Prenatal Exposure to Proton Pump Inhibitors and Risk of Serious Infections in Offspring During the First Year of Life: A Nationwide Cohort Study.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2025-03-01 Epub Date: 2024-12-04 DOI:10.1007/s40264-024-01496-4
Mylène Tisseyre, Mathis Collier, Nathanaël Beeker, Florentia Kaguelidou, Jean-Marc Treluyer, Laurent Chouchana
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Abstract

Introduction and objective: Proton pump inhibitor (PPI) use in children increases the risk of infections, prompting inquiry into the impact of prenatal PPIs exposure on serious infections in offspring. As a research gap in this area exists, this study aimed to address it by assessing the association between prenatal PPIs exposure and serious infections in infants during their first year of life.

Methods: Using the French health insurance data warehouse (SNDS) (2013-2018), we conducted a retrospective cohort study on singleton, full-term liveborn non-immunocompromised infants, stratified by PPI use during the first three months of life (early-life use). Proton pump inhibitor dispensing in ambulatory care settings during pregnancy defined exposure. Outcomes concerned any serious infections in offspring aged between 3 and 12 months. Adjusted odds ratios (aORs) were estimated using logistic regression with multivariable models to control for potential confounders.

Results: Of the 2,485,545 infants included, 497,060 (23.3%) were prenatally exposed to PPIs and 97,767 (4.6%) had PPI use during the first three months of life. Prenatal PPI exposure was associated with serious infections in offspring (aOR, 1.09 [95% CI, 1.07-1.10]) in infants without early-life PPIs use. No association was found for infants with early-life PPI use (aOR, 1.05 [95% CI, 1.00-1.11]). Gastrointestinal infections were the sole site with persistent significance.

Conclusion: Prenatal PPI exposure is common and is not associated with a major risk of serious infections in infants during their first year. However, even after adjusting for several confounding factors, a weak association remains, especially in infants without early-life PPI use. While offering reassurance, adherence to clinical guidelines is still crucial.

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产前暴露于质子泵抑制剂和一年内后代严重感染的风险:一项全国性队列研究。
前言和目的:儿童使用质子泵抑制剂(PPI)会增加感染的风险,这促使人们探讨产前暴露于PPI对后代严重感染的影响。由于这一领域存在研究空白,本研究旨在通过评估产前PPIs暴露与婴儿出生后第一年严重感染之间的关系来解决这一问题。方法:使用法国健康保险数据仓库(SNDS)(2013-2018),我们对单胎足月活产非免疫功能低下婴儿进行了一项回顾性队列研究,按生命前三个月(生命早期使用)使用PPI进行分层。质子泵抑制剂分配在门诊护理设置在怀孕期间定义暴露。结果涉及3至12个月大的后代是否有严重感染。校正优势比(aORs)使用多变量模型的逻辑回归进行估计,以控制潜在的混杂因素。结果:在纳入的2,485,545名婴儿中,497,060名(23.3%)在产前暴露于PPI, 97,767名(4.6%)在出生后的前三个月使用过PPI。产前PPI暴露与未使用PPI的婴儿后代严重感染相关(aOR, 1.09 [95% CI, 1.07-1.10])。婴儿与早期使用PPI没有关联(aOR, 1.05 [95% CI, 1.00-1.11])。胃肠道感染是唯一具有持续性意义的部位。结论:产前PPI暴露是常见的,与婴儿第一年严重感染的主要风险无关。然而,即使在调整了几个混杂因素后,相关性仍然很弱,特别是在没有早期使用PPI的婴儿中。在提供保证的同时,遵守临床指南仍然至关重要。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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