本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2310392

摘要内容如下：

背景

包括替奈普酶在内的溶栓剂一般在中风症状出现后4.5小时内使用。关于4.5小时后替奈普酶是否有益的信息有限。

方法

我们进行了一项涉及缺血性卒中患者的多中心、双盲、随机、安慰剂对照试验，以比较替奈普酶（0.25 mg/kg体重，最多25 mg）与安慰剂（在患者最后一次已知良好的时间后4.5至24小时给药）的疗效。患者必须有大脑中动脉或颈内动脉闭塞的证据，并通过灌注成像确定可挽救的组织。主要转归是第90天时改良Rankin量表的顺序评分（范围为0至6，评分越高表示残疾越严重，评分为6表示死亡）。安全性转归包括死亡和症状性颅内出血。

结果

该试验纳入了458名患者，其中77.3%的患者随后接受了血栓切除术；228名患者接受替奈普酶治疗，230名患者接受安慰剂治疗。替奈普酶组和安慰剂组的患者最后一次被认为良好的时间和随机分组之间的中位时间分别约为12小时和13小时。在90天时，每组的改良Rankin量表的中位得分为3。与安慰剂组相比，替奈普酶组90天改良Rankin量表评分分布的校正共同比值比为1.13（95%置信区间，0.82至1.57；P=0.45）。安全性人群中，替奈普酶组和安慰剂组90天死亡率分别为19.7%和18.2%，症状性颅内出血发生率分别为3.2%和2.3%。

结论

对于大脑中动脉或颈内动脉闭塞的患者（其中大多数已接受血管内血栓切除术），在卒中发作后4.5至24小时开始替奈普酶治疗并未获得比安慰剂组更好的临床结果。两组症状性脑出血的发生率相似。（由Genentech资助；Timeless ClinicalTrials.gov编号，NCT03785678。）

英文原文如下：

Abstracts

BACKGROUND  Thrombolytic agents, including tenecteplase, are generally used within 4.5 hours after the onset of stroke symptoms. Information on whether tenecteplase confers benefit beyond 4.5 hours is limited.

METHODS  We conducted a multicenter, double-blind, randomized, placebo-controlled trial involving patients with ischemic stroke to compare tenecteplase (0.25 mg per kilogram of body weight, up to 25 mg) with placebo administered 4.5 to 24 hours after the time that the patient was last known to be well. Patients had to have evidence of occlusion of the middle cerebral artery or internal carotid artery and salvageable tissue as determined on perfusion imaging. The primary outcome was the ordinal score on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death) at day 90. Safety outcomes included death and symptomatic intracranial hemorrhage.

RESULTS  The trial enrolled 458 patients, 77.3% of whom subsequently underwent thrombectomy; 228 patients were assigned to receive tenecteplase, and 230 to receive placebo. The median time between the time the patient was last known to be well and randomization was approximately 12 hours in the tenecteplase group and approximately 13 hours in the placebo group. The median score on the modified Rankin scale at 90 days was 3 in each group. The adjusted common odds ratio for the distribution of scores on the modified Rankin scale at 90 days for tenecteplase as compared with placebo was 1.13 (95% confidence interval, 0.82 to 1.57; P = 0.45). In the safety population, mortality at 90 days was 19.7% in the tenecteplase group and 18.2% in the placebo group, and the incidence of symptomatic intracranial hemorrhage was 3.2% and 2.3%, respectively.

CONCLUSIONS  Tenecteplase therapy that was initiated 4.5 to 24 hours after stroke onset in patients with occlusions of the middle cerebral artery or internal carotid artery, most of whom had undergone endovascular thrombectomy, did not result in better clinical outcomes than those with placebo. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by Genentech; TIMELESS ClinicalTrials.gov number, NCT03785678.).

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