来氟米特治疗类风湿关节炎的临床研究

目的 比较新型抗炎免疫抑制药来氟米特(leflunomide, LEF)和阳性对照药甲氨喋呤(methotrexate, MTX)治疗活动期类风湿关节炎(RA)的疗效及安全性。方法 采用随机、单盲对照方法, 选择疾病活动期RA 患者95 例。来氟米特组用LEF 20 mg·d^-1; 甲氨喋呤组用MTX 15 mg/w k。12 wk为1 疗程。结果 LEF 与MTX 均能显著改善RA 患者的症状、体征及实验室指标。来氟米特组与甲氨喋呤组在12 wk总有效率分别为90.0 %(n =50)、95.6%(n =45)。两组疗效在12 wk时无显著差异(P >0.05)。来氟米特组有7 例(14 %)发生与药物有关的不良反应,程度较轻。甲氨喋呤组有7 例(15.6 %)发生不良反应。经χ² 检验两药不良反应发生率无明显差异(P =0.83), 但来氟米特组不良反应程度轻, 病人耐受性好。结论 LEF 对我国RA 患者有良好的治疗作用且副作用小。

Clinical study of leflunomide in the treatment of patients with active rheumatoid arthritis

Aim To compare the effectiveness and safety of leflunomide (LEF) with those of methotrexate (MTX)in patients with active rheumatoid arthritis (RA). Methods 95 RA patients were randomly assigned to receive LEF or MTX. The patients in the treated group received LEF 20 mg·d^-1 and in the controlled group who received MTX 15 mg/wk totally 12 weeks. Results The total effective rates of the treated group and the controlled group were 90.0 % (n =50) and 95.6 %(n =45)respectively. There was no statistical significance between the two groups in the effectiveness (P >0.05).The adverse react ion rate was 14.0 % (7 case)in the treated group and 15.6 %(7 cases)in the controlled group. There was no significance difference between the two groups (P =0.83).But the adverse reactions were more tolerable in LEF group than in MTX group. Conclusion This study suggests that LEF is an effective and more safe drug for active rheumatoid arthritis in our country.