Division of Neonatology, Department of Paediatrics, University Hospital A. Gemelli, Catholic University of Sacred Heart, Largo Agostino Gemelli no. 8, Rome 00168, Italy.
Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):53-6. doi: 10.1016/j.ejogrb.2011.06.035. Epub 2011 Jul 12.
Phenobarbital crosses the placenta quickly, and the balance between maternal and fetal blood is achieved in a few minutes. Data on the clinical outcomes of infants born to mothers under phenobarbital treatment during pregnancy show that they are at risk of adverse events, such as sedation and abstinence syndrome. The aim of this study was to analyse the correlation between serum levels of phenobarbital and clinical features of neonates.
Twenty-three infants born between 2001 and 2008 were studied. Maternal, neonatal and pharmacological variables were considered.
Eleven infants displayed symptoms related to phenobarbital. Withdrawal syndrome was seen in seven infants and sedation syndrome was seen in four infants. One infant had severe cardiorespiratory depression at birth. None of the infants had severe neonatal abstinence syndrome. No statistically significant differences were found between symptomatic and asymptomatic infants. At birth, the mean serum level of phenobarbital of the 23 infants was 15.4 [standard deviation (SD) 6.2] μg/ml. A peak (16.1 μg/ml, SD 5.5) was seen on Day 3, followed by a gradual decrease to non-therapeutic levels (<10 μg/ml) by Day 8 (9.3 μg/ml, SD 1.0). Phenobarbital levels were higher in symptomatic infants than asymptomatic infants, although the difference was not statistically significant.
Serum levels of phenobarbital remained in the therapeutic range for both mothers and infants, and reduced gradually in infants. However, some infants displayed symptoms related to phenobarbital. As such, a clinical pharmacological surveillance protocol is necessary.
苯巴比妥迅速通过胎盘，母体和胎儿血液之间的平衡在数分钟内达到。在怀孕期间接受苯巴比妥治疗的母亲所生婴儿的临床结局数据表明，他们存在镇静和戒断综合征等不良事件的风险。本研究旨在分析苯巴比妥血清水平与新生儿临床特征之间的相关性。
研究了 2001 年至 2008 年间出生的 23 名婴儿。考虑了母亲、新生儿和药理学变量。
11 名婴儿出现与苯巴比妥相关的症状。7 名婴儿出现戒断综合征，4 名婴儿出现镇静综合征。1 名婴儿出生时出现严重心肺抑制。没有婴儿出现严重新生儿戒断综合征。有症状和无症状婴儿之间无统计学差异。出生时，23 名婴儿的苯巴比妥平均血清水平为 15.4μg/ml（标准差 6.2μg/ml）。第 3 天出现峰值（16.1μg/ml，标准差 5.5μg/ml），随后逐渐降至非治疗水平（<10μg/ml），第 8 天（9.3μg/ml，标准差 1.0μg/ml）。尽管差异无统计学意义，但有症状婴儿的苯巴比妥水平高于无症状婴儿。
母亲和婴儿的苯巴比妥血清水平均保持在治疗范围内，并逐渐在婴儿体内降低。然而，一些婴儿出现了与苯巴比妥相关的症状。因此，需要制定临床药理学监测方案。
