尼塞韦单抗减少婴儿急性中耳炎感染——一项全国性中断时间序列分析。
Nirsevimab reduced acute otitis media infections in infants-a nationwide interrupted time-series analysis.
文献信息
| PMID | 42855657 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Niko Leskinen |
| 作者单位 | Institute of Clinical Medicine, University of Eastern Finland, P.O. Box 1627, 70211, Kuopio, Finland. nikolesk@uef.fi. |
| 期刊 | European journal of pediatrics |
| SCI 分区 | Q1 |
| IF | 3 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
未标注： 呼吸道合胞病毒（RSV）是全球幼儿急性呼吸道感染的主要原因。急性中耳炎（AOM）是RSV感染最常见的并发症之一，也是该年龄组抗生素处方的主要指征。本研究旨在评估尼塞韦单抗在降低婴儿AOM发病率方面的有效性。我们开展了一项基于全国登记的中断时间序列研究，使用连续四个RSV流行季（2022-2023至2025-2026）的活产、实验室确诊RSV检出和AOM诊断数据。从出生队列重建每月高危婴儿人群，以估计RSV流行高峰季（12月至3月）的发病率，并在<12月龄婴儿中比较实施前两个RSV流行季与实施后两个RSV流行季，按0-2、3-5和6-11月龄分层。研究人群包括181,999名婴儿，随访包括2,022,261个婴儿月。主要分析共纳入3,699例RSV阳性结果和15,830例AOM诊断。尼塞韦单抗实施后，<12月龄婴儿的AOM和RSV发病率分别下降44%（RR 0.56，95% CI 0.54-0.58）和83%（RR 0.17，95% CI 0.15-0.18）。降幅在最小年龄组（0-2月龄）最大。
结论： 实施尼塞韦单抗免疫规划与<12月龄婴儿AOM发病率大幅下降相关，提示RSV免疫接种可能减轻幼儿期AOM负担。
已知： • RSV是婴儿期发病的主要原因，急性中耳炎是其最常见的并发症之一。• 尼塞韦单抗在预防幼儿严重RSV疾病方面已显示出高效力；然而，其对门诊RSV相关并发症的影响尚未充分确立。
新发现： • 本研究提供了尼塞韦单抗对急性中耳炎影响的人群真实世界证据。• 实施尼塞韦单抗预防后，婴儿急性中耳炎发病率显著下降。
英文摘要
UNLABELLED: Respiratory syncytial virus (RSV) is a major cause of acute respiratory tract infections in young children worldwide. Acute otitis media (AOM) is among the most frequent complications of RSV infection and the leading indication for antibiotic prescribing in this age group. The aim of this study was to evaluate the effectiveness of nirsevimab in reducing the incidence of AOM among infants. We conducted a nationwide register-based interrupted time-series study using data on live births, laboratory-confirmed RSV detections, and AOM diagnoses from four consecutive RSV seasons (2022-2023 to 2025-2026). Monthly infant populations at risk were reconstructed from birth cohorts to estimate incidence rates during the peak RSV seasons (December-March) which were compared between two pre-implementation and two post-implementation RSV seasons in infants aged < 12 months, stratified into age groups of 0-2, 3-5, and 6-11 months. The study population consisted of 181,999 infants and the follow-up consisted of 2,022,261 infant-months. A total of 3699 RSV-positive findings and 15,830 AOM diagnoses were included in the primary analysis. Following nirsevimab implementation, the incidence of AOM and RSV among infants aged < 12 months decreased by 44% (RR 0.56, 95% CI 0.54-0.58) and 83% (RR 0.17, 95% CI 0.15-0.18), respectively. The reduction was greatest in the youngest age (0-2 months) group.
CONCLUSION: Implementation of a nirsevimab immunisation programme was associated with a substantial reduction in AOM incidence among infants aged < 12 months, suggesting that RSV immunisation may reduce the burden of AOM in early childhood.
WHAT'S KNOWN: • RSV is a major cause of morbidity during infancy, and acute otitis media is among its most frequent complications. • Nirsevimab has demonstrated high efficacy in preventing severe RSV disease in young children; however, its effect on outpatient RSV-related complications has not been well established.
WHAT IS NEW: • This study provides population-based real-world evidence on the impact of nirsevimab on acute otitis media. • Following the implementation of nirsevimab prophylaxis, the incidence of acute otitis media among infants decreased significantly.