本拉珠单抗治疗重症嗜酸粒细胞型哮喘的系统评价

Systematic evaluation of Benralizumab in treatment of severe eosinophilic asthma

目的:本拉珠单抗是一种单克隆抗体,以白细胞介素5受体α亚基为靶点,使血嗜酸性粒细胞耗竭。本研究系统评价本拉珠单抗辅助治疗重症嗜酸粒细胞型支气管哮喘的有效性及安全性。方法:使用计算机检索中英文数据库,包括万方、中国知网(CNKI)、维普(VIP)、PubMed、Embase、The Cochrane图书馆,搜集本拉珠单抗辅助治疗重症嗜酸粒细胞型哮喘的相关随机对照试验(RCT),检索时间为各数据库建库至2020年3月。由2位研究者独立地、分别依据纳入和排除标准对文献进行筛选,并提取资料,在进行偏倚风险评估后,使用统计软件RevMan 5.3进行统计分析。结果:纳入8个RCTs,共3946例患者。本拉珠单抗作为重症嗜酸粒细胞型哮喘患者的附加治疗与安慰剂相比,能显著降低哮喘年急性发作率[OR=0.54,95%CI(0.40,0.73),P<0.0001],提高患者FEV1[MD=0.15,95%CI(0.10,0.19),P<0.00001],改善哮喘患者肺功能,降低ACQ-6评分[MD=−0.22,95%CI(−0.29,−0.15),P<0.00001],提高AQLQ评分[MD=0.22,95%CI(0.13,0.30),P<0.00001],提高患者生存质量,不良反应与安慰剂对照组类似[OR=0.88,95%CI(0.76,1.03),P=0.12],严重不良反应较安慰剂组低[OR=0.76,95%CI(0.61,0.94),P=0.01]表明本拉珠单抗治疗哮喘具有良好的安全性。结论:本拉珠单抗作为重症嗜酸粒细胞型哮喘患者的附加治疗,可以显著改善患者的肺功能,减轻哮喘症状,控制哮喘症状的每年急性发作率,与安慰剂相比,具有良好的安全性。

Objective:Benralizumab is a monoclonal antibody that targets interleukin-5 receptorαsubunit and depletes blood eosinophils.This study systematically evaluated the efficacy and safety of Benralizumab in the adjuvant treatment of severe eosinophilic bronchial asthma.Methods:Wanfang,CNKI,VIP,PubMed,Embase,The Cochrane Library,and other databases were searched by computer to collect randomized controlled trials(RCTs)of Benralizumab in the adjuvant treatment of severe eosinophilic asthma.The retrieval time was set up until March 2020.After the two evaluators independently screened the literatures according to the inclusion and exclusion criterion,extracted the datum and evaluated the risk of bias,RevMan 5.3 software was used for statistical analysis.Results:A total of 3946 patients were included in 8 RCTs.Benralizumab as an adjunct therapy in patients with severe eosinophilic asthma could significantly reduce the annual asthma exacerbation rate compared to placebo[OR=0.54,95%CI(0.40,0.73),P<0.0001],improve FEV1 significantly[MD=0.15,95%CI(0.10,0.19),P<0.00001],reduce the Asthma Control Questionnaire-6 scores(ACQ-6)[MD=−0.22,95%CI(−0.29,−0.15),P<0.00001],and improve Asthma Quality of Life Questionnaire scores(AQLQ)[MD=0.22,95%CI(0.13,0.30),P<0.00001].The adverse events are similar[OR=0.88,95%CI(0.76,1.03),P=0.12],and severe adverse events were lower than those in the placebo group[OR=0.76,95%CI(0.61,0.94),P=0.01].It showed that Benralizumab has good safety in the treatment of asthma.Conclusion:Benralizumab,as an additional treatment for severe eosinophilic asthma,can significantly improve lung function,reduce the annual asthma exacerbation rate,control asthma symptoms,and has a good safety compared with placebo.