尼尔塞维马布对预防呼吸道结核病毒感染的长期影响,使用现实世界的全球数据库
Taito Kitano1, Shinya Tsuzuki2, Haruhisa Fukuda3
1Department of Pediatrics, Nara Prefecture General Medical Center, Nara, Japan; Clinical Research Center, Nara Prefecture General Medical Center, Nara, Japan; AMR Clinical Reference Center, Japan Institute for Health Security, Tokyo, Japan; Disease Control and Prevention Center, Japan Institute for Health Security, Tokyo, Japan.
The Journal of infection
|November 9, 2025
概括
长期作用的抗体nirsevimab有效地防止了婴儿在12个月内感染呼吸道同胞病毒 (RSV). 然而,其预防作用在12个月后会减弱,这表明对RSV的保护时间有限.
科学领域:
- 儿科 儿科 儿科
- 传染性疾病 传染性疾病
- 免疫学 免疫学 免疫学
背景情况:
- 呼吸道同胞病毒 (RSV) 是婴儿呼吸道疾病的主要原因之一.
- 长效单克隆抗体Nirsevimab提供了对RSV的被动免疫.
- 尼尔塞维玛布的预防效果持续时间超过六个月需要进一步评估.
研究的目的:
- 评估nirsevimab在婴儿中长达六个月以上的RSV感染的预防性疗效.
- 使用全球健康数据库分析nirsevimab的有效性.
主要方法:
- 使用TriNetX全球数据库进行的回顾性多中心研究.
- 包括需要RSV核酸检测的24个月以下儿童 (2023年7月至2025年6月).
- 使用倾向性得分匹配,比较尼尔塞维马布接受者 (6个月,6-11个月,>12个月内服用) 与非接受者.
主要成果:
- 在6个月内服用nirsevimab显示,积极的RSV测试结果显著减少 (OR 0.49,p<0.001).
- 在6-11个月之间观察到保护 (OR 0.67,p<0.020),但不超过12个月 (OR 1.21,p=0.234).
- 总共有4627,861和532名儿童在各自的时间范围内接受了nirsevimab,而对照组为210,626.
结论:
- 尼尔西维马布在给药后长达12个月的时间内提供了对RSV感染的持续保护.
- 尼尔塞维马布的预防作用在12个月以上没有观察到.
- 由于固有的局限性,研究结果应谨慎解释.
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