Abstract：
The present study was aimed at investigating the effects of anti-seizure medications (ASMs), patient demographic characteristics, and the seizure type and frequency on the development of congenital malformations (CMs) in the infants of pregnant women with epilepsy (PWWE).
PWWE followed up at the neurology outpatient clinic of 21 centers between 2014 and 2019 were included in this prospective study. The follow-up of PWWE was conducted using structured, general pregnant follow-up forms prepared by the Pregnancy and Epilepsy Study Committee. The newborns were examined by a neonatologist after delivery and at 1 and 3 months postpartum.
Of the infants of 759 PWWE, 7.2% had CMs, with 5.6% having major CMs. Polytherapy, monotherapy, and no medications were received by 168 (22.1%), 548 (72.2 %), and 43 (5.7 %) patients, respectively. CMs were detected at an incidence of 2.3% in infants of PWWE who did not receive medication, 5.7% in infants of PWWE who received monotherapy, and 13.7% in infants of PWWE who received polytherapy. The risk of malformation was 2.31-fold (95% confidence interval (CI): 1.48-4.61, p < .001) higher in infants of PWWE who received polytherapy. Levetiracetam was the most frequently used seizure medication as monotherapy, with the highest incidence of CMs occurring with valproic acid (VPA) use (8.5%) and the lowest with lamotrigine use (2.1%). The incidence of CMs was 5% at a carbamazepine dose <700 mg, 10% at a carbamazepine dose ≥700 mg, 5.5% at a VPA dose <750 mg, and 14.8% at a VPA dose ≥750 mg. Thus the risk of malformation increased 2.33 times (p = .041) in infants of PWWE receiving high-dose ASMs.
Birth outcomes of PWWE receiving and not receiving ASMs were evaluated. The risk of CMs occurrence was higher, particularly in infants of PWWE using VPA and receiving polytherapy. The incidence of CMs was found to be lower in infants of PWWE receiving lamotrigine.
PWWE followed up at the neurology outpatient clinic of 21 centers between 2014 and 2019 were included in this prospective study. The follow-up of PWWE was conducted using structured, general pregnant follow-up forms prepared by the Pregnancy and Epilepsy Study Committee. The newborns were examined by a neonatologist after delivery and at 1 and 3 months postpartum.
Of the infants of 759 PWWE, 7.2% had CMs, with 5.6% having major CMs. Polytherapy, monotherapy, and no medications were received by 168 (22.1%), 548 (72.2 %), and 43 (5.7 %) patients, respectively. CMs were detected at an incidence of 2.3% in infants of PWWE who did not receive medication, 5.7% in infants of PWWE who received monotherapy, and 13.7% in infants of PWWE who received polytherapy. The risk of malformation was 2.31-fold (95% confidence interval (CI): 1.48-4.61, p < .001) higher in infants of PWWE who received polytherapy. Levetiracetam was the most frequently used seizure medication as monotherapy, with the highest incidence of CMs occurring with valproic acid (VPA) use (8.5%) and the lowest with lamotrigine use (2.1%). The incidence of CMs was 5% at a carbamazepine dose <700 mg, 10% at a carbamazepine dose ≥700 mg, 5.5% at a VPA dose <750 mg, and 14.8% at a VPA dose ≥750 mg. Thus the risk of malformation increased 2.33 times (p = .041) in infants of PWWE receiving high-dose ASMs.
Birth outcomes of PWWE receiving and not receiving ASMs were evaluated. The risk of CMs occurrence was higher, particularly in infants of PWWE using VPA and receiving polytherapy. The incidence of CMs was found to be lower in infants of PWWE receiving lamotrigine.
摘要：
目的：本研究旨在调查抗癫痫药物（ASM）的作用，患者人口统计学特征，以及癫痫孕妇（PWWE）婴儿先天性畸形（CM）的发作类型和频率。
方法：这项前瞻性研究包括2014年至2019年在21个中心的神经科门诊进行的PWWE随访。PWWE的随访是使用结构化的，妊娠和癫痫研究委员会准备的一般妊娠随访表。新生儿在1岁时由新生儿学家检查。and3.产后几个月。
结果：在759PWWE的婴儿中，7.2%有CM，5.6%的人有主要的CMs。多元疗法，单一疗法,145人(19.1%)没有接受药物治疗，517（68.1%），42名患者,分别。在未接受药物治疗的婴儿中，CMs的发生率为2.3％，接受单一疗法的婴儿中占5.7％，接受综合疗法的婴儿为13.7%。接受综合疗法的PWWE婴儿的畸形风险高2.31倍（95％置信区间：1.48-4.61，p<0.001）。左乙拉西坦是最常用的癫痫药物作为单一疗法，使用丙戊酸（VPA）时CM的发生率最高（8.5％），使用拉莫三嗪时最低（2.1％）。卡马西平剂量<700mg时，CM的发生率为5％，卡马西平剂量≥700mg时的10％，VPA剂量<750mg时5.5%，VPA剂量≥750mg时，为14.8%。因此，在接受大剂量ASM的婴儿中，畸形风险增加了2.33倍（p=0.041）。
结论：评估了接受和未接受ASM的PWWE的出生结局。CMs发生的风险较高，特别是在使用VPA和接受综合疗法的PWWE婴儿中。发现接受拉莫三嗪的PWWE婴儿的CM发生率较低。
方法：这项前瞻性研究包括2014年至2019年在21个中心的神经科门诊进行的PWWE随访。PWWE的随访是使用结构化的，妊娠和癫痫研究委员会准备的一般妊娠随访表。新生儿在1岁时由新生儿学家检查。and3.产后几个月。
结果：在759PWWE的婴儿中，7.2%有CM，5.6%的人有主要的CMs。多元疗法，单一疗法,145人(19.1%)没有接受药物治疗，517（68.1%），42名患者,分别。在未接受药物治疗的婴儿中，CMs的发生率为2.3％，接受单一疗法的婴儿中占5.7％，接受综合疗法的婴儿为13.7%。接受综合疗法的PWWE婴儿的畸形风险高2.31倍（95％置信区间：1.48-4.61，p<0.001）。左乙拉西坦是最常用的癫痫药物作为单一疗法，使用丙戊酸（VPA）时CM的发生率最高（8.5％），使用拉莫三嗪时最低（2.1％）。卡马西平剂量<700mg时，CM的发生率为5％，卡马西平剂量≥700mg时的10％，VPA剂量<750mg时5.5%，VPA剂量≥750mg时，为14.8%。因此，在接受大剂量ASM的婴儿中，畸形风险增加了2.33倍（p=0.041）。
结论：评估了接受和未接受ASM的PWWE的出生结局。CMs发生的风险较高，特别是在使用VPA和接受综合疗法的PWWE婴儿中。发现接受拉莫三嗪的PWWE婴儿的CM发生率较低。
