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单克隆抗体尼塞韦林进行普遍免疫接种对减轻需要儿科重症监护的严重细支气管炎负担的影响。

Impact of universal immunization program with monoclonal antibody nirsevimab on reducing the burden of serious bronchiolitis that need pediatric intensive care.

机构信息

Pediatric Intensive Care Unit, Hospital Sant Joan de Déu, Passeig de Sant Joan de Déu, 2, Esplugues de Llobregat, Barcelona, 08950, Spain.

Immunological and Respiratory Disorders in the Pediatric Critical Patient Research Group, Institut de Recerca Sant Joan de Déu, University of Barcelona, Barcelona, Spain.

出版信息

Eur J Pediatr. 2024 Sep;183(9):3897-3904. doi: 10.1007/s00431-024-05634-z. Epub 2024 Jun 23.

DOI:10.1007/s00431-024-05634-z
PMID:38910199
Abstract

UNLABELLED

RSV bronchiolitis remains the leading cause of hospitalization in children under 1 year of age. It is estimated that 2-6% of cases will be hospitalized on pediatric intensive care units (PICUs). In October 2023, a universal immunization program with the monoclonal antibody nirsevimab was implemented in Catalonia. The aim of the study was to analyze the impact of the nirsevimab immunization on the burden of bronchiolitis admitted to a PICU and resulting changes in epidemiological, clinical, and microbiological characteristics comparing the pre-nirsevimab (pre-N) with the post-nirsevimab (post-N) period. This was a prospective, descriptive, and observational study. Patients with severe bronchiolitis admitted to reference children's hospital PICU, between September 2010 and February 2024 were included. Demographic and clinical data were collected and viral laboratory etiological diagnosis was carried out. 1531 patients were recruited, 1458 in the pre-N seasons and 73 after its introduction (58% males, median age 52 days), of which 67% were immunized with nirsevimab. The total number of PICU bronchiolitis admissions, the ratio, and the RSV etiology were significantly lower in the post-N period (p = 0.03, p < 0.001, and p = 0.039, respectively). Significant higher age at admission (p < 0.001) and lower hospital length of stay (p < 0.001) was observed comparing pre-N vs. post-N period.

CONCLUSION

Nirsevimab appears to have an important impact on reducing the number and length of stay of PICU admissions due to RSV bronchiolitis.

WHAT IS KNOWN

• Bronchiolitis is the most common viral infection of the lower respiratory tract in infants. • It represents 13% of the total pediatric intensive care admissions, typically during winter. This is one of the causes that produces a collapse in the health care systems all around the world.

WHAT IS NEW

• In October 2023, universal immunization with monoclonal antibody nirsevimab of all children under 6 months of age was started in the majority of autonomous communities in Spain. • Recent publications from the nirsevimab clinical trials have evidenced a high RSV protective effect, but data on its effect on real life patients who require pediatric intensive care unit admission are missing.

摘要

目的

分析在加泰罗尼亚实施 RSV 单克隆抗体 nirsevimab 普遍免疫接种计划对儿科重症监护病房(PICU)收治毛细支气管炎负担的影响,并比较 nirsevimab 免疫接种前(pre-N)和免疫接种后(post-N)时期,毛细支气管炎的流行病学、临床和微生物学特征的变化。

方法

这是一项前瞻性、描述性和观察性研究。纳入 2010 年 9 月至 2024 年 2 月期间在参考儿童医院 PICU 因严重毛细支气管炎入院的患者。收集人口统计学和临床数据,并进行病毒实验室病因学诊断。

结果

共纳入 1531 例患者,pre-N 季节 1458 例,引入后 73 例(男性占 58%,中位年龄 52 天),其中 67%接受了 nirsevimab 免疫接种。post-N 期 PICU 毛细支气管炎入院人数、比例和 RSV 病因明显减少(p=0.03,p<0.001 和 p=0.039)。与 pre-N 期相比,post-N 期入院时年龄显著增加(p<0.001),住院时间缩短(p<0.001)。

结论

nirsevimab 似乎可显著减少因 RSV 毛细支气管炎导致的 PICU 入院人数和住院时间。

已知情况

•毛细支气管炎是婴儿下呼吸道最常见的病毒感染。•它占儿科重症监护病房总入院人数的 13%,通常发生在冬季。这是导致全球医疗保健系统崩溃的原因之一。

新情况

•2023 年 10 月,西班牙大部分自治区开始对所有 6 个月以下儿童进行 nirsevimab 单克隆抗体普遍免疫接种。•nirsevimab 临床试验的最新出版物表明 RSV 具有高度保护作用,但缺乏关于其对需要入住儿科重症监护病房的真实患者影响的数据。

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