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大麻素与惊厥不良反应:法国报告病例的药物警戒与成瘾性警戒分析

Cannabinoids and Adverse Convulsive Effects: A Pharmacovigilance and Addictovigilance Analysis of Cases Reported in France.

作者信息

Laroche Marie-Laure, Labetoulle Marion, Jouanjus Emilie, Kröger Edeltraut, Zongo Arsène

机构信息

Regional Centre of Pharmacovigilance, CHU Limoges, Limoges, France.

CEIP-Addictovigilance, CHU de Toulouse, Toulouse, France.

出版信息

Fundam Clin Pharmacol. 2025 Aug;39(4):e70028. doi: 10.1111/fcp.70028.

DOI:10.1111/fcp.70028
PMID:40540313
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12200219/
Abstract

BACKGROUND

Seizures after the use of cannabinoids are reported, but no precise descriptions of the characteristics of subjects and factors that may trigger seizures are available.

OBJECTIVES

To study the characteristics and circumstances associated with the occurrence of seizures in individuals using cannabinoids for medical or recreational purposes.

METHODS

A retrospective analysis of spontaneous reports of adverse drug effects issued by the French pharmacovigilance and addictovigilance systems, and by manufacturers, extracted data from the Eudravigilance database (01/01/1985-21/07/2023). The request used the broad MedDRA SMQ term 'convulsive', with all products containing cannabinoids (THC, CBD, cannabis or natural cannabinoids).

RESULTS

Among 4296 notifications with cannabinoids, 130 (3%) reports of convulsive effects were analysed: 29 cases (23.3%) related to medical use (27 CBD, 1 THC and 2 combined THC/CBD preparations) and 98 (75.4%) related to recreational use. The median age was 29.0 years (min-max: 3-75), 78.7% were men and 81.1% were serious cases. Among the recreational users, 38.8% used Cannabis sativa with a history of epilepsy, and 68.4% of them were taking antiepileptics. In total, 67.7% of individuals had at least one risk factor for seizures, i.e., 31.0% among medical users and 78.6% among recreational users. The main risk factors with medical use were inefficacy of CBD (17.2%), fatigue (13.8%) and concomitant epileptogenic medications (10.3%). The main risk with recreational use was concomitant epileptogenic medications (39.8%), consumption of illicit drugs (33.7%) and alcohol (32.7%).

CONCLUSION

This analysis demonstrates the importance of alerting cannabinoid users, particularly recreational cannabis users and those with a history of epilepsy, about seizure-associated risks. Moreover, educational information should be provided together with the prescription of licensed cannabinoids and medical cannabis.

摘要

背景

有使用大麻素后发生癫痫发作的报道,但对于相关个体特征以及可能引发癫痫发作的因素尚无确切描述。

目的

研究出于医疗或娱乐目的使用大麻素的个体发生癫痫发作的相关特征及情况。

方法

对法国药物警戒和成瘾警戒系统以及制造商发布的药物不良反应自发报告进行回顾性分析,从欧洲药物警戒数据库(1985年1月1日至2023年7月21日)中提取数据。检索使用了MedDRA标准医学术语集中宽泛的“惊厥性”一词,涉及所有含大麻素(四氢大麻酚、大麻二酚、大麻或天然大麻素)的产品。

结果

在4296份含大麻素的报告中,分析了130份(3%)惊厥性效应报告:29例(23.3%)与医疗用途有关(27例为大麻二酚,1例为四氢大麻酚,2例为四氢大麻酚/大麻二酚联合制剂),98例(75.4%)与娱乐用途有关。中位年龄为29.0岁(最小 - 最大:3 - 75岁),78.7%为男性,81.1%为严重病例。在娱乐使用者中,38.8%使用印度大麻且有癫痫病史,其中68.4%正在服用抗癫痫药物。总体而言,67.7%的个体至少有一项癫痫发作风险因素,即医疗使用者中为31.0%,娱乐使用者中为78.6%。医疗用途的主要风险因素是大麻二酚无效(17.2%)、疲劳(13.8%)和同时使用致痫药物(10.3%)。娱乐用途的主要风险是同时使用致痫药物(39.8%)、使用非法药物(33.7%)和饮酒(32.7%)。

结论

该分析表明,向大麻素使用者,尤其是娱乐性大麻使用者和有癫痫病史者警示癫痫发作相关风险非常重要。此外,在开具合法大麻素和医用大麻处方时应同时提供教育信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d5a/12200219/4b5edde97b30/FCP-39-0-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d5a/12200219/4b5edde97b30/FCP-39-0-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d5a/12200219/4b5edde97b30/FCP-39-0-g001.jpg

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Ensuring safety in cannabinoid prescriptions: A call for critical assessment.确保大麻素处方的安全性:呼吁进行批判性评估。
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JAMA Netw Open. 2023 Apr 3;6(4):e239126. doi: 10.1001/jamanetworkopen.2023.9126.
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Experience of Cannabis Use from Adolescence to Adulthood in France: An Interpretative Phenomenological Analysis.法国青少年至成年期的大麻使用体验:一种解释性现象学分析。
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