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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Pharmacokinetic and Pharmacodynamic Evaluation of Intravenous Levetiracetam in Children With Epilepsy
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Pharmacokinetic and Pharmacodynamic Evaluation of Intravenous Levetiracetam in Children With Epilepsy

机译：癫痫患儿静脉内左霉素的药代动力学和药效学评价

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Abstract This study aimed to evaluate the safety and tolerability of intravenous (IV) levetiracetam (LEV) as a monotherapy in children aged 1 month‐16 years and to explore the pharmacokinetics (PK) of IV LEV and the time to seizure after IV then oral administration of LEV in pediatric children with epilepsy. Children diagnosed with acute unprovoked seizures requiring in‐hospital IV LEV administration were included. After administration, the clinical seizure outcomes, side effects, and the Korean‐Child Behavior Checklist were monitored and the PK and repeated time to seizure were analyzed via modeling using NONMEM software. Overall, 37 children with epilepsy were enrolled and underwent a PK analysis (median age, 4.6?years; median weight, 18.0?kg). Nine children (24.3%) had seizure recurrence during the follow‐up period (median, 3.8?months) and 5 children (13.5%) experienced LEV‐associated adverse events such as irritability (n?=?2; 5.4%) and somnolence (n?=?3; 8.1%). The plasma LEV concentrations after IV LEV were best described by a one‐compartment linear PK model. Only body weight was associated with both the clearance and volume of distribution of LEV. The Weibull distribution model described the time to seizure recurrence well; no statistically significant predictor for the time to seizure was identified. Therefore, IV LEV was a well‐tolerated and effective alternative in children with acute unprovoked seizures, and models for the PK and time to repeated seizure recurrence after LEV were successfully developed. In particular, the current use of a weight‐based IV LEV dosing regimen in pediatric children is practical.
机译：摘要本研究旨在评估静脉内（IV）Levetiracetam（Lev）作为1个月 - 16岁儿童的单一疗法的安全性和耐受性，并探索IV Lev的药代动力学（PK）以及IV后癫痫发作的时间癫痫小儿儿童的救生人员。诊断出患有医院IV留下押尿管理的急性未加工的癫痫发作的儿童被包括在内。在给药后，监测临床癫痫发作结果，副作用和朝鲜儿童行为核对表，通过使用非梅尔软件建模分析PK和重复时间来癫痫发作。总体而言，37名癫痫患儿童入学并经历了PK分析（中位年龄，4.6岁;年龄;中位重18.0？Kg）。九个儿童（24.3％）在后续期间（中位数，3.8？月）和5名儿童（13.5％）癫痫发作（13.5％）的癫痫发作（13.5％），如烦躁（n？=？2; 5.4％）和嗜睡（n？=？3; 8.1％）。 IV LEV之后的等离子体LEV浓度最佳地由单室线性PK模型描述。只有体重与Lev分布的间隙和体积均相关。 Weibull分布模型描述了癫痫发作的时间很好;鉴定了癫痫发作时间没有统计学意义的预测因子。因此，IV LeL是急性未加工的癫痫发作的患儿耐受良好且有效的替代品，并且PK和时间在LEV后重复癫痫发作复发的模型。特别地，目前使用在儿科儿童中的重量为基于的IV Lev剂量方案是实用的。

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