Fetal and neonatal outcomes in women taking domperidone during pregnancy
Fetal and neonatal outcomes in women taking domperidone during pregnancy
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DOI：
10.3109/01443615.2012.734871
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发表时间：
2013-02-01
影响因子：
1.3
通讯作者：
Koren, G.
中科院分区：
文献类型：
--
作者：
Choi, J-S.;Han, J-Y.;Koren, G.
多潘立酮在妊娠期的安全性仍然未知。因此，本研究旨在前瞻性评价妊娠期间服用多潘立酮的女性的胎儿结局。在一项前瞻性队列研究设计中，对120名服用多潘立酮控制胃肠道症状的妊娠早期女性和212名年龄匹配的未暴露于任何潜在致畸剂的妊娠女性进行随访，直至分娩。在病例组中，多潘立酮用于控制59.2%的功能性胃肠道疾病，最大剂量为30 mg/天，暴露发生在妊娠2（+4）至20周之间。两个研究组的胎儿结局，包括出生时胎龄、出生体重和身长、出生时头围以及1分钟和5分钟Apgar评分相似。每组中有3名婴儿出生时畸形（OR = 0.6; 95%CI 0.1，2.8）。总之，多潘立酮似乎不是一种主要的人类致畸剂。然而，我们的研究结果需要在更大的研究中进一步证实。
The safety of domperidone in pregnancy remains unknown. Therefore, the study aimed to prospectively evaluate the fetal outcomes of women who were taking domperidone during pregnancy. In a prospective cohort study design, 120 1st-trimester pregnant women who were taking domperidone for controlling gastrointestinal tract symptoms and 212 age-matched pregnant women not exposed to any potential teratogenic agent, were followed-up until delivery. In the case group, domperidone was indicated for control of functional gastrointestinal disorders in 59.2%, the maximum dose was 30 mg/day and exposure occurred between 2(+4) and 20 weeks' gestation. Fetal outcomes including gestational age at birth, birth weight and length, head circumference at birth, and 1- and 5-min Apgar score were similar in the two study groups. There were three babies born with malformations in each group (OR = 0.6; 95% CI 0.1, 2.8). In conclusion, domperidone does not appear to be a major human teratogen. However, our findings require further confirmation in larger studies.