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人类临床精神药理学中的伦理问题:关注点应该是安慰剂给药吗?

Ethical questions in human clinical psychopharmacology: should the focus be on placebo administration?

作者信息

Kotzalidis Gd, Pacchiarotti I, Manfredi G, Savoja V, Torrent C, Mazzarini L, Tatarelli C, Amann B, Di Marzo S, Sánchez-Moreno J, Sani G, Girardi P, Colom F, Vieta E

机构信息

Department of Psychiatry, Sant'Andrea Hospital, La Sapienza University, Rome, Italy.

出版信息

J Psychopharmacol. 2008 Aug;22(6):590-7. doi: 10.1177/0269881108089576. Epub 2008 May 30.

Abstract

Of all ethical issues in clinical trial designs, only placebo use is dealt with acrimony and unwarranted, rhetoric emphasis. Many misconceptions are biased and may hamper research in the mechanisms of healing and recovery if placebo is banned from clinical trials, as some influential ethicists propose. Current treatments in psychiatry are by no means optimal and may vary in their effect across studies, rendering difficult to find the best available therapeutic method with which to compare new drugs. Because drugs possess specific mechanisms, it is not possible to compare drugs with different mechanisms as to their relevance in the pathophysiology of a given disorder. Placebo acts through non-specific mechanisms and is the ideal control for any disorder whose pathophysiology is relatively unknown and its treatment is still suboptimal. Sticking to short-term patient benefit in a trial reflects an individualistically oriented thinking in contemporary ethics and is likely to limit further research and efforts to better understand the mechanisms of disease and drug action, but also those related to general body reactance and self-healing, which are enhanced by placebo administration. Because in history ethics are swinging between two opposed views, it is possible that in the near future, the balance will move towards communitarianism, which is more likely to better serve long-term patient needs. Ethicists should also consider some other aspects of human experimentation, such as the consistency of research lines and the trend to substitute older drugs with their metabolites or enantiomers.

摘要

在临床试验设计中的所有伦理问题中,只有安慰剂的使用受到了激烈且毫无根据的、言辞上的过度强调。许多误解存在偏差,如果像一些有影响力的伦理学家提议的那样,在临床试验中禁止使用安慰剂,可能会阻碍对治愈和康复机制的研究。目前精神病学的治疗方法绝非最佳,而且不同研究中的效果可能存在差异,这使得很难找到可用于与新药进行比较的最佳治疗方法。由于药物具有特定机制,对于不同机制的药物,无法就其在特定疾病病理生理学中的相关性进行比较。安慰剂通过非特异性机制起作用,对于任何病理生理学相对未知且治疗仍不理想的疾病来说,它都是理想的对照。在试验中坚持短期患者受益反映了当代伦理学中以个人主义为导向的思维方式,这可能会限制进一步的研究以及更好地理解疾病和药物作用机制的努力,也会限制与一般身体反应和自我修复相关的研究,而安慰剂给药会增强这些反应。由于历史上伦理学一直在两种对立观点之间摇摆,在不久的将来,天平有可能会向社群主义倾斜,社群主义更有可能更好地满足患者的长期需求。伦理学家还应考虑人体实验的其他一些方面,比如研究路线的一致性以及用药物的代谢物或对映体替代旧药的趋势。

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