NYU Langone Comprehensive Epilepsy Center and NYU Langone School of Medicine, New York, New York.
Saint Barnabas Institute of Neurology and Neurosurgery, Livingston, New Jersey.
Curr Opin Neurol. 2019 Apr;32(2):220-226. doi: 10.1097/WCO.0000000000000660.
To review the history, pharmacology, and clinical science of cannabidiol (CBD) in the treatment of epilepsy.
Phase III randomized controlled trials and prospective open label trials have provided efficacy and safety data for the use of CBD in pediatric onset severe epilepsies. The product that was studied in the vast majority of these published trials, Epidiolex (>99% of CBD and <0.10% Δ9-tetrahydrocannabinol (THC); GW pharmaceuticals, Cambridge, UK), has now been FDA approved based on this published data.
Identification of CBD, Δ9-THC, and the endocannabinoid system in the mid-20th century has led to advancement of cannabis-based therapies for epilepsy. Based on clinical trial data, Epidiolex is the first CBD medication approved by a national regulatory agency (US Food and Drug Administration for Dravet and Lennox Gastaut syndrome; European Medicines Agency for Lennox Gastaut syndrome). Approval of CBD as a treatment for these rare and severe pediatric-onset epilepsy syndromes is an important milestone, but the complete spectrum of use of cannabis-derived products, and the use of CBD for other epilepsy syndromes remains to be determined.
综述目的：回顾大麻二酚（CBD）在癫痫治疗中的历史、药理学和临床科学。
最新发现：III 期随机对照试验和前瞻性开放标签试验为 CBD 在儿科起病的严重癫痫中的应用提供了疗效和安全性数据。在这些已发表的试验中，绝大多数研究的产品是 Epidiolex（>99%的 CBD 和 <0.10% Δ9-四氢大麻酚（THC）；GW 制药，英国剑桥），基于这些已发表的数据，该产品现已获得 FDA 批准。
摘要：20 世纪中叶 CBD、Δ9-THC 和内源性大麻素系统的发现，推动了以大麻为基础的癫痫治疗方法的进步。基于临床试验数据，Epidiolex 是第一个获得国家监管机构（美国食品和药物管理局批准用于 Dravet 和 Lennox-Gastaut 综合征；欧洲药品管理局批准用于 Lennox-Gastaut 综合征）批准的 CBD 药物。批准 CBD 作为这些罕见且严重的儿科起病癫痫综合征的治疗方法是一个重要的里程碑，但大麻衍生产品的完整应用范围以及 CBD 用于其他癫痫综合征的用途仍有待确定。
