蛛网膜下腔出血恢复和加兰他明:一项多中心随机安慰剂对照试验。

IF 3.6 3区 医学 Q2 CLINICAL NEUROLOGY
Bosco Seong Kyu Yang, Jude P J Savarraj, Elena Moreno, Kevin E Immanuel, Georgene Hergenroeder, Glenda Torres, Jung Hwan Kim, Sophie Samuel, Claudia Pedroza, James C Grotta, Andrew Barreto, H Alex Choi
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引用次数: 0

摘要

背景:蛛网膜下腔出血(SAH)导致终身神经功能障碍。外周炎症过程作为脑损伤的反应已被证明会使SAH后的预后恶化。加兰他明已被证明可以减少促炎小胶质细胞活动并改善突触连接。我们假设在SAH后加兰他明治疗可以减轻炎症介导的神经元损伤并改善预后。我们进行了一项试点临床试验,以检查加兰他明对SAH患者的耐受性和安全性。方法:这项前瞻性、多中心、双盲、随机、安慰剂对照研究连续筛选和入组了在症状出现72小时内出现Fisher分级为3的动脉瘤性SAH的成年患者。共有60名患者以1:1的比例入组两个治疗组。前30名患者被随机分配接受每12小时8毫克的加兰他明或安慰剂治疗,另外30名患者被随机分配接受每12小时12毫克的加兰他明或安慰剂治疗。所有药物在固定动脉瘤后36小时内开始,并持续90天。主要结局——耐受性(通过因研究药物相关的不良事件而停止研究药物的患者数量和研究药物导致的死亡率来评估)在90天进行评估。结果:两组患者的耐受性和安全性均无差异。心动过缓是最常见的不良事件(37%),其次是临床癫痫发作(3%)和皮疹(3%)。加兰他明组的一名研究参与者因皮疹停药,安慰剂组的另一名研究参与者因恶心停药(p = 0.92)。两组之间的死亡率没有差异。在第90天,加兰他明组的一名研究参与者和安慰剂组的四名研究参与者死亡(p = 0.34)。结论:基于在SAH早期和亚急性期给予SAH患者的停药率和死亡率,加兰他明与安慰剂一样可耐受且安全。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
SAHRANG: Subarachnoid Hemorrhage Recovery and Galantamine: A Pilot Multicenter Randomized Placebo-Controlled Trial.

Background: Subarachnoid hemorrhage (SAH) causes life-long neurologic dysfunction. Peripheral inflammatory processes as a reaction to brain injury have been shown to worsen outcomes after SAH. Galantamine has been shown to reduce proinflammatory microglial activities and improve synaptic connections. We hypothesize that galantamine treatment after SAH mitigates inflammation-mediated neuronal injury and improve outcomes. We conducted a pilot clinical trial to examine the tolerability and safety of galantamine in patients with SAH.

Methods: This prospective, multicenter, double-masked, randomized, placebo-controlled study contiguously screened and enrolled adult patients presenting with aneurysmal SAH with a Fisher grade of 3 within 72 h of symptom onset. A total of 60 patients were enrolled with a 1:1 ratio to two treatment arms. The first 30 patients were randomly assigned to receive galantamine at 8 mg every 12 h or a placebo, and the other 30 patients to were randomly assigned to receive either galantamine at 12 mg every 12 h or a placebo. All medications were started within 36 h after securing the aneurysm and continued for 90 days. Primary outcomes-tolerability as assessed by the number of patients who stop study medication due to adverse events associated with the study drug and mortality due to the study drug-were assessed at 90 days.

Results: There were no differences in tolerability and safety between the two groups. Bradycardia was the most common adverse event (37%), followed by clinical seizure (3%) and skin rash (3%). One study participant in the galantamine group discontinued medication due to a skin rash, and another study participant from the placebo group discontinued due to nausea (p = 0.92). Mortality did not differ between the two groups. At 90 days, one study participant from the galantamine group and four study participants from the placebo group died (p = 0.34).

Conclusions: Galantamine was as tolerable and safe as a placebo based on discontinuation rates and mortality in patients with SAH when administered to patients with SAH during the early and subacute stages of the disease.

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来源期刊
Neurocritical Care
Neurocritical Care 医学-临床神经学
CiteScore
7.40
自引率
8.60%
发文量
221
审稿时长
4-8 weeks
期刊介绍: Neurocritical Care is a peer reviewed scientific publication whose major goal is to disseminate new knowledge on all aspects of acute neurological care. It is directed towards neurosurgeons, neuro-intensivists, neurologists, anesthesiologists, emergency physicians, and critical care nurses treating patients with urgent neurologic disorders. These are conditions that may potentially evolve rapidly and could need immediate medical or surgical intervention. Neurocritical Care provides a comprehensive overview of current developments in intensive care neurology, neurosurgery and neuroanesthesia and includes information about new therapeutic avenues and technological innovations. Neurocritical Care is the official journal of the Neurocritical Care Society.
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