Verrotti Alberto, Mencaroni Elisabetta, Castagnino Miriam, Zaccara Gaetano
a 1 University of Perugia, Department of Pediatrics , S. Andrea delle Fratte, Perugia, Italy , +39 07 55 78 44 15 ;
b 2 Unit of Neurology, Florence Health Authority, Department of Medicine , Florence, Italy.
Expert Opin Drug Saf. 2015 Oct;14(10):1563-71. doi: 10.1517/14740338.2015.1084288. Epub 2015 Sep 2.
Drugs teratogenicity has been studied for many years, especially teratogenic effects of antiepileptic drugs, because of the important impact that epilepsy has always had for young women, but data from literature are often conflicting.
We have carried out a critical review of all human studies about the antiepileptic drugs teratogenicity. A systematic search was performed in Medline and PubMed up to May 1, 2015. The use of older antiepileptic drugs in pregnancy is associated with an increased risk of fetus malformations; in particular, Valproate can determine neural-tube-like defects; in Phenytoin and Phenobarbital-exposed pregnancies, orofacial clefts, cardiac and genitourinary malformations are the major anomalies described. Spina bifida is the only specific major congenital malformation significantly associated with exposure to Carbamazepine monotherapy Despite the small number of studies on the teratogenic effects of new antiepileptic drugs, the analysis of the literature shows that exposure of the fetus to the new antiepileptic drugs is associated with a lower risk of major congenital malformations compared to the use of older drugs.
Where possible, Valproate should be avoided in women of childbearing potential. Results about the safety of newer antiepileptic drugs require validation and further investigation.
药物致畸性已被研究多年,尤其是抗癫痫药物的致畸作用,因为癫痫对年轻女性一直有着重要影响,但文献数据往往相互矛盾。
我们对所有关于抗癫痫药物致畸性的人体研究进行了批判性综述。截至2015年5月1日,在Medline和PubMed上进行了系统检索。孕期使用 older抗癫痫药物会增加胎儿畸形风险;特别是丙戊酸盐可导致神经管样缺陷;在暴露于苯妥英和苯巴比妥的孕期中,口面部裂隙、心脏和泌尿生殖系统畸形是所描述的主要异常。脊柱裂是唯一与卡马西平单药治疗显著相关的特定主要先天性畸形。尽管关于新型抗癫痫药物致畸作用的研究数量较少,但文献分析表明,与使用 older药物相比,胎儿暴露于新型抗癫痫药物会导致主要先天性畸形的风险较低。
在可能的情况下,应避免有生育潜力的女性使用丙戊酸盐。关于新型抗癫痫药物安全性的结果需要验证和进一步研究。