Rodríguez-Fernández R, González-Martínez F, Ojeda Velázquez I, Rodríguez Díaz M, Capozzi Bucciol M V, González-Sánchez M I, Pérez-Moreno J, Toledo Del Castillo B
Rosa Rodriguez-Fernández. Sección de Pediatría Interna Hospitalaria. Servicio de Pediatría. Hospital Gregorio Marañón. Calle O'Donnell 50, 28007, Madrid, Spain.
Rev Esp Quimioter. 2024 Dec;37(6):498-503. doi: 10.37201/req/026.2024. Epub 2024 Sep 23.
Respiratory syncytial virus (RSV) bronchiolitis is the leading cause of hospitalization in infants. This season, a long half-life monoclonal antibody (Nirsevimab) is available to prevent this disease for all infants born from 1 April-30 September to 2023 and all those born during RSV season (October2023- March 2024). The aim of this study was to evaluate the impact of the implementation of this antibody on RSV admissions in a tertiary hospital.
Observational, retrospective and analytical study. All patients <6 months in October admitted for bronchiolitis at 2 time points were included: T1 or Pre-nirsevimab time: 1 September 2015-30 September 2023 and T2 or Nirsevimab time: 1 October-31 December 2023. Total admissions due to any cause of infants <6 months in the same period were used as the reference population. To assess the impact of the implementation of nirsevimab, we calculated the reduction in the percentage of admissions due to RSV with respect to total admissions in both periods, and also in the 2023-2024 season we calculated the double negative test to calculate the effectiveness of the intervention (1-Odds ratio) x 100.
In infants under 6 months of age, we found significant differences in the number of admissions for RSV bronchiolitis between the last season and the previous 7 seasons [574/1195 (48%) vs 6/138 (4.3%); p<0.01, RPI: 91%). In the 2023/2024 season, the effectiveness of nirsevimab in preventing admission for RSV bronchiolitis in children under 6 months of age was 85% (CI 95%: 32-97%).
The implementation of nirsevimab has had an important impact on the number of hospital admissions for RSV bronchiolitis. There were no differences in the severity of bronchiolitis.
呼吸道合胞病毒（RSV）细支气管炎是婴儿住院的主要原因。本季节，一种半衰期长的单克隆抗体（尼塞韦单抗）可用于预防2023年4月1日至9月30日出生的所有婴儿以及RSV流行季节（2023年10月至2024年3月）出生的所有婴儿的这种疾病。本研究的目的是评估在一家三级医院实施这种抗体对RSV住院率的影响。
观察性、回顾性和分析性研究。纳入10月份在两个时间点因细支气管炎入院的所有6个月以下患者：T1或尼塞韦单抗前时间：2015年9月1日至2023年9月30日，T2或尼塞韦单抗时间：2023年10月1日至12月31日。同期因任何原因入院的6个月以下婴儿总数用作参考人群。为评估尼塞韦单抗实施的影响，我们计算了两个时期RSV导致的住院率相对于总住院率的降低百分比，并且在2023 - 2024季节我们计算了双阴性检验以计算干预的有效性（1 - 优势比）×100。
在6个月以下婴儿中，我们发现上一季节与之前7个季节相比，RSV细支气管炎住院人数存在显著差异[574/1195（48%）对6/138（4.3%）；p<0.01，RPI：91%]。在2023/2024季节，尼塞韦单抗预防6个月以下儿童RSV细支气管炎住院的有效性为85%（95%CI：32 - 97%）。
尼塞韦单抗的实施对RSV细支气管炎的住院人数产生了重要影响。细支气管炎的严重程度没有差异。
