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大麻二酚与巴西的癫痫:当前综述。

Cannabidiol and epilepsy in Brazil: a current review.

机构信息

Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Neurologia, São Paulo, SP, Brazil.

出版信息

Arq Neuropsiquiatr. 2022 May;80(5 Suppl 1):182-192. doi: 10.1590/0004-282X-ANP-2022-S137.

DOI:10.1590/0004-282X-ANP-2022-S137
PMID:35976327
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9491442/
Abstract

BACKGROUND

Cannabidiol (CBD) has become a promising therapeutic option in the treatment of epilepsy. Recent studies provide robust evidence that CBD is effective and safe. Limitations in current knowledge and regulatory issues still limit CBD use. CBD use regarding epilepsy types still lacks clear guidelines.

OBJECTIVE

To critically review the main current pharmacological features and clinical issues regarding CBD use in epilepsy, to provide current regulatory background regarding CBD use in Brazil, and to suggest a practical CBD therapeutic guide in Brazil.

METHODS

Non-systematic literature review (up to February 2022) of current concepts of CBD and epilepsy, including the authors' personal experience.

RESULTS

Five pivotal trials have led to CBD approval as an adjunctive treatment for Dravet and Lennox-Gastaut syndromes, and for the tuberous sclerosis complex. Efficacy of CBD in other drug-resistant epilepsies remains not completely understood. CBD adverse event profile and drug interactions are better understood. CBD is well tolerated. In Brazil, CBD is not classified as a medication, but as a product subject to a distinct regulatory legislation. CBD is still not offered by the National Brazilian health system, but can be purchased in authorized pharmacies or imported under prescription and signed informed consent.

CONCLUSION

CBD is a recognized novel treatment for epilepsy. Future well-designed studies and public health strategies are needed to offer widespread access to CBD, and to improve the quality of life of people living with epilepsy in Brazil.

摘要

背景

大麻二酚(CBD)已成为治疗癫痫的一种有前途的治疗选择。最近的研究提供了强有力的证据,证明 CBD 是有效且安全的。目前知识的局限性和监管问题仍然限制了 CBD 的使用。关于癫痫类型的 CBD 使用仍然缺乏明确的指南。

目的

批判性地回顾 CBD 在癫痫中的主要当前药理学特征和临床问题,提供巴西 CBD 使用的当前监管背景,并在巴西提出 CBD 治疗的实用指南。

方法

非系统文献综述(截至 2022 年 2 月),涉及 CBD 和癫痫的当前概念,包括作者的个人经验。

结果

五项关键试验导致 CBD 被批准作为 Dravet 和 Lennox-Gastaut 综合征以及结节性硬化症的辅助治疗药物。CBD 对其他耐药性癫痫的疗效仍不完全清楚。CBD 的不良反应谱和药物相互作用得到了更好的理解。CBD 具有良好的耐受性。在巴西,CBD 不作为药物分类,而是作为受特定监管法规约束的产品。巴西国家卫生系统尚未提供 CBD,但可以在授权的药店购买,或根据处方和签署的知情同意书进口。

结论

CBD 是一种公认的癫痫新疗法。需要进行未来精心设计的研究和公共卫生策略,以广泛提供 CBD,并改善巴西癫痫患者的生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/9491442/5a53f7d5dc79/1678-4227-anp-80-05-s1-s137-gf3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/9491442/8ddd2d9a03a4/1678-4227-anp-80-05-s1-s137-gf1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/9491442/a90e5413b482/1678-4227-anp-80-05-s1-s137-gf2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/9491442/5a53f7d5dc79/1678-4227-anp-80-05-s1-s137-gf3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/9491442/8ddd2d9a03a4/1678-4227-anp-80-05-s1-s137-gf1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/9491442/a90e5413b482/1678-4227-anp-80-05-s1-s137-gf2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/9491442/5a53f7d5dc79/1678-4227-anp-80-05-s1-s137-gf3.jpg

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本文引用的文献

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Epilepsia. 2022 May;63(5):1189-1199. doi: 10.1111/epi.17199. Epub 2022 Mar 4.
2
High dose cannabidiol (CBD) in the treatment of new-onset refractory status epilepticus (NORSE).高剂量大麻二酚(CBD)治疗新发难治性癫痫持续状态(NORSE)。
Seizure. 2022 Jan;94:126-128. doi: 10.1016/j.seizure.2021.11.020. Epub 2021 Nov 26.
3
Safety and Tolerability of Transdermal Cannabidiol Gel in Children With Developmental and Epileptic Encephalopathies: A Nonrandomized Controlled Trial.
经皮使用大麻二酚凝胶治疗伴有发育和癫痫性脑病儿童的安全性和耐受性:一项非随机对照试验。
JAMA Netw Open. 2021 Sep 1;4(9):e2123930. doi: 10.1001/jamanetworkopen.2021.23930.
4
Add-on cannabidiol in patients with Dravet syndrome: Results of a long-term open-label extension trial.难治性癫痫综合征患者添加大麻二酚治疗:一项长期开放标签扩展试验的结果
Epilepsia. 2021 Oct;62(10):2505-2517. doi: 10.1111/epi.17036. Epub 2021 Aug 18.
5
Long-term safety and efficacy of add-on cannabidiol in patients with Lennox-Gastaut syndrome: Results of a long-term open-label extension trial.Lennox-Gastaut 综合征患者添加使用 Cannabidiol 的长期安全性和疗效:一项长期开放标签扩展试验的结果。
Epilepsia. 2021 Sep;62(9):2228-2239. doi: 10.1111/epi.17000. Epub 2021 Jul 20.
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Epilepsia. 2021 May;62(5):1130-1140. doi: 10.1111/epi.16878. Epub 2021 Apr 2.
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Clin Drug Investig. 2021 Mar;41(3):211-220. doi: 10.1007/s40261-021-01003-y. Epub 2021 Feb 9.