[尼塞韦单抗对新生儿呼吸道合胞病毒住院治疗的免疫效果：在西班牙纳瓦拉使用的两个季节]

[Nirsevimab immunization effectiveness against respiratory syncytial virus hospitalization in newborns: two season of use in Navarre, Spain].

作者信息

Vera-Punzano Noelia, Navascués Ana, Armendáriz Leticia, Viguria Natividad, Herranz-Aguirre Mercedes, García Cenoz Manuel, Trobajo-Sanmartín Camino, Echeverria Aitziber, Martínez-Baz Iván, Ezpeleta Carmen, Ezpeleta Guillermo, Castilla Jesús

机构信息

Instituto de Investigación Sanitaria de Navarra.

Servicio Navarro de Salud-Osasunbidea. Hospital Universitario de Navarra. Servicio de Microbiología Clínica. Pamplona, Navarra. España.

出版信息

An Sist Sanit Navar. 2025 Aug 29;48(2):e1133. doi: 10.23938/ASSN.1133.

DOI:10.23938/ASSN.1133

PMID:40879409

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12481417/

Abstract

BACKGROUND

Respiratory syncytial virus (RSV) is the leading cause of infant hospitalisation. In 2022, nirsevimab was approved in the European Union to prevent severe respiratory disease due to RSV during the first year of life. Our aim is to evaluate the effectiveness of nirsevimab immunoprophylaxis in new-borns for preventing RSV -related hospitalisations in Navarre, Spain, during its first two seasons of use.

METHODS

Nirsevimab was offered free of charge to infants born from October to December 2023 and from September to December 2024. Each cohort was followed until February of the following year. Cases were infants hospitalised for PCR-confirmed RSV infection. Cox regression was used to estimate the hazard ratio of hospitalisation for immunised versus non-immunised children.

RESULTS

Nirsevimab was offered to 2,699 new-borns; of them, 2,541 (94.1%) received nirsevimab. In the 2023-2024 season, 17 RSV-related hospitalisations were recorded and 24 in the 2024-2025 season. The average risk of RSV hospitalisation was 7.6% in non-immunised new-borns versus 1.1% in immunised ones. Overall, effectiveness of nirsevimab was 79.5% (95% CI: 59.2 - 89.7), with estimates of 89.9% in 2023-2024 and 52.8% in 2024-2025, with no significant differences between seasons (p=0.055). On average, one RSV hospitalisation was prevented per 22.6 immunised infants.

CONCLUSIONS

Nirsevimab immunoprophylaxis substantially reduces RSV hospitalisations, helping ease paediatric hospital burden. However, as some immunised infants were still hospitalised, additional preventive measures remain necessary.

摘要

背景

呼吸道合胞病毒（RSV）是婴儿住院的主要原因。2022年，尼塞韦单抗在欧盟获批，用于预防出生后第一年因RSV引起的严重呼吸道疾病。我们的目的是评估尼塞韦单抗免疫预防在西班牙纳瓦拉新生儿中预防RSV相关住院的有效性，观察其使用的前两个季节情况。

方法

为2023年10月至12月以及2024年9月至12月出生的婴儿免费提供尼塞韦单抗。每个队列随访至次年2月。病例为因PCR确诊RSV感染而住院的婴儿。采用Cox回归估计免疫儿童与未免疫儿童的住院风险比。

结果

共为2699名新生儿提供了尼塞韦单抗；其中2541名（94.1%）接受了尼塞韦单抗。在2023 - 2024季节，记录到17例与RSV相关的住院病例，在2024 - 2025季节为24例。未免疫新生儿中RSV住院的平均风险为7.6%，而免疫新生儿为1.1%。总体而言，尼塞韦单抗的有效性为79.5%（95%置信区间：59.2 - 89.7），2023 - 2024年估计为89.9%，2024 - 2025年为52.8%，不同季节之间无显著差异（p = 0.055）。平均每22.6名免疫婴儿可预防1例RSV住院。