Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke
Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke
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DOI：
10.1056/nejmoa0804656
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发表时间：
2008-09-25
影响因子：
158.5
通讯作者：
Toni, Danilo
中科院分区：
文献类型：
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作者：
Hacke, Werner;Kaste, Markku;Toni, Danilo
背景：静脉注射溶血用高倍酶是唯一批准的急性缺血性中风的治疗方法，但是在尚未确定症状发作后超过3小时后，其功效和安全性尚未确定。我们测试了中风发作后3到4.5小时之间给予的高度和安全性的功效和安全性。方法：排除在计算机断层扫描上检测到的脑出血或主要梗塞的患者，我们随机分配了急性缺血性患者以1：1的双盲方式中风，以静脉注射高倍酶（每公斤体重0.9 mg）或安慰剂进行治疗。主要终点是90天的残疾，二分法是一个有利的结果（在修改后的兰金等级上的得分为0或1，范围为0到6，其中0完全没有症状，6表示死亡）或不利的结果（在修改后的Rankin量表上得分为2至6）。次要终点是对四个神经系统和残疾分数的总体结果分析。安全终点包括死亡，有症状的颅内出血和其他严重的不良事件。回报：我们在研究中总共招募了821名患者，并将418例随机分配到Alteplase组，403组和安慰剂组。高速倍增倍数的中位时间为3小时59分钟。与安慰剂相比，患者的效果比（52.4％vs. 45.2％；优势比，1.34; 95％置信区间[CI]，1.02至1.76； P = 0.04）。在全球分析中，与安慰剂相比，Alteplase的结果也得到了改善（优势比，1.28; 95％CI，1.00至1.65; P
Background: Intravenous thrombolysis with alteplase is the only approved treatment for acute ischemic stroke, but its efficacy and safety when administered more than 3 hours after the onset of symptoms have not been established. We tested the efficacy and safety of alteplase administered between 3 and 4.5 hours after the onset of a stroke.Methods: After exclusion of patients with a brain hemorrhage or major infarction, as detected on a computed tomographic scan, we randomly assigned patients with acute ischemic stroke in a 1:1 double-blind fashion to receive treatment with intravenous alteplase (0.9 mg per kilogram of body weight) or placebo. The primary end point was disability at 90 days, dichotomized as a favorable outcome (a score of 0 or 1 on the modified Rankin scale, which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) or an unfavorable outcome (a score of 2 to 6 on the modified Rankin scale). The secondary end point was a global outcome analysis of four neurologic and disability scores combined. Safety end points included death, symptomatic intracranial hemorrhage, and other serious adverse events.Results: We enrolled a total of 821 patients in the study and randomly assigned 418 to the alteplase group and 403 to the placebo group. The median time for the administration of alteplase was 3 hours 59 minutes. More patients had a favorable outcome with alteplase than with placebo (52.4% vs. 45.2%; odds ratio, 1.34; 95% confidence interval [CI], 1.02 to 1.76; P=0.04). In the global analysis, the outcome was also improved with alteplase as compared with placebo (odds ratio, 1.28; 95% CI, 1.00 to 1.65; P