Malformation risks of antiepileptic drug monotherapies in pregnancy: updated results from the UK and Ireland Epilepsy and Pregnancy Registers
Malformation risks of antiepileptic drug monotherapies in pregnancy: updated results from the UK and Ireland Epilepsy and Pregnancy Registers
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DOI：
10.1136/jnnp-2013-306318
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发表时间：
2014-09-01
影响因子：
11
通讯作者：
Morrow, J.
中科院分区：
文献类型：
--
作者：
Campbell, E.;Kennedy, F.;Morrow, J.
目的：妊娠期抗癫痫药物（AED）暴露可增加重大先天性畸形（MCMs）的风险。这种风险的大小因AED暴露而异。在这里，我们提供了最新的结果，从英国癫痫和妊娠登记单药治疗暴露于丙戊酸盐，卡马西平和lamotrigine.Methods 15年的前瞻性观察性研究1996年至2012年后MCMs的风险。主要的结局指标是MCM率。结果5206例病例获得了信息性结局。1290例女性暴露于丙戊酸盐单药治疗，1718例暴露于卡马西平单药治疗，2198例暴露于拉莫三嗪单药治疗。丙戊酸盐单药治疗宫内暴露的MCM风险为6.7%（95% CI 5.5%-8.3%），而卡马西平为2.6%（95% CI 1.9%-3.5%），拉莫三嗪为2.3%（95% CI 1.8%-3.1%）。在丙戊酸盐（p = 0.0006）和卡马西平（p = 0.03）暴露妊娠中观察到显著剂量效应。拉莫三嗪组的MCM率随剂量增加呈非显著性升高趋势。高剂量拉莫三嗪（> 400 mg/d）的MCM率低于暴露于以下药物的妊娠的MCM率：
Objectives Antiepileptic drug (AED) exposure during pregnancy increases the risk of major congenital malformations (MCMs). The magnitude of this risk varies by AED exposure. Here we provide updated results from the UK Epilepsy and Pregnancy Register of the risk of MCMs after monotherapy exposure to valproate, carbamazepine and lamotrigine.Methods Fifteen-year prospective observational study from 1996 until 2012. The main outcome measure is the MCM rate.Results Informative outcomes were available for 5206 cases. 1290 women were exposed to valproate monotherapy, 1718 to carbamazepine monotherapy and 2198 to lamotrigine monotherapy. The MCM risk with valproate monotherapy exposure in utero was 6.7% (95% CI 5.5% to 8.3%) compared with 2.6% with carbamazepine (95% CI 1.9% to 3.5%) and 2.3% with lamotrigine (95% CI 1.8% to 3.1%). A significant dose effect was seen with valproate (p=0.0006) and carbamazepine (p=0.03) exposed pregnancies. A nonsignificant trend towards higher MCM rate with increasing dose was found with lamotrigine. MCM rate for high-dose lamotrigine (>400 mg daily) was lower than the MCM rate for pregnancies exposed to