Raucci Umberto, Pietrafusa Nicola, Paolino Maria Chiara, Di Nardo Giovanni, Villa Maria Pia, Pavone Piero, Terrin Gianluca, Specchio Nicola, Striano Pasquale, Parisi Pasquale
Pediatric Emergency Department, Bambino Gesù Children's Hospital, Istituto di Ricerca e Cura a Carattere Scientifico, Rome, Italy.
Rare and Complex Epilepsy Unit, Department of Neuroscience and Neurorehabilitation, Member of European Reference Network EpiCare, Bambino Gesù Children's Hospital, Istituto di Ricerca e Cura a Carattere Scientifico, Rome, Italy.
Front Pharmacol. 2020 Sep 29;11:586110. doi: 10.3389/fphar.2020.586110. eCollection 2020.
Cannabis extracts in oil are becoming increasingly available, and, during the last years, there has been growing public and scientific interest about therapeutic properties of these compounds for the treatment of several neurologic diseases, not just epilepsy. The discovered role of the endocannabinoid system in epileptogenesis has provided the basis to investigate the pharmacological use of exogenously produced cannabinoids, to treat epilepsy. Although, physicians show reluctance to recommend Cannabis extracts given the lack of high-quality safety available data, from literature data cannabidiol (CBD) results to be a promising and safe anticonvulsant drug with low side-effect. In particular, according to early studies, CBD can reduce the frequency of seizures and lead to improvements in quality of life in children affected by refractory epilepsy. So, for these reasons, the detailed study of the interactions between CBD and anticonvulsant drugs (AEDs) administered simultaneously in polytherapy, is arousing increasing interest, to clarify and to assess the incidence of adverse effects and the relation between dose escalation and quality of life measures. To date, in pediatric age, CBD efficacy and safety is not supported by well-designed trials and strong scientific evidence are not available. These studies are either retrospective or small-scale observational and only during the last years Class I evidence data for a pure form of CBD have been available, as demonstrated in placebo-controlled RCTs for patients affected by Lennox-Gastaut syndrome and Dravet syndrome. It is necessary to investigate CBD safety, pharmacokinetics and interaction with other AEDs alongside performing double-blinded placebo-controlled trials to obtain conclusive data on its efficacy and safety in the most frequent epilepsies in children, not just in the epileptic encephalopathy. This review was aimed to revise the available data to describe the scientific evidence for CBD in Pediatric Epilepsies.
油状大麻提取物越来越容易获得,在过去几年中,公众和科学界对这些化合物治疗多种神经系统疾病(而不仅仅是癫痫)的治疗特性的兴趣日益浓厚。内源性大麻素系统在癫痫发生中所起的作用为研究外源性大麻素的药理学用途以治疗癫痫提供了基础。尽管由于缺乏高质量的安全性数据,医生们不愿推荐大麻提取物,但从文献数据来看,大麻二酚(CBD)是一种有前景且安全的抗惊厥药物,副作用较小。特别是,根据早期研究,CBD可以降低癫痫发作频率,并改善难治性癫痫患儿的生活质量。因此,出于这些原因,详细研究CBD与多药联合治疗中同时使用的抗惊厥药物(AEDs)之间的相互作用,越来越引起人们的兴趣,以阐明和评估不良反应的发生率以及剂量增加与生活质量指标之间的关系。迄今为止,在儿童期,CBD的疗效和安全性尚未得到精心设计的试验支持,也没有强有力的科学证据。这些研究要么是回顾性的,要么是小规模观察性的,仅在过去几年才有关于纯形式CBD的I类证据数据,如针对患有伦诺克斯 - 加斯托综合征和德雷维特综合征患者的安慰剂对照随机对照试验所证明的那样。有必要在进行双盲安慰剂对照试验的同时,研究CBD的安全性、药代动力学以及与其他AEDs的相互作用,以获得关于其在儿童最常见癫痫(而不仅仅是癫痫性脑病)中的疗效和安全性的确切数据。这篇综述旨在修订现有数据,以描述CBD在儿童癫痫中的科学证据。