中国感染控制杂志2026，Vol.25Issue(3)：372-378,7.DOI:10.12138/j.issn.1671-9638.20262846
尼塞韦单抗预防婴儿RSV感染有效性和安全性的系统评价:一项Meta分析
Systematic review on the efficacy and safety of nirsevimab in preventing respiratory syncytial virus infection in infants:a Meta-analysis
摘要
Abstract
Objective To systematically evaluate the effectiveness and safety of nirsevimab in preventing respira-tory syncytial virus(RSV)infection in infants.Methods Clinical trials related to the prevention of RSV infection by using nirsevimab in infants were systematically retrieved from database such as PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),and Wanfang,as well as Chinese and American Clinical Trial Registry platforms,the search period was from the establishment of the databases to December 31,2024.Literatures were screened based on inclusion and exclusion criteria,the included information of literatures were extracted,and the quality of included studies was evaluated by Cochrane risk of bias assessment tool.Results A total of 5 randomized controlled studies were included in analysis.Data analysis showed that compared with placebo/blank control group,vaccination of nirsevimab before the RSV epidemic season could reduce the risk of RSV-related lower respiratory tract infection(RR=0.24,95%CI:0.17-0.34,P<0.01)and RSV infection-related hospitali-zation risk(RR=0.20,95%CI:0.13-0.30,P<0.01)in infants.In addition,compared with placebo/blank control group,there were no statistically significant differences in the incidences of all adverse events(RR=1.04,95%CI:0.96-1.12,P=0.37),drug-related adverse events(RR=0.93,95%CI:0.52-1.67,P=0.82),death-leading adverse events(RR=0.95,95%CI:0.07-12.88,P=0.97),severe adverse events(RR=0.91,95%CI:0.63-1.30,P=0.59),and special concerned adverse events(RR=1.29,95%CI:0.43-3.82,P=0.65)in infants in niresvimab treatment group.Compared with palivizumab,nirsevimab showed no significant differences in terms of efficacy(RR=0.83,95%CI:0.20-3.43,P=0.79)and safety(mortality:RR=2.48,95%CI[0.29-21.10],P=0.41;serious adverse events:RR=1.04,95%CI[0.73-1.50],P=0.82).Conclusion Nirsevimab has good safety in preventing RSV infection and reducing hospitalization rates,demonstrating promising application prospects.关键词
尼塞韦单抗/呼吸道合胞病毒/婴儿/安全性/有效性/Meta分析Key words
nirsevimab/respiratory syncytial virus/infant/safety/effectiveness/Meta-analysis分类
医药卫生引用本文复制引用
陶兴茹,王瑞丽,段彦彦,裴保方,孙冲,张胜男..尼塞韦单抗预防婴儿RSV感染有效性和安全性的系统评价:一项Meta分析[J].中国感染控制杂志,2026,25(3):372-378,7.基金项目
郑州市医学重点(培育)学科(儿科药学)(2023ZZSZDXK02) （培育）
河南省科技攻关项目(252102311123) （252102311123）
