Kuhnz W, Koch S, Jakob S, Hartmann A, Helge H, Nau H
Br J Clin Pharmacol. 1984 Nov;18(5):671-7. doi: 10.1111/j.1365-2125.1984.tb02528.x.
A total of 10 epileptic mothers treated with ethosuximide (ES) as well as their 13 newborns were included in this study. At birth foetal/maternal serum concentration ratios were 0.97 +/- 0.02 (n = 7) and ES half-lives in three neonates were 32, 37 and 38 h. The breast milk concentrations of ES were similar to those in maternal serum (milk/serum: 0.86 +/- 0.08, n = 12) and the nursed infants maintained serum levels between 15 and 40 micrograms/ml. Two major malformations (bilateral clefting, hare-lip) were observed in two neonates whose mothers received either ES/PB or ES/PMD comedication. The number of minor anomalies was higher in the ES group (6.2, n = 12) than in the pair-matched control group of infants born to non-epileptic mothers (2.1, n = 10). Neonatal behaviour complications occurred in seven infants, two of them were severely affected.
本研究纳入了10名接受乙琥胺(ES)治疗的癫痫母亲及其13名新生儿。出生时胎儿/母体血清浓度比为0.97±0.02(n = 7),3名新生儿的ES半衰期分别为32、37和38小时。ES在母乳中的浓度与母体血清中的浓度相似(母乳/血清:0.86±0.08,n = 12),接受母乳喂养的婴儿血清水平维持在15至40微克/毫升之间。在两名母亲接受ES/PB或ES/PMD联合用药的新生儿中观察到两种主要畸形(双侧唇腭裂、唇裂)。ES组(6.2,n = 12)的轻微异常数量高于非癫痫母亲所生婴儿的配对对照组(2.1,n = 10)。7名婴儿出现新生儿行为并发症,其中2名受严重影响。