2023 年 9 月至 2024 年 1 月期间法国儿科重症监护病房住院的呼吸道合胞病毒毛细支气管炎病例中尼赛利珠单抗的有效性。
Nirsevimab Effectiveness Against Cases of Respiratory Syncytial Virus Bronchiolitis Hospitalised in Paediatric Intensive Care Units in France, September 2023-January 2024.
机构信息
Direction des maladies infectieuses, Santé publique France, Saint-Maurice, France.
Mathematical Modelling of Infectious Diseases Unit, Institut Pasteur, Université Paris Cité, CNRS UMR 2000, Paris, France.
出版信息
Influenza Other Respir Viruses. 2024 Jun;18(6):e13311. doi: 10.1111/irv.13311.
Abstract
In September 2023, France was one of the first countries that started a national immunisation campaign with nirsevimab, a new monoclonal antibody against respiratory syncytial virus (RSV). Using data from a network of paediatric intensive care units (PICUs), we aimed to estimate nirsevimab effectiveness against severe cases of RSV bronchiolitis in France. We conducted a case-control study based on the test-negative design and included 288 infants reported by 20 PICUs. We estimated nirsevimab effectiveness at 75.9% (48.5-88.7) in the main analysis and 80.6% (61.6-90.3) and 80.4% (61.7-89.9) in two sensitivity analyses. These real-world estimates confirmed the efficacy observed in clinical studies.
摘要
2023 年 9 月，法国是第一个启动尼司他丁（一种针对呼吸道合胞病毒的新型单克隆抗体）全国免疫接种运动的国家之一。利用来自儿科重症监护病房（PICU）网络的数据，我们旨在评估尼司他丁在法国预防严重 RSV 细支气管炎的效果。我们进行了一项基于测试阴性设计的病例对照研究，纳入了 20 个 PICU 报告的 288 名婴儿。在主要分析中，我们估计尼司他丁的有效性为 75.9%（48.5-88.7），在两次敏感性分析中，有效性分别为 80.6%（61.6-90.3）和 80.4%（61.7-89.9）。这些真实世界的估计结果证实了临床试验中观察到的疗效。
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