Faculty of Health and Life Science, Swansea University, Swansea, Wales, United Kingdom.
Quantitative Safety & Epidemiology, Novartis Pharmaceuticals, East Hanover, NJ, United States of America.
PLoS One. 2023 Apr 26;18(4):e0284128. doi: 10.1371/journal.pone.0284128. eCollection 2023.
Information on the impact of medicines on breastfeeding and the breastfed infant remains scarce. The aims of this review were to identify databases and cohorts holding this information, and pinpoint current information and research deficits.
We searched 12 electronic databases, including PubMed/ Medline and Scopus, using a combination of controlled vocabulary (MeSH terms) and free text terms. We included studies reporting data from databases with information on breastfeeding, medicines exposure, and infant outcomes. We excluded studies not reporting all three parameters. Two reviewers independently selected papers and extracted data using a standardised spreadsheet. Risk of bias was assessed. Recruited cohorts with relevant information were tabulated separately. Discrepancies were resolved by discussion.
From 752 unique records, 69 studies were identified for full review. Eleven papers reported analyses from ten established databases with information on maternal prescription or non-prescription drugs, breastfeeding and infant outcomes. Twenty-four cohort studies were also identified. No studies reported educational or long-term developmental outcomes. The data are too sparse to warrant any firm conclusions, beyond the need for more data. The overall picture hints at 1) unquantifiable, but probably rare, serious harms to infants exposed to medicines via breastmilk, 2) unknown long-term harms, and 3) a more insidious but more pervasive harm in terms of reduced breastfeeding rates following medicines exposure in late pregnancy and peri-partum.
Analyses of databases reporting on the full population are needed to quantify any adverse effects of medicines and identify dyads at risk of harm from prescribed medicines while breastfeeding. This information is essential to ensure 1) infants are monitored appropriately for any adverse drug reactions 2) inform breastfeeding patients using long-term medicines as to whether the benefits of breastfeeding outweigh exposure to medicines via breastmilk and 3) target additional support to breastfeeding patients whose medicines may affect breastfeeding. The protocol is registered with the Registry of Systematic Reviews, no.994.
关于药物对母乳喂养和母乳喂养婴儿影响的信息仍然很少。本研究的目的是确定包含这些信息的数据库和队列,并指出当前信息和研究的不足。
我们使用受控词汇(MeSH 术语)和自由文本术语组合,搜索了 12 个电子数据库,包括 PubMed/Medline 和 Scopus。我们纳入了报告数据库中有关母乳喂养、药物暴露和婴儿结局信息的研究。我们排除了未报告所有三个参数的研究。两名审查员独立选择论文,并使用标准化电子表格提取数据。评估了偏倚风险。分别列出了具有相关信息的招募队列。通过讨论解决了差异。
从 752 条独特的记录中,确定了 69 项进行全面审查的研究。有 11 篇论文报告了来自十个具有母亲处方或非处方药物、母乳喂养和婴儿结局信息的已建立数据库的分析结果。还确定了 24 项队列研究。没有研究报告教育或长期发育结局。数据过于稀疏,无法得出任何确凿的结论,除了需要更多的数据。整体情况暗示:1)通过母乳暴露于药物的婴儿受到无法量化但可能罕见的严重伤害;2)未知的长期伤害;3)在妊娠晚期和围产期暴露于药物后母乳喂养率降低,这是一种更隐蔽但更普遍的伤害。
需要对报告全人群的数据库进行分析,以量化药物的任何不良影响,并确定母乳喂养期间暴露于药物的婴儿和母亲处于风险中的对子。这些信息对于确保:1)婴儿受到适当监测,以发现任何药物不良反应;2)告知正在使用长期药物的母乳喂养患者,母乳喂养对他们的益处是否超过通过母乳暴露于药物的风险;3)针对可能影响母乳喂养的药物的母乳喂养患者提供额外支持,这是必不可少的。该方案已在系统评价注册库中注册,编号为 994。