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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Optimal Outcome Measures for Detecting Clinical Benefits of Early Reperfusion: Insights from the DEFUSE Study
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Optimal Outcome Measures for Detecting Clinical Benefits of Early Reperfusion: Insights from the DEFUSE Study

机译：检测早期再灌注临床获益的最佳结果指标：DEFUSE研究的启示

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Background: There is no consensus regarding which clinical outcome scales are the most sensitive indicators of early reperfusion in patients with acute stroke. Methods: Patients with acute stroke enrolled in the Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution (DEFUSE) study with a perfusion-/diffusion-weighted imaging mismatch at baseline magnetic resonance imaging were studied. Prespecified secondary outcome measures were evaluated at both 30 and 90 days after treatment with intravenous tissue plasminogen activator. A nonpara-metric recursive partitioning algorithm was also used to identify the optimal dichot-omous splits for differentiating patients who experienced early reperfusion from those who did not. Results: In all, 34 of the 74 patients enrolled in DEFUSE met the inclusion criteria for this study. Statistically significant benefits of reperfusion were documented on multiple outcome measures. The most powerful predefined outcome measure was improvement in the National Institutes of Health Stroke Scale (NIHSS) score of greater than or equal to 11 points between baseline and day 90 and/ or a day-90 NIHSS score of 0 to 1 (odds ratio 22.5, P = .0021). The recursive partitioning algorithm analysis identified an improvement of greater than or equal to 10 on the NIHSS score between baseline and 30 days and an NIHSS score of less than or equal to 2 at 30 days as optimal end points. Conclusions: For patients with stroke and a perfusion-/diffusion-weighted imaging mismatch treated with intravenous tissue plasminogen activator at 3 to 6 hours, a substantial change in the baseline NIHSS score (>=10 points) is a potent discriminator of patients who experience early reperfusion from those who do not. In addition, an NIHSS score of less than or equal to 2 appears to be an excellent end point for phase II studies of reperfusion therapies.
机译：背景：关于哪些临床结果量表是急性中风患者早期再灌注的最敏感指标，目前尚无共识。方法：研究了在基线磁共振成像中采用弥散/弥散加权成像不匹配的扩散和灌注成像评估以了解中风演变（DEFUSE）研究的急性中风患者。在用静脉内组织纤溶酶原激活剂治疗后的30天和90天，评估了预定的次要结局指标。还使用非参数递归分区算法来识别最佳二分法拆分，以区分经历早期再灌注的患者和未经历早期再灌注的患者。结果：参加DEFUSE的74例患者中，有34例符合本研究的纳入标准。在多种结果测量中记录了再灌注的统计学显着优势。最有效的预定义结局指标是美国国立卫生研究院卒中量表（NIHSS）得分在基线与第90天和/或90天NIHSS得分之间的比值大于或等于11，为0比1（比值22.5） ，P = .0021）。递归分区算法分析确定了基线和30天之间NIHSS得分大于或等于10的改进，以及30天时NIHSS得分小于或等于2的改进为最佳终点。结论：对于中风并在3至6小时用静脉内纤溶酶原激活剂治疗的灌注/弥散加权成像不匹配的患者，基线NIHSS评分（> = 10分）的实质性变化是有经验患者的有效区分因素那些没有的早期再灌注。此外，NIHSS评分小于或等于2似乎是再灌注治疗II期研究的理想终点。

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