Advances in Pharmacotherapy Development: Human Clinical Studies
Advances in Pharmacotherapy Development: Human Clinical Studies
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DOI：
10.1007/164_2017_79
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发表时间：
2018-01-01
期刊：
影响因子：
--
通讯作者：
Leggio, Lorenzo
中科院分区：
文献类型：
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作者：
Litten, Raye Z.;Falk, Daniel E.;Leggio, Lorenzo
25年多来，研究人员在开发治疗酒精使用障碍（AUD）的药物方面取得了进展，美国食品和药物管理局（FDA）批准了双硫仑、纳曲酮（口服和长效）和阿坎酸。这些药物也在欧洲获得批准，欧洲药品管理局（EMA）最近增加了第四种药物纳美芬，用于AUD。尽管有这些进步，今天的药物具有较小的效应量，仅对有限数量的AUD患者显示出疗效。然而，许多作用于各种药理学靶点的新药正在开发中，并已在许多人体研究中进行了评估。本文回顾了目前正在人体试验中测试的药物的有效性和安全性，并着眼于正在进行的努力，以确定候选化合物在人体研究。正如国家酒精滥用和酒精中毒研究所2017-2021年战略计划（https：//www.example.com sites/default/files/StrategicPlan_NIAAA_optimized_2017-2020.pdf）中所提到的，药物开发仍然是一个高度优先事项。www.niaaa.nih.gov/通过开发更有效和安全的药物，并确定那些将从这些治疗中受益最多的患者，我们可以为临床医生提供治疗这种毁灭性疾病所需的工具，为患者及其家属提供救济，并显着改善公共卫生和安全。
For more than 25 years, researchers have made advances in developing medications to treat alcohol use disorder (AUD), highlighted by the US Food and Drug Administration's (FDA's) approval of disulfiram, naltrexone (oral and long-acting), and acamprosate. These medications are also approved in Europe, where the European Medicines Agency (EMA) recently added a fourth medication, nalmefene, for AUD. Despite these advances, today's medications have a small effect size, showing efficacy for only a limited number of individuals with AUD. However, a host of new medications, which act on variety of pharmacologic targets, are in the pipeline and have been evaluated in numerous human studies. This article reviews the efficacy and safety of medications currently being tested in human trials and looks at ongoing efforts to identify candidate compounds in human studies. As mentioned in the National Institute on Alcohol Abuse and Alcoholism's Strategic Plan 2017-2021 (https://www.niaaa.nih.gov/ sites/default/files/StrategicPlan_NIAAA_optimized_2017-2020.pdf), medications development remains a high priority. By developing more effective and safe medications, and identifying those patients who will benefit the most from these treatments, we can provide clinicians with the tools they need to treat this devastating disorder, providing relief for patients and their families and markedly improving public health and safety.