抗IL-13抗体治疗中重度特应性皮炎疗效与安全性的荟萃分析

Efficacy and safety of anti-interleukin-13 monoclonal antibodies for moderateto-severe atopic dermatitis in adults:a Meta-analysis

目的:系统性评价抗IL-13单克隆抗体治疗成人中重度特应性皮炎(AD)的疗效与安全性。方法:检索PubMed、Cochrane Library、Embase和ClinicalTrials.gov 4个数据库,从中筛选出有关抗IL-13抗体治疗AD的临床研究,对纳入的文献进行偏倚风险评价和数据提取,使用RevMan5.3软件进行荟萃分析。结果:5篇文献被纳入分析中,共含6个随机对照试验,2 669例AD患者。荟萃分析结果显示,接受抗IL-13抗体治疗的患者湿疹面积及严重程度指数评分[SMD=-0.54,95%CI(-0.63,-0.45),P<0.000 01]明显改善,研究者整体评分为0或1的患者数显著多于安慰剂组[RR=1.75,95%CI(1.46,2.11),P<0.000 01],总体不良反应发生率与接受安慰剂的患者相比差异无统计学意义[RR=1.01,95%CI(0.95,1.06),P=0.85],注射部位反应和结膜炎事件发生率明显升高[RR=3.47,95%CI(1.58,7.60),P=0.002][RR=1.93,95%CI(1.29,2.89),P=0.001]。结论:抗IL-13单克隆抗体能有效治疗成人中重度AD,且安全性良好。

Objective:To evaluate the efficacy and safety of anti-IL-13 monoclonal antibodies for the treatment of moderate-to-severe atopic dermatitis(AD)in adults.Methods:PubMed,Cochrane Library,Embase and ClinicalTrials. gov four databases were searched. Clinical trials related to the treatment of AD with anti-IL-13 antibody were screened out. Then,risk of bias assessment and data extraction were performed on the included literature. Version5.3 was used for statistical analysis.Results:Five articles were included in the analysis,including 6 randomized controlled trials,2 669 patients with AD. The results of the meta-analysis showed that the eczema area and severity index score[SMD=-0.54,95%CI(-0.63,-0.45),P<0.000 01]was significantly improved in patients receiving anti-IL-13 antibody treatment,the number of patients with investigator′s global assessment of 0 or 1 increased significantly[RR=1.75,95%CI(1.46,2.11),P<0.000 01]. Compared with patients receiving placebo,the overall incidence of adverse reactions had no significant difference[RR=1.01,95%CI(0.95,1.06),P=0.85]. The risk of injection-site reactions and conjunctivitis were significantly increased in anti-IL-13 antibodies group[RR=3.47,95%CI(1.58,7.60),P=0.002][RR=1.93,95%CI(1.29,2.89),P=0.001].Conclusion:Anti-IL-13 monoclonal antibodies are effective and safe for the treatment of moderate-to-severe AD in adults.