A Randomized Trial of Tenecteplase versus Alteplase for Acute Ischemic Stroke
A Randomized Trial of Tenecteplase versus Alteplase for Acute Ischemic Stroke
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DOI：
10.1056/nejmoa1109842
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发表时间：
2012-03-22
影响因子：
158.5
通讯作者：
Levi, Christopher
中科院分区：
文献类型：
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作者：
Parsons, Mark;Spratt, Neil;Levi, Christopher
背景：静脉注射阿替普酶是唯一被批准的治疗急性缺血性卒中的药物。Tenecteplase是一种基因工程突变型组织纤溶酶原激活剂，是一种替代的溶栓剂。方法：在这项2B期临床试验中，我们随机分配75名患者，在缺血性卒中发生后不到6小时接受阿替普酶（每公斤体重0.9 mg）或替奈普酶（每公斤0.1 mg或0.25 mg）治疗。为了选择最有可能从溶栓治疗中获益的患者，资格标准是灌注病灶在基线时比CT灌注成像显示的梗死核心至少大20%，CT血管造影显示的相关血管闭塞。主要终点为灌注加权磁共振成像显示灌注损伤在24小时内再灌注的比例，以及按照美国国立卫生研究院卒中量表（NIHSS， 42分制，分数越高表明神经功能缺陷越严重）评估的24小时临床改善程度。结果三个治疗组各25例。所有患者基线时NIHSS平均（+/- SD）评分为14.4 +/- 2.6，治疗时间为2.9 +/- 0.8小时。两组患者再灌注增强（P=0.004），临床改善（P=0.004）
BACKGROUNDIntravenous alteplase is the only approved treatment for acute ischemic stroke. Tenecteplase, a genetically engineered mutant tissue plasminogen activator, is an alternative thrombolytic agent.METHODSIn this phase 2B trial, we randomly assigned 75 patients to receive alteplase (0.9 mg per kilogram of body weight) or tenecteplase (0.1 mg per kilogram or 0.25 mg per kilogram) less than 6 hours after the onset of ischemic stroke. To favor the selection of patients most likely to benefit from thrombolytic therapy, the eligibility criteria were a perfusion lesion at least 20% greater than the infarct core on computed tomographic (CT) perfusion imaging at baseline and an associated vessel occlusion on CT angiography. The coprimary end points were the proportion of the perfusion lesion that was reperfused at 24 hours on perfusion-weighted magnetic resonance imaging and the extent of clinical improvement at 24 hours as assessed on the National Institutes of Health Stroke Scale (NIHSS, a 42-point scale on which higher scores indicate more severe neurologic deficits).RESULTSThe three treatment groups each comprised 25 patients. The mean (+/- SD) NIHSS score at baseline for all patients was 14.4 +/- 2.6, and the time to treatment was 2.9 +/- 0.8 hours. Together, the two tenecteplase groups had greater reperfusion (P=0.004) and clinical improvement (P