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静脉注射重组组织型纤溶酶原激活剂治疗缺血性卒中的一年期结局:一项真实世界研究

One-Year Outcomes After Intravenous Recombinant Tissue Plasminogen Activator for Ischemic Stroke: A Real-World Study.

作者信息

Xue Rui, Gong Xiaoxian, Huang Yuhui, Zhong Wansi, Jin Haidi, Chen Zhicai, Chen Yi, Yan Shenqiang, Hu Haitao, Yuan Changzheng, Lou Min

机构信息

Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

State Key Laboratory of Transvascular Implantation Devices, Hangzhou, China.

出版信息

CNS Neurosci Ther. 2025 Aug;31(8):e70543. doi: 10.1111/cns.70543.

Abstract

BACKGROUND

The longer-term benefits of intravenous recombinant tissue plasminogen activator (IV rt-PA) in Chinese acute ischemic stroke (AIS) patients remain lacking. We aimed to evaluate the 1-year clinical outcomes after IV rt-PA for Chinese AIS patients in a real-world setting.

METHODS

Based on a prospective multicenter stroke registry in China, we analyzed the data of patients with AIS (aged ≥ 18 years) who arrived at hospital within 4.5 h of symptom onset. Participants were from 80 stroke centers in China between January 2017 and March 2020. IV rt-PA-treated patients were propensity score-matched (1:1) by baseline characteristics with non-reperfusion patients. Primary outcome was 1-year all-cause mortality. Secondary outcomes included 1-year functional outcomes.

RESULTS

Participants were mostly male (59.9%), with a mean age of 70.2 years. One-year all-cause mortality was similar between the two groups (11.1% vs. 12.2%; HR, 0.90 [95% CI: 0.78-1.05], p = 0.183). At 1 year, the IV rt-PA group had a higher proportion of functional independence (modified Rankin Scale [mRS] 0-2: 70.9% vs. 66.4%; OR, 1.25 [95% CI, 1.12-1.39]) and favorable outcome (mRS 0-1: 59.5% vs. 54.6%; OR, 1.23 [95% CI, 1.11-1.36]) compared to the non-reperfusion group (both p < 0.001). A lower proportion of severe disability/death was also observed in the IV rt-PA group versus the non-reperfusion group (mRS 5-6: 15.9% vs. 20.3%; OR, 0.73 [95% CI, 0.64-0.83]) (all p < 0.001).

CONCLUSIONS

IV rt-PA treatment in Chinese AIS patients eligible for thrombolysis was associated with improved 1-year functional outcomes despite having similar mortality to those who did not receive any reperfusion treatments.

TRIAL REGISTRATION

This study is registered on https://clinicaltrials.gov; Unique identifier: NCT0539533.

摘要

背景

静脉注射重组组织型纤溶酶原激活剂(IV rt-PA)对中国急性缺血性卒中(AIS)患者的长期益处仍不明确。我们旨在评估在真实世界中,IV rt-PA治疗中国AIS患者1年的临床结局。

方法

基于中国一项前瞻性多中心卒中登记研究,我们分析了症状发作后4.5小时内入院的AIS患者(年龄≥18岁)的数据。参与者来自2017年1月至2020年3月期间中国的80个卒中中心。接受IV rt-PA治疗的患者与未进行再灌注治疗的患者按基线特征进行倾向评分匹配(1:1)。主要结局是1年全因死亡率。次要结局包括1年功能结局。

结果

参与者大多为男性(59.9%),平均年龄70.2岁。两组的1年全因死亡率相似(11.1%对12.2%;HR,0.90[95%CI:0.78 - 1.05],p = 0.183)。在1年时,与未进行再灌注治疗的组相比,IV rt-PA组功能独立的比例更高(改良Rankin量表[mRS]0 - 2:70.9%对66.4%;OR,1.25[95%CI,1.12 - 1.39]),且预后良好的比例更高(mRS 0 - 1:59.5%对54.6%;OR,1.23[95%CI,1.11 - 1.36])(均p < 0.001)。与未进行再灌注治疗的组相比,IV rt-PA组严重残疾/死亡的比例也更低(mRS 5 - 6:15.9%对20.3%;OR,0.73[95%CI,0.64 - 0.83])(均p < 0.0

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