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左乙拉西坦治疗 1 个月至 16 岁儿童部分性发作癫痫的疗效和安全性。

Safety and efficacy of levetiracetam for the treatment of partial onset seizures in children from one month of age.

机构信息

Massachusetts General Hospital, Department of Neurology, Programs in Child Neurology and Neurophysiology, Boston, MA, USA.

出版信息

Neuropsychiatr Dis Treat. 2013;9:295-306. doi: 10.2147/NDT.S30224. Epub 2013 Feb 21.

Abstract

Epilepsy is a common neurological disorder in the pediatric population, affecting up to one percent of children, and for which the mainstay of treatment is anticonvulsant medication. Despite the frequent use of anticonvulsant drugs, remarkably little is known about the safety and efficacy of most of these medications in the pediatric epilepsy population. Of 34 anticonvulsants currently approved for use by the US Food and Drug Administration (FDA), only 13 have been approved for use in children. Although infants and young children are disproportionately affected by epilepsy, there are currently only three anticonvulsant medications that have been specifically evaluated and approved for use in children younger than 2 years of age. In 2012, the FDA approved levetiracetam as an adjunctive treatment for partial onset seizures in infants and children from one month of age. Here we review the available data on levetiracetam in the pediatric epilepsy population. We first discuss the pharmacological profile of levetiracetam, including its mechanism of action, formulations and dosing, and pharmacokinetics in children. We then review the available efficacy, safety, and tolerability data in children from one month of age with partial onset seizures. We conclude that the current data leading to the approval of levetiracetam for use in infants and children with partial onset seizures is encouraging, although more work needs to be done before definitive conclusions can be drawn about the efficacy of levetiracetam across different pediatric age groups.

摘要

癫痫是儿科人群中常见的神经紊乱疾病,影响高达 1%的儿童,其主要治疗方法是抗癫痫药物。尽管经常使用抗癫痫药物,但对于大多数这些药物在儿科癫痫人群中的安全性和疗效却知之甚少。在美国食品和药物管理局(FDA)批准的 34 种抗癫痫药物中,只有 13 种被批准用于儿童。尽管婴儿和幼儿受癫痫的影响不成比例,但目前只有三种抗癫痫药物经过专门评估并批准用于 2 岁以下儿童。2012 年,FDA 批准左乙拉西坦作为一种辅助治疗婴儿和 1 个月大儿童部分发作性癫痫的药物。在这里,我们回顾了左乙拉西坦在儿科癫痫人群中的可用数据。我们首先讨论了左乙拉西坦的药理学特征,包括其作用机制、制剂和剂量以及在儿童中的药代动力学。然后,我们回顾了在有部分发作性癫痫的 1 个月大的儿童中获得的有效性、安全性和耐受性数据。我们得出的结论是,目前批准左乙拉西坦用于婴儿和儿童部分发作性癫痫的现有数据令人鼓舞,尽管在得出关于左乙拉西坦在不同儿科年龄组中的疗效的明确结论之前,还需要做更多的工作。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07bb/3582481/8c9347f8ddd8/ndt-9-295Fig1.jpg

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