Objective To systematically evaluate the effect and safety of Secukinumab for the treatment of rheumatic arthritis (RA).Methods We searched and selected and assessed the articles about randomized controlled trials (RCTs) of evaluating the efficacy and safety of Secukinumab for patients with RA published up to August 31,2016 from PubMed,Medline,EMBase,Web of Science,the Food and Drug Administration (FDA) Website,Clinical Trials Website,Cochrane Library,CNKI,Wanfang Data and VIP.Meta-analysis of data was performed by the RevMan 5.2 software and Stata 12.0 software.Results Six RCTs involving 903 patients were included.Compared with placebo,Secukinumab was more effective in achieving ACR20 [RR=1.56,95％CI (1.31,1.87),P＜0.000 01],ACR50 [RR =2.11,95％CI (1.51,2.93),P＜0.000 01],ACR70 [RR =2.75,95％ CI (1.39,5.43),P =0.004].Secukinumab significantly reduced DAS28-CRP [WMD=-0.48,95％ CI (-0.67,-0.29),P ＜0.000 01],DAS28-ESR [WMD =-0.43,95％ CI (-0.69,-0.16),P=0.001],HAQ-DI [WMD=-0.16,95％CI (-0.24,-0.08),P=0.000 1].In aspect of safety,the risks of severe adverse events [RR =1.97,95％ CI (1.10,3.52),P =0.02] and gastrointestinal disorder [RR =1.81,95％ CI (1.15,2.86),P =0.01] caused by Secukinumab were higher than those by placebo.Egger testing found that,there was no publication bias in the included articles about RCTs of evaluating the efficacy and safety of Secukinumab for RA patients (P =0.205).Conclusion Secukinumab is safe and effective for the treatment of RA.However,due to the small sample size of studies included,it is necessary to develop higher quality RCTs data with larger sample size to evaluate its effectiveness and safety.%目的 系统评价苏金单抗治疗风湿性关节炎(RA)的有效性和安全性.方法 计算机检索PubMed、Medline、EMBase、Web of Science、the Food and Drug Administration (FDA) Website、Clinical Trials Website、Cochrane Library、中国知网、万方数据知识服务平台、维普网等数据库中关于苏金单抗治疗RA有效性和安全性的随机对照试验(RCT),检索时间从建库至2016-08-31.进行资料提取及质量评价,采用RevMan 5.2及Stata 12.0软件对数据进行Meta分析.结果 共纳入6篇RCT,903例患者.Meta分析结果显示,苏金单抗组ACR20率[RR=1.56,95％ CI(1.31,1.87),P＜0.000 01]、ACR50率[RR=2.11,95％ CI (1.51,2.93),P＜0.000 01]、ACR70率[RR=2.75,95％CI (1.39,5.43),P=O.004]较对照组升高.苏金单抗组疾病活动性评分28 (DAS28)-C反应蛋白(CRP)[加权均数差(WMD)=-0.48,95％CI(-0.67,-0.29),P＜0.000 01]、DAS28-红细胞沉降率(ESR)[WMD=-O.43,95％ CI(-0.69,-0.16),P=0.001]、健康评估问卷残疾指数(HAQ-DI)[WMD=-0.16,95％CI(-0.24,-0.08),P=0.000 1]较对照组降低.苏金单抗组严重不良反应事件发生率[RR=1.97,95％CI(1.10,3.52),P=O.02]、消化道功能紊乱发生率[RR=1.81,95％CI (1.15,2.86),P=0.01]较对照组升高.Egger检验结果提示,苏金单抗组与对照组比较,纳入研究间不存在发表偏倚风险(P =0.205).结论 现有证据表明苏金单抗治疗RA安全有效.然而,由于纳入研究样本量较小,有必要进一步开展高质量、大样本RCT评价其疗效和安全性.
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