Effects of 0.6 mg/kg Intravenous Alteplase on Vascular and Clinical Outcomes in Middle Cerebral Artery Occlusion Japan Alteplase Clinical Trial II (J-ACT II)
Effects of 0.6 mg/kg Intravenous Alteplase on Vascular and Clinical Outcomes in Middle Cerebral Artery Occlusion Japan Alteplase Clinical Trial II (J-ACT II)
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DOI：
10.1161/strokeaha.109.573477
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发表时间：
2010-03-01
期刊：
影响因子：
8.3
通讯作者：
Hirano, Teruyuki
中科院分区：
文献类型：
--
作者：
Mori, Etsuro;Minematsu, Kazuo;Hirano, Teruyuki
背景和目的-本研究的目的是在一项前瞻性队列研究设计的上市后IV期试验中进一步评估0.6 mg/kg静脉注射阿替普酶对大脑中动脉闭塞患者血管和临床结局的疗效。大脑中动脉闭塞根据改良的Mori分级，在症状发作后6小时和24小时通过MR血管造影评价血管结局。主要终点还包括良好的结局（发病后3个月时改良兰金量表评分为0 - 1）和治疗后36小时内症状性颅内出血的发生率。血管再通对临床结果的影响通过逐步逻辑回归分析进行评估。6小时MR血管造影和24小时MR血管造影的再通率分别为51.7%和69.0%。46.6%的患者获得了良好的临床结局。无症状性颅内出血。在logistic回归模型中，6小时或24小时MR血管造影的再通是临床结局以及基线国立卫生研究院卒中量表score. Conclusions的独立预测因子，早期再通闭塞的大脑中动脉可以引起0.6 mg/kg静脉注射阿替普酶，并可能诱导良好的临床结局。再通率和有利结局与先前报告的0.9 mg/kg剂量相当。（中风。2010;41：461-465）。
Background and Purpose-The purpose of this study was to evaluate further the efficacy of 0.6 mg/kg intravenous alteplase on vascular and clinical outcomes in patients with middle cerebral artery occlusion in a postmarketing Phase IV trial of prospective cohort study design.Methods-Alteplase was given intravenously at 0.6 mg/kg to patients with ischemic stroke within 3 hours of onset with MR angiography-documented middle cerebral artery occlusion. Vascular outcome was evaluated by MR angiography at 6 and 24 hours after symptom onset based on the modified Mori grade. The primary end points also included a favorable outcome (modified Rankin Scale 0 to 1 at 3 months after onset) and incidence of symptomatic intracranial hemorrhage within 36 hours after treatment. The impact of recanalization on clinical outcome was assessed by stepwise logistic regression analysis.Results-Fifty-eight patients were enrolled. Recanalization was noted in 51.7% on 6-hour MR angiography and 69.0% on 24-hour MR angiography. A favorable clinical outcome was achieved in 46.6%. None had symptomatic intracranial hemorrhage. In logistic regression models, recanalization on either 6-hour or 24-hour MR angiography was an independent predictor for clinical outcome as well as the baseline National Institutes of Health Stroke Scale score.Conclusions-Early recanalization of an occluded middle cerebral artery can be provoked by 0.6 mg/kg intravenous alteplase and may induce a favorable clinical outcome. The rates of recanalization and favorable outcome are comparable to that previously reported with the 0.9-mg/kg dose. (Stroke. 2010;41:461-465.)