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在促进中风恢复药物临床试验中采用特定模态结局指标的理由。

The case for modality-specific outcome measures in clinical trials of stroke recovery-promoting agents.

作者信息

Cramer Steven C, Koroshetz Walter J, Finklestein Seth P

机构信息

Department of Neurology, University of California, Irvine, CA, USA.

出版信息

Stroke. 2007 Apr;38(4):1393-5. doi: 10.1161/01.STR.0000260087.67462.80. Epub 2007 Mar 1.

Abstract

Clinical trials for acute stroke treatments have often used composite clinical rating scales as primary outcome measures of treatment efficacy. Recent preclinical and clinical studies highlight the opportunity to administer treatments in the subacute and chronic phase of stroke to promote neurological recovery. Because different neurological deficits recover to different extents at different rates after stroke, putative stroke recovery-promoting treatments may exert differential effects on various functional aspects of stroke recovery. For this reason, we propose that the use of modality-specific outcome measures may be best suited as primary end points in clinical trials of stroke recovery-promoting agents. The use of such end points may result in a more selective labeling of stroke recovery treatments.

摘要

急性中风治疗的临床试验通常使用综合临床评分量表作为治疗效果的主要衡量指标。最近的临床前和临床研究强调了在中风亚急性期和慢性期进行治疗以促进神经恢复的机会。由于中风后不同的神经功能缺损以不同的速度恢复到不同的程度,假定的促进中风恢复的治疗可能对中风恢复的各个功能方面产生不同的影响。因此,我们建议使用特定模态的结果测量方法可能最适合作为促进中风恢复药物临床试验的主要终点。使用这些终点可能会使中风恢复治疗的标签更具选择性。

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