浙江大学楼敏团队的一项最新研究研制了阿替普酶治疗4.5 ~ 24小时后循环缺血性卒中。2025年4月3日，国际知名学术期刊《新英格兰医学杂志》发表了这一成果。

背景：后循环缺血性卒中发生后4.5 ~ 24小时内静脉溶栓的效果和风险尚未得到充分研究。

方法：在中国进行的一项试验中，该课题组人员随机分配后循环卒中患者，这些患者在计算机断层扫描上没有广泛的早期低密度，也没有计划取栓，接受阿替普酶治疗(每公斤体重0.9 mg；最大剂量为90毫克)或在症状出现后4.5至24小时进行标准药物治疗。主要结局是功能独立性(定义为在修改的Rankin量表上得分0到2分；评分范围从0到6，分数越高表明残疾程度越严重)。主要的安全结局是症状性颅内出血和死亡。

结果：共纳入234名患者；117名患者被分配到阿替普酶组，117名被分配到标准治疗组。美国国立卫生研究院卒中量表的中位数得分为3（四分位数间距为2至6）（得分范围为0至42，得分越高，表明神经功能缺损越严重）。阿替普酶组在90天时具有功能独立性的患者比例高于标准治疗组（89.6%对72.6%；调整后的风险比为1.16；95%置信区间[CI]为1.03至1.30；P=0.01）。阿替普酶组36小时内症状性颅内出血的发生率为1.7%，标准治疗组为0.9%。在90天时，阿替普酶组5.2%的患者和标准治疗组8.5%的患者死亡。

研究结果表明，在未接受血栓切除术的中国轻度后循环卒中患者中，在卒中发作后4.5 - 24小时服用阿替普酶，在90天内功能独立的频率高于标准医疗护理。

附：英文原文

Title: Alteplase for Posterior Circulation Ischemic Stroke at 4.5 to 24 Hours

Author: Shenqiang Yan, Ying Zhou, Maarten G. Lansberg, David S. Liebeskind, Changzheng Yuan, Han Yu, Fujian Chen, Hongfang Chen, Bing Zhang, Lingqun Mao, Xiaoling Zhang, Xiaona Wang, Xuting Zhang, Yi Chen, Huan Zhou, Wansi Zhong, Yaode He, Kun Chen, Jianbing Wang, Hui Chen, Yuhui Huang, Bruce C.V. Campbell, Min Lou

Issue&Volume: 2025-04-03

Abstract: BACKGROUND

The effects and risks of the use of intravenous thrombolysis between 4.5 and 24 hours after the onset of a posterior circulation ischemic stroke are not well studied.

METHODS

In a trial conducted in China, we randomly assigned patients with posterior circulation stroke, without extensive early hypodensity on computed tomography and with no planned thrombectomy, to receive alteplase (0.9 mg per kilogram of body weight; maximum dose, 90 mg) or standard medical treatment 4.5 to 24 hours after the onset of symptoms. The primary outcome was functional independence (defined as a score of 0 to 2 on the modified Rankin scale; scores range from 0 to 6, with higher scores indicating greater disability) at 90 days. The key safety outcomes were symptomatic intracranial hemorrhage and death.

RESULTS

A total of 234 patients were enrolled; 117 were assigned to the alteplase group and 117 to the standard treatment group. The median score on the National Institutes of Health Stroke Scale was 3 (interquartile range, 2 to 6) (scores range from 0 to 42, with higher scores indicating greater neurologic deficit). A higher percentage of patients in the alteplase group than in the standard treatment group had functional independence at 90 days (89.6% vs. 72.6%; adjusted risk ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.30; P=0.01). The incidence of symptomatic intracranial hemorrhage within 36 hours was 1.7% in the alteplase group and 0.9% in the standard treatment group. At 90 days, 5.2% of the patients in the alteplase group and 8.5% of those in the standard treatment group had died.

CONCLUSIONS

Among Chinese patients with mainly mild posterior circulation stroke who did not receive thrombectomy, alteplase administered 4.5 to 24 hours after stroke onset resulted in a higher frequency of functional independence at 90 days than standard medical care.

DOI: NJ202504033921308

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2413344