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高纯度大麻二酚治疗耐药性癫痫:来自意大利单中心的真实世界研究对发作频率、生活质量、行为和睡眠模式的影响。

Highly purified cannabidiol in the treatment of drug-resistant epilepsies: A real-life impact on seizure frequency, quality of life, behavior, and sleep patterns from a single Italian center.

机构信息

Regional Center for Epilepsy- Sleep Medicine, ASST Santi Paolo e Carlo, Milan, Italy; Department of Health Sciences, University of Milan, Milan, Italy.

Regional Center for Epilepsy- Sleep Medicine, ASST Santi Paolo e Carlo, Milan, Italy; Department of Health Sciences, University of Milan, Milan, Italy.

出版信息

Epilepsy Behav. 2023 Oct;147:109409. doi: 10.1016/j.yebeh.2023.109409. Epub 2023 Sep 6.

DOI:10.1016/j.yebeh.2023.109409
PMID:37677907
Abstract

Seizure frequency in treatment-resistant epilepsies seems to be decreased by cannabidiol (CBD), but contrasting data are available on its effect on sleep, behavior, and quality of life (QoL), and no data is reported on its effect on parental stress in patients with epilepsy (PWE). Thus, we conducted a retrospective study on a cohort of children and adults with drug-resistant epilepsy (DRE) who had been treated with highly purified, pharmaceutical-grade CBD to evaluate its effects on seizure frequency, QoL, behavior, parental stress, and sleep. Eighteen patients (12 adults and 6 children) were included in the cohort and followed for a median of 9 months. At the last follow-up (Tn), nine patients (50%) were considered CBD responders with at least a 50% decrease in seizure frequency. No serious adverse effects were found. No statistically significant differences were found concerning sleep, including daytime sleepiness, and no statistically significant effect was found on parental stress at Tn. An improvement was found for social interaction in quality of life (p < 0.05) for all patients. Our results demonstrate that CBD is a safe and effective antiseizure medication (ASM). CBD doesn't seem to affect sleep measures in adults and children or worsen daytime sleepiness. However, CBD improves specific QoL measures, which could indicate a possible use of CBD for other childhood disabilities. No impact of CBD was seen on parental stress, which could possibly be due to the limited follow-up or could mean that parental stress is not dependent on seizure frequency.

摘要

在耐药性癫痫患者中,癫痫发作频率似乎会因大麻二酚(CBD)而降低,但关于其对睡眠、行为和生活质量(QoL)的影响存在相互矛盾的数据,并且关于其对癫痫患者(PWE)父母压力的影响尚无数据报告。因此,我们对一组接受高纯度、药物级 CBD 治疗的耐药性癫痫(DRE)儿童和成人患者进行了回顾性研究,以评估其对癫痫发作频率、QoL、行为、父母压力和睡眠的影响。该队列纳入了 18 例患者(12 例成人和 6 例儿童),并进行了中位数为 9 个月的随访。在最后一次随访(Tn)时,9 例患者(50%)被认为是 CBD 反应者,癫痫发作频率至少降低了 50%。未发现严重不良反应。在睡眠方面,包括日间嗜睡,以及在 Tn 时对父母压力没有统计学上的显著影响,未发现统计学上的显著差异。所有患者的社会交往生活质量都有所改善(p < 0.05)。我们的结果表明,CBD 是一种安全有效的抗癫痫药物(ASM)。CBD 似乎不会影响成人和儿童的睡眠测量值,也不会加重日间嗜睡。然而,CBD 改善了特定的 QoL 指标,这可能表明 CBD 可能用于治疗其他儿童残疾。在父母压力方面,CBD 没有影响,这可能是由于随访时间有限,或者可能意味着父母压力不依赖于癫痫发作频率。

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