中国热带、亚热带地区婴幼儿呼吸道合胞病毒单克隆抗体免疫预防专家共识
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周文浩,男,教授,广州医科大学附属妇女儿童医疗中心,Email:zhouwenhao@fudan.edu.cn
文飞球,男,教授,《中国当代儿科杂志》编辑部/深圳市儿童医院,Email:fwen62@126.com
周伟,男,教授,广州医科大学附属妇女儿童医疗中心,Email:zhouwei_pu002@126.com。

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Expert consensus on monoclonal antibody immunoprophylaxis against respiratory syncytial virus in infants and young children in tropical and subtropical regions of China
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    摘要:

    呼吸道合胞病毒(respiratory syncytial virus, RSV)是婴幼儿急性下呼吸道感染的主要病原体之一,在热带、亚热带地区呈现全年流行模式,尤其对1岁以内婴儿构成严重健康威胁。现有治疗手段以对症支持治疗为主,抗病毒药物疗效有限。近年来,随着单克隆抗体(简称单抗)研发的突破,长效RSV单抗——尼塞韦单抗在全球及我国陆续应用于临床,已成为婴幼儿RSV感染免疫预防的核心干预措施。该共识结合国内外最新循证医学证据和我国热带、亚热带地区的流行病学特征,从RSV的流行特点、RSV感染的疾病负担和临床表现、RSV单抗的用法用量、RSV单抗的疗效和安全性、婴幼儿全年免疫预防策略、特殊健康状态婴幼儿的免疫预防策略、RSV单抗与免疫规划疫苗的联合接种及长效RSV单抗免疫预防的管理措施等方面提出推荐意见,旨在为临床一线及公共卫生实践提供科学、规范的预防和管理指导,以降低婴幼儿RSV感染的发生率、重症率和公共卫生负担。

    Abstract:

    Respiratory syncytial virus (RSV) is one of the main pathogens of acute lower respiratory tract infection in infants and young children and shows a year-round transmission pattern in tropical and subtropical regions, posing a serious health threat, especially to infants under one year of age. Current treatment is mainly symptomatic and supportive, and antiviral drugs have limited efficacy. In recent years, with advances in monoclonal antibody development, the long-acting RSV monoclonal antibody nirsevimab has been introduced into clinical practice worldwide, including in China, and has become a core intervention for immunoprophylaxis in infants and young children. Recommendations are proposed in this consensus based on the latest domestic and international evidence and the epidemiological characteristics of tropical and subtropical regions in China. They cover: epidemiological features of RSV; disease burden and clinical manifestations of RSV infection; dosage and administration of RSV monoclonal antibodies; efficacy and safety of RSV monoclonal antibodies; year-round immunoprophylaxis strategies for infants and young children; immunoprophylaxis strategies for infants and young children with special health conditions; coadministration of RSV monoclonal antibodies with vaccines in the national immunization program; and management measures for immunoprophylaxis with long-acting RSV monoclonal antibodies. The aim is to provide scientific and standardized guidance for frontline clinical and public health practice to reduce the incidence, severity, and public health burden of RSV infection in infants and young children.

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  • 收稿日期:2025-09-02
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  • 在线发布日期: 2026-01-26
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