改善病情抗风湿药联合治疗类风湿性关节炎的疗效及安全性比较

Comparison of Efficacy and Safety of Different DMARDs Combination Therapies for Rheumatoid Arthritis

目的比较甲氨蝶呤+来氟米特+白芍总甙胶囊(MTX+LEF)与甲氨蝶呤+柳氮磺胺吡啶+羟氯喹(MTX+SSZ+HCQ)治疗类风湿性关节炎的疗效和安全性。方法将350例类风湿性关节炎患者分为2组:其中180例给予MTX+LEF治疗,170例给予MTX+SSZ+HCQ治疗,观察治疗前及治疗4周、12周后疼痛指数、肿胀指数、功能障碍指数、晨僵、红细胞沉降率(ESR)和C反应蛋白(CRP)、类风湿因子(RF)等指标,并记录其不良反应。结果治疗4周、12周后2组的各项指标较治疗前均有改善,且2组内治疗后不同时间观察指标比较差异有统计学意义,治疗4周后MTX+LEF组各项指标改善优于MTX+SSZ+HCQ组。治疗12周后,MTX+LEF组对ESR、RF的改善与MTX+SSZ+HCQ组比较,差异有统计学意义。2组总体疗效比较显示,治疗4周后MTX+LEF组疗效优于MTX+SSZ+HCQ组,但治疗后12周差异无统计学意义。2组不良反应总发生率比较差异无统计学意义。结论2组联合用药方案均安全有效,但MTX+LEF治疗类风湿性关节炎起效快。

Objective To observe the efficacy and safety of different combination therapy of amethopterin and leflunomide （MTX ＋ LEF） versus amethopterin, salazosulfapyridine and hydroxychloroquine （MTX ＋ SSZ ＋ HCQ ） for patients with rheumatoid arthritis. Methods A total of 350 patents with RA were divided into two groups randomly, 180 patients were given MTX ＋ LEF, and 170 patients given MTX ＋ SSZ ＋ HCQ, both for 12 weeks. Efficacy parameters including the time of early morning stiffness, engorgement index, functional disturbance index and erythrocyte sedimentation rate（ESR） , C-reactive protein（CRP） and rheumatoid factor（RF） before and after the treatment were observed and the side effects of the therapies were recorded. Results All the parameters in both groups were improved after 4 weeks and 12 weeks treatment and for each group, the parameters were significantly different in different period after the treatment. Compared to MTX ＋ SSZ ＋ HCQ group, all the parameters of MTX ＋ LEF group were better improved after 4 weeks treatment, and the improvement of ESR, RF kept predominant after 12 weeks treatment. The total efficacy analysis showed that MTX ＋ LEF therapy was superior to MTX ＋ SSZ ＋ HCQ therapy, but no significant difference of the total efficacy was observed between the two groups after 12 weeks treatment. Conclusion Both DMARDs combination therapies were effective and safe, but the effect of combined therapy with MTX and LEF could appear earlier.