目的 系统评价玛巴洛沙韦治疗儿童流行性感冒的有效性和安全性.方法 检索PubMed、Em-base、Web of Science、Cochrane Library、中国生物医学文献数据库、中国知网、万方和维普等数据库,检索时间为建库至2023年11月15日,选取关于玛巴洛沙韦治疗儿童流感病毒感染的随机对照试验和队列研究,分别采用Co-chrane风险偏倚评价工具和纽卡斯尔-渥太华量表(Newcastle-Ottawa Scale,NOS)进行文献质量评价,采用Rev-Man 5.3软件进行Meta分析.结果 共纳入11篇文献,包括3篇随机对照试验和8篇队列研究.与神经氨酸酶抑制剂(奥司他韦、扎那米韦、帕拉米韦和拉尼米韦)相比,玛巴洛沙韦治疗乙型流感的中位发热持续时间较短(17.0 h vs.48.3 h,P＜0.01).与奥司他韦相比,在甲流和乙流亚组中,玛巴洛沙韦组发热持续时间(甲流:MD=-6.30,95％CI:-10.12～-2.49,P=0.001;乙流:MD=-26.94,95％CI:-47.11～-6.77,P=0.009)、症状持续时间[甲流:MD=-11.13,95％CI:-19.34～-2.93,P=0.008;乙流:(4.9±1.3)dvs.(5.4±2.4)d,P＜0.01]均更短;在甲流亚组中,玛巴洛沙韦组的中位病毒清除率(单位:log10拷贝数/d)更高[0.81(0.52,1.12)vs.0.63(0.44,0.93),P=0.007];玛巴洛沙韦组复诊率更低(8.05％vs.24.84％,P＜0.001).与扎那米韦相比,玛巴洛沙韦的中位病毒清除率(单位:log10拷贝数/d)差异无统计学意义[甲流:0.81(0.52,1.12)vs.0.90(0.65,1.08),P＞0.05;乙流:0.77(0.38,1.04)vs.0.55(0.27,0.77),P＞0.05].与拉尼米韦相比,玛巴洛沙韦的中位病毒清除率(单位:log10拷贝数/d)[甲流:0.81(0.52,1.12)vs.0.76(0.45,1.06),P＞0.05;乙流:0.77(0.38,1.04)vs.0.37(0.29,0.56),P＞0.05]、复诊率差异无统计学意义(8.05％vs.12.35％,P=0.79).在安全性方面,玛巴洛沙韦与奥司他韦相比,药物相关不良事件发生率更低(OR=0.66,95％CI:0.44～0.98,P＜0.05),总不良事件发生率差异无统计学意义(OR=0.85,95％CI:0.69～1.05,P＞0.05).结论 玛巴洛沙韦治疗儿童流感的有效性和安全性良好,还需开展更高质量研究进一步验证.
Systematic review and Meta-analysis of the efficacy and safety of baloxavir marboxil in the treatment of influenza in children
Objective To systematically evaluate the efficacy and safety of baloxavir marboxil in the treat-ment of influenza in children.Methods From the establishment of the database to November 15,2023,a search was conducted in databases including PubMed,Embase,Web of Science,Cochrane Library,China Biology Medicine,CNKI,Wanfang Database,and VIP.The randomized controlled trials and cohort studies on the use of baloxavir mar-boxil in treating influenza virus infections in children were selected.The quality of the included studies was assessed using the Cochrane Bias Risk tool for RCT and the newcastle-Ottawa Scale(NOS)for cohort studies.RevMan 5.3 soft-ware was employed to conduct the meta-analysis.Results A total of 11 articles were included,including 3 randomized controlled trials and 8 cohort studies.Compared with neuraminidase inhibitors(oseltamivir,zanamivir,peramivir,and laninamivir),the median duration of fever in patients with influenza B treated with baloxavir marboxil was shorter(17.0 h vs.48.3 h,P＜0.01).Compared with oseltamivir,in the influenza A and B subgroups,the duration of fever(in-fluenza A:MD=-6.30,95％CI:-10.12～-2.49,P=0.001;influenza B:MD=-26.94,95％CI:-47.11～-6.77,P=0.009)and duration of symptoms[influenza A:MD=-11.13,95％CI:-19.34～-2.93,P=0.008;influenza B:(4.9±1.3)d vs.(5.4±2.4)d,P＜0.01]in the baloxavir marboxil group were shorter.In the influenza A subgroup,the median viral clearance rate in the baloxavir marboxil group was significantly higher[0.81(0.52,1.12)log10 copies/day vs.0.63(0.44,0.93),P=0.007];the revisit rate was lower in the baloxavir marboxil group(8.05％vs.24.84％,P＜0.001).Compared with zanamivir,there was no statistical difference in the median viral clearance rate of baloxavir marboxil[influenza A:0.81(0.52,1.12)log10 copies/day vs.0.90(0.65,1.08)log10 copies/day,P＞0.05;influenza B:0.77(0.38,1.04)log10 copies/day vs.0.55(0.27,0.77)log10 copies/day,P＞0.05].Compared with laninamivir,there was no statistical differ-ence in the median viral clearance rate of baloxavir marboxil[influenza A:0.81(0.52,1.12)log10 copies/day vs.0.76(0.45,1.06)log10 copies/day,P＞0.05;influenza B:0.77(0.38,1.04)log 10 copies/day vs.0.37(0.29,0.56)log10 copies/day,P＞0.05]or the revisit rate(8.05％vs.12.35％,P=0.79).In terms of safety,the incidence of drug-related adverse events in the baloxavir marboxil group was lower than that in the oseltamivir group(OR=0.66,95％CI:0.44～0.98,P＜0.05),while there was no statistical difference in the incidence of adverse events(OR=0.85,95％CI:0.69～1.05,P＞0.05).Conclusion Current evidence shows that baloxavir marboxil is effective and safe for the treatment of influenza in children,but higher quality studies are needed for further verification.
万方数据
维普
