Department of Philosophy and Religious Studies, Old Dominion University, Norfolk, VA 23529, USA.
Theor Med Bioeth. 2010 Apr;31(2):107-22. doi: 10.1007/s11017-010-9139-8.
Robert Truog describes the controversial randomized controlled trials (RCTs) of extracorporeal membrane oxygenation (ECMO) therapy in newborns. Because early results with ECMO indicated that it might be a great advance, saving many lives, Truog argues that ECMO should not have been tested using RCTs, but that a long-term, large-scale observational study of actual clinical practice should have been conducted instead. Central to Truog's argument, however, is the idea that ECMO is an unusual case. Thus, it is an open question whether Truog's conclusions can be extended to other areas of medical research. In this paper, I look at epistemological and ethical issues arising in the care of patients with chronic diseases, using ECMO as a starting point. Both the similarities and the dissimilarities of these two cases highlight important issues in biomedical research and support a conclusion similar to Truog's. Observational studies of clinical practice provide the best evidence to inform the treatment of patients with chronic disease.
罗伯特·特鲁格（Robert Truog）描述了体外膜氧合（ECMO）疗法在新生儿中的有争议的随机对照试验（RCT）。由于 ECMO 的早期结果表明它可能是一项重大进展，可以挽救许多生命，因此特鲁格认为，不应该使用 RCT 来测试 ECMO，而应该进行一项长期的、大规模的观察性研究，以实际的临床实践为研究对象。然而，特鲁格的论点的核心是 ECMO 是一个不寻常的案例。因此，特鲁格的结论是否可以推广到其他医学研究领域，这是一个悬而未决的问题。在本文中，我以 ECMO 为起点，探讨了在治疗慢性疾病患者时出现的认识论和伦理问题。这两个案例的相似之处和不同之处突出了生物医学研究中的重要问题，并支持了类似于特鲁格的结论。观察性临床实践研究为慢性疾病患者的治疗提供了最佳证据。
