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量化急性卒中院前快速治疗的益处:未来创新临床试验的基准

Quantifying the Benefit of Prehospital Rapid Treatment in Acute Stroke: Benchmark for Future Innovative Clinical Trials.

作者信息

Lorenz Matthias W, Lauer Arne, Foerch Christian

机构信息

From the Department of Neurology, University Hospital Frankfurt, Frankfurt/Main, Germany.

出版信息

Stroke. 2015 Nov;46(11):3168-76. doi: 10.1161/STROKEAHA.115.010445. Epub 2015 Oct 6.

Abstract

BACKGROUND AND PURPOSE

In acute ischemic stroke, time from onset to tissue-type plasminogen activator treatment (OTT) is a major determinant of outcome. To reduce OTT, clinical trials have been undertaken evaluating prehospital cerebral imaging with mobile computed tomographic scanners. Furthermore, blood biomarkers may allow rapid differentiation between ischemic stroke and intracerebral hemorrhage before hospital admission. How such treatment strategies translate into clinical benefit has not been specifically evaluated.

METHODS

We constructed decision models to estimate the net clinical benefit yielded by shorter OTT. In different scenarios, we estimated the proportion of patients with favorable outcome and the average quality of life.

RESULTS

An OTT reduction of 60 minutes increases the probability of favorable outcome by 6.6% in a mixed stroke population. For comparison, the average effect of tissue-type plasminogen activator itself is 7.0%. Prehospital mobile computed tomography gaining 25 to 40 minutes increases the probability of favorable outcome by 3.0% to 4.6%. The additional benefit of prehospital computed tomography to deliver patients with large vessel occlusion directly to endovascular treatment centers increases the probability of favorable outcome by another 0.2% to 1.0%. A blood test discriminating ischemic stroke and intracerebral hemorrhage may beneficially substitute brain scan before tissue-type plasminogen activator if >32 to 40 minutes are gained and if sensitivity for intracerebral hemorrhage is >75% to 80%.

CONCLUSIONS

Reducing the OTT has robust beneficial effects for acute stroke patients. Prehospital tissue-type plasminogen activator treatment without brain imaging may become conceivable under several preconditions, including a point-of-care test with >75% to 80% sensitivity to detect intracerebral hemorrhage and a time gain of >32 to 40 minutes. Ethical implications remain to be addressed.

摘要

背景与目的

在急性缺血性卒中中,从发病到组织型纤溶酶原激活剂治疗(OTT)的时间是预后的主要决定因素。为了缩短OTT,已开展临床试验评估使用移动计算机断层扫描仪进行院前脑成像。此外,血液生物标志物可能有助于在入院前快速区分缺血性卒中和脑出血。尚未对这些治疗策略如何转化为临床获益进行具体评估。

方法

我们构建决策模型以估计缩短OTT所产生的净临床获益。在不同场景下,我们估计了预后良好患者的比例和平均生活质量。

结果

在混合性卒中人群中,OTT缩短60分钟可使预后良好的概率提高6.6%。相比之下,组织型纤溶酶原激活剂本身的平均效果为7.0%。院前移动计算机断层扫描节省25至40分钟可使预后良好的概率提高3.0%至4.6%。院前计算机断层扫描将大血管闭塞患者直接送至血管内治疗中心的额外获益可使预后良好的概率再提高0.2%至1.0%。如果能够节省32至40分钟且对脑出血的敏感度>75%至80%,则一种区分缺血性卒中和脑出血的血液检测可能有益地替代在使用组织型纤溶酶原激活剂之前进行的脑部扫描。

结论

缩短OTT对急性卒中患者具有显著的有益效果。在包括对脑出血检测敏感度>75%至80%的即时检验以及节省>32至40分钟时间等若干前提下,院前不进行脑成像的组织型纤溶酶原激活剂治疗可能是可行的。伦理问题仍有待解决。

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