Frey O R, von Brenndorff A I, Probst W
Department of Pharmacy, Hospital of Heidenheim, Germany.
Ann Pharmacother. 1998 Mar;32(3):300-3. doi: 10.1345/aph.17120.
To compare the serum concentrations attained following intravenous and oral administration of phenytoin in premature neonates.
A prospective, uncontrolled study was conducted over 6 years. Phenhydan concentrate for infusion (Desitin, Hamburg, Germany) was used for intravenous infusion, and Epanutin suspension (Parke-Davis, Freiburg, Germany) was used for oral therapy. Blood samples were analyzed by using a fluorescence polarization immunoassay analyzer TDx model by Abbott Laboratories.
A university-affiliated district hospital.
Twenty premature neonates who were administered intravenous and/or oral phenytoin between February 1991 and February 1997.
Serum phenytoin concentrations on intravenous and oral phenytoin.
Nine patients received intravenous (group A) and 15 patients received oral (group B) therapy. Mean +/- SD postnatal age (41 +/- 8.7 vs. 48 +/- 17 d; p = 0.03) and actual body weight (1.56 +/- 0.38 vs. 1.88 +/- 0.75 kg; p = 0.02) were slightly higher in group B. There were no significant differences between the groups in mean +/- SD gestational age (26.1 +/- 1.37 vs. 26.9 +/- 3.30 wk), 5-minute Apgar score (8.7 +/- 1.11 vs. 7.7 +/- 2.26), daily dosage (8.1 +/- 3.86 vs. 8.1 +/- 4.21 mg/kg/d), and phenytoin serum concentration (8.7 +/- 7.36 vs. 9.6 +/- 5.83 micrograms/mL).
Contrary to data in the current literature, reliable serum concentrations in premature neonates were achieved by oral administration of phenytoin suspension. Oral therapy offers a number of advantages and considerably reduces the cost of therapy. Due to substantial variations in phenytoin pharmacokinetics in neonates, close monitoring of serum concentrations is required. Further investigation is required to confirm these results, especially in neonates younger than 20 days' postnatal age and those receiving products other than Epanutin.
比较苯妥英钠静脉注射和口服给药后在早产儿体内达到的血清浓度。
一项前瞻性非对照研究持续了6年。使用用于静脉输注的苯妥英钠浓缩液（德国汉堡德西丁公司），口服治疗则使用乙苯妥英混悬液（德国弗莱堡帕克-戴维斯公司）。血样通过雅培实验室的荧光偏振免疫分析TDx型分析仪进行分析。
一家大学附属医院。
1991年2月至1997年2月间接受静脉注射和/或口服苯妥英钠的20名早产儿。
静脉注射和口服苯妥英钠后的血清苯妥英浓度。
9名患者接受静脉治疗（A组），15名患者接受口服治疗（B组）。B组的平均±标准差出生后年龄（41±8.7天对48±17天；p = 0.03）和实际体重（1.56±0.38千克对1.88±0.75千克；p = 0.02）略高。两组间在平均±标准差胎龄（26.1±1.37周对26.9±3.30周）、5分钟阿氏评分（8.7±1.11对7.7±2.26）、每日剂量（8.1±3.86对8.1±4.21毫克/千克/天）以及苯妥英血清浓度（8.7±7.36对9.6±5.83微克/毫升）方面均无显著差异。
与当前文献中的数据相反，口服乙苯妥英混悬液在早产儿中可达到可靠的血清浓度。口服治疗具有诸多优势，并能大幅降低治疗成本。由于新生儿苯妥英药代动力学存在显著差异，需要密切监测血清浓度。需要进一步研究以证实这些结果，尤其是对于出生后年龄小于20天的新生儿以及使用乙苯妥英以外产品的新生儿。
