瑞利珠单抗辅助治疗难治性哮喘疗效和安全性的meta分析  

Efficacy and safety of reslizumab in adjuvant therapy for patients with refractory asthma:a meta‑analysis

作　　者：陈满如 梁翠绿 张吟[1] 陈琪莹 陈彩云[1] Chen Manru;Liang Cuilyu;Zhang Yin;Chen Qiying;Chen Caiyun(Department of Pharmacy,Second Affiliated Hospital,Fujian Medical University,Fujian Province,Quanzhou 362000,China;College of Pharmacy,Fujian Medical University,Fujian Province,Fuzhou 350000,Chin)

机构地区：[1]福建医科大学附属第二医院药学部,泉州362000 [2]福建医科大学药学院,福州350000

出　　处：《药物不良反应杂志》2023年第5期299-307,共9页Adverse Drug Reactions Journal

摘　　要：目的系统评价以白细胞介素5为靶点的瑞利珠单抗辅助治疗难治性哮喘的疗效与安全性。方法计算机检索PubMed、Embase、Cochrane Library、ClinicalTrials.gov、中国知网、维普网和万方数据库(截至2022年6月),收集瑞利珠单抗辅助治疗难治性哮喘的随机对照试验(RCT),试验组在哮喘常规治疗基础上加用瑞利珠单抗,对照组加用安慰剂。主要结局指标包括哮喘急性发作发生率,第1秒用力呼气容积(FEV_(1))、哮喘控制问卷(ACQ)评分、哮喘生活质量问卷(AQLQ)评分和血嗜酸粒细胞计数较治疗前变化值,以及不良事件发生率。应用RevMan 5.3软件进行meta分析,计数资料效应量为比值比(OR)及其95%置信区间(CI),计量资料效应量为均数差(MD)及其95%CI。结果共7项RCT纳入分析,包括2506例患者,试验组1456例,对照组1050例。meta分析结果显示,与对照组相比,试验组治疗期间哮喘急性发作发生率明显减少[18.1%(263/1456)比31.3%(329/1050),OR=0.50,95%CI:0.41~0.62,P<0.001],FEV1和AQLQ评分较治疗前明显升高(MD=0.13 L,95%CI:0.08~0.17 L,P<0.001;MD=0.18分,95%CI:0.04~0.33分,P=0.01),ACQ评分和血嗜酸粒细胞计数明显降低(MD=-0.19分,95%CI:-0.28~-0.10分,P<0.001;MD=-0.45×10^(9)/L,95%CI:-0.48×10^(9)/L~-0.42×10^(9)/L,P<0.001);总体不良事件、严重不良事件、过敏反应和肺炎发生率与对照组比较差异均无统计学意义[63.7%(928/1456)比71.4%(750/1050),OR=0.76,95%CI:0.55~1.06,P=0.10;6.4%(93/1456)比8.2%(86/1050),OR=0.91,95%CI:0.66~1.24,P=0.55;0.4%(5/1403)比0.1%(1/997),OR=1.66,95%CI:0.41~6.65,P=0.47;0.6%(9/1456)比1.0%(10/1050),OR=0.81,95%CI:0.35~1.87,P=0.63]。结论瑞利珠单抗辅助治疗难治性哮喘具有较好的疗效和安全性。Objective:To systematically evaluate the efficacy and safety of reslizumab targeting interleukin 5 in adjuvant therapy for patients with refractory asthma.Methods:The PubMed,Embase,Cochrane Library,Clinicaltrials.gov,CNKI,VIP,and Wanfang databases were searched(up to June 2022).Randomized controlled trials(RCTs)of reslizumab in adjuvant therapy of refractory asthma were collected.On the basis of conventional treatment for asthma,patients in the trial group was given additional reslizumab while the control group was given placebo.Primary outcome measures included the acute asthma attacks incidence,the changes of forced expiratory volume in the first second(FEV 1),asthma control questionnaire(ACQ)score,asthma quality of life questionnaire(AQLQ)score,and blood eosinophil count before and after adjuvant therapy,and incidence of adverse events.RevMan 5.3 software was used for meta-analysis.The effect sizes of counting data were odds ratio(OR)and its 95%confidence interval(CI),while the effect sizes of measurement data were mean difference(MD)and its 95%CI.Results:A total of 7 RCTs and 2506 patients were entered in the analysis,including 1456 in the trial group and 1050 in the control group.The meta-analysis showed that,compared to the control group,the acute asthma attacks incidence was lower in patients of the trial group during adjuvant therapy[18.1%(263/1456)vs.31.3%(329/1050),OR=0.50,95%CI:0.41-0.62,P<0.001];FEV1 and AQLQ score after treatment were higher(MD=0.13 L,95%CI:0.08-0.17 L,P<0.001;MD=0.18,95%CI:0.04-0.33,P=0.01);the ACQ score and blood eosinophil count were higher(MD=-0.19,95%CI:-0.28--0.10,P<0.001;MD=-0.45×10^(9)/L,95%CI:-0.48×10^(9)/L--0.42×10^(9)/L,P<0.001).There were no statistically significant difference in the incidences of overall adverse events,serious adverse events,allergic reactions,and pneumonia compared to those in the control group[63.7%(928/1456)vs.71.4%(750/1050),OR=0.76,95%CI:0.55-1.06,P=0.10;6.4%(93/1456)vs.8.2%(86/1050),OR=0.91,95%CI:0.66-1.24,P=0.55;0.4%(5/1403)vs.0.1%(1/997),OR=1

关 键 词：白细胞介素5 哮喘 有效性 安全性 META分析 瑞利珠单抗 

分 类 号：R562.25[医药卫生—呼吸系统]