来源：风湿病与关节炎,2019,8（11）:36-42.

注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗幼年特发性关节炎临床疗效的Meta分析（循证研究）

蒋　总¹，唐　芳²，马武开²，姚晓玲¹，卢向阳¹，陈琳英³，李　宇¹，兰维娅¹，樊　梅¹，蔡　鑫¹

　　【摘　要】目的：通过搜集注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（商品名：益赛普/强克）治疗幼年特发性关节炎的随机对照试验（RCT），统计分析其临床疗效及不良反应，评估疗效及用药安全。方法：计算机检索中文数据库中国知网（CNKI）、万方、维普（VIP）、中国生物医学文献数据库（CBM）及外文数据库Pumbed、Medline、ScienceDirect，检索时间为数据库建立至2019年2月，以益赛普/强克或联合常规抗风湿药治疗幼年特发性关节炎RCT为研究对象。文献提取和验证由2位研究员独立完成，并采用RevMan 5.3软件进行偏倚风险评估。结果：共纳入10个RCT研究，总样本量为490例，其中治疗组255例，对照组235例。Meta分析结果显示，益赛普/强克治疗或联合常规抗风湿药治疗能提高疗效（RR = 3.73，95%CI = ［1.99，6.99］，P < 0.000 1］，且ACR30（WMD = 3.64，95%CI = ［1.74，7.64］，P = 0.000 6）、ACR50（WMD = 6.29，95%CI = ［1.37，28.75］，P = 0.02）、ACR70（WMD = 4.73，95%CI =［1.38，16.21］，P = 0.01）、ESR（WMD = -0.82，95%CI = ［-1.47，-0.16］，P < 0.02）、

CRP（WMD = -0.65，95%CI = ［-0.93，-0.38］，P < 0.000 01）、MMP（WMD = -0.82，95%CI = ［-1.13，-0.51］，P < 0.000 01）等指标改善均优于对照组；TNF-α与对照组比较，差异无统计学意义（WMD = -0.27，95%CI = ［-0.93，0.39］，P = 0.42）。纳入的研究有5个提及不良反应，3个提及无不良反应，其余未提及。结论：益赛普/强克治疗幼年特发性关节炎在改善病情，缓解临床症状方面优于常规抗风湿药，疗效可靠、用药安全，可临床推广应用。

　　【关键词】　幼年特发性关节炎；注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白；益赛普；强克；随机对照试验；Meta分析

Meta-analysis of the Clinical Effect of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion protein for interjection on Juvenile Idiopathic Arthritis

JIANG Zong,TANG Fang,MA wu-kai,YAO Xiao-ling,LU Xiang-yang,CHEN Lin-ying,LI Yu,LAN Wei-ya,FAN Mei,CAI Xin

【ABSTRACT】Objective:To collect randomized controlled trials（RCTs）of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion protein for interjection（trade name:Etanercept or Qiangke）in the treatment of juvenile idiopathic arthritis and to analyze the clinical efficacy and adverse reactions and evaluate the efficacy and drug safety.Methods:Randomized controlled trials（RCTs）of treating juvenile idiopathic arthritis with Etanercept or Qiangke or their combination were retrieved in the databases such as CNKI,Wanfang,VIP,CBM and pumbed,Medline and ScienceDirect（from the establishment of the databases to February 2019）.Literature selection and validation was completed by two researchers independently,and bias risk assessment was conducted by software Revman 5.3.Results:A total of 490 Cases were included in ten RCTs,including 255 cases

in the treatment group and 235 cases in the control group.Meta analysis showed that Etanercept or Qiangke or their combination with with conventional anti-rheumatic medicine could improve the efficacy（RR = 3.73,95%CI = ［1.99,6.99］,P < 0.000 1）,and the improvement of indicators such as ACR30（WMD = 3.64,95%CI = ［1.74,7.64］,P = 0.000 6）,ACR50（WMD = 6.29,95%CI =［1.37,28.75］,P = 0.02）,ACR70（WMD = 4.73，95%CI  = ［1.38,16.21］,P = 0.01）,ESR（WMD = -0.82,95%CI =［-1.47,-.16］,P < 0.02）,CRP（WMD = -0.65,95%CI = ［-0.93,-0.38］,P < 0.000 01）,MMP（WMD = -0.82,95%CI = ［-1.13,-0.51］,P < 0.000 01）were better than the control group.There was no statistically significant difference of TNF-α compared with the control group（WMD = -0.27,95%CI =［- 0.93,0.39］,P = 0.42）.In this paper,there were five studies with adverse reactions,three without adverse reactions,and the adverse reactions were unknown in the rest.Conclusion:Etanercept or Qiangke can improve condition and alleviate clinical symptoms,reliable,safe,and better than conventional anti rheumatic medicine in the treatment of juvenile idiopathic arthritis,which can be widely used in clinic.

　　【Keywords】 juvenile idiopathic arthritis;Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion protein for interjection;Etanercept;Qiangke; randomized controlled trial;meta-analysis