阿替普酶治疗4.5 ~ 24小时后循环缺血性卒中

浙江大学楼敏团队最新研究开发了阿替普酶治疗4.5 ~ 24小时后循环缺血性卒中。这一成果于2025年4月3日在世界著名学术期刊《新英格兰医学杂志》上发表。

背景：后循环缺血性卒中后4.5 ~ 静脉溶栓在24小时内的作用和风险尚未得到充分研究。

方法:在中国的一项实验中，研究小组成员随机分配后循环中风患者。这些患者在计算机断层扫描中没有普遍的初始低密度，也没有计划取栓和接受阿替普酶治疗(每公斤重0.9公斤。 mg;在症状出现后4.5-24小时内，最大剂量为90mg)或标准用药治疗。其主要结果是功能独立性(定义为在修改后的Rankin量表上得分0-2分;得分范围从0到6不等，得分越高，残疾程度越严重)。其主要安全结果是疾病性脑出血和死亡。

结果:共有234名患者;117名患者被分配到阿替普酶组，117名患者被分配到标准治疗组。美国国家卫生研究院卒中量表中位数分为3(四位数间距为2-6)(分数范围为0-42，分数越高，神经功能缺损越严重)。90天内阿替普酶组功能独立的患者比例高于标准治疗组(89.6%对72.6%;调整后的风险比例为1.16;95%置信区间[CI]为1.03至1.30;P=0.01)。在36小时内，阿替普酶组发病率为1.7%，标准治疗组为0.9%。阿替普酶组5.2%的患者和标准治疗组8.5%的患者在90天内死亡。

结果表明，在没有接受血栓切除术的中国轻度后循环卒中患者中，卒中后4.5 - 服用阿替普酶24小时，90天内功能单独数量高于标准医疗护理。

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.