Silverstein Faye S, Ferriero Donna M
Department of Pediatrics and Neurology, University of Michigan, Ann Arbor, Michigan 48109-5646, USA.
Pediatr Neurol. 2008 Aug;39(2):77-9. doi: 10.1016/j.pediatrneurol.2008.04.008.
Medically refractory neonatal seizures represent a major therapeutic challenge in neonatal intensive care units. Conventional antiepileptic drugs demonstrate limited efficacy. Previous studies documented a high frequency of off-label drug therapy in neonates. We sought to determine if pediatric neurologists are recommending treatment of neonatal seizures with newer agents, despite a lack of information about their safety or efficacy in this population. Surveys were distributed at the 2007 Annual Meeting of the Child Neurology Society. Responses from 55 pediatric neurologists were analyzed. Seventy-three percent (40/55) recommended treatment of neonatal seizures with one or both of levetiracetam and topiramate; 47% (26/55) recommended levetiracetam; and 55% (30/55) recommended topiramate. Despite an absence of data on neonatal pharmacokinetics of either drug, neurologists made different dosing recommendations for these two drugs (P = 0.003, chi-square test). Respondents considered both agents to be efficacious in the majority of cases; adverse effects were recognized more frequently with topiramate. These results highlight the urgent need for rigorous clinical trials to understand the risks and benefits of new drug therapies for neonatal seizures.
药物难治性新生儿惊厥是新生儿重症监护病房面临的一项重大治疗挑战。传统抗癫痫药物疗效有限。此前的研究记录了新生儿中使用标签外药物治疗的高频率情况。我们试图确定儿科神经科医生是否会推荐使用新型药物治疗新生儿惊厥，尽管缺乏这些药物在该人群中的安全性或疗效信息。在2007年儿童神经学会年会上发放了调查问卷。对55位儿科神经科医生的回复进行了分析。73%（40/55）的医生推荐使用左乙拉西坦和托吡酯中的一种或两种来治疗新生儿惊厥；47%（26/55）的医生推荐左乙拉西坦；55%（30/55）的医生推荐托吡酯。尽管缺乏这两种药物新生儿药代动力学的数据，但神经科医生对这两种药物给出了不同的给药建议（P = 0.003，卡方检验）。受访者认为这两种药物在大多数情况下都有效；托吡酯更常被认为会产生不良反应。这些结果凸显了迫切需要进行严格的临床试验，以了解新型药物治疗新生儿惊厥的风险和益处。
