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头低位倾斜 15°在实验性脑出血中的应用:一项随机非劣效安全性试验。

Head down tilt 15° in experimental intracerebral hemorrhage: a randomized noninferiority safety trial.

机构信息

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.

Department of Neuroscience, ASST Monza, San Gerardo Hospital, Monza, Italy.

出版信息

Eur J Neurol. 2021 Feb;28(2):525-531. doi: 10.1111/ene.14560. Epub 2020 Oct 25.

DOI:10.1111/ene.14560
PMID:32986293
Abstract

BACKGROUND AND PURPOSE

Head down tilt 15° (HDT15°), applied before recanalization, increases collateral flow and improves outcome in experimental ischemic stroke. For its simplicity and low cost, HDT15° holds considerable potential to be developed as an emergency treatment of acute stroke in the prehospital setting, where hemorrhagic stroke is the major mimic of ischemic stroke. In this study, we assessed safety of HDT15° in the acute phase of experimental intracerebral hemorrhage.

METHODS

Intracerebral hemorrhage was produced by stereotaxic injection of collagenase in Wistar rats. A randomized noninferiority trial design was used to assign rats to HDT15° or flat position (n = 64). HDT15° was applied for 1 h during the time window of hematoma expansion. The primary outcome was hematoma volume at 24 h. Secondary outcomes were mass effect, mortality, and functional deficit in the main study and acute changes of intracranial pressure, hematoma growth, and cardiorespiratory parameters in separate sets of randomized animals (n = 32).

RESULTS

HDT15° achieved the specified criteria of noninferiority for hematoma volume at 24 h. Mass effect, mortality, and functional deficit at 24 h showed no difference in the two groups. HDT15° induced a mild increase in intracranial pressure with respect to the pretreatment values (+2.91 ± 1.76 mmHg). HDT15° had a neutral effect on MRI-based analysis of hematoma growth and cardiorespiratory parameters.

CONCLUSIONS

Application of HDT15° in the hyperacute phase of experimental intracerebral hemorrhage does not worsen early outcome. Further research is needed to implement HDT15° as an emergency collateral therapeutic for acute stroke.

摘要

背景与目的

头低位倾斜 15°(HDT15°)在再通前应用可增加侧支血流并改善实验性缺血性卒中的预后。由于其简单性和低成本,HDT15°在院前环境中作为急性卒中的紧急治疗具有相当大的潜力,其中出血性卒中是缺血性卒中的主要模拟。在本研究中,我们评估了 HDT15°在实验性脑出血急性期的安全性。

方法

通过立体定向注射胶原酶在 Wistar 大鼠中产生脑出血。采用随机非劣效性试验设计将大鼠分为 HDT15°或平卧位(n=64)。HDT15°在血肿扩大的时间窗内应用 1 小时。主要结局是 24 小时时的血肿体积。次要结局是主要研究中的质量效应、死亡率和功能缺陷,以及在另一组随机动物(n=32)中急性颅内压变化、血肿生长和心肺参数的变化。

结果

HDT15°在 24 小时时达到了血肿体积的非劣效性指定标准。两组在 24 小时时的质量效应、死亡率和功能缺陷无差异。HDT15°引起颅内压相对于预处理值轻微升高(+2.91±1.76mmHg)。HDT15°对 MRI 分析的血肿生长和心肺参数无影响。

结论

在实验性脑出血的超急性期应用 HDT15°不会加重早期预后。需要进一步研究将 HDT15°作为急性卒中的紧急侧支治疗。

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