急性缺血性卒中的细胞保护:近期临床试验的批判性评价。
摘要
最近已完成了几项测试细胞保护方法的III期临床试验,其中许多研究报告了临床获益。根据这些试验的具体设计审查其结果,揭示了令人关注的结果。采用较短治疗时间窗(≤24小时)且以高再通治疗率为特征的试验设计,主要显示中性结果,即无治疗获益。…
正文 待译
Several phase III clinical trials testing cytoprotective approaches have recently been completed, and many of these studies report a clinical benefit. Reviewing the outcomes of these trials in light of their specific designs reveals intriguing results. Trials designed with shorter treatment time windows (≤24 hours) and featuring high rates of recanalization therapies predominantly show neutral outcomes, that is, no therapeutic benefit. Studies using later time points (>24 hours to 14 days) and often enrolling patients in whom recanalization is not or only infrequently established show clear treatment effects. These results challenge our current understanding of cytoprotective approaches, which are believed to primarily target the penumbra as the key to therapeutic success. The reasons for this are unclear. They may include other, potentially unknown mechanisms of action that improve clinical outcome even when applied within longer time windows rather than exerting acute cytoprotection. Here, we discuss such potential mechanisms, to what extent they could explain the results of recent cytoprotection trials, and review consequences for future translational and clinical research.
English
Several phase III clinical trials testing cytoprotective approaches have recently been completed, and many of these studies report a clinical benefit. Reviewing the outcomes of these trials in light of their specific designs reveals intriguing results. Trials designed with shorter treatment time windows (≤24 hours) and featuring high rates of recanalization therapies predominantly show neutral outcomes, that is, no therapeutic benefit.…