Department of Medical Ethics, Faculty of Medicine, Ankara University, Ankara, Turkey.
J Med Ethics. 2012 Feb;38(2):117-20. doi: 10.1136/medethics-2011-100107. Epub 2011 Oct 12.
The randomised controlled trial (RCT) constitutes a quantitative, comparative, controlled study of a particular treatment, and provides invaluable evidence regarding its pharmacotherapeutic efficacy. These studies are generally predicated upon the ethical principle of clinical equipoise. However, this may be insufficient to justify withholding treatment from a control group while assessing drug therapy in a potentially fatal disease. Thus, the criteria for randomisation, informed consent methodology and timing, and consideration of treatment options in such a scenario remain the province of medical ethics. This paper addresses the need for an RCT of ribavirin in the treatment of Crimean Congo haemorrhagic fever, and highlights underlying ethical concerns in light of the current medical, virological and ethical literature.
随机对照试验（RCT）是对特定治疗方法的一种定量、对比、对照研究，为其药物治疗效果提供了宝贵的证据。这些研究通常基于临床平衡的伦理原则。然而，在评估潜在致命疾病的药物治疗时，这可能不足以证明对对照组不进行治疗是合理的。因此，随机分组的标准、知情同意方法和时机，以及在这种情况下对治疗方案的考虑仍然是医学伦理学的范畴。本文针对克里米亚-刚果出血热的利巴韦林治疗进行了 RCT 的必要性，并根据当前的医学、病毒学和伦理学文献，强调了其中存在的伦理问题。
