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颅内动脉瘤性蛛网膜下腔出血后腰椎引流脑脊液:一项前瞻性、随机、对照试验(LUMAS)。

Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

机构信息

Department of Neurosurgery, Level G Jubilee Wing, Leeds General Infirmary, Great George Street, Leeds, West Yorkshire, UK LS1 3EX.

出版信息

Stroke. 2012 Mar;43(3):677-82. doi: 10.1161/STROKEAHA.111.625731. Epub 2012 Jan 26.

Abstract

BACKGROUND AND PURPOSE

A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome.

METHODS

Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit.

RESULTS

Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively).

CONCLUSIONS

Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage.

CLINICAL TRIAL REGISTRATION

URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

摘要

背景与目的

本研究开展了一项单中心前瞻性随机对照试验,旨在确定蛛网膜下腔出血后腰椎引流脑脊液是否能降低迟发性缺血性神经功能缺损的发生率,并改善临床结局。

方法

本研究纳入 WFNS 分级 1-3 级和改良 Fisher 分级 2、3、4 和 3+4 级的蛛网膜下腔出血患者,将其随机分配至标准治疗加腰椎引流组(研究组,n=105)或标准治疗组(对照组,n=105)。主要结局指标为迟发性缺血性神经功能缺损的发生率。

结果

共 210 例蛛网膜下腔出血患者(女性 166 例,男性 44 例;中位年龄 54 岁,四分位间距 45-62 岁)被纳入该研究的对照组(n=105)和研究组(n=105)。WFNS 分级为:1 级(n=139),2 级(n=60),3 级(n=11);改良 Fisher 分级为:2 级(n=87),3 级(n=85),4 级(n=38)。对照组和研究组的迟发性缺血性神经功能缺损发生率分别为 35.2%和 21.0%(P=0.021)。对照组和研究组在第 10 天及第 6 个月时改良 Rankin 量表评分 4、5 或 6 分的发生率分别为 62.5%和 18.6%(P=0.009)和 44.8%和 19.8%(P=0.83)。

结论

蛛网膜下腔出血后腰椎引流可降低迟发性缺血性神经功能缺损的发生率,改善早期临床结局,但未能改善蛛网膜下腔出血后 6 个月的结局。

临床试验注册

网址:www.clinicaltrials.gov。唯一识别码:NCT00842049。

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