Crippa José A S, Crippa Ana C S, Hallak Jaime E C, Martín-Santos Rocio, Zuardi Antonio W
Department of Neuroscience and Behavior, University of São Paulo Ribeirão Preto, Brazil.
Department of Clinical Medicine, Federal University of Paraná Curitiba, Brazil.
Front Pharmacol. 2016 Sep 30;7:359. doi: 10.3389/fphar.2016.00359. eCollection 2016.
Animal studies and preliminary clinical trials have shown that cannabidiol (CBD)-enriched extracts may have beneficial effects for children with treatment-resistant epilepsy. However, these compounds are not yet registered as medicines by regulatory agencies. We describe the cases of two children with treatment-resistant epilepsy (Case A with left frontal dysplasia and Case B with Dravet Syndrome) with initial symptom improvement after the introduction of CBD extracts followed by seizure worsening after a short time. The children presented typical signs of intoxication by Δ9-THC (inappropriate laughter, ataxia, reduced attention, and eye redness) after using a CBD-enriched extract. The extract was replaced by the same dose of purified CBD with no Δ9-THC in both cases, which led to improvement in intoxication signs and seizure remission. These cases support pre-clinical and preliminary clinical evidence suggesting that CBD may be effective for some patients with epilepsy. Moreover, the cases highlight the need for randomized clinical trials using high-quality and reliable substances to ascertain the safety and efficacy of cannabinoids as medicines.
动物研究和初步临床试验表明,富含大麻二酚(CBD)的提取物可能对难治性癫痫患儿有益。然而,这些化合物尚未被监管机构注册为药品。我们描述了两名难治性癫痫患儿的病例(病例A为左额叶发育异常,病例B为德雷维特综合征),在引入CBD提取物后最初症状有所改善,但短时间后癫痫发作恶化。使用富含CBD的提取物后,患儿出现了典型的Δ9-四氢大麻酚中毒症状(不适当的笑声、共济失调、注意力下降和眼睛发红)。在这两个病例中,提取物均被相同剂量不含Δ9-四氢大麻酚的纯化CBD取代,这导致中毒症状改善且癫痫发作缓解。这些病例支持了临床前和初步临床证据,表明CBD可能对一些癫痫患者有效。此外,这些病例凸显了进行随机临床试验的必要性,使用高质量和可靠的物质来确定大麻素作为药物的安全性和有效性。