新桥医院（陆军军医大学第二附属医院）杨清武团队近日研究了脑卒中取栓前静脉注射替奈普酶对患者预后的影响。2025年5月21日出版的《新英格兰医学杂志》发表了这项成果。

大血管闭塞性急性缺血性卒中患者血管内取栓前静脉滴注替奈普酶治疗的安全性和有效性尚不确定。

在中国进行的这项开放标签试验中，研究组随机分配了发病后4.5小时内出现且符合溶栓条件的大血管闭塞急性缺血性卒中患者，分别接受静脉滴注替奈普酶+血管内取栓或单独血管内取栓。主要结果是功能独立性(在修改的Rankin量表上得分为0到2分；范围从0到6，分数越高表明残疾越严重)。次要结局包括取栓前后的再灌注成功。安全性指标包括48小时内出现症状性颅内出血，90天内死亡。

278例患者被随机分配到替奈普酶+血管内取栓组，272例患者被随机分配到单纯取栓组。替奈普酶+血管内取栓组的147例患者（52.9%）和单独取栓组的120例患者（44.1%）在90天功能独立(未调整的风险比，1.20；95%置信区间为1.01 ~ 1.43；P = 0.04)。替奈普酶+血管内取栓组组和单独取栓组分别有6.1%和1.1%的患者在取栓前再灌注成功，取栓后再灌注成功的比例分别为91.4%和94.1%。替奈普酶+血管内取栓组患者48小时内出现症状性颅内出血的发生率为8.5%，单独溶栓组为6.7%；90天死亡率分别为22.3%和19.9%。

研究结果表明，在发病后4.5小时内出现的大血管闭塞性急性缺血性卒中患者中，静脉注射替奈普酶联合血管内取栓比单独血管内取栓在90天功能独立的患者比例更高。

附：英文原文

Title: Intravenous Tenecteplase before Thrombectomy in Stroke

Author: Zhongming Qiu, Fengli Li, Hongfei Sang, Guangxiong Yuan, Dongjing Xie, Kai Zhou, Maohua Li, Zhaoyou Meng, Zhenyu Kong, Zhongfan Ruan, Chaoqun Li, Guangui Yang, Junxiong Wu, Chen Long, Bo Yang, Hai Hu, Yanling Li, Jun Luo, Zhonghua Shi, Xianjun Huang, Shunfu Jiang, Tingyu Yi, Guoyong Zeng, Jincheng Liu, Xiaojun Luo, Shudong Liu, Mingze Chang, Youlin Wu, Yufeng Tang, Zhenxuan Tian, Zhizhong Yan, Haojin Zhao, Yuqi Peng, Hongguo Dai, Peiyang Zhou, Huagang Li, Wenhua Liu, Dengwen Song, Bo Lei, Zhongbin Xia, Xiaolin Tan, Maojun Zhao, Xinggang Feng, Lingyu Cai, Qi Li, Yuelu Wu, Bingwu Jiang, Yan Tian, Linyu Li, Ling Jiang, Xingmin Long, Feng You, Jian Tao, Jin Zhou, Derong Wu, Chong Zheng, Congguo Yin, Duolao Wang, Mengjie Lu, Gregory W. Albers, Raul G. Nogueira, Bruce C.V. Campbell, Thanh N. Nguyen, Jeffrey L. Saver, Wenjie Zi, Qingwu Yang

Issue&Volume: 2025-05-21

Abstract:

BACKGROUND

The safety and efficacy of treatment with intravenous tenecteplase before endovascular thrombectomy in patients with acute ischemic stroke due to large-vessel occlusion remain uncertain.

METHODS

In this open-label trial conducted in China, we randomly assigned patients with acute ischemic stroke due to large-vessel occlusion who had presented within 4.5 hours after onset and were eligible for thrombolysis to receive either intravenous tenecteplase followed by endovascular thrombectomy or endovascular thrombectomy alone. The primary outcome was functional independence (a score of 0 to 2 on the modified Rankin scale; range, 0 to 6, with higher scores indicating more severe disability) at 90 days. Secondary outcomes included successful reperfusion before and after thrombectomy. Safety outcomes included symptomatic intracranial hemorrhage within 48 hours and death within 90 days.

RESULTS

A total of 278 patients were randomly assigned to the tenecteplase–thrombectomy group and 272 to the thrombectomy-alone group. Functional independence at 90 days was observed in 147 patients (52.9%) in the tenecteplase–thrombectomy group and in 120 patients (44.1%) in the thrombectomy-alone group (unadjusted risk ratio, 1.20; 95% confidence interval, 1.01 to 1.43; P=0.04). A total of 6.1% of the patients in the tenecteplase–thrombectomy group and 1.1% of those in the thrombectomy-alone group had successful reperfusion before thrombectomy, and 91.4% and 94.1%, respectively, had successful reperfusion after thrombectomy. Symptomatic intracranial hemorrhage within 48 hours occurred in 8.5% of the patients in the tenecteplase–thrombectomy group and in 6.7% of those in the thrombectomy-alone group; mortality at 90 days was 22.3% and 19.9%, respectively.

CONCLUSIONS

Among patients with acute ischemic stroke due to large-vessel occlusion who had presented within 4.5 hours after onset, the percentage of patients with functional independence at 90 days was higher with intravenous tenecteplase plus endovascular thrombectomy than with endovascular thrombectomy alone.

DOI: NJ202505210000001

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2503867