Bullock M R, Lyeth B G, Muizelaar J P
Division of Neurosurgery, Medical College of Virginia, Virginia Commonwealth University, Richmond, USA.
Neurosurgery. 1999 Aug;45(2):207-17; discussion 217-20. doi: 10.1097/00006123-199908000-00001.
Laboratory studies have identified numerous potential therapeutic interventions that might have clinical application for the treatment of human traumatic brain injury. Many of these therapies have progressed into human clinical trials in severe traumatic brain injury. Numerous trials have been completed, and many others have been prematurely terminated or are currently in various phases of testing. The results of the completed Phase III trials have been generally disappointing, compared with the expectations produced by the successes of these interventions in animal laboratory studies. In this review, we summarize the current status of human traumatic brain injury clinical trials, as well as the animal laboratory studies that led to some of these trials. We summarize criteria for conducting clinical trials in severe traumatic brain injury, with suggestions for future improvements. We also attempt to identify factors that might contribute to the discrepancies between animal and human trials, and we propose recommendations that could help investigators avoid certain pitfalls in future clinical trials in traumatic brain injury.
实验室研究已经确定了许多潜在的治疗干预措施，这些措施可能在人类创伤性脑损伤的治疗中具有临床应用价值。其中许多疗法已进入重度创伤性脑损伤的人体临床试验阶段。众多试验已经完成，还有许多试验被提前终止或目前正处于不同的测试阶段。与这些干预措施在动物实验室研究中的成功所产生的预期相比，已完成的III期试验结果总体上令人失望。在这篇综述中，我们总结了人类创伤性脑损伤临床试验的现状，以及促成其中一些试验的动物实验室研究情况。我们总结了重度创伤性脑损伤临床试验的开展标准，并提出了未来改进的建议。我们还试图找出可能导致动物试验和人体试验结果差异的因素，并提出一些建议，以帮助研究人员在未来的创伤性脑损伤临床试验中避免某些陷阱。
