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在埃博拉疫情期间,审视临床试验之外临床应用未经证实干预措施的伦理问题。

Examining the ethics of clinical use of unproven interventions outside of clinical trials during the Ebola epidemic.

机构信息

a Clinical Center Department of Bioethics, Division of AIDS, National Institutes of Health , Bethesda , Maryland , USA.

出版信息

Am J Bioeth. 2015;15(4):11-6. doi: 10.1080/15265161.2015.1010996.

DOI:10.1080/15265161.2015.1010996
PMID:25856592
Abstract

The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease (EVD), debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned with the interests of their providers and drug developers. Second, we focus on the resource constraints facing providers, funders, and patients and conclude that they often counsel against the use of unproven interventions against EVD.

摘要

最近在西非爆发的埃博拉疫情始于 2014 年春季,至今已造成 6000 多人死亡。由于目前尚无专门针对埃博拉病毒病 (EVD) 的经批准的治疗方法或预防方法,因此争议的焦点是是否应该在临床试验之外向埃博拉患者提供未经证实的干预措施。然而,参与辩论的人迅速对这一复杂和不断演变的危机做出了反应,这场辩论并没有为深入分析提供太多机会。此外,关于获得未经证实疗法的现有文献主要集中在艾滋病毒/艾滋病和肿瘤学等领域,这些领域与埃博拉疫情有很大的不同。在本文中,我们将在最近的埃博拉疫情背景下探讨获得未经证实疗法的伦理问题,以对这一有争议且尚未解决的问题产生新的见解。我们首先认为,在这种情况下,患者获得未经证实的疗法的利益与他们的提供者和药物开发商的利益不完全一致。其次,我们重点关注提供者、资助者和患者面临的资源限制,并得出结论,他们经常不建议使用未经证实的干预措施来对抗 EVD。

相似文献

1
Examining the ethics of clinical use of unproven interventions outside of clinical trials during the Ebola epidemic.在埃博拉疫情期间,审视临床试验之外临床应用未经证实干预措施的伦理问题。
Am J Bioeth. 2015;15(4):11-6. doi: 10.1080/15265161.2015.1010996.
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Placing and evaluating unproven interventions within a clinical ethical taxonomy of treatments for Ebola virus disease.将未经证实的干预措施纳入埃博拉病毒病治疗的临床伦理分类法并进行评估。
Am J Bioeth. 2015;15(4):50-3. doi: 10.1080/15265161.2015.1009567.
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In particular circumstances attempting unproven interventions is permissible and even obligatory.在特定情况下,尝试未经证实的干预措施是允许的,甚至是必要的。
Am J Bioeth. 2015;15(4):53-5. doi: 10.1080/15265161.2015.1009566.
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The Ebola clinical trials: a precedent for research ethics in disasters.埃博拉临床试验:灾难研究伦理学的先例。
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Everyday ethics and Ebola: planning for the unlikely.日常伦理与埃博拉:为不太可能发生的情况做准备。
Am J Bioeth. 2015;15(4):68-70. doi: 10.1080/15265161.2015.1010020.
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Ethical challenges posed by the Ebola virus epidemic in West Africa.西非埃博拉病毒疫情引发的伦理挑战。
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Ethical allocation of drugs and vaccines in the West African ebola epidemic.西非埃博拉疫情中药物和疫苗的伦理分配
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Ethical considerations in the conduct of research on therapies for the prevention and treatment of Ebola virus disease in developing countries.在发展中国家开展埃博拉病毒病预防和治疗疗法研究中的伦理考量
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What clinicians should know about the 2014 Ebola outbreak.临床医生应该了解的2014年埃博拉疫情。
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Ebola virus in West Africa: waiting for the owl of Minerva.西非的埃博拉病毒:等待密涅瓦的猫头鹰。
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The Ebola clinical trials: a precedent for research ethics in disasters.埃博拉临床试验:灾难研究伦理学的先例。
J Med Ethics. 2018 Jan;44(1):3-8. doi: 10.1136/medethics-2016-103474. Epub 2016 Aug 29.
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Ethical considerations surrounding the response to Ebola: the Spanish experience.埃博拉应对中的伦理考量:西班牙的经验
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