Shin Jae Won, Jung Yun Seob, Park Kyungsoo, Lee Soon Min, Eun Ho Seon, Park Min Soo, Park Kook In, Namgung Ran
Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
Department of Pharmacology, Yonsei University College of Medicine, Seoul, Korea.
Korean J Pediatr. 2017 Feb;60(2):50-54. doi: 10.3345/kjp.2017.60.2.50. Epub 2017 Feb 27.
The aims of this study were to evaluate the safety and pharmacokinetics of levetiracetam (LEV) in neonates with seizures and to establish a population pharmacokinetics (PPK) model by using the software NONMEM.
A retrospective analysis of 18 neonatal patients with seizures, who were treated with LEV, including 151 serum samples, was performed. The mean loading dose was 20 mg/kg, followed by a mean maintenance dose of 29 mg/kg/day.
Seventeen neonates (94%) had seizure cessation within 1 week and 16 (84%) remained seizure-free at 30 days under the LEV therapy. The mean serum concentration of LEV was 8.7 µg/mL. Eight samples (5%) were found above the therapeutic range. No serious adverse effects were detected. In the PPK analysis for Korean neonates, the half-life was 9.6 hours; clearance, 0.357 L/hr; and volume of distribution, 4.947 L, showing differences from those in adults.
LEV is a safe and effective option for the treatment of neonatal seizures with careful therapeutic drug monitoring.
本研究旨在评估左乙拉西坦（LEV）在新生儿癫痫患者中的安全性和药代动力学，并使用NONMEM软件建立群体药代动力学（PPK）模型。
对18例接受LEV治疗的新生儿癫痫患者进行回顾性分析，共收集151份血清样本。平均负荷剂量为20mg/kg，随后平均维持剂量为29mg/kg/天。
17例新生儿（94%）在1周内癫痫发作停止，16例（84%）在接受LEV治疗30天时无癫痫发作。LEV的平均血清浓度为8.7µg/mL。8份样本（5%）超过治疗范围。未检测到严重不良反应。在韩国新生儿的PPK分析中，半衰期为9.6小时；清除率为0.357L/小时；分布容积为4.947L，与成人有所不同。
在进行仔细的治疗药物监测的情况下，LEV是治疗新生儿癫痫的一种安全有效的选择。
