Baratta F, Pignata I, Ravetto Enri L, Brusa P
Department of Drug Science and Technology, University of Turin, Turin, Italy.
Front Pharmacol. 2022 May 25;13:888903. doi: 10.3389/fphar.2022.888903. eCollection 2022.
has long been regarded as a recreational substance in the Western world. The recent marketing authorization of some medicinal products of industrial origin and the introduction onto the market of inflorescences for medical use mean that medical doctors can now prescribe -based medicines in those countries which allow it. Nevertheless, there is still considerable controversy on this topic in the scientific community. In particular, this controversy concerns: the plant species to be used; the pathologies that can be treated and consequently the efficacy and safety of use; the routes of administration; the methods of preparation; the type and dosage of cannabinoids to be used; and, the active molecules of interest. As such, although medical has been historically used, the results of currently completed and internationally published studies are inconclusive and often discordant. In light of these considerations, the aim of this work is to analyse the current legislation in countries that allow the use of medical , in relation to the impact that this legislation has had on clinical trials. First of all, a literature search has been performed (PubMed and SciFinder) on clinical trials which involved the administration of for medical use over the last 3 years. Of the numerous studies extrapolated from the literature, only about 43 reported data on clinical trials on medical , with these mainly being performed in Australia, Brazil, Canada, Denmark, Germany, Israel, Netherlands, Switzerland, the United Kingdom and the United States of America. Once the reference countries were identified, an evaluation of the legislation in relation to for medical use in each was carried out via the consultation of the pertinent scientific literature, but also of official government documentation and that of local regulatory authorities. This analysis provided us with an overview of the different legislation in these countries and, consequently, allowed us to analyse, with greater awareness, the results of the clinical trials published in the last 3 years in order to obtain general interest indications in the prosecution of scientific research in this area.
在西方世界,它长期以来一直被视为一种消遣性物质。近期一些工业来源的医药产品获得上市许可,以及医用花序进入市场,这意味着在允许的国家,医生现在可以开具基于它的药物。然而,科学界在这个问题上仍然存在相当大的争议。特别是,这场争议涉及:要使用的植物种类;可以治疗的病症以及使用的有效性和安全性;给药途径;制备方法;要使用的大麻素的类型和剂量;以及,相关的活性分子。因此,尽管医用它在历史上就已被使用,但目前已完成并在国际上发表的研究结果尚无定论,且往往相互矛盾。鉴于这些考虑因素,这项工作的目的是分析允许使用医用它的国家的现行立法,以及该立法对临床试验的影响。首先,对过去三年涉及医用它给药的临床试验进行了文献检索(PubMed和SciFinder)。从文献中推断出的众多研究中,只有约43项报告了医用它的临床试验数据,这些试验主要在澳大利亚、巴西、加拿大、丹麦、德国、以色列、荷兰、瑞士、英国和美国进行。一旦确定了参考国家,就通过查阅相关科学文献、政府官方文件以及当地监管机构的文件,对每个国家关于医用它的立法进行了评估。这一分析为我们提供了这些国家不同立法的概述,因此,使我们能够更清楚地分析过去三年发表的临床试验结果,以便在该领域的科学研究中获得具有普遍意义的指示。