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尼塞韦单抗是一种长效单克隆抗体，于2023年12月26日被国家药品监督管理局批准，用于即将进入或出生在第一个呼吸道合胞病毒（RSV）感染季的新生儿和婴儿预防RSV引起的下呼吸道感染。现有的临床试验表明，尼塞韦单抗预防RSV引起的婴幼儿下呼吸道感染具有良好的有效性和安全性，一剂用药可提供至少5个月的保护。本文介绍了该单抗的作用机制、安全性、有效性，以及其他预防RSV感染的手段，为临床用药提供依据和参考。
Abstract：Nirsevimab is a long-acting monoclonal antibody, approved by National Medical Products Administration on 26 th December 2023, for the prevention of lower respiratory tract infection(LRTI) caused by respiratory syncytial virus(RSV) among infants and children. The existing clinical trials have shown that nirsevimab has good efficacy and safety in the prevention of RSV-associated LRTI among infants and children, and a single dose can provide at least 5 months of protection. This paper introduced the mechanism of action, safety, and efficacy of nirsevimab, as well as other ways for RSV prevention, in order to provide basis and reference for clinical medication.
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基本信息:
DOI：10.14109/j.cnki.xyylc.2025.12.05
中图分类号:R978.7
引用信息:
[1]李小亚,张海莲.呼吸道合胞病毒感染预防药物尼塞韦单抗[J].中国新药与临床杂志,2025,44(12):908-911.DOI:10.14109/j.cnki.xyylc.2025.12.05.
2025-12-08
2025-12-08
2025-12-08