戈利木单抗治疗类风湿性关节炎的系统评价
作者：范小冬;向霞;孔文强;张春燕;罗宗伟;
Author：
收稿日期： 年卷（期）页码：2018,33(04):-445-449
期刊名称：华西药学杂志
Journal Name：WEST CHINA JOURNAL OF PHARMACEUTICAL SCIENCES
关键字：戈利木单抗;类风湿性关节炎;甲氨蝶呤;疗效;安全性;系统评价;Meta分析
Key words：
基金项目：
中文摘要
系统评价戈利木单抗治疗类风湿关节炎(RA)的疗效与安全性。采用计算机检索Pub Med、Cochrane Library、EMbase、EBSCO、CBM、CNKI、VIP、Wan Fang Data等数据库,收集戈利木单抗治疗类风湿性关节炎的随机对照试验(RCT),检索时限为2000年1月至2017年10月。根据纳入与排除标准筛选文献、提取数据并对纳入研究进行质量评价,采用Cochrane协作网推荐的Rev Man 5.0软件对各效应指标进行Meta分析。共纳入6个RCT,合计2079例患者。Meta分析显示:50或100 mg戈利木单抗+甲氨蝶呤(MTX)组在ACR20、ACR50、ACR70、EULAR应答及DAS28缓解等方面的疗效均优于安慰剂+MTX组;100 mg戈利木单抗+MTX组与50 mg戈利木单抗+MTX组的临床疗效相当,差异无统计学意义;3组患者在不良事件、严重不良事件、感染、严重感染及恶性肿瘤发生率等方面的差异无统计学意义。戈利木单抗联合MTX治疗RA的疗效优于MTX单药治疗,且50与100mg戈利木单抗剂量间疗效无差异。
参考文献
[1]夏雷,许玉本,李鹏,等.塞来昔布联合正清风痛宁片对类风湿关节炎的疗效分析[J].川北医学院学报,2016,31(5):720-722.
[2]Tanaka Y,Senoo A,Baker D.Evaluation of golimumab for the treatment of patients with active rheumatoid arthritis[J].Expert Opin Drug Metab Toxicol,2016,12(3):319-326.
[3]邹羽真,杜小莉.新型抗风湿药戈利木单抗注射剂[J].中国新药杂志,2014,23(23):2707-2711.
[4]Wei ST,Sun YH,Zong SH,et al.Serum levels of IL-6 and TNF-αmay correlate with activity and severity of rheumatoid arthritis[J].Med Sci Moint,2015,24(21):6030-4038.
[5]伍伟,何东初.类风湿关节炎的生物治疗进展[J].华南国防医学杂志,2016,30(9):618-622.
[6]Keystone EC,Genovese MC,Klareskog L,et al.Golimumab,a human antibody to tumour necrosis factor(alpha)given by monthly subcutaneous injections,inactive rheumatoid arthritis despite methotrexate therapy:The GO-FORWARD Study[J].Ann Rheum Dis,2009,68:789-796.
[7]Kay J,Matteson EL,Dasgupta B,et al.Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate:A randomized,double-blind,placebo-controlled,doseranging study[J].Arthritis Rheum,2008,58:964-975.
[8]Smolen JS,Kay J,Doyle MK,et al.Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors(GO-AFTER study):A multicentre,randomised,double-blind,placebo-controlled,phaseⅢtrial[J].Lancet,2009,374:210-221.
[9]Emery P,Fleischmann RM,Moreland LW,et al.Golimumab,a human anti-tumor necrosis factoralpha monoclonal antibody,injected subcutaneously every fourweeks in methotrexate-naive patients with active rheumatoid arthritis:Twenty-four-week results of a phase III,multicenter,randomized,double-blind,placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis[J].Arthritis Rheum,2009,60:2272-2283.
[10]Tanaka Y,Harigai M,Takeuchi T,et al.Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis:Results of the GO-FORTH study[J].Ann Rheum Dis,2012,71(10):817-824.
[11]Li ZG,Zhang FC,Kay J,et al.Efficacy and safety results from a phase 3,randomized,placebo-controlled trial of subcutaneous Golimumab in Chinese patients with active rheumatoid arthritis despite methotrexate therapy[J].Int J Rheumatic Diseases,2015:1-14.
[12]Hutas G.Golimumab,a fully human monoclonal antibody against TNF alpha[J].Curr Opin Mol Ther,2008,10(4):393-406.
[13]舒荣,白秋江.抗类风湿关节炎新药戈利木单抗[J].药物流行病学杂志,2011,20(1):50-52.
[14]杜彪,谢星星,张杰,等.瑞舒伐他汀治疗中国原发性高胆固醇血症患者疗效与安全性的系统评价[J].吉林大学学报:医学版,2016,42(5):968-974.
[15]Sato E,Tanaka E,Nakajima A,et al.Assessment of the effectiveness of golimumab 50 mg and 100 mg regimens in patients with rheumatoid arthritis in daily practice[J].Mod Rheumatol,2015,25(4):528-533.
[16]谢希,陈进伟,彭佑铭,等.抗肿瘤坏死因子-α治疗类风湿关节炎致感染风险的Meta分析[J].中南大学学报:医学版,2013,38(7):722-736.
[17]Goodman SM,Menon I,Christos PJ,et al.Management of perioperative tumour necrosis factorαinhibitors in rheumatoid arthritis patients undergoing arthroplasty:A systematic review and Metaanalysis[J].Rheumatology(Oxford),2016,55(3):573-582.
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