艾拉莫德联合甲氨蝶呤治疗类风湿关节炎有效性和安全性的系统评价和Meta分析

doi:10.12092/j.issn.1009-2501.2018.10.008

中国临床药理学与治疗学 ›› 2018, Vol. 23 ›› Issue (10): 1132-1140.doi: 10.12092/j.issn.1009-2501.2018.10.008

艾拉莫德联合甲氨蝶呤治疗类风湿关节炎有效性和安全性的系统评价和Meta分析

伍嘉琪¹，杨俏雯²，陈秀敏²，黄闰月³，黄清春²，赵越³，吴晓东³

¹广州中医药大学第二临床医学院，广州 510405，广东；²广东省中医院风湿科，广州 510006，广东；³广东省中医药科学院，广州 510006，广东

收稿日期:2017-10-19 修回日期:2017-12-05 出版日期:2018-10-26 发布日期:2018-10-25
通讯作者: 黄清春，男，医学博士，主任医师，研究方向：风湿免疫学。 Tel：13922230939 E-mail: qch1963@163.com
作者简介:伍嘉琪，女，硕士研究生，研究方向：风湿免疫学。 Tel：15914322161 E-mail:jiaqiwu92@hotmail.com
基金资助:
广东省自然科学基金（2015A030313352）；广东省中医药科学院中医药科技转化医学研究专项（2014KT1642）

Efficacy and safety of iguratimod combined with methotrexate in rheumatoid arthritis: A systematic review and Meta-analysis

WU Jiaqi ¹, YANG Qiaowen ², CHEN Xiumin ², HUANG Runyue ³, HUANG Qingchun², ZHAO Yue ³, WU Xiaodong³

¹Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510405, Guangdong,China; ² The Department of Rheumatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510006, Guangdong,China; ³Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou 510006, Guangdong, China

Received:2017-10-19 Revised:2017-12-05 Online:2018-10-26 Published:2018-10-25

摘要/Abstract

摘要：

目的: 系统分析艾拉莫德（iguratimod, IGU）联合甲氨蝶呤（methotrexate,MTX）治疗类风湿关节炎（rheumatoid arthritis,RA）的临床疗效和安全性，为IGU在RA治疗中的合理规范应用提供依据。方法: 检索Pubmed、Cochrane Library、Embase、中国知网数据库（CNKI）、重庆维普中文科技期刊数据库（VIP）、中国生物医学文献数据库（CBM）、万方数据库（Wanfang data）和中国科技期刊数据库等电子数据库。检索时间从建库至2017年6月。纳入IGU联合MTX对比MTX治疗RA的临床随机对照试验（RCT）。由2位研究者根据纳入和排除标准独立选择符合标准的RCT并提取相关数据。用Cochrane系统评价手册进行文献质量分析，运用Review Manager 5.3统计软件对各疗效指标进行系统评价与Meta分析。结果: 共纳入6篇RCT，病例数合计553例。6篇文献的整体Meta分析结果显示，IGU联合MTX治疗RA其主要疗效指标ACR20/50/70应答率均优于MTX组（ACR20：RR=1.53，95%CI：1.13～2.06，P=0.006；ACR50：RR=2.15，95%CI：1.64～2.81，P<0.001；ACR70：RR=2.93，95%CI：1.54～3.72，P<0.001）；次要疗效评价指标方面，IGU联合MTX在降低血沉（ESR）、医生评估的疾病总体状况VAS评分（Physician VAS）和DAS28方面效果均显著优于MTX组，但两组出现的不良事件比较无明显差异（RR=1.06，95%CI：0.91～1.24，P=0.46）。系统评价结果显示，IGU联合MTX治疗方案在降低CRP、TJC28、SJC28、Pain VAS、Patient VAS及HAQ效果方面不亚于MTX单用。结论: 对比单纯使用MTX，IGU联合MTX治疗RA在ACR20/50/70达标率、改善ESR、DAS28方面疗效更优，且并不增加治疗期间不良反应的发生概率，有较好的疗效和安全性，值得在RA临床治疗中推广使用。

关键词: 艾拉莫德, 甲氨蝶呤, 类风湿关节炎, 系统评价, Meta分析

Abstract:

AIM: To evaluate the efficacy and the safety of the combination therapy of iguratimod (IGU) and methotrexate (MTX) as compared with MTX monotherapy in adults with rheumatoid arthritis (RA) through a Meta-analysis on randomized controlled trials (RCTs). METHODS: A systematic review was conducted by searching multiple databases including PubMed, Embase, Cochrane Library, the China National Knowledge Infrastructure (CNKI), VIP, the Chinese Biomedical Literature Database, Wanfang Data, the Chinese Scientific and Technological Journals Database. The systematic literature search was carried out up to June 2017. RCTs related the efficacy and/or safety of IGU combined with MTX to treat RA were selected. The quality of included studies was assessed using the Cochrane Handbook for Systematic Reviews of Interventions and Jadad scoring, and Meta-analysis was performed using Rev2Man5.3 software. RESULTS: Six RCTs involving 553 patients were included. Compared with MTX, IGU combined with MTX showed better effects in ACR20 ［RR:1.53, 95%CI(1.13,2.06), P=0.006］, ACR50［RR:2.15, 95%CI(1.64,2.81), P<0.001］, ACR70［RR:2.93, 95%CI(1.54,3.72), P<0.001］, and had a better result in lowering ESR, physician VAS and DAS28 level with the similar adverse effects (AEs) ［RR:1.06, 95%CI(0.91,1.24), P=0.46］. Meanwhile, the systematic review shows that IGU combined with MTX was no less effective than MTX monotherapy in reducing CRP, TJC28, SJC28, Pain VAS, Patient VAS and HAQ after treatment. CONCLUSION: For RA, IGU combined with MTX has a better clinical efficacy than MTX monotherapy, and adverse drug reactions remain stable of the combination therapy, which is referential for clinical application.

Key words: iguratimod, methotrexate, rheumatoid arthritis, systematic review, Meta-analysis

中图分类号:

R593.22

伍嘉琪，杨俏雯，陈秀敏，黄闰月，黄清春，赵越，吴晓东. 艾拉莫德联合甲氨蝶呤治疗类风湿关节炎有效性和安全性的系统评价和Meta分析[J]. 中国临床药理学与治疗学, 2018, 23(10): 1132-1140.

WU Jiaqi, YANG Qiaowen, CHEN Xiumin, HUANG Runyue, HUANG Qingchun, ZHAO Yue, WU Xiaodong. Efficacy and safety of iguratimod combined with methotrexate in rheumatoid arthritis: A systematic review and Meta-analysis[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2018, 23(10): 1132-1140.

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艾拉莫德联合甲氨蝶呤治疗类风湿关节炎有效性和安全性的系统评价和Meta分析

Efficacy and safety of iguratimod combined with methotrexate in rheumatoid arthritis: A systematic review and Meta-analysis

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