van der Meer Douwe H, Wieringa Andre, Wegner Ilse, Wilffert Bob, Ter Horst Peter G J
Department of Clinical Pharmacy, Isala Medical Centre, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
Br J Clin Pharmacol. 2015 Apr;79(4):558-65. doi: 10.1111/bcp.12524.
The aim of this review was to investigate the quality of the current literature on the transfer of anticonvulsants to breast milk to provide an overview of which anticonvulsants are in need of further research.
We reviewed the quality of the available lactation studies for 19 anticonvulsants against the guidelines of the Food and Drug Administration (FDA) and the International Lactation Consultant Association (ILCA).
Except for one study on lamotrigine and one case report on gabapentin, no study on anticonvulsants had both the absolute infant dose (AID) and milk to plasma ratio (M : P) correctly assessed. Only one study on carbamazepine, phenytoin and vigabatrin was found that correctly assessed the AID. The main cause for this low number is the lack of essential details in published studies, since 25 of 62 studies were case reports, letters or abstracts. Other major shortcomings were the lack of information on sampling methods, the number of samples in a particular dose interval as well as the low number of study participants.
The quality of the current literature on the transfer of anticonvulsants to breast milk is low, except for lamotrigine, which makes it hard to draw conclusions about the safety of the use of anticonvulsants during the lactation period. Therefore, further research is needed.
本综述旨在调查当前关于抗惊厥药物向母乳中转移的文献质量，以概述哪些抗惊厥药物需要进一步研究。
我们对照美国食品药品监督管理局（FDA）和国际泌乳顾问协会（ILCA）的指南，审查了19种抗惊厥药物现有泌乳研究的质量。
除了一项关于拉莫三嗪的研究和一项关于加巴喷丁的病例报告外，没有关于抗惊厥药物的研究同时正确评估了绝对婴儿剂量（AID）和母乳与血浆比值（M∶P）。仅发现一项关于卡马西平、苯妥英和氨己烯酸的研究正确评估了AID。数量如此之少的主要原因是已发表研究中缺乏关键细节，因为62项研究中有25项是病例报告、信函或摘要。其他主要缺点包括缺乏关于采样方法的信息、特定剂量间隔内的样本数量以及研究参与者数量较少。
除拉莫三嗪外，当前关于抗惊厥药物向母乳中转移的文献质量较低，这使得难以就哺乳期使用抗惊厥药物的安全性得出结论。因此，需要进一步研究。
