{"title":"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疗效:一项现实世界研究。","authors":"Rui Xue, Xiaoxian Gong, Yuhui Huang, Wansi Zhong, Haidi Jin, Zhicai Chen, Yi Chen, Shenqiang Yan, Haitao Hu, Changzheng Yuan, Min Lou","doi":"10.1111/cns.70543","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>This study is registered on https://clinicaltrials.gov; Unique identifier: NCT0539533.</p>","PeriodicalId":154,"journal":{"name":"CNS Neuroscience & Therapeutics","volume":"31 8","pages":"e70543"},"PeriodicalIF":5.0000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12329421/pdf/","citationCount":"0","resultStr":"{\"title\":\"One-Year Outcomes After Intravenous Recombinant Tissue Plasminogen Activator for Ischemic Stroke: A Real-World Study.\",\"authors\":\"Rui Xue, Xiaoxian Gong, Yuhui Huang, Wansi Zhong, Haidi Jin, Zhicai Chen, Yi Chen, Shenqiang Yan, Haitao Hu, Changzheng Yuan, Min Lou\",\"doi\":\"10.1111/cns.70543\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>This study is registered on https://clinicaltrials.gov; Unique identifier: NCT0539533.</p>\",\"PeriodicalId\":154,\"journal\":{\"name\":\"CNS Neuroscience & Therapeutics\",\"volume\":\"31 8\",\"pages\":\"e70543\"},\"PeriodicalIF\":5.0000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12329421/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CNS Neuroscience & Therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/cns.70543\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"NEUROSCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CNS Neuroscience & Therapeutics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/cns.70543","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NEUROSCIENCES","Score":null,"Total":0}
引用次数: 0
摘要
背景:静脉注射重组组织型纤溶酶原激活剂(IV rt-PA)治疗中国急性缺血性卒中(AIS)患者的长期获益尚不明确。我们的目的是在现实环境中评估中国AIS患者静脉注射rt-PA后1年的临床结果。方法:基于中国前瞻性多中心卒中登记,我们分析了在症状出现4.5小时内到达医院的AIS患者(年龄≥18岁)的数据。2017年1月至2020年3月期间,参与者来自中国80个中风中心。静脉注射rt- pa治疗的患者与非再灌注患者的基线特征倾向评分匹配(1:1)。主要终点为1年全因死亡率。次要结局包括1年功能结局。结果:参与者以男性居多(59.9%),平均年龄70.2岁。两组一年全因死亡率相似(11.1% vs 12.2%;HR, 0.90 [95% CI: 0.78-1.05], p = 0.183)。1年时,静脉注射rt-PA组功能独立性比例更高(修正Rankin量表[mRS] 0-2: 70.9% vs. 66.4%;OR, 1.25 [95% CI, 1.12-1.39])和有利结果(mRS 0-1: 59.5% vs. 54.6%;OR为1.23 [95% CI, 1.11-1.36])(均为p)。结论:在符合溶栓条件的中国AIS患者中,静脉rt-PA治疗与1年功能预后改善相关,尽管其死亡率与未接受任何再灌注治疗的患者相似。试验注册:本研究在https://clinicaltrials.gov上注册;唯一标识符:NCT0539533。
One-Year Outcomes After Intravenous Recombinant Tissue Plasminogen Activator for Ischemic Stroke: A Real-World Study.
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.
期刊介绍:
CNS Neuroscience & Therapeutics provides a medium for rapid publication of original clinical, experimental, and translational research papers, timely reviews and reports of novel findings of therapeutic relevance to the central nervous system, as well as papers related to clinical pharmacology, drug development and novel methodologies for drug evaluation. The journal focuses on neurological and psychiatric diseases such as stroke, Parkinson’s disease, Alzheimer’s disease, depression, schizophrenia, epilepsy, and drug abuse.