甲氨蝶呤联合艾拉莫德治疗活动性类风湿关节炎的随机对照试验

A Randomized Controlled Trial of Combination Therapy of Methotrexate with Iguratimod for Patients with Active Rheumatoid Arthritis

目的评估甲氨蝶呤(MTX)联合艾拉莫德对活动性类风湿关节炎(RA)患者的短期疗效及安全性。方法将60例活动期RA患者随机分为治疗组和对照组,每组30例。治疗组给予MTX 10mg,每周1次口服;艾拉莫德25mg,每日2次口服。对照组给予MTX 10mg,每周1次口服;雷公藤多苷片20mg,每日3次口服,疗程12周。在第0,4,8,12周时进行临床疗效评估,观察2组的不良反应。结果治疗第4,8,12周时,2组患者的疾病活动性评分(DAS)28均明显改善。治疗第8周时,治疗组的DAS28评分与对照组比较,差别有统计学意义[(2.78±1.25)vs(3.25±1.56),P<0.05];治疗12周后,治疗组的红细胞沉降率、C-反应蛋白等指标与治疗前比较明显下降,差别有统计学意义(P<0.05);治疗12周后,治疗组的类风湿因子、免疫球蛋白与治疗前及对照组比较,差别均有统计学意义(P<0.05)。2组均无严重不良反应发生。结论 MTX联合艾拉莫德对活动期RA患者的临床疗效较好,且较安全。

Objective To observe the clinical efficacy and safety of methotrexate(MTX)combined with iguratimod for patients with active rheumatoid arthritis(RA). Methods A total of 60 patients with active RA were divided into two groups randomly:the treatment group(n=30)treated with MTX 10 mg once a week and iguratimod 25 mg twice a day,and the control group(n=30)treated with MTX 10 mg once a week together with tripterygium glycosides 20 mg three times a day for 12 weeks. The clinical efficacy and the incidence of adverse reactions of the both groups were evaluated at the 0,4 th,8 th,and 12 th week. Results The disease activity score(DAS)28 of the two groups were significantly improved at the 4 th,8 th and 12 th week. Compared with the control group,the improvement of DAS28 in the treatment group at the 8 th week was statistically significant[(2.78±1.25)vs(3.25±1.56),P<0.05]. The erythrocyte sedimentation rate(ESR),C-reactive protein(CRP)and other indexes decreased significantly in both groups after 12 weeks of treatment and the levels of Rheumatoid Factor(RF),and immunoglobulin(IgG,IgM)in treatment group were significantly decreased than those before treatment and than those in control group(P<0.05). No serious adverse reactions occurred in both groups. Conclusion MTX combined with iguratimod for patients with active RA has better clinical efficacy and safety.