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尼塞韦单抗对呼吸道合胞病毒细支气管炎患儿急诊就诊的有效性:一项阴性对照设计研究。

Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study.

作者信息

Lenglart Lea, Levy Corinne, Basmaci Romain, Levieux Karine, Kramer Rolf, Mari Karine, Béchet Stéphane, Launay Elise, Cohen Laure, Aupiais Camille, de Pontual Loic, Rybak Alexis, Lassoued Yannis, Ouldali Naim, Cohen Robert

机构信息

Paediatric Emergency Department, Robert Debré Hospital, Assistance Publique - Hôpitaux de Paris, 48 Boulevard Sérurier 75019, Paris, France.

IAME (Infection, Antimicrobials, Modelling, Evolution), INSERM UMR 1137, Paris Cité University, Paris, France.

出版信息

Eur J Pediatr. 2025 Feb 1;184(2):171. doi: 10.1007/s00431-025-06008-9.

DOI:10.1007/s00431-025-06008-9
PMID:39893316
Abstract

UNLABELLED

Bronchiolitis is one of the leading reasons for paediatric emergency department (PED) visits. France was one of the few countries in the world to implement nirsevimab during winter 2023-2024 in order to reduce the burden of bronchiolitis each year. We conducted a test-negative design study, including all infants younger than 1, diagnosed with a first episode of bronchiolitis. We included all cases presenting to the PED of five university hospitals across France, between October 1, 2023, and February 29, 2024, and undergoing a nasopharyngeal sample for RSV testing. Case patients were the RSV-positive bronchiolitis and control patients the RSV-negative. As a follow-up, all parents were contacted by e-mail 15 days after inclusion. We included 383 bronchiolitis patients, of which 274 tested positive for RSV (75.2%). Among case patients, 27/274 (9.8%) received nirsevimab, compared to 50/109 (46.2%) among control patients. Nirsevimab had an adjusted estimated effectiveness of 82.5% (95% CI [68.0-90.8]) at PEDs. Sensitivity analyses found similar results. At 15-day follow-up, characteristics were similar between children immunized by nirsevimab or not.

CONCLUSION

Our findings advocate for nirsevimab widespread adoption to alleviate the burden of RSV bronchiolitis in paediatric emergency departments.

TRIAL REGISTRATION

NCT04743609 (date of registration: February 4, 2021).

WHAT IS KNOWN

• Each year, RSV-bronchiolitis places significant pressure on pediatric emergency services. • France is one of the first countries in the world to have implemented nirsevimab in septembre 2023.

WHAT IS NEW

• Nirsevimab effectiveness on pediatric emergency visits for RSV-bronchiolitis has been estimated to 82.5% (95% CI [68.0-90.8]) in our study. • The effectiveness was as strong to prevent hospitalizations and sever illnesses.

摘要

未标注

细支气管炎是儿科急诊科就诊的主要原因之一。法国是世界上少数几个在2023 - 2024年冬季实施nirsevimab以减轻每年细支气管炎负担的国家之一。我们进行了一项检测阴性设计研究,纳入了所有1岁以下首次诊断为细支气管炎的婴儿。我们纳入了2023年10月1日至2024年2月29日期间在法国五所大学医院儿科急诊科就诊并接受呼吸道合胞病毒(RSV)检测的鼻咽样本的所有病例。病例患者为RSV阳性的细支气管炎患者,对照患者为RSV阴性患者。作为随访,在纳入研究15天后通过电子邮件联系所有家长。我们纳入了383例细支气管炎患者,其中274例RSV检测呈阳性(75.2%)。在病例患者中,274例中有27例(9.8%)接受了nirsevimab,而对照患者中为109例中有50例(46.2%)。在儿科急诊科,nirsevimab调整后的估计有效性为82.5%(95%置信区间[68.0 - 90.8])。敏感性分析得出了类似结果。在15天随访时,接受nirsevimab免疫和未接受免疫的儿童特征相似。

结论

我们的研究结果支持广泛采用nirsevimab以减轻儿科急诊科RSV细支气管炎的负担。

试验注册

NCT04743609(注册日期:2021年2月4日)。

已知信息

• 每年,RSV细支气管炎给儿科急诊服务带来巨大压力。• 法国是世界上最早在2023年9月实施nirsevimab的国家之一。

新发现

• 在我们的研究中,nirsevimab对儿科因RSV细支气管炎就诊的有效性估计为82.5%(95%置信区间[68.0 - 90.8])。• 其预防住院和严重疾病的有效性同样显著。

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Front Public Health. 2024 Aug 16;12:1441786. doi: 10.3389/fpubh.2024.1441786. eCollection 2024.
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