Porcari Giulia S, Fu Cary, Doll Emily D, Carter Emma G, Carson Robert P
Vanderbilt University School of Medicine, USA.
Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt and Vanderbilt University, Nashville, TN, USA.
Epilepsy Behav. 2018 Mar;80:240-246. doi: 10.1016/j.yebeh.2018.01.026. Epub 2018 Feb 9.
Medically refractory epilepsy continues to be a challenge worldwide, and despite an increasing number of medical therapies, approximately 1 in 3 patients continues to have seizures. Cannabidiol (CBD), one of many constituents of the Cannabis sativa or marijuana plant, has received renewed interest in the treatment of epilepsy. While highly purified CBD awaits Food and Drug Administration (FDA) approval, artisanal formulations of CBD are readily available and are seeing increased use in our patient population. Although randomized controlled trials of CBD are ongoing and promising, data regarding artisanal formulations of CBD are minimal and largely anecdotal. Here, we report a retrospective study to define the efficacy of artisanal CBD preparations in children with epilepsy. Given the known interaction between CBD and clobazam, we also conducted a subgroup comparison to determine if clobazam use was related to any beneficial effects of CBD. Additionally, we compared response rates with CBD and with clobazam alone within an overlapping patient cohort. A pediatric cohort with epilepsy of 108 patients was identified through a medical record search for patients using CBD oil. The addition of CBD resulted in 39% of patients having a >50% reduction in seizures, with 10% becoming seizure-free. The responder rate for clobazam was similar. No patients achieved CBD monotherapy, although the weaning of other antiepileptic drugs (AEDs) became possible in 22% of patients. A comparable proportion had AED additions during CBD therapy. With concomitant use of clobazam, 44% of patients had a 50% reduction in seizures upon addition of CBD compared with 33% in the population not taking clobazam; this difference was not statistically significant. The most common reported side effect of CBD was sedation in less than 4% of patients, all of whom were also taking clobazam. Increased alertness and improved verbal interactions were reported in 14% of patients in the CBD group and 8% of patients in the CBD and clobazam group. Benefits were more marked in the CBD alone group, in contrast to the CBD and clobazam group, but this difference was not statistically significant. In summary, these findings support efficacy of artisanal CBD preparations in seizure reduction with few significant side effects. The response to CBD was independent of concurrent clobazam use, although clobazam may contribute to the sedation seen with concurrent CBD use.
药物难治性癫痫在全球范围内仍然是一个挑战，尽管医学治疗方法越来越多，但仍有大约三分之一的患者继续发作。大麻二酚（CBD）是大麻植物或大麻中的众多成分之一，在癫痫治疗方面重新引起了人们的关注。虽然高纯度的CBD正在等待美国食品药品监督管理局（FDA）的批准，但手工制作的CBD制剂很容易获得，并且在我们的患者群体中使用越来越多。尽管关于CBD的随机对照试验正在进行且前景乐观，但关于手工制作的CBD制剂的数据很少，且大多是轶事性的。在此，我们报告一项回顾性研究，以确定手工制作的CBD制剂对癫痫患儿的疗效。鉴于已知CBD与氯巴占之间存在相互作用，我们还进行了亚组比较，以确定氯巴占的使用是否与CBD的任何有益效果有关。此外，我们在一个重叠的患者队列中比较了CBD与单独使用氯巴占的缓解率。通过病历搜索使用CBD油的患者，确定了一个由108名癫痫患儿组成的队列。添加CBD后，39%的患者癫痫发作减少了50%以上，10%的患者不再发作。氯巴占的缓解率相似。没有患者实现CBD单药治疗，尽管22%的患者有可能停用其他抗癫痫药物（AEDs）。在CBD治疗期间，有相当比例的患者添加了AEDs。同时使用氯巴占时，添加CBD后44%的患者癫痫发作减少了50%，而未服用氯巴占的人群中这一比例为33%；这一差异无统计学意义。报告的CBD最常见副作用是不到4%的患者出现镇静作用，所有这些患者也在服用氯巴占。CBD组14%的患者和CBD与氯巴占组8%的患者报告警觉性提高和语言互动改善。与CBD和氯巴占组相比，单独使用CBD组的益处更为明显，但这一差异无统计学意义。总之，这些发现支持了手工制作的CBD制剂在减少癫痫发作方面的疗效，且副作用很少。对CBD的反应与同时使用氯巴占无关，尽管氯巴占可能导致同时使用CBD时出现的镇静作用。
