甲氨蝶呤与艾拉莫德治疗类风湿关节炎的有效性及安全性研究

Efficacy and Safety of Iguratimod and Methotrexate in Treatment of Active Rheumatoid Arthritis

目的:研究艾拉莫德(IGU)与甲氨蝶呤(MTX)治疗类风湿关节炎(RA)的有效性及安全性。方法:对我院就诊的活动期RA患者120例,随机分为3组,MTX组、IGU组、MTX+IGU组,每组各40例。治疗24 w后进行疗效及安全性评估。结果:治疗后,MTX组ACR20(20%美国风湿病学会标准改善率)有19例(47.5%),IGU组ACR20有20例(50.0%),MTX+IGU组ACR20有29例(72.5%),MTX+IGU组明显优于单药治疗组,3组比较有统计学意义( P <0.05)。治疗后DAS28(完全缓解率)比较无统计学差异,MTX+IGU组DAS28比例最高(27.5%),高于MTX组(12.5%)及IGU组(15.0%)。比较ACR标准各个项目均有所好转,且IGU与MTX疗效相当,MTX+IGU优于单药治疗,3组比较有统计学意义。不同治疗组不良反应发生率无显著性差异。结论:本研究显示IGU、MTX治疗活动期RA的疗效及安全性无显著差异,MTX+IGU治疗优于单药治疗且具有良好的安全性,可为临床用药提供参考。

Objective :This study aimed to investigate the efficacy and safety of rheumatoid monotherapy combined with methotrexate in the treatment of rheumatoid arthritis. Methods : 120 patients with active rheumatoid arthritis (RA) were divided into three groups: methotrexate group (MTX)( n= 40), Iguratimod group (IGU)( n= 40), and methotrexate plus Iguratimod group (MTX plus IGU)( n= 40). The course of treatment was 24 weeks, and the efficacy and safety were evaluated at 24 weeks. Results : After 24 weeks of treatment, there were 19 cases (47.5%) of ACR20 in MTX group, 20 cases (50.0%) in IGU group, and 29 cases (72.5%) in IGU plus MTX group. The efficacy and safety of MTX plus IGU were significantly superior to that of a single use of IGU or MTX ( P <0.05). There was no significant difference in the EULALR remission rate (DAS28 remission) between groups after 24 weeks of treatment (MTX plus IGU: 27.5% vs. MTX: 12.5% vs. IGU: 15.0%, P> 0.05). All items in ACR criteria at 24 weeks have been improved compared with that at 0 weeks. Moreover, a significant difference was observed between groups in the improvement of items in ACR criteria. Among that, MTX plus IGU was superior to a single use of IGU or MTX, while no difference between IGU and MTX. There was no significant difference in the incidence of adverse reactions between groups. Conclusion : There is no significant difference in the efficacy and safety between iguratimod and methotrexate in the treatment of active rheumatoid arthritis. A combination of Iguratimod with methotrexate provides better efficacy and safety compared with a single use of Iguratimod or methotrexate.