Zhang Melvyn W, Harris Keith M, Ho Roger C
National Addiction Management Service, Institute of Mental Health, 10 Buangkok Green Medical Park, 539 747, Singapore, Singapore.
School of Psychology, University of Queensland, Queensland, Australia.
BMC Med Ethics. 2016 Jan 14;17:4. doi: 10.1186/s12910-016-0087-3.
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.
抑郁症是一种常见的精神疾病形式，会导致严重的残疾。监管机构、医学界和公众要求抗抑郁药物具备高安全标准，以保护脆弱的精神疾病患者。氯胺酮是一种解离麻醉剂，是一种致幻剂（苯环己哌啶）的衍生物。其滥用是一个全球性的重大公共卫生问题。氯胺酮是一种受管制药物，因其滥用可能性而使用受限。最近的临床试验报告称，氯胺酮的使用在难治性抑郁症患者中产生了快速的抗抑郁效果。然而，研究设计中的各种缺陷以及可能存在的结果报告偏差，可能影响了这些发现。需要对氯胺酮的使用进行进一步分析以确保患者安全。
氯胺酮在抑郁症研究和治疗中的使用存在争议。最近，心理健康专业人员对英国正在进行的一项氯胺酮试验提出了伦理担忧。此外，一家加拿大机构审查了现有证据，不建议开氯胺酮治疗抑郁症。在严格控制的研究环境中获得的结果不易转化为临床实践，因为药物滥用通常与抑郁症合并存在。一种有效的抗抑郁药应减轻抑郁症状的严重程度且不存在滥用问题。尽管美国食品药品监督管理局尚未批准使用氯胺酮治疗抑郁症，但一些精神科医生会提供氯胺酮的非标签重复处方。开氯胺酮治疗抑郁症需要大量的实证证据。临床医生还应考虑关于氯胺酮滥用的研究结果。抑郁症可能是慢性病，目前的证据并不排除氯胺酮重复处方后药物滥用的风险。氯胺酮在治疗抑郁症中的非标签使用可能违反伦理和道德标准，尤其是在受氯胺酮滥用严重影响的国家。本文呈现了两个真实世界的临床案例，突出了与氯胺酮非标签使用相关的伦理原则和理论，包括自主性、不伤害原则、忠诚原则和结果论。
我们敦促临床医生通过考虑氯胺酮特性的实证证据，并在考虑氯胺酮非标签使用之前尝试所有标准抗抑郁疗法，将伤害患者的风险降至最低。
