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溶栓治疗的急性缺血性卒中患者早期强化降压对脑灌注参数影响的随机试验的原理与设计

Rationale and design of a randomized trial of early intensive blood pressure lowering on cerebral perfusion parameters in thrombolysed acute ischemic stroke patients.

作者信息

Sharma Vijay K, Tan Benjamin Y Q, Sim M Ying, Kulkarni Amit, Seow Philip A, Hong Chiew S, Du Zhengdao, Wong Lily Y H, Chen Jintao, Chee Elaine Y H, Ng Bridget S M, Low Yingliang, Ngiam Nicholas J H, Yeo Leonard L L, Teoh Hock L, Paliwal Prakash R, Rathakrishnan Rahul, Sinha Arvind K, Chan Bernard P L, Butcher Kenneth, Anderson Craig S

机构信息

Division of Neurology, Department of Medicine, National University Health System.

Yong Loo Lin School of Medicine, National University of Singapore.

出版信息

Medicine (Baltimore). 2018 Oct;97(40):e12721. doi: 10.1097/MD.0000000000012721.

DOI:10.1097/MD.0000000000012721
PMID:30290680
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6200458/
Abstract

BACKGROUND AND RATIONALE

Uncertainty persists over the optimal management of blood pressure (BP) in the early phase of acute ischemic stroke (AIS). This study aims to determine the safety and effects of intensive BP lowering on cerebral blood flow (CBF) and functional in AIS patients treated with intravenous thrombolysis.

METHODS

In a randomized controlled trial, 54 thrombolysed AIS patients with a systolic BP of 160 to 180 mm Hg will be randomized to early intensive BP lowering (systolic target range 140-160 mm Hg) or guideline-based BP management (systolic range 160-180 mm Hg) during first 72-hours using primarily intravenous labetalol. We hypothesize that early intensive BP lowering will not reduce CBF by 20% and/or increase the volume of hypoperfused tissue by >20% on computed tomographic perfusion. Clinical outcome will be assessed using a dichotomized modified Rankin scale (scores 0-1 as excellent outcome vs scores 2-6 as dead or dependent) at 90 days. Other outcome would be symptomatic intracerebral hemorrhage. The trial is registered at ClinicalTrials.gov, NCT03443596.

CONCLUSION

This randomized study will provide important information about the physiological effects of BP reduction on cerebral perfusion after intravenous thrombolysis in AIS.

摘要

背景与理论依据

急性缺血性卒中(AIS)早期血压(BP)的最佳管理仍存在不确定性。本研究旨在确定强化降压对接受静脉溶栓治疗的AIS患者脑血流量(CBF)和功能的安全性及影响。

方法

在一项随机对照试验中,54例收缩压为160至180 mmHg的溶栓AIS患者将被随机分为两组,在最初72小时内分别接受早期强化降压(收缩压目标范围140 - 160 mmHg)或基于指南的血压管理(收缩压范围160 - 180 mmHg),主要使用静脉注射拉贝洛尔。我们假设早期强化降压不会使脑血流量减少20%,和/或在计算机断层扫描灌注时使灌注不足组织体积增加超过20%。90天时将使用二分法改良Rankin量表(评分0 - 1为良好预后,评分2 - 6为死亡或依赖)评估临床结局。其他结局为症状性脑出血。该试验已在ClinicalTrials.gov注册,注册号为NCT03443596。

结论

这项随机研究将提供关于AIS静脉溶栓后血压降低对脑灌注生理影响的重要信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43d1/6200458/1cbdb1e0f8e1/medi-97-e12721-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43d1/6200458/1cbdb1e0f8e1/medi-97-e12721-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43d1/6200458/1cbdb1e0f8e1/medi-97-e12721-g003.jpg

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