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尼塞韦单抗免疫接种对婴儿呼吸道疾病的实际影响:一项多国回顾性分析。

Real-world impact of nirsevimab immunisation against respiratory disease on emergency department attendances and admissions among infants: a multinational retrospective analysis.

作者信息

Perramon-Malavez Aida, Buonsenso Danilo, Morello Rosa, Coma Ermengol, Foster Steve, Leonard Paul, Marlow Robin, Martínez-Marcos Montserrat, Mendioroz Jacobo, Vila Jorgina, Creus-Costa Anna, Prats Clara, Roland Damian, Williams Thomas C, Soriano-Arandes Antoni

机构信息

Computational Biology and Complex Systems (BIOCOM-SC) Group, Department of Physics, Universitat Politècnica de Catalunya (UPC), Catalonia, Spain.

Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

出版信息

Lancet Reg Health Eur. 2025 Jun 3;55:101334. doi: 10.1016/j.lanepe.2025.101334. eCollection 2025 Aug.

DOI:10.1016/j.lanepe.2025.101334
PMID:40950943
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC12426819/
Abstract

BACKGROUND

Nirsevimab, a novel monoclonal antibody with a long half-life, has received European Union approval to prevent lower respiratory tract infections (LRTIs) caused by respiratory syncytial virus (RSV) during the first season of exposure. It was implemented in Catalonia (Spain) in the 2023-2024 season. Our main objective was to analyse the impact of the nirsevimab on LRTIs presenting to the Emergency Department (ED) in Catalonia (Spain) by comparing presentations to those at five sites in the United Kingdom (UK) and Rome (Italy).

METHODS

In this multi-national retrospective analysis of emergency department attendances and admissions, we retrospectively collected information for all diagnoses, respiratory diagnoses excluding bronchiolitis, and bronchiolitis, for different age groups from 68 hospitals in Catalonia (Spain), one hospital in Rome (Italy), and four hospitals in the UK (Bristol, Leicester, Glasgow, and Edinburgh), from May 1st, 2018, to April 30th 2024. Applying a generalised linear model (GLM) in Poisson regression, we obtained the risk ratio (RR) and 95% confidence intervals (CI) of bronchiolitis in 2023-2024 season compared to the mean of all previous seasons. We analysed data in annual bins, from May 1st to April 30th, excluding 2020-21 as a COVID year, for a total of 5 years of data.

FINDINGS

Data was available for 1,574,392 ED attendances (96,028 for bronchiolitis) and 255,689 hospital admissions (27,691 for bronchiolitis). In the 2023-2024 season, in Catalonia there was a reduction in the RR for bronchiolitis hospital admissions in the youngest infants aged <6 months (0.52, 95% CI: 0.48-0.55). There was also a reduction in Catalonia in the RR for hospital attendances for bronchiolitis in nirsevimab eligible age groups (0-11 months), with a RR of 0.56 (95% CI: 0.54-0.58) for infants <6 m and 0.93 (95% CI: 0.89-0.97) for infants 6-11 m. None of the other sites or age groups showed a significant reduction in the RR for attendances or admissions for the 2023-2024 season compared to previous years.

INTERPRETATION

Nirsevimab had a clear impact in reducing attendances and admissions for infants with bronchiolitis aged <6 months in Catalonia. However, the impact on older infants was less clear.

FUNDING

None.

摘要

背景

尼塞韦单抗是一种新型单克隆抗体,半衰期长,已获得欧盟批准,用于预防首次接触呼吸道合胞病毒(RSV)季节期间由其引起的下呼吸道感染(LRTIs)。它于2023 - 2024赛季在西班牙加泰罗尼亚实施。我们的主要目标是通过比较西班牙加泰罗尼亚地区与英国五个地点和意大利罗马的就诊情况,分析尼塞韦单抗对加泰罗尼亚地区急诊科(ED)因LRTIs就诊的影响。

方法

在这项关于急诊科就诊和住院情况的多国回顾性分析中,我们回顾性收集了2018年5月1日至2024年4月30日期间,西班牙加泰罗尼亚地区68家医院、意大利罗马一家医院以及英国四家医院(布里斯托尔、莱斯特、格拉斯哥和爱丁堡)不同年龄组的所有诊断、排除细支气管炎的呼吸道诊断以及细支气管炎的信息。在泊松回归中应用广义线性模型(GLM),我们获得了2023 - 2024赛季与之前所有赛季均值相比细支气管炎的风险比(RR)和95%置信区间(CI)。我们按年度区间(5月1日至4月30日)分析数据,不包括2020 - 2021年这个新冠疫情年,总共5年的数据。

结果

有1,574,392例急诊科就诊数据(细支气管炎96,028例)和255,689例住院数据(细支气管炎27,691例)。在2023 - 2024赛季,在加泰罗尼亚,6个月以下最年幼婴儿因细支气管炎住院的RR有所降低(0.52,95%CI:0.48 - 0.55)。在加泰罗尼亚,尼塞韦单抗适用年龄组(0 - 11个月)因细支气管炎就诊的RR也有所降低,6个月以下婴儿的RR为0.56(95%CI:0.54 - 0.58),6 - 11个月婴儿的RR为0.93(95%CI:0.89 - 0.97)。与前几年相比,2023 - 2024赛季其他地点或年龄组的就诊或住院RR均未出现显著降低。

解读

尼塞韦单抗对加泰罗尼亚地区6个月以下患细支气管炎婴儿的就诊和住院情况有明显影响。然而,对年龄较大婴儿的影响不太明确。

资金来源

无。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63a9/12426819/4280f7d0e578/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63a9/12426819/72eb26d8d60b/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63a9/12426819/4280f7d0e578/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63a9/12426819/72eb26d8d60b/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63a9/12426819/4280f7d0e578/gr2.jpg

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本文引用的文献

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Eur J Pediatr. 2024 Dec;183(12):5181-5189. doi: 10.1007/s00431-024-05779-x. Epub 2024 Sep 28.
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Nirsevimab and Acute Bronchiolitis Episodes in Pediatric Emergency Departments.尼赛珠单抗与儿科急诊急性细支气管炎发作
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Clinical Impact of Serious Respiratory Disease in Children Under the Age of 2 Years During the 2021-2022 Bronchiolitis Season in England, Scotland, and Ireland.
2021-2022 年英国、苏格兰和爱尔兰毛细支气管炎季节期间 2 岁以下儿童严重呼吸道疾病的临床影响。
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Comprehensive Summary of Safety Data on Nirsevimab in Infants and Children from All Pivotal Randomized Clinical Trials.来自所有关键随机临床试验的关于Nirsevimab在婴幼儿中的安全性数据综合总结。
Pathogens. 2024 Jun 13;13(6):503. doi: 10.3390/pathogens13060503.
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Effectiveness of nirsevimab immunoprophylaxis against respiratory syncytial virus-related outcomes in hospital and primary care settings: a retrospective cohort study in infants in Catalonia (Spain).尼氏司他单抗免疫预防在医院和初级保健环境中对呼吸道合胞病毒相关结局的有效性:加泰罗尼亚(西班牙)婴儿的回顾性队列研究。
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