Benevent Justine, Araujo Mélanie, Hurault-Delarue Caroline, Montastruc Jean-Louis, Sommet Agnès, Lacroix Isabelle, Damase-Michel Christine
Laboratoire de pharmacologie médicale et clinique, faculté de médecine de Toulouse, 31000 Toulouse, France; Service de pharmacologie médicale et clinique, centre Midi-Pyrénées de pharmacovigilance, pharmacoépidémiologie et d'informations sur le médicament, pharmacopôle, centre hospitalier universitaire de Toulouse, 31000 Toulouse, France; Inserm UMR 1027, faculté de médecine de Toulouse, 31000 Toulouse, France.
Service de pharmacologie médicale et clinique, centre Midi-Pyrénées de pharmacovigilance, pharmacoépidémiologie et d'informations sur le médicament, pharmacopôle, centre hospitalier universitaire de Toulouse, 31000 Toulouse, France.
Therapie. 2019 Apr;74(2):289-300. doi: 10.1016/j.therap.2018.11.014. Epub 2019 Jan 31.
Taking a medication is usually a challenge for a pregnant woman as the beneficial drug effect on the mother has to be considered regarding its potential adverse effects, not only for her but also for her unborn child. As medication use is common in pregnant women, by chance or necessity, it gives the opportunity to evaluate the consequences of prenatal drug exposure in real life through pharmacoepidemiological studies. This paper provides an overview of data sources, study designs and data analysis methods that can be used for pregnancy medication safety studies. In the future, the implementation of responsive international networks may be the keystones of drug evaluation in pregnancy.
对于孕妇来说,服用药物通常是一项挑战,因为在考虑药物对母亲的有益作用时,必须兼顾其潜在的不良反应,这不仅关乎母亲本人,还涉及到她未出生的孩子。由于孕妇用药无论是出于偶然还是必要都很常见,这就为通过药物流行病学研究评估现实生活中产前药物暴露的后果提供了契机。本文概述了可用于妊娠用药安全性研究的数据源、研究设计和数据分析方法。未来,建立反应迅速的国际网络可能是孕期药物评估的关键所在。