IL-6抑制剂Sirukumab治疗类风湿关节炎疗效和安全性的meta分析

Meta-analysis of Efficacy and Safety of Interleukin-6 Inhibitor Sirukumab for Treatment of Rheumatoid Arthritis

目的评价白细胞介素-6(interleukin-6,IL-6)抑制剂Sirukumab对类风湿关节炎(rheumatoid arthritis,RA)患者的疗效和安全性。方法计算机检索PubMed、Embase、Web of Science、Clinical Trials Website、Cochrane Library、中国知网(CNKI)、万方、维普等数据库中关于Sirukumab治疗RA有效性和安全性的随机对照试验(randomizedcontrolledtrials,RCTs),采用RevMan 5.3软件对数据进行meta分析。结果共纳入6篇RCTs,3197例患者。Meta分析结果显示,Sirukumab2个剂量组(50,100 mg)ACR20、ACR50、ACR70的有效率均高于安慰剂组(P<0.0001)。Sirukumab 2个剂量组不良反应、严重不良反应、严重感染、注射部位反应、因不良反应终止试验等的发生率高于对照组(P<0.05)。与阳性药Adalimumab比较,Sirukumab 2个剂量组DAS28-ESR的有效率较高(P<0.05),ACR50有效率差异无统计学意义(P>0.05)。结论现有证据表明Sirukumab治疗RA安全有效。受纳入文献数量的限制,上述结论还需进一步开展高质量的临床试验来评价其有效性和安全性。

OBJECTIVE To assess the efficacy and safety of interleukin-6(IL-6)inhibitor of Sirukumab for rheumatoid arthritis(RA).METHODS All randomized controlled trials(RCTs)about the efficacy and safety of treating RA by Sirukumab were searched and retrieved from the databases including PubMed,Embase,Web of Science,Clinical Trials Website,Cochrane Library,CNKI,WanFang,and VIP database.Meta-analysis of the datas were performed by RevMan 5.3 software.RESULTS Included 6 RCTs with 3197 patients.Compared with placebo,the effective rate of ACR20,ACR50 and ACR70 in the both doses groups of Sirukumab were higher(P<0.0001).And the same with the incidence rate of adverse reactions,serious adverse events,serious infections,injection site reactions and termination of trial due to adverse reactions in Sirukumab group were higher(P<0.05).Compared with Adalimumab,the effective rate of DAS28-ESR in the both dose groups of Sirukumab were higher(P<0.05).There was no statistically significant difference in the ACR50 between the Sirukumab group and the Adalimumab group(P>0.05).CONCLUSION Available evidences suggest that Sirukumab is safe and effective in treating RA.Limited by the number of included references,the above conclusions require further high-quality clinical trials to evaluate the effectiveness and safety.