Kompanje Erwin J O
Department of Intensive Care, Erasmus MC University Medical Center Rotterdam, P.O. Box 2040, Rotterdam, 3000 CA, The Netherlands.
Sci Eng Ethics. 2007 Sep;13(3):371-81. doi: 10.1007/s11948-007-9027-4.
Severe Traumatic Brain Injury (TBI) remains a major cause of death and disability afflicting mostly young adult males and elderly people, resulting in high economic costs to society. Therapeutic approaches focus on reducing the risk on secondary brain injury. Specific ethical issues pertaining in clinical testing of pharmacological neuroprotective agents in TBI include the emergency nature of the research, the incapacity of the patients to informed consent before inclusion, short therapeutic time windows, and a risk-benefit ratio based on concept that in relation to the severity of the trauma, significant adverse side effects may be acceptable for possible beneficial treatments. Randomized controlled phase III trials investigating the safety and efficacy of agents in TBI with promising benefit, conducted in acute emergency situations with short therapeutic time windows, should allow randomization under deferred consent or waiver of consent. Making progress in knowledge of treatment in acute neurological and other intensive care conditions is only possible if national regulations and legislations allow waiver of consent or deferred consent for clinical trials.
重度创伤性脑损伤（TBI）仍然是导致死亡和残疾的主要原因，主要影响青壮年男性和老年人，给社会带来高昂的经济成本。治疗方法侧重于降低继发性脑损伤的风险。在TBI中进行药理学神经保护剂临床试验所涉及的特定伦理问题包括研究的紧急性质、患者在纳入研究前无法给予知情同意、治疗时间窗短，以及基于这样一种概念的风险效益比，即相对于创伤的严重程度而言，可能的有益治疗所带来的显著不良副作用也许是可以接受的。在治疗时间窗短的急性紧急情况下进行的、旨在研究TBI中具有潜在益处的药物安全性和有效性的随机对照III期试验，应允许在延迟同意或放弃同意的情况下进行随机分组。只有国家法规允许在临床试验中放弃同意或延迟同意，才有可能在急性神经科和其他重症监护疾病的治疗知识方面取得进展。
