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Nirsevimab降低3个月以下婴儿因细支气管炎在急诊科住院率的有效性:一项回顾性研究。

Effectiveness of nirsevimab in reducing hospitalizations in emergency departments due to bronchiolitis among infants under 3 months: a retrospective study.

作者信息

Marouk Alexis, Verrat Bernadette, Pontais Isabelle, Cojocaru Dumitru, Chappuy Hélène, Craiu Irina, Quagliaro Pauline, Gajdos Vincent, Soussan-Banini Valérie, Gallien Yves, Feral-Pierssens Anne-Laure

机构信息

SAMU 93 - SMUR - Emergency Department, Avicenne Hospital, Public Assistance Hospitals Paris, Bobigny, France.

Faculty of Health Sciences, Sorbonne University, Paris, France.

出版信息

Eur J Pediatr. 2025 Mar 5;184(3):229. doi: 10.1007/s00431-025-06050-7.

Abstract

UNLABELLED

Respiratory syncytial virus (RSV) is a leading cause of infant morbidity. France has implemented a national campaign using nirsevimab to prevent RSV-related infections in infants. This study assessed its effectiveness in preventing hospitalization due to bronchiolitis in emergency department (ED). This retrospective study was conducted among six pediatric EDs in the Greater Paris area, France, and included infants aged < 3 months with a clinical diagnosis of bronchiolitis during the 2023-2024 RSV epidemic season. The primary outcome was hospitalization after the ED visits. The association with nirsevimab immunization was assessed using a multiple logistic model adjusted for potential confounding factors, with missing data handled using random forest imputation. Secondary analyses examined the risk of admission to the pediatric intensive care unit (PICU), RSV positivity, and subgroup analyses of prematurity, neonates, and deprivation using the FDep index (area-based measure of social deprivation in France). Between October 2 and December 31, 2023, 739 infants were included in the study. A total of 531 (72%) patients had a documented nirsevimab immunization status, and 402 (54%) were hospitalized following a bronchiolitis diagnosis. Nirsevimab showed 53.5% adjusted effectiveness in reducing hospitalizations (95% CI 34.1-67.3). Sensitivity analyses of complete-case data and propensity score matching yielded similar results. Nirsevimab also resulted in 51.1% reduction in PICU admissions (95% CI 10.7-74.3) and 79.6% reduction in RSV positivity (95% CI 68.0-87.1). The protective effect of immunization was consistent for preterm infants, neonates, and deprived groups, though the results were not statistically significant in these smaller subgroups.

CONCLUSIONS

Immunization with nirsevimab reduced hospitalization following an ED visit for bronchiolitis among infants aged < 3 months.

WHAT IS KNOWN

• Nirsevimab reduces the risk of bronchiolitis-related hospitalizations in clinical trials. • Real-world data from the immunization campaign in France remain limited.

WHAT IS NEW

• Nirsevimab showed 53.5% (95% CI 34.1-67.3) adjusted effectiveness in reducing hospitalizations for all-cause bronchiolitis in infants aged < 3 months in emergency departments. • Analyses included social deprivation and highlighted potential disparities in immunization access.

摘要

未标注

呼吸道合胞病毒(RSV)是婴儿发病的主要原因。法国开展了一项全国性运动,使用尼塞韦单抗预防婴儿RSV相关感染。本研究评估了其在急诊科预防因细支气管炎住院的有效性。这项回顾性研究在法国大巴黎地区的6个儿科急诊科进行,纳入了2023 - 2024年RSV流行季节临床诊断为细支气管炎的<3个月婴儿。主要结局是急诊就诊后的住院情况。使用针对潜在混杂因素进行调整的多元逻辑模型评估与尼塞韦单抗免疫接种的关联,缺失数据采用随机森林插补法处理。二次分析考察了入住儿科重症监护病房(PICU)的风险、RSV阳性情况,以及使用FDep指数(法国基于区域的社会剥夺衡量指标)对早产、新生儿和贫困亚组的分析。2023年10月2日至12月31日,739名婴儿纳入研究。共有531名(72%)患者有尼塞韦单抗免疫接种记录,402名(54%)在诊断为细支气管炎后住院。尼塞韦单抗在降低住院率方面显示出53.5%的调整后有效性(95%CI 34.1 - 67.3)。完整病例数据和倾向得分匹配的敏感性分析得出了类似结果。尼塞韦单抗还使PICU入院率降低了51.1%(95%CI 10.7 - 74.3),RSV阳性率降低了79.6%(95%CI 68.0 - 87.1)。免疫接种的保护作用在早产儿、新生儿和贫困组中是一致的,尽管在这些较小亚组中的结果无统计学意义。

结论

尼塞韦单抗免疫接种降低了<3个月婴儿因细支气管炎急诊就诊后的住院率。

已知信息

• 尼塞韦单抗在临床试验中降低了细支气管炎相关住院风险。• 法国免疫接种运动的真实世界数据仍然有限。

新发现

• 尼塞韦单抗在降低<3个月婴儿急诊科全因细支气管炎住院率方面显示出53.5%(95%CI 34.1 - 67.3)的调整后有效性。• 分析包括社会剥夺情况,并突出了免疫接种可及性方面的潜在差异。

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