{"title":"静脉注射重组纤溶酶原激活剂治疗中国80岁以上急性缺血性卒中患者的有效性:一项回顾性队列研究。","authors":"Jiansheng Yang, Yu-Hui Huang, Wansi Zhong, Xiaoxian Gong, Yi Chen, Zhicai Chen, Haidi Jin, Shenqiang Yan, Liyan Huang, Chang-Zheng Yuan, Min Lou","doi":"10.1136/svn-2024-004004","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Risks and benefits of intravenous recombinant tissue plasminogen activator (rt-PA) remain unclear among elderly patients with acute ischaemic stroke (AIS). This study investigated 1-year clinical outcomes of intravenous rt-PA treatment in Chinese patients aged >80 years with AIS.</p><p><strong>Methods: </strong>This retrospective multicentre study included patients with AIS aged >80 years from the Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation stroke registry platform between January 2017 and March 2020 who arrived at the hospital within 4.5 hours of symptom onset. Patients who received intravenous rt-PA were propensity score-matched (1:1) by baseline characteristics with those who did not receive reperfusion therapy. The primary outcome was modified Rankin scale (mRS) score 0-1 at 1 year; secondary outcomes were any intracranial haemorrhage (ICH) and all-cause mortality during hospitalisation, mRS 0-2, mRS score distribution and all-cause mortality at 1 year.</p><p><strong>Results: </strong>The analysis included 1560 propensity score-matched elderly patients (intravenous rt-PA, n=780; non-reperfusion, n=780). At 1 year, the intravenous rt-PA group had a higher proportion of patients with mRS 0-1 (27.7% vs 23.8%; OR 1.87, 95% CI 1.35 to 2.59, p<0.001), mRS 0-2 (37.3% vs 33.7%; OR 2.02, 95% CI 1.48 to 2.75, p<i><</i>0.001) and an overall shift towards better outcomes than placebo (mRS mean±SD score: 3.5±2.4 vs 3.7±2.3; OR 0.77, 95% CI 0.64 to 0.93, p=0.007). No significant differences were observed in any ICH and all-cause mortality during hospitalisation and at 1 year.</p><p><strong>Conclusions: </strong>This study provided real-world evidence for a positive benefit-risk profile of intravenous rt-PA in Chinese patients with AIS aged >80 years.</p><p><strong>Trial registration number: </strong>NCT05401149.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effectiveness of intravenous recombinant plasminogen activator treatment in Chinese patients with acute ischaemic stroke aged over 80 years: a retrospective cohort study.\",\"authors\":\"Jiansheng Yang, Yu-Hui Huang, Wansi Zhong, Xiaoxian Gong, Yi Chen, Zhicai Chen, Haidi Jin, Shenqiang Yan, Liyan Huang, Chang-Zheng Yuan, Min Lou\",\"doi\":\"10.1136/svn-2024-004004\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Risks and benefits of intravenous recombinant tissue plasminogen activator (rt-PA) remain unclear among elderly patients with acute ischaemic stroke (AIS). This study investigated 1-year clinical outcomes of intravenous rt-PA treatment in Chinese patients aged >80 years with AIS.</p><p><strong>Methods: </strong>This retrospective multicentre study included patients with AIS aged >80 years from the Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation stroke registry platform between January 2017 and March 2020 who arrived at the hospital within 4.5 hours of symptom onset. Patients who received intravenous rt-PA were propensity score-matched (1:1) by baseline characteristics with those who did not receive reperfusion therapy. The primary outcome was modified Rankin scale (mRS) score 0-1 at 1 year; secondary outcomes were any intracranial haemorrhage (ICH) and all-cause mortality during hospitalisation, mRS 0-2, mRS score distribution and all-cause mortality at 1 year.</p><p><strong>Results: </strong>The analysis included 1560 propensity score-matched elderly patients (intravenous rt-PA, n=780; non-reperfusion, n=780). At 1 year, the intravenous rt-PA group had a higher proportion of patients with mRS 0-1 (27.7% vs 23.8%; OR 1.87, 95% CI 1.35 to 2.59, p<0.001), mRS 0-2 (37.3% vs 33.7%; OR 2.02, 95% CI 1.48 to 2.75, p<i><</i>0.001) and an overall shift towards better outcomes than placebo (mRS mean±SD score: 3.5±2.4 vs 3.7±2.3; OR 0.77, 95% CI 0.64 to 0.93, p=0.007). No significant differences were observed in any ICH and all-cause mortality during hospitalisation and at 1 year.</p><p><strong>Conclusions: </strong>This study provided real-world evidence for a positive benefit-risk profile of intravenous rt-PA in Chinese patients with AIS aged >80 years.</p><p><strong>Trial registration number: </strong>NCT05401149.</p>\",\"PeriodicalId\":48733,\"journal\":{\"name\":\"Journal of Investigative Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-04-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Investigative Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/svn-2024-004004\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Investigative Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/svn-2024-004004","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","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(rt-PA)在老年急性缺血性卒中(AIS)患者中的风险和益处尚不清楚。本研究调查了中国年龄在100 ~ 80岁的AIS患者静脉注射rt-PA治疗1年的临床结果。方法:这项回顾性多中心研究纳入了2017年1月至2020年3月期间在症状出现4.5小时内到达医院的急性卒中患者计算机在线数据库卒中管理质量评估卒中登记平台中年龄在bb0 ~ 80岁的AIS患者。接受静脉注射rt-PA的患者与未接受再灌注治疗的患者基线特征倾向评分匹配(1:1)。主要预后指标为1年时的改良Rankin量表(mRS)评分0-1分;次要结局是住院期间颅内出血(ICH)和全因死亡率、mRS 0-2、mRS评分分布和1年全因死亡率。结果:纳入1560例倾向评分匹配的老年患者(静脉注射rt-PA, n=780;non-reperfusion, n = 780)。1年时,静脉注射rt-PA组mRS 0-1的患者比例更高(27.7% vs 23.8%;OR 1.87, 95% CI 1.35至2.59,p0.001),总体上转向比安慰剂更好的结局(mRS平均±SD评分:3.5±2.4 vs 3.7±2.3;OR 0.77, 95% CI 0.64 ~ 0.93, p=0.007)。在住院期间和1年内,未观察到任何脑出血和全因死亡率的显著差异。结论:本研究提供了真实世界的证据,证明静脉注射rt-PA对中国80岁的AIS患者具有积极的获益-风险特征。试验注册号:NCT05401149。
Effectiveness of intravenous recombinant plasminogen activator treatment in Chinese patients with acute ischaemic stroke aged over 80 years: a retrospective cohort study.
Background: Risks and benefits of intravenous recombinant tissue plasminogen activator (rt-PA) remain unclear among elderly patients with acute ischaemic stroke (AIS). This study investigated 1-year clinical outcomes of intravenous rt-PA treatment in Chinese patients aged >80 years with AIS.
Methods: This retrospective multicentre study included patients with AIS aged >80 years from the Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation stroke registry platform between January 2017 and March 2020 who arrived at the hospital within 4.5 hours of symptom onset. Patients who received intravenous rt-PA were propensity score-matched (1:1) by baseline characteristics with those who did not receive reperfusion therapy. The primary outcome was modified Rankin scale (mRS) score 0-1 at 1 year; secondary outcomes were any intracranial haemorrhage (ICH) and all-cause mortality during hospitalisation, mRS 0-2, mRS score distribution and all-cause mortality at 1 year.
Results: The analysis included 1560 propensity score-matched elderly patients (intravenous rt-PA, n=780; non-reperfusion, n=780). At 1 year, the intravenous rt-PA group had a higher proportion of patients with mRS 0-1 (27.7% vs 23.8%; OR 1.87, 95% CI 1.35 to 2.59, p<0.001), mRS 0-2 (37.3% vs 33.7%; OR 2.02, 95% CI 1.48 to 2.75, p<0.001) and an overall shift towards better outcomes than placebo (mRS mean±SD score: 3.5±2.4 vs 3.7±2.3; OR 0.77, 95% CI 0.64 to 0.93, p=0.007). No significant differences were observed in any ICH and all-cause mortality during hospitalisation and at 1 year.
Conclusions: This study provided real-world evidence for a positive benefit-risk profile of intravenous rt-PA in Chinese patients with AIS aged >80 years.
期刊介绍:
Journal of Investigative Medicine (JIM) is the official publication of the American Federation for Medical Research. The journal is peer-reviewed and publishes high-quality original articles and reviews in the areas of basic, clinical, and translational medical research.
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