Randomized trial of intraarterial infusion of urokinase within 6 hours of middle cerebral artery stroke - The Middle Cerebral Artery Embolism Local Fibrinolytic Intervention Trial (MELT) Japan
Randomized trial of intraarterial infusion of urokinase within 6 hours of middle cerebral artery stroke - The Middle Cerebral Artery Embolism Local Fibrinolytic Intervention Trial (MELT) Japan
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DOI：
10.1161/strokeaha.107.488551
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发表时间：
2007-10-01
期刊：
影响因子：
8.3
通讯作者：
Inoue, Takashi
中科院分区：
文献类型：
--
作者：
Ogawa, Akira;Mori, Etsuro;Inoue, Takashi
背景和目的：组织了日本大脑中动脉栓塞局部纤溶干预试验（MELT），以确定中风患者发病6小时内动脉内输注尿激酶（UK）的安全性和临床疗效。方法：缺血性卒中患者发病6小时内，颈动脉造影显示大脑中动脉M1或M2部分闭塞，随机分为UK组或对照组。临床结果采用改良Rankin量表、美国国立卫生研究院卒中量表和Barthel指数进行评估。结果：在日本批准静脉输注重组组织纤溶酶原激活剂后，独立监测委员会建议停止该试验。114例患者接受随机分组，每组57例。两组间背景特征具有可比性。在第90天，英国组的主要终点（改进的Rankin量表0至2）比对照组更频繁（49.1%和38.6%,OR: 1.54, 95% CI: 0.73至3.23），但未达到显著水平（P = 0.345）。然而，在90天，一个预先计划的次要终点，良好的功能结局（修改的Rankin量表0至1）在英国组比对照组更常见（42.1%和22.8%,P = 0.045, OR: 2.46, 95% CI: 1.09至5.54）。与对照组相比，英国组在第90天达到美国国立卫生研究院卒中量表0级或1级的患者明显增多（P = 0.017）。英国组90天累积死亡率为5.3%，对照组为3.5% (P = 1.000)，治疗后24小时内脑出血发生率分别为9%和2% （P = 0.206）。结论：该试验过早终止，主要终点未达到统计学意义。然而，二次分析表明，动脉内纤溶有可能增加良好功能结果的可能性。
Background and Purpose - The Middle Cerebral Artery Embolism Local Fibrinolytic Intervention Trial (MELT) Japan was organized to determine the safety and clinical efficacy of intraarterial infusion of urokinase (UK) in patients with stroke within 6 hours of onset.Methods - Patients with ischemic stroke presenting within 6 hours of onset and displaying occlusions of the M1 or M2 portion of the middle cerebral artery on carotid angiography were randomized to the UK or control groups. Clinical outcome was assessed by the modified Rankin Scale, National Institutes of Health Stroke Scale, and Barthel Index.Results - The Independent Monitoring Committee recommended stopping the trial after approval of intravenous infusion of recombinant tissue plasminogen activator in Japan. A total of 114 patients underwent randomization, 57 patients in each group. Background characteristics were comparable between the 2 groups. The primary end point of favorable outcome (modified Rankin Scale 0 to 2) at 90 days was somewhat more frequent in the UK group than in the control group (49.1% and 38.6%, OR: 1.54, 95% CI: 0.73 to 3.23) but did not reach a significant level (P = 0.345). However, excellent functional outcome (modified Rankin Scale 0 to 1) at 90 days, a preplanned secondary end point, was more frequent in the UK group than in the control group (42.1% and 22.8%, P = 0.045, OR: 2.46, 95% CI: 1.09 to 5.54). There were significantly more patients with National Institutes of Health Stroke Scale 0 or 1 at 90 days in the UK group than the control group (P = 0.017). The 90- day cumulative mortality was 5.3% in the UK group and 3.5% in the control group (P = 1.000), and intracerebral hemorrhage within 24 hours of treatment occurred in 9% and 2%, respectively (P = 0.206).Conclusions - The trial was aborted prematurely and the primary end point did not reach statistical significance. Nevertheless, the secondary analyses suggested that intraarterial fibrinolysis has the potential to increase the likelihood of excellent functional outcome.