Hishinuma Kayoko, Yamane Ritsuko, Yokoo Ikuko, Arimoto Takahide, Takahashi Kunihiko, Goto Mikako, Saito Yoshiyuki, Nakajima Ken, Murashima Atsuko, Hayashi Masahiro
Department of Pharmacy, Toranomon Hospital, Minato-ku, Tokyo, Japan.
Department of Obstetrics and Gynecology, Toranomon Hospital, Minato-ku, Tokyo, Japan.
J Obstet Gynaecol Res. 2021 May;47(5):1704-1710. doi: 10.1111/jog.14709. Epub 2021 Feb 25.
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.
通过比较服用多潘立酮的孕妇与对照组中严重畸形的发生率，评估多潘立酮的致畸风险。
获取了1988年4月至2017年12月间在日本两家为孕期用药提供咨询的机构中孕妇的妊娠结局数据。计算了在妊娠早期服用多潘立酮（n = 519）、非致畸药物（对照组，n = 1673）或甲氧氯普胺（参照组，n = 241）的孕妇所分娩婴儿中严重畸形的发生率。以对照组为参照，采用单变量逻辑回归分析计算多潘立酮组和甲氧氯普胺组中严重畸形发生率的粗比值比（OR）。还采用针对各种其他因素进行调整的多变量逻辑回归分析计算调整后的OR。
多潘立酮组中严重畸形的发生率为2.9%（14/485，95%置信区间[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）。调整后的多变量逻辑回归分析显示，对照组与多潘立酮组之间的发生率无显著差异（调整后OR：1.86 [95%CI：0.73 - 4.70]，p = 0.191），对照组与甲氧氯普胺组之间也无显著差异（调整后OR：2.20 [95%CI：0.69 - 6.98]，p = 0.183）。
这项观察性队列研究表明，妊娠早期暴露于多潘立酮与婴儿严重畸形风险增加无关。这些结果可能有助于减轻孕期服用多潘立酮的患者的焦虑。
