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

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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

齐东旭,刘颖,黄东辉

吉林省一汽总医院,吉林省一汽总医院,吉林省中医药科学院第一临床医院

收稿日期:2018-10-31 修回日期:2019-05-20 出版日期:2019-06-25 发布日期:2019-06-25

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

Qidongxu, and

FAW genernal hospital,FAW genernal hospital,First Clinical Hospital of Jilin Academy of Traditional Chinese Medicine

Received:2018-10-31 Revised:2019-05-20 Online:2019-06-25 Published:2019-06-25

摘要/Abstract

摘要： 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。

Abstract: 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.

齐东旭,刘颖,黄东辉. 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[J]. .

Qidongxu, and. Efficacy and Safety of Iguratimod and Methotrexate in Treatment of Active Rheumatoid Arthritis[J]. .

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