Pregnancy outcome after first trimester exposure to domperidone-An observational cohort study.
Pregnancy outcome after first trimester exposure to domperidone-An observational cohort study.
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DOI：
10.1111/jog.14709
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发表时间：
2021-05
期刊：
影响因子：
--
通讯作者：
Hayashi M
中科院分区：
文献类型：
--
作者：
Hishinuma K;Yamane R;Yokoo I;Arimoto T;Takahashi K;Goto M;Saito Y;Nakajima K;Murashima A;Hayashi M
通过比较多潘立酮与对照组的主要畸形发生率，评估多潘立酮的致畸风险。在1988年4月至2017年12月期间，在两家日本机构提供怀孕期间药物使用咨询的妇女的妊娠结局数据。计算妊娠前三个月服用多潘立酮（n = 519）、非致畸药物（对照，n = 1673）或甲氧氯普胺（参考，n = 241）的妇女所生婴儿的严重畸形发生率。以对照组为参照，采用单变量logistic回归分析计算多潘立酮组和甲氧氯普胺组重大畸形发生率的粗比值比（OR）。调整后的OR也使用多变量逻辑回归分析计算，调整了各种其他因素。多潘立酮组严重畸形发生率为2.9%(14/485,95%可信区间[CI]: 1.6 ~ 4.8)，对照组为1.7% (27/1554,95%CI: 1.1 ~ 2.5)，甲氧氯普胺组为3.6% （8/224,95%CI: 1.6 ~ 6.9）。经校正的多变量logistic回归分析显示，对照组与多潘立酮组（校正OR: 1.86 [95%CI: 0.73-4.70], p = 0.191）、对照组与甲氧氯普胺组（校正OR: 2.20 [95%CI: 0.69-6.98], p = 0.183）的发生率无显著差异。这项观察性队列研究表明，妊娠前三个月多潘立酮暴露与婴儿主要畸形的风险增加无关。这些结果可能有助于减轻怀孕期间服用多潘立酮的患者的焦虑。
To assess the teratogenic risk of domperidone by comparing the incidence of major malformation with domperidone to a control. Pregnancy outcome data were obtained for women at two Japanese facilities that provide counseling on drug use during pregnancy between April 1988 and December 2017. The incidence of major malformation was calculated among infants born to women taking domperidone (n = 519), nonteratogenic drugs (control, n = 1673), or metoclopramide (reference, n = 241) during the first trimester of pregnancy. Using the control group as reference, the crude odds ratio (OR) of the incidence of major malformation in the domperidone and metoclopramide groups was calculated using univariable logistic regression analysis. Adjusted OR was also calculated using multivariable logistic regression analysis adjusted for various other factors. The incidence of major malformation was 2.9% (14/485, 95% confidence interval [CI]: 1.6–4.8) in the domperidone group, 1.7% (27/1554, 95%CI: 1.1–2.5) in the control group, and 3.6% (8/224, 95%CI: 1.6–6.9) in the metoclopramide group. The adjusted multivariable logistic regression analysis showed no significant difference in incidence between the control and domperidone groups (adjusted OR: 1.86 [95%CI: 0.73–4.70], p = 0.191) or between the control and metoclopramide groups (adjusted OR: 2.20 [95%CI: 0.69–6.98], p = 0.183). This observational cohort study showed that domperidone exposure during the first trimester was not associated with increased risk of major malformation in infants. These results may help alleviate the anxiety of patients who took domperidone during pregnancy.
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