Calapai Fabrizio, Mannucci Carmen, McQuain Liana, Salvo Francesco
Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, 98125 Messina, Italy.
Department of Biomedical and Dental Sciences and Morphological and Functional Imaging, University of Messina, 98125 Messina, Italy.
Pharmaceuticals (Basel). 2023 Oct 5;16(10):1420. doi: 10.3390/ph16101420.
Cannabidiol is the first cannabis-derived drug approved for the treatment of Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex. In the current study, we performed a descriptive analysis followed by a disproportionality analysis of potential adverse events caused by CBD extracted from the VigiBase database. Furthermore, the biological plausibility of the association between CBD and the serotonin 5-HT receptor as a possible cause of adverse events was analyzed and discussed. Data were extracted from the VigiBase database using the VigiLyze signal detection and signal management tool. Adverse events in VigiBase reports were coded using MedDRA, version 19 of Preferred Terms (PTs). Data were uploaded into SPSS software and analyzed via a disproportionality analysis. Statistically significant disproportionality signals for CBD were found for "weight decreased" (5.19 (95% CI: 4.54-5.70)), "hypophagia" (3.68 (95% CI: 3.22-5.27)), and "insomnia" (1.6 (95% CI: 1.40-1.83)). Positive IC025 values were found for "weight decreased" (2.2), "hypophagia" (1.3), and "insomnia" (0.5), indicating a surplus of reported cases. CBD's interactions with 5-HT serotonin receptors may offer a potential biological explanation for the occurrence of insomnia in patients. It is noteworthy that the risk profiles mentioned in the information for prescribing CBD as an antiepileptic agent by regulatory agencies showed disparities specifically related to the adverse event "insomnia".
大麻二酚是第一种被批准用于治疗伦诺克斯 - 加斯托综合征、德雷维特综合征和结节性硬化症的大麻衍生药物。在本研究中，我们对从VigiBase数据库中提取的大麻二酚引起的潜在不良事件进行了描述性分析，随后进行了不成比例分析。此外，还分析和讨论了大麻二酚与血清素5 - HT受体之间关联作为不良事件可能原因的生物学合理性。使用VigiLyze信号检测和信号管理工具从VigiBase数据库中提取数据。VigiBase报告中的不良事件使用MedDRA第19版首选术语（PTs）进行编码。数据上传到SPSS软件中，并通过不成比例分析进行分析。发现大麻二酚在“体重减轻”（5.19（95%置信区间：4.54 - 5.70））、“食欲减退”（3.68（95%置信区间：3.22 - 5.27））和“失眠”（1.6（95%置信区间：1.40 - 1.83））方面存在具有统计学意义的不成比例信号。“体重减轻”（2.2）、“食欲减退”（1.3）和“失眠”（0.5）的IC025值为阳性，表明报告病例过多。大麻二酚与5 - HT血清素受体的相互作用可能为患者失眠的发生提供潜在的生物学解释。值得注意的是，监管机构在将大麻二酚作为抗癫痫药物的处方信息中提到的风险概况显示，与不良事件“失眠”存在特定差异。
