Araujo Mélanie, Vabre Clémentine, Benevent Justine, Sommet Agnès, Damase-Michel Christine, Hurault-Delarue Caroline, Lacroix Isabelle
Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France.
Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), CIC 1436, Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d'Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine), 37 allées Jules Guesde, 31000, Toulouse, France.
Drug Saf. 2021 Jul;44(7):787-796. doi: 10.1007/s40264-021-01077-9. Epub 2021 May 10.
Domperidone is widely used during pregnancy, although the risks associated with pregnant women have not been adequately evaluated.
The objective of this study was to compare the rate of pregnancy outcomes and congenital anomalies between pregnant women exposed and unexposed to domperidone during pregnancy.
We conducted a retrospective cohort study comparing pregnant women exposed and unexposed to domperidone during pregnancy. We used the EFEMERIS database containing the prescriptions and dispensing of drugs to pregnant women in Haute-Garonne, who had a pregnancy outcome between July 2004 and December 2017. We compared pregnant women who were exposed to domperidone at least once during pregnancy to unexposed pregnant women. Logistic regression and Cox proportional risk models were applied.
Overall, 13,964 pregnancies (10.3% of pregnancies) were given domperidone. A reduction in the number of pregnant women exposed to domperidone (2004: 17.1% to 2017: 1.2%) was noted. More than 75% of pregnancies were exposed to domperidone in the first trimester of pregnancy. The rate of natural pregnancy termination in pregnant women exposed to domperidone was lower than that in unexposed pregnant women (adjusted hazard ratio = 0.78 [0.71-0.87]). The malformation rate in fetuses/newborns exposed in utero (first trimester) to domperidone is comparable to that of unexposed fetuses/newborns (adjusted odd ratio = 0.89 [0.77-1.03]).
This is the first comparative study to enrol a large number of pregnant women exposed to domperidone. Data regarding the malformation rate following exposure to domperidone during the first trimester of pregnancy are reassuring. Women exposed to domperidone during pregnancy have a decreased risk for natural pregnancy termination, probably owing to an indication bias.
多潘立酮在孕期被广泛使用，尽管其与孕妇相关的风险尚未得到充分评估。
本研究的目的是比较孕期接触和未接触多潘立酮的孕妇的妊娠结局和先天性异常发生率。
我们进行了一项回顾性队列研究，比较孕期接触和未接触多潘立酮的孕妇。我们使用了EFEMERIS数据库，该数据库包含上加龙省向孕妇开具和配发药物的记录，这些孕妇在2004年7月至2017年12月期间有妊娠结局。我们将孕期至少接触一次多潘立酮的孕妇与未接触的孕妇进行比较。应用逻辑回归和Cox比例风险模型。
总体而言，13964例妊娠（占妊娠总数的10.3%）使用了多潘立酮。注意到孕期接触多潘立酮的孕妇数量有所减少（2004年：17.1%至2017年：1.2%）。超过75%的妊娠在孕早期接触了多潘立酮。接触多潘立酮的孕妇自然流产率低于未接触的孕妇（调整后风险比=0.78[0.71-0.87]）。子宫内（孕早期）接触多潘立酮的胎儿/新生儿的畸形率与未接触的胎儿/新生儿相当（调整后比值比=0.89[0.77-1.03]）。
这是第一项纳入大量接触多潘立酮孕妇的比较研究。关于孕早期接触多潘立酮后畸形率的数据令人放心。孕期接触多潘立酮的女性自然流产风险降低，可能是由于指征偏倚。
