nirseimab、RSV母疫苗和RSV疫苗对老年人的实际有效性和安全性：一项实时系统评价和荟萃分析

IF 7.7 1区医学 Q1 RESPIRATORY SYSTEM

Thorax Pub Date : 2025-09-10 DOI:10.1136/thorax-2025-223376

Bohee Lee, Daira Trusinska, Sohail Ferdous, Ruonan Pei, Harley H Y Kwok, Jürgen Schwarze, Thomas Christie Williams, Cheryl Gibbons, Jennifer K Quint, Aziz Sheikh, Simon B Drysdale, Ting Shi

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引用次数: 0

摘要

2023年，长效单克隆抗体nirseimab和呼吸道合胞病毒（RSV）疫苗可用于预防严重RSV相关疾病。虽然临床试验显示了良好的疗效和安全性，但其限制性的纳入标准、小样本量和短随访限制了其普遍性。我们的目的是总结真实世界的证据，证明nirseimab、RSV母疫苗和RSV疫苗对老年人的有效性和安全性。方法进行实时系统评价和荟萃分析，在三个数据库中进行5个月更新检索。符合条件的研究发表于2022年12月1日至2025年3月10日。采用随机效应模型对nirseimab和RSV疫苗的有效性进行meta分析。对安全数据进行叙述总结。结果共纳入50份出版物，覆盖约760万人。Nirsevimab对与rsv相关的急诊科就诊有效率为80.7% （95% CI: 75.7%至85.7%；7项研究），对住院有效率为80.7% （95% CI: 76.1%至85.2%；17项研究），对重症监护病房入院有效率为75.6% （95% CI: 63.3%至87.9%；8项研究）。RSV疫苗对老年人预防RSV相关住院的有效性为79.6% （95% CI: 73.8%至85.3；三项研究）。没有关于RSV母体疫苗有效性的数据。没有报道nirseimab的严重不良事件，而老年人RSV疫苗每百万剂量的格林-巴- 综合征病例少于10例。虽然证据有限，但没有报道RSV母体疫苗的严重不良事件。结论：我们的综述表明，nirseimab在降低rsv相关的婴儿医疗保健利用率方面具有很高的有效性，并且具有良好的安全性。需要更多的证据来评估孕妇和老年人的呼吸道合胞病毒疫苗。普洛斯彼罗注册号CRD42025643585。如有合理要求，可提供资料。

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Real-world effectiveness and safety of nirsevimab, RSV maternal vaccine and RSV vaccines for older adults: a living systematic review and meta-analysis

Background The long-acting monoclonal antibody nirsevimab and respiratory syncytial virus (RSV) vaccines became available for prevention of severe RSV-associated disease in 2023. While clinical trials showed good efficacy and safety, their restrictive inclusion criteria, small sample sizes and short follow-up limit generalisability. We aimed to summarise real-world evidence on the effectiveness and safety of nirsevimab, RSV maternal vaccine and RSV vaccines for older adults. Methods A living systematic review and meta-analysis, with 5 monthly updated searches in three databases was performed. Eligible studies were published from 1 December 2022 to 10 March 2025. Meta-analyses for the effectiveness of nirsevimab and RSV vaccines were carried out using random-effects model. Safety data were summarised narratively. Results A total of 50 publications, covering approximately 7.6 million people, were included. Nirsevimab showed 80.7% effectiveness (95% CI: 75.7% to 85.7%; seven studies) against RSV-related emergency department visits, 80.7% (95% CI: 76.1% to 85.2%; 17 studies) against hospital admissions and 75.6% (95% CI: 63.3% to 87.9%; eight studies) against intensive care unit admissions. The effectiveness of RSV vaccines for older adults against RSV-related hospital admissions was 79.6% (95% CI: 73.8% to 85.3; three studies). No effectiveness data were available for RSV maternal vaccine. No severe adverse events were reported for nirsevimab, while RSV vaccines in older adults had fewer than 10 Guillain-Barré syndrome cases per million doses. No severe adverse events were reported for RSV maternal vaccine, although evidence was limited. Conclusions Our review demonstrated high effectiveness of nirsevimab in reducing RSV-related healthcare utilisation in infants and a favourable safety profile. More evidence is needed for evaluating RSV vaccines in pregnant people and older adults. PROSPERO registration number CRD42025643585. Data are available upon reasonable request.

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来源期刊

Thorax 医学-呼吸系统

CiteScore

16.10

自引率

2.00%

发文量

197

审稿时长

1 months

期刊介绍： Thorax stands as one of the premier respiratory medicine journals globally, featuring clinical and experimental research articles spanning respiratory medicine, pediatrics, immunology, pharmacology, pathology, and surgery. The journal's mission is to publish noteworthy advancements in scientific understanding that are poised to influence clinical practice significantly. This encompasses articles delving into basic and translational mechanisms applicable to clinical material, covering areas such as cell and molecular biology, genetics, epidemiology, and immunology.