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在停止使用帕利珠单抗后,极早产儿出生后第一年呼吸道合胞病毒相关住院和门诊就诊次数增加。

Increased Respiratory Syncytial Virus-Associated Hospitalizations and Ambulatory Visits in Very Preterm Infants in the First Year of Life following Discontinuation of Access to Palivizumab.

作者信息

Evong Yolanda, Luo Jiaxin, Ye Lingyun, Fahey John, Breeze Janis L, Attenborough Rebecca, Wong Kenny, Langley Joanne M

机构信息

Department of Pediatrics, Dalhousie University Faculty of Medicine, Izaak Walton Killam Health Centre, Halifax, Nova Scotia, Canada.

Canadian Center for Vaccinology (Dalhousie University, IWK Health and Nova Scotia Health), Halifax, Nova Scotia, Halifax, Nova Scotia, Canada.

出版信息

Am J Perinatol. 2025 Jan 31. doi: 10.1055/a-2512-9453.

Abstract

From 2002 to 2023, palivizumab was the only intervention to reduce respiratory syncytial virus (RSV)-associated hospitalizations in high-risk infants in Canada but advances in RSV prevention are drastically changing this landscape. Eligibility criteria for this monoclonal antibody for preterm infants varied over time across each of 10 Canadian provinces and 3 territories. The National Professional Pediatric Association (Canadian Pediatric Society) revised its eligibility recommendations in 2015, removing access for preterm infants 30 to 32 weeks gestation (WG). The province of Nova Scotia followed these recommendations the next season. This study aimed to determine if the removal of access to palivizumab in these previously eligible infants was associated with a change in hospital admissions, deaths, or ambulatory visits associated with RSV.We identified a retrospective cohort of Nova Scotia infants born between 30 and 32 WG, without other risk factors for RSV-H, from April 2012 to September 2019 by linking six population-based provincial databases, and followed each infant through the first year of life. Episodes of RSV-associated hospitalization (RSV-H), ambulatory visits (RSV-A), or death were identified by the International Statistical Classification of Diseases and Related Health Disorders (ICD) RSV-associated diagnostic codes.Of 4,835 infants born during the study period, 250 were 30 to 32 WG and eligible for the cohort. RSV-H increased approximately 10-fold following restricted access to palivizumab (from no RSV-H (0/123) to 9.4%; 95% CI 5.0, 15.9; risk difference 9.4), but no RSV-associated deaths occurred. RSV-A also increased from 5.7 to 17.3% (risk difference 11.6).Discontinuation of access to a prophylactic anti-RSV monoclonal antibody in very preterm infants was associated with a higher risk of RSV-H and RSV-A. Evaluation of health care policy change on patient well-being is essential to assess the impact and guide future decision-making at the population level. · Discontinuation of access to a prophylactic anti-RSV monoclonal antibody in very preterm infants 30 to 32 WG was associated with a higher risk of RSV-H and RSV-A. Evaluation of changes to health care policy on patient well-being is essential to assess impact and guide future decision-making at the population level.. · Removing access to palivizumab led to higher RSV admissions in 30 to 32 WG infants.. · The effect of health care policy changes on child well-being should be assessed routinely.. · No deaths associated with RSV were identified prior to or after the policy change..

摘要

从2002年到2023年,帕利珠单抗是加拿大降低高危婴儿呼吸道合胞病毒(RSV)相关住院率的唯一干预措施,但RSV预防方面的进展正在彻底改变这一局面。在加拿大10个省和3个地区中,这种针对早产儿的单克隆抗体的资格标准随时间有所不同。国家专业儿科协会(加拿大儿科学会)在2015年修订了其资格建议,不再将孕30至32周(WG)的早产儿纳入适用范围。新斯科舍省在下个季节遵循了这些建议。本研究旨在确定在这些先前符合条件的婴儿中停用帕利珠单抗是否与RSV相关的住院、死亡或门诊就诊的变化有关。我们通过链接六个基于人群的省级数据库,确定了2012年4月至2019年9月在新斯科舍省出生的30至32周WG且无其他RSV-H风险因素的婴儿的回顾性队列,并对每个婴儿进行了一岁以内的随访。通过国际疾病和相关健康问题统计分类(ICD)RSV相关诊断代码确定RSV相关住院(RSV-H)、门诊就诊(RSV-A)或死亡事件。在研究期间出生的4835名婴儿中,250名是30至32周WG且符合队列条件。在限制使用帕利珠单抗后,RSV-H增加了约10倍(从无RSV-H(0/123)增至9.4%;95%置信区间5.0,15.9;风险差异9.4),但未发生RSV相关死亡。RSV-A也从5.7%增至17.3%(风险差异11.6)。停用针对极早产儿的预防性抗RSV单克隆抗体与RSV-H和RSV-A的较高风险相关。评估医疗保健政策变化对患者福祉的影响对于评估其影响并指导人群层面的未来决策至关重要。· 停用针对孕30至32周极早产儿的预防性抗RSV单克隆抗体与RSV-H和RSV-A的较高风险相关。评估医疗保健政策变化对患者福祉的影响对于评估其影响并指导人群层面的未来决策至关重要。· 停用帕利珠单抗导致30至32周WG婴儿的RSV住院率升高。· 应定期评估医疗保健政策变化对儿童福祉的影响。· 在政策变化之前或之后均未发现与RSV相关的死亡。

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