Parental reporting of response to oral cannabis extracts for treatment of refractory epilepsy
Parental reporting of response to oral cannabis extracts for treatment of refractory epilepsy
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DOI：
10.1016/j.yebeh.2015.02.043
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发表时间：
2015-04-01
影响因子：
2.6
通讯作者：
Chapman, Kevin E.
中科院分区：
文献类型：
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作者：
Press, Craig A.;Knupp, Kelly G.;Chapman, Kevin E.
目的：口服大麻提取物（OCEs）已用于治疗癫痫;然而，没有研究表明明确的疗效。我们报告了一个队列的儿童癫痫患者谁是OCE，并遵循在一个单一的三级epilepsy center.Methods：一个回顾性的图表审查的儿童和青少年谁是OCE治疗他们的epilepsy centered.Results：75例患者被确定为其中57%的癫痫发作控制的任何改善和33%的癫痫发作（反应者）减少了> 50%。如果家庭已经搬到CO进行OCE治疗，则应答率为47%，而已经在CO的儿童为22%。应答率根据癫痫综合征而变化：Dravet 23%，Doose 0%和Lennox-Gastaut综合征（LGS）88.9%。EEG数据可用的8名应答者的背景EEG没有改善。报告的其他益处包括：改善行为/警觉性（33%），改善语言（10%）和改善运动技能（10%）。44%的患者发生不良事件（AE），包括癫痫发作增加（13%）和嗜睡/疲乏（12%）。罕见的不良事件包括发育退化，异常运动，癫痫持续状态需要插管，和death.Significance：我们的回顾性研究OCE使用在儿童癫痫患者表明，一些家庭报告的患者改善治疗，但是，我们也发现了各种挑战和可能的混杂因素，在研究OCE回顾性开放标签的方式。我们强烈支持需要进行对照、设盲研究，使用准确的癫痫发作计数、正式的神经认知评估以及EEG作为生物标志物来评价OCE治疗儿童癫痫的疗效和安全性。本研究提供了III类证据，证明癫痫儿童和青少年对OCE耐受良好。(C)2015 Elsevier Inc. All rights reserved.
Objective: Oral cannabis extracts (OCEs) have been used in the treatment of epilepsy; however, no studies demonstrate clear efficacy. We report on a cohort of pediatric patients with epilepsy who were given OCE and followed in a single tertiary epilepsy center.Methods: A retrospective chart review of children and adolescents who were given OCE for treatment of their epilepsy was performed.Results: Seventy-five patients were identified of which 57% reported any improvement in seizure control and 33% reported a > 50% reduction in seizures (responders). If the family had moved to CO for OCE treatment, the responder rate was 47% vs. 22% for children who already were in CO. The responder rate varied based on epilepsy syndrome: Dravet 23%, Doose 0%, and Lennox-Gastaut syndrome (LGS) 88.9%. The background EEG of the 8 responders where EEG data were available was not improved. Additional benefits reported included: improved behavior/alertness (33%), improved language (10%), and improved motor skills (10%). Adverse events (AEs) occurred in 44% of patients including increased seizures (13%) and somnolence/fatigue (12%). Rare adverse events included developmental regression, abnormal movements, status epilepticus requiring intubation, and death.Significance: Our retrospective study of OCE use in pediatric patients with epilepsy demonstrates that some families reported patient improvement with treatment; however, we also found a variety of challenges and possible confounding factors in studying OCE retrospectively in an open-labeled fashion. We strongly support the need for controlled, blinded studies to evaluate the efficacy and safety of OCE for treatment of pediatric epilepsies using accurate seizure counts, formal neurocognitive assessments, as well as EEG as a biomarker. This study provides Class III evidence that OCE is well tolerated by children and adolescents with epilepsy. (C) 2015 Elsevier Inc. All rights reserved.