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简单的风险指数和急性缺血性脑卒中的溶栓治疗反应。

A simple risk index and thrombolytic treatment response in acute ischemic stroke.

机构信息

Department of Neurosciences, Medical University of South Carolina, Charleston.

Department of Epidemiology and Biostatistics, Michigan State University, East Lansing.

出版信息

JAMA Neurol. 2014 Jul 1;71(7):848-54. doi: 10.1001/jamaneurol.2014.689.

DOI:10.1001/jamaneurol.2014.689
PMID:24798141
Abstract

IMPORTANCE

The Stroke Prognostication using Age and the NIH Stroke Scale index, created by combining age in years plus a National Institutes of Health (NIH) Stroke Scale score of 100 or higher (and hereafter referred to as the SPAN-100 index), is a simple risk score for estimating clinical outcomes for patients with acute ischemic stroke (AIS). The association between this index and response to intravenous thrombolysis for AIS has not been properly evaluated.

OBJECTIVE

To assess the relationship between SPAN-100 index status and outcome following treatment with intravenous thrombolysis for AIS.

DESIGN, SETTING, AND PARTICIPANTS: Using the Virtual International Stroke Trials Archive (VISTA) database, an international repository of clinical trials data, we assessed the SPAN-100 index among 7093 patients with AIS who participated in 4 clinical trials from 2000 to 2006. The SPAN-100 index is considered positive if the sum of the age and the NIH Stroke Scale (a 15-item neurological examination scale with scores ranging from 0 to 42, with higher scores indicating more severe strokes) score is greater than or equal to 100. Multivariable logistic regression analyses were used to determine the independent association between SPAN-100 index status and 90-day outcomes.

MAIN OUTCOMES AND MEASURES

The primary outcome was a composite of severe disability or death measured 90 days after stroke, and the secondary outcomes were death alone and a composite of no disability/modest disability.

RESULTS

Of 7093 patients, 743 (10.5%) were SPAN-100 positive, and 2731 (38.5%) received intravenous thrombolysis. Compared with SPAN-100-negative patients, SPAN-100-positive patients were more likely to experience a catastrophic outcome (adjusted odds ratio [AOR], 9.03 [95% CI, 6.68-12.21]) or death alone (AOR, 5.03 [95% CI, 4.06-6.23]) and less likely to experience a favorable outcome (AOR, 0.08 [95% CI, 0.06-0.13]). However, there was an interaction between SPAN-100 index status and thrombolysis treatment (P < .001) revealing a reduction in the likelihood of severe disability/death with thrombolytic treatment for SPAN-100-positive (AOR, 0.46 [95% CI, 0.29-0.71]) but not SPAN-100-negative patients (AOR, 0.96 [95% CI, 0.85-1.07]). Similar interactions between SPAN-100 index status and thrombolysis treatment were observed for the 2 secondary outcomes.

CONCLUSION AND RELEVANCE

Compared with the SPAN-100-negative patients with AIS, the SPAN-100-positive patients with AIS seem to have poorer 3-month outcomes but may derive greater benefit when treated with intravenous thrombolysis. The SPAN-100-positive patients are often excluded from AIS clinical trials but should probably not be denied thrombolysis treatment on the basis of such a profile alone.

摘要

重要性

由年龄加美国国立卫生研究院卒中量表(NIHSS)评分 100 或更高(以下简称 SPAN-100 指数)组成的卒中预后评分(Stroke Prognostication using Age and the NIH Stroke Scale index),是一种用于评估急性缺血性卒中(AIS)患者临床结局的简单风险评分。该指数与 AIS 患者静脉溶栓治疗的反应之间的关系尚未得到充分评估。

目的

评估 SPAN-100 指数状态与 AIS 患者接受静脉溶栓治疗后的结局之间的关系。

设计、设置和参与者:利用虚拟国际卒中试验档案(VISTA)数据库,该数据库是临床试验数据的国际存储库,我们评估了 7093 例 AIS 患者的 SPAN-100 指数,这些患者参加了 2000 年至 2006 年的 4 项临床试验。如果年龄和 NIHSS 评分(一项 15 项的神经学检查量表,评分范围为 0 至 42,得分越高表示卒中越严重)的总和大于或等于 100,则认为 SPAN-100 指数为阳性。采用多变量逻辑回归分析确定 SPAN-100 指数状态与 90 天结局之间的独立关联。

主要结局和测量指标

主要结局是卒中后 90 天的严重残疾或死亡的复合结局,次要结局是单独死亡和无残疾/轻度残疾的复合结局。

结果

在 7093 例患者中,743 例(10.5%)为 SPAN-100 阳性,2731 例(38.5%)接受了静脉溶栓治疗。与 SPAN-100 阴性患者相比,SPAN-100 阳性患者更有可能发生灾难性结局(调整后的优势比 [AOR],9.03 [95%CI,6.68-12.21])或单独死亡(AOR,5.03 [95%CI,4.06-6.23]),且更不可能获得良好结局(AOR,0.08 [95%CI,0.06-0.13])。然而,SPAN-100 指数状态和溶栓治疗之间存在交互作用(P < .001),提示对于 SPAN-100 阳性患者,溶栓治疗降低了严重残疾/死亡的可能性(AOR,0.46 [95%CI,0.29-0.71]),但对 SPAN-100 阴性患者无此作用(AOR,0.96 [95%CI,0.85-1.07])。对于这两个次要结局,也观察到了 SPAN-100 指数状态和溶栓治疗之间的类似交互作用。

结论和相关性

与 SPAN-100 阴性的 AIS 患者相比,SPAN-100 阳性的 AIS 患者似乎有更差的 3 个月结局,但接受静脉溶栓治疗可能会获益更大。SPAN-100 阳性患者通常被排除在 AIS 临床试验之外,但不应仅基于这样的特征就拒绝给予溶栓治疗。

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