不同DMARDs联合用药治疗类风湿关节炎疗效与安全性的研究

Comparison of efficacy and safety of different DMARDs combination therapy regime for rheumatoid arthritis

目的甲氨喋呤-来氟米特(MTX-LEF)二联和甲氨喋呤-氯喹-柳氮磺吡啶(MTX-CQ-SSZ)三联治疗活动性类风湿关节炎(rheumatoidarthritis,RA)1年的疗效和安全性比较。方法随访45例接受甲氨喋呤-来氟米特二联治疗和42例接受甲氨喋呤-氯喹-柳氮磺吡啶三联治疗的RA患者1a;比较两组患者治疗后不同时点各项疗效评价指标的改善情况,并记录不良反应。结果治疗1个月后,二联组各项指标及总体疗效的改善显著优于三联组;治疗后12个月二联组关节功能的改善显著优于三联组;血清RF﹥100I-U/mL且X线分期>I期的患者在治疗后6个月、12个月的疗效比较二联组显著优于三联组。所有患者耐受性好,不良事件发生率无显著性差异。结论两种联合用药方案均安全有效;MTX-LEF二联组起效早,对血清RF>100IU/mL且X线分期﹥I期患者疗效优于MTX-CQ-SSZ三联组。

To compare efficacy and safety of one year combination therapy of methotrexate(MTX) and leflunomind(LEF) versus of methotrexate(MTX),chloquine(CQ) and sulfasalazine(SSZ) for patients with active rheumatoid arthritis. 87 RA patients with active disease were randomized to two groups with 45 cases treated with MTX and LEFcombination and 42 with MTX, CQ and SSZ combination. The improvement of the indices were observed at different time points after therapy initiation between two groups. Meanwhile the adverse reactions were recorded. The indices and the global curative effect in double- therapy group improved more significantly than in triple-therapy group after 1 month; The improvement of joint function class in double-therapy group was significantly better than in triple-therapy group after 12 months; The efficacy of patients who had RF﹥100 IU/ml and X ray classification above phase I treated with MTX-LEF was significantly superior to that of triple-therapy group after 6 and 12months. All of the patients tolerated well and there was no significant differences in adverse effects incidence between two groups. [Conclusions] Both combination regimes are effective and safe; Double therapy with MTX and LEF worked earlier and afforded more benefits for patients who have RF﹥100 IU/mL and X ray classification above phase I comparatively compared with triple-therapy of MTX,CQ and SSZ.