Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy.
Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy.
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作者：
Pearl PL;McCarter R;McGavin CL;Yu Y;Sandoval F;Trzcinski S;Atabaki SM;Tsuchida T;van den Anker J;He J;Klein P
在严重创伤性脑损伤（TBI）后，高达20%的儿童会发生创伤后癫痫发作。年龄6-17岁的儿童，有一个或多个创伤后癫痫的发展风险因素，包括颅内出血，凹陷性颅骨骨折，穿透伤或发生创伤后癫痫发作的存在，被招募到这个第二阶段的研究。治疗受试者接受左乙拉西坦55 mg/kg/天b.i.d. 30天，在受伤后8小时内开始。招募目标为20例接受治疗的患者。招募了20名在TBI后8-24小时内出现并且在其他方面符合合格标准的患者进行观察。随访时间为两年。45名在头部损伤8小时内筛选的患者符合合格标准，20名被招募到治疗组。TBI后儿科入选的最常见风险因素是立即癫痫发作。服药依从性为95%。无患者死亡; 20例治疗患者中有19例保留; 1例观察患者失访。治疗受试者中最常见的严重不良事件为头痛、疲劳、嗜睡和易怒。与观察组受试者相比，治疗组受试者的感染、情绪变化或行为问题的发生率并不高。40名受试者中只有1名（2.5%）发生了创伤后癫痫（定义为创伤后癫痫发作> 7天）。本研究证明了在创伤性脑损伤高危人群中进行儿童创伤后癫痫预防研究的可行性。左乙拉西坦在该人群中安全且耐受性良好。这项研究为实施一项前瞻性研究以预防高危人群中的创伤后癫痫奠定了基础。
Post-traumatic seizures develop in up to 20% of children following severe traumatic brain injury (TBI). Children ages 6-17 years with one or more risk factors for the development of post-traumatic epilepsy, including presence of intracranial hemorrhage, depressed skull fracture, penetrating injury or occurrence of post-traumatic seizure were recruited into this phase two study. Treatment subjects received levetiracetam 55mg/kg/day b.i.d. for 30 days, started within 8 hours post-injury. The recruitment goal was 20 treated patients. Twenty patients who presented within 8-24 hours post-TBI and otherwise met eligibility criteria were recruited for observation. Follow-up was for two years. 45 patients screened within 8 hours of head injury met eligibility criteria and 20 were recruited into the treatment arm. The most common risk factor present for pediatric inclusion following TBI was an immediate seizure. Medication compliance was 95%. No patients died; 19 of 20 treatment patients were retained; one observation patient was lost to follow-up. The most common severe adverse events in treatment subjects were headache, fatigue, drowsiness, and irritability. There was no higher incidence of infection, mood changes, or behavior problems among treatment subjects compared to observation subjects. Only 1 of 40 subjects (2.5%) developed post-traumatic epilepsy (defined as seizures > 7 days after trauma). This study demonstrates the feasibility of a pediatric post-traumatic epilepsy prevention study in an at-risk traumatic brain injury population. Levetiracetam was safe and well tolerated in this population. This study sets the stage for implementation of a prospective study to prevent post-traumatic epilepsy in an at-risk population.
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