Fasinu Pius S, Phillips Sarah, ElSohly Mahmoud A, Walker Larry A
The National Center for Natural Products Research, School of Pharmacy, The University of Mississippi, University, MS.
Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS.
Pharmacotherapy. 2016 Jul;36(7):781-96. doi: 10.1002/phar.1780.
States and the federal government are under growing pressure to legalize the use of cannabis products for medical purposes in the United States. Sixteen states have legalized (or decriminalized possession of) products high in cannabidiol (CBD) and with restricted ∆(9) -tetrahydrocannabinol (∆(9) -THC) content. In most of these states, the intent is for use in refractory epileptic seizures in children, but in a few states, the indications are broader. This review provides an overview of the pharmacology and toxicology of CBD; summarizes some of the regulatory, safety, and cultural issues relevant to the further exploitation of its antiepileptic or other pharmacologic activities; and assesses the current status and prospects for clinical development of CBD and CBD-rich preparations for medical use in the United States. Unlike Δ(9) -THC, CBD elicits its pharmacologic effects without exerting any significant intrinsic activity on the cannabinoid receptors, whose activation results in the psychotropic effects characteristic of Δ(9) -THC, and CBD possesses several pharmacologic activities that give it a high potential for therapeutic use. CBD exhibits neuroprotective, antiepileptic, anxiolytic, antipsychotic, and antiinflammatory properties. In combination with Δ(9) -THC, CBD has received regulatory approvals in several European countries and is currently under study in trials registered by the U.S. Food and Drug Administration in the United States. A number of states have passed legislation to allow for the use of CBD-rich, limited Δ(9) -THC-content preparations of cannabis for certain pathologic conditions. CBD is currently being studied in several clinical trials and is at different stages of clinical development for various medical indications. Judging from clinical findings reported so far, CBD and CBD-enriched preparations have great potential utility, but uncertainties regarding sourcing, long-term safety, abuse potential, and regulatory dilemmas remain.
在美国，州政府和联邦政府面临着越来越大的压力，要求将大麻产品用于医疗目的合法化。16个州已经将大麻二酚（CBD）含量高且Δ(9)-四氢大麻酚（Δ(9)-THC）含量受限的产品合法化（或对持有此类产品进行非刑事化处理）。在这些州中的大多数，其意图是用于治疗儿童难治性癫痫发作，但在少数几个州，适用范围更广。本综述概述了CBD的药理学和毒理学；总结了与进一步开发其抗癫痫或其他药理活性相关的一些监管、安全和文化问题；并评估了CBD及富含CBD的医用制剂在美国临床开发的现状和前景。与Δ(9)-THC不同，CBD发挥其药理作用时，对大麻素受体没有任何显著的内在活性，而Δ(9)-THC对大麻素受体的激活会导致其精神活性效应，并且CBD具有多种药理活性，使其具有很高的治疗应用潜力。CBD具有神经保护、抗癫痫、抗焦虑、抗精神病和抗炎特性。与Δ(9)-THC联合使用时，CBD已在几个欧洲国家获得监管批准，目前正在美国食品药品监督管理局注册的试验中进行研究。一些州已经通过立法，允许使用富含CBD、Δ(9)-THC含量有限的大麻制剂来治疗某些病理状况。目前正在对CBD进行多项临床试验，并且针对各种医学适应症处于不同的临床开发阶段。从目前报道的临床结果来看，CBD及富含CBD的制剂具有很大的潜在应用价值，但在来源、长期安全性、滥用可能性和监管困境方面仍存在不确定性。
