Is off-label repeat prescription of ketamine as a rapid antidepressant safe? Controversies, ethical concerns, and legal implications.
Is off-label repeat prescription of ketamine as a rapid antidepressant safe? Controversies, ethical concerns, and legal implications.
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标签不重复的氯胺酮作为快速抗抑郁药安全吗？争议，道德问题和法律意义。
DOI：
10.1186/s12910-016-0087-3
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发表时间：
2016-01-14
影响因子：
2.7
通讯作者：
Ho RC
中科院分区：
文献类型：
--
作者：
Zhang MW;Harris KM;Ho RC
抑郁障碍是一种常见的精神疾病，会导致严重的残疾。监管当局、医疗行业和公众对抗抑郁药物提出了高标准的要求，以保护脆弱的精神病人。氯胺酮是一种解离麻醉剂，是一种迷幻剂(苯环利定)的衍生物。它的滥用是一个重大的世界性公共卫生问题。氯胺酮是一种受管制的药物，由于其滥用的可能性，其使用受到限制。最近的临床试验报告说，在患有难治性抑郁症的患者中，使用氯胺酮能迅速产生抗抑郁效果。然而，研究设计中的各种缺陷，以及可能对结果有偏见的报告，可能影响了这些发现。需要对氯胺酮的使用进行进一步的分析，以确保患者的安全。在抑郁症的研究和治疗中使用氯胺酮是有争议的。最近，心理健康专家对英国正在进行的一项氯胺酮试验提出了伦理担忧。此外，加拿大一家机构审查了现有证据，不建议开氯胺酮治疗抑郁症。从严格控制的研究环境中获得的研究结果不容易转化为临床实践，因为药物滥用通常与抑郁障碍共存。一种有效的抗抑郁药应该可以减轻抑郁症状的严重程度，而不会出现责任问题。尽管美国FDA没有批准使用氯胺酮治疗抑郁症，但一些精神病学家提供了标签外的重复处方氯胺酮。开出氯胺酮治疗抑郁症需要大量的经验证据。临床医生也应该考虑关于氯胺酮滥用的研究结果。抑郁障碍可能是慢性疾病，目前的证据不排除重复开出氯胺酮后药物滥用的风险。标签外使用氯胺酮治疗抑郁症可能违反伦理和道德标准，特别是在受氯胺酮滥用严重影响的国家。这篇文章介绍了两个真实世界的临床小插曲，突出了与非标签氯胺酮使用有关的伦理原则和理论，包括自主、非恶意、忠诚和结果主义。我们敦促临床医生在考虑非标签使用氯胺酮之前，考虑有关氯胺酮特性的经验证据，并尝试所有标准的抗抑郁药物治疗，从而将伤害患者的风险降至最低。
Depressive disorders are a common form of psychiatric illness and cause significant disability. Regulation authorities, the medical profession and the public require high safety standards for antidepressants to protect vulnerable psychiatric patients. Ketamine is a dissociative anaesthetic and a derivative of a hallucinogen (phencyclidine). Its abuse is a major worldwide public health problem. Ketamine is a scheduled drug and its usage is restricted due to its abuse liability. Recent clinical trials have reported that ketamine use led to rapid antidepressant effects in patients suffering from treatment-resistant depression. However, various flaws in study designs, and possible biased reporting of results, may have influenced those findings. Further analyses of ketamine use are needed to ensure patient safety. The use of ketamine in research and treatment of depressive disorders is controversial. Recently, mental health professionals raised ethical concerns about an ongoing ketamine trial in the UK. Also, a Canadian agency reviewed the existing evidence and did not recommend prescribing ketamine to treat depressive disorders. Findings obtained from tightly controlled research settings cannot be easily translated to clinical practice as substance abuse is commonly comorbid with depressive disorders. An effective antidepressant should reduce severity of depressive symptoms without liability problems. Although the US FDA has not approved the use of ketamine to treat depressive disorders, some psychiatrists offer off-label repeat prescription of ketamine. Prescribing ketamine for treating depressive disorders requires substantial empirical evidence. Clinicians should also consider research findings on ketamine abuse. Depressive disorders can be chronic conditions and the current evidence does not rule out the risk of substance abuse after repeat prescription of ketamine. Off-label ketamine use in treating depressive disorders may breach ethical and moral standards, especially in countries seriously affected by ketamine abuse. This article presents two real-world clinical vignettes which highlight ethical principles and theories, including autonomy, nonmaleficience, fidelity and consequentialism, as related to off-label ketamine use. We urge clinicians to minimise the risk of harming patients by considering the empirical evidence on ketamine properties and attempting all standard antidepressant therapies before considering the off-label use of ketamine.