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在基层医疗环境中,尼塞韦单抗对严重呼吸道合胞病毒感染的有效性。

Nirsevimab Effectiveness Against Severe Respiratory Syncytial Virus Infection in the Primary Care Setting.

作者信息

López-Lacort Mónica, Muñoz-Quiles Cintia, Mira-Iglesias Ainara, Xavier López-Labrador F, Garcés-Sánchez María, Escribano-López Begoña, Zornoza-Moreno Matilde, Jesús Pérez-Martín Jaime, Alfayate-Miguelez Santiago, Iofrío-De Arce Antonio, Pastor-Villalba Eliseo, Antonio Lluch-Rodrigo José, Díez-Domingo Javier, Orrico-Sánchez Alejandro

机构信息

Vaccine Research Department, Fisabio-Public Health, Valencia, Spain.

CIBERESP, Instituto de Salud Carlos III, Madrid, Spain.

出版信息

Pediatrics. 2025 Jan 1;155(1). doi: 10.1542/peds.2024-066393.

Abstract

OBJECTIVES

This study assesses the effectiveness of nirsevimab, a monoclonal antibody, in preventing medically attended respiratory syncytial virus-lower respiratory tract infections (RSV-LRTIs) in a large primary care network in Spain, in both overall and catch-up infants aged younger than 10 months.

METHODS

The 2023-2024 immunization campaign with nirsevimab in Spain targeted all infants born after April 1, 2023. Those born after October 1 received it at birth in hospitals, whereas others received it through a catch-up program. The MEDIPRIM network of primary care centers recruited all infants with LRTI for RSV polymerase chain reaction testing and employed a test-negative design approach to estimate the effectiveness of nirsevimab.

RESULTS

The study included 160 infants; 141 (88%) of them received nirsevimab and 128 belonged to the catch-up group (88% received nirsevimab). Overall, RSV was detected in 44 infants (27.5%). Within the catch-up group, 37 (28.9%) were positive for RSV. The overall effectiveness was 75.8% (95% credible interval: 40.4-92.7), and 80.2% (95% credible interval: 44.3-95.4) in infants belonging to the catch-up group.

CONCLUSIONS

This study underscores the effectiveness of nirsevimab in preventing medically attended LRTI in infants in outpatient settings and emphasizes the importance of a catch-up immunization program to reduce the disease burden in primary care.

摘要

目的

本研究评估单克隆抗体nirsevimab在西班牙一个大型初级保健网络中预防10个月以下婴儿因呼吸道合胞病毒引起的下呼吸道感染(RSV-LRTIs)的有效性,包括总体婴儿和补种婴儿。

方法

2023 - 2024年西班牙nirsevimab免疫接种活动针对2023年4月1日之后出生的所有婴儿。10月1日之后出生的婴儿在医院出生时接种,其他婴儿通过补种计划接种。初级保健中心的MEDIPRIM网络招募所有患有下呼吸道感染的婴儿进行RSV聚合酶链反应检测,并采用检测阴性设计方法来估计nirsevimab的有效性。

结果

该研究纳入了160名婴儿;其中141名(88%)接种了nirsevimab,128名属于补种组(88%接种了nirsevimab)。总体而言,44名婴儿(27.5%)检测出RSV。在补种组中,37名(28.9%)RSV呈阳性。总体有效性为75.8%(95%可信区间:40.4 - 92.7),补种组婴儿的有效性为80.2%(95%可信区间:44.3 - 95.4)。

结论

本研究强调了nirsevimab在门诊环境中预防婴儿因下呼吸道感染就医的有效性,并强调了补种免疫计划对于减轻初级保健中疾病负担的重要性。

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