良反应程度较MTX组轻。结论 :LEF治疗RA见效快、疗效确切、安全 ,且耐受性较好。

Objective:To evaluate the efficacy and safety of leflunomide (LEF) in comparison with methotrexate (MTX) in treatment of rheumatoid arthritis (RA).Methods:50 patients with active RA were randomly divided into two groups.The first group received 20 mg daily LEF.The second group received small dose (7.5～10 mg weekly) of MTX.We compared the degree of the morning stiffness and the number of swelling,aching joints and the change of ESR,CRP and RF in RA patients between LEF group and MTX group.Results:The response rate in the LEF group was higher than that in the MTX group 1 month later( P <0.05).The response rate was not different between the LEF group and the MTX group 3 months later ( P >0.05).1 month after therapy,the clinical situation and experimental findings were much ameliorated in LEF group as compared with before ( P <0.05).Significant difference in the clinical manifestations and experimental findings were found between LEF group and MTX group ( P <0.05).3 months after therapy,the clinical situation and experiment findings were much ameliorated in both groups ( P <0.001) .No significant difference in the clinical manifestations and experimental findings were found between LEF group and MTX group ( P > 0.05) . The incidence of adverse events for LEF and MTX groups were 3/30 and 2/20 respectively , and there was no significant difference ( P >0.05).Conclusion:LEF is an effective agent for treatment ofRA with better tolerability,and there are few adverse effects.