Suppr超能文献

药理学应处于所有关于新型精神活性物质(娱乐性药物)的临床前和临床研究的核心位置。

Pharmacology should be at the centre of all preclinical and clinical studies on new psychoactive substances (recreational drugs).

作者信息

Green A Richard, Nutt David J

机构信息

School of Life Sciences, Queen's Medical Centre, University of Nottingham, Nottingham, UK

Division of Neurosciences and Mental Health, Imperial College London, London, UK.

出版信息

J Psychopharmacol. 2014 Aug;28(8):711-8. doi: 10.1177/0269881114528593. Epub 2014 Mar 27.

Abstract

Despite the publication of a substantial body of preclinical and clinical information on recent recreational drugs such as 3,4-methylenedioxymethamphetamine (MDMA, 'ecstasy') and cathinone compounds such as mephedrone there remains a disturbing lack of consensus as to how dangerous these compounds are to the health of the individual and to society in general. This perspective proposes that use of good pharmacological practice should be mandatory in all preclinical and clinical studies. Its use will assist both translation and reverse translation of information produced in animals and clinical subjects. We propose several basic rules to be followed in all future studies. Preclinical studies should employ pharmacokinetic-pharmacodynamic integration thereby exposing animals to known or calculable drug concentrations. This will provide results relevant to pharmacology rather than toxicology and, crucially, data relevant to human drug use. Full experimental detail should be routinely provided, to allow comparison with other similar work. In clinical studies evidence should be provided that the drug under investigation has been ingested by the subjects being examined, and details given of all other drugs being ingested. Drug-drug interactions are an unavoidable confound but studies of a size that allows reliable statistical evaluation and preferably allows sub-group analysis, particularly by using meta-analysis, should help with this problem. This may require greater collaboration between investigative groups, as routinely occurs during pharmaceutical clinical trials. Other proposals include greater integration of preclinical and clinical scientists in both preclinical and clinical studies and changes in the law regarding Good Manufacturing Process (GMP) sourcing of drug for human studies.

摘要

尽管已经发表了大量关于近期娱乐性药物的临床前和临床信息,比如3,4-亚甲基二氧甲基苯丙胺(摇头丸,MDMA)以及卡西酮类化合物如甲麻黄碱,但对于这些化合物对个人健康以及整个社会的危害程度,仍然缺乏令人不安的共识。本文观点认为,在所有临床前和临床研究中都应强制采用良好的药理学实践。其应用将有助于动物和临床研究对象所产生信息的正向和反向转化。我们提出了未来所有研究都应遵循的几条基本规则。临床前研究应采用药代动力学-药效学整合方法,从而使动物接触已知或可计算的药物浓度。这将提供与药理学而非毒理学相关的结果,并且至关重要的是,提供与人类药物使用相关的数据。应常规提供完整的实验细节,以便与其他类似研究进行比较。在临床研究中,应提供证据证明所研究的药物已被受试对象摄入,并给出所有其他正在摄入药物的详细信息。药物相互作用是一个不可避免的混杂因素,但进行规模足够大、能够进行可靠统计评估且最好能进行亚组分析(特别是通过荟萃分析)的研究,应有助于解决这个问题。这可能需要研究团队之间加强合作,就像制药临床试验中经常发生的那样。其他建议包括在临床前和临床研究中,临床前科学家和临床科学家之间加强整合,以及修改关于用于人体研究的药物的药品生产质量管理规范(GMP)采购的法律。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验