Why do neuroprotective drugs work in animals but not humans?
Why do neuroprotective drugs work in animals but not humans?
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DOI：
10.1016/s0733-8619(05)70203-6
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发表时间：
2000-05-01
影响因子：
2.4
通讯作者：
Pettigrew, LC
中科院分区：
文献类型：
--
作者：
DeGraba, TJ;Pettigrew, LC
许多在缺血性脑损伤动物研究中看起来很有希望的神经保护药物在临床试验中被证明没有效果，这表明转化研究的基本要素需要更好的定义。由于早期的对照试验未能证实动物数据提出的假设，许多修改导致了临床前和人体研究的改进。持续的重新评估和共享来自实验室工作台或患者床边的信息，最终应导致急性卒中中有效的神经保护。应该仔细研究实验数据，以提高进入临床试验的药物的质量，并设计有效确定药物安全性和有效性的试验阶段。本文将探讨临床前建模及其对急性卒中治疗的前瞻性研究的转化，并将重点放在针对临床试验设计的一些潜在解决方案上。
Many neuroprotective agents that seemed promising in animal studies of ischemic brain injury prove to have no effect when tested in clinical trials, suggesting that fundamental elements of translational research require better definition. A number of modifications have led to improvements in preclinical and human studies since the earliest controlled trials failed to confirm hypotheses suggested by animal data. Continued re-evaluation and sharing of information derived from the laboratory bench or the patient's bedside should eventually lead to effective neuroprotection in acute stroke. Experimental data should be carefully studied to improve the quality of agents coming to clinical trials and to design trial phasing that effectively determines drug safety and efficacy. This article will examine preclinical modeling and its translation to prospective studies of acute stroke therapy and will focus on some potential solutions directed at clinical trial design.