度普利尤单抗治疗支气管哮喘疗效和安全性的meta分析

Meta-analysis of the efficacy and safety of dupilumab on the treatment of bronchial asthma

目的系统评价度普利尤单抗治疗支气管哮喘的临床疗效和安全性。方法检索中国期刊全文数据库(CNKI)、万方数据库(Wanfang Database)、维普数据库(VIP)、中国生物医学文献数据库(CBM)、Cochrane Library、PubMed、Embase、Web of Science等数据库,检索时间为建库至2023年2月20日,纳入度普利尤单抗治疗支气管哮喘患者的随机对照试验(RCT),使用RevMan5.4软件进行Meta分析。结果总纳入11项RCTs,共3759例患者,Meta分析结果显示,试验组哮喘急性加重人数[RR=0.48,95%CI(0.40,0.57),P<0.01]、哮喘控制问卷评分(Asthma control questionnaire,ACQ)[MD=-0.32,95%CI(-0.43,-0.21),P<0.01]均少于对照组,试验组第1秒用力呼气容积(Forced expiratory volume in 1s,FEV 1)[MD=0.51,95%CI(0.31,0.71),P<0.01]、哮喘生活质量问卷评分(Asthma quality of life questionnaire,AQLQ)[MD=0.32,95%CI(0.20,0.44),P<0.01]均高于对照组,差异有统计学意义(P<0.05);在血液嗜酸性粒细胞数<300/μl的哮喘人数[RR=1.10,95%CI(0.93,1.31),P=0.26]、不良事件[RR=1.03,95%CI(0.98,1.08),P=0.22]、严重不良事件[RR=1.21,95%CI(0.86,1.71),P=0.28]等方面,两组基本一致,差异无统计学意义(P>0.05)。结论度普利尤单抗可有效减少哮喘急性加重人数、改善肺功能和提高患者的生活质量,且有较好的安全性。

Objective To systematically evaluate the efficacy and safety of dupilumab on the treatment of bronchial asthma.Methods Randomized controlled trials(RCTs)reporting the treatment of dupilumab for bronchial asthma published from database establishment to February 20 in 2023 were systematically searched in CNKI,Wanfang Database,VIP,Chinese Biomedical Literature Database(CBM),Cochrane Library,PubMed,Embase and Web of Science.Meta-analysis was performed by RevMan5.4 software.Results A total of 11 RCTs involving 3759 bronchial asthma patients were enrolled.Meta-analysis results showed that the number of patients with acute exacerbation of asthma(RR=0.48,95%CI:0.40,0.57,P<0.01)and the Asthma Control Questionnaire(ACQ)score(MD=-0.32,95%CI:-0.43,-0.21,P<0.01)were significantly lower in the experimental group than those of control group.The forced expiratory volume in 1s(FEV 1,MD=0.51,95%CI:0.31,0.71,P<0.01)and the Asthma Quality of Life Questionnaire(AQLQ)score(MD=0.32,95%CI:0.20,0.44,P<0.01)were significantly higher than those of the control group.There were no significant differences in the number of bronchial asthma patients with blood eosinophil count<300/μl(RR=1.10,95%CI:0.93,1.31,P=0.26),incidence of adverse events(RR=1.03,95%CI:0.98,1.08,P=0.22)and incidence of serious adverse events(RR=1.21,95%CI:0.86,1.71,P=0.28)between groups(P>0.05).Conclusion Dupilumab can decrease the number of asthma exacerbations,improve pulmonary function and quality of life with a high safety.