急性缺血性卒中患者替奈普酶静脉溶栓治疗的良好预后影响因素分析

doi:10.3969/j.issn.1673-5765.2026.06.008

摘要/Abstract

摘要： 目的基于中国急性缺血性卒中静脉替奈普酶治疗（intravenous TNK for acute ischemic stroke in China，INTACT-China）前瞻性、多中心登记研究的数据，探索替奈普酶静脉溶栓治疗急性缺血性卒中的结局预测因素。
方法对INTACT-China研究中具有90 d结局且基线临床资料完整的患者进行事后分析。根据90 d mRS评分将患者分为结局良好（mRS评分0～1分）组和结局不良（mRS评分2～6分）组，进行组间比较及多因素logistic回归分析。
结果本研究共纳入873例急性缺血性卒中患者，结局良好组544例（62.3%），结局不良组329例（37.7%）。单因素分析提示，患者年龄、吸烟史、饮酒史、高血压病史、糖尿病病史、心房颤动病史、卒中病史、入院NIHSS评分、发病前mRS评分、发病到入院时间、入院到治疗时间、是否接受血管内治疗、TOAST分型等因素与90 d功能结局相关。多因素logistic回归分析提示，入院NIHSS评分（OR 0.858，95%CI 0.825～0.893，P<0.001）、发病前mRS评分（OR 0.427，95%CI 0.258～0.705，P<0.001）和小动脉闭塞型卒中（OR 3.339，95%CI 1.593～7.000，P<0.001）是替奈普酶静脉溶栓治疗急性缺血性卒中结局的独立预测因素。
结论较低的入院NIHSS评分、较低的发病前mRS评分和小动脉闭塞型卒中是急性缺血性卒中患者接受替奈普酶静脉溶栓治疗后90 d良好功能结局的独立预测因素，且静脉溶栓后获得良好功能结局的比例随着卒中严重程度的增加而降低。

文章导读： 本研究基于前瞻性登记研究进行分析，结果提示入院NIHSS评分、发病前mRS评分和小动脉闭塞型卒中是急性缺血性卒中患者接受替奈普酶静脉溶栓治疗后90 d功能结局的独立预测因素。

关键词: 急性缺血性卒中; 静脉溶栓; 替奈普酶; 登记研究; 预测因素

Abstract: Objective To explore predictors of outcomes after intravenous thrombolysis with tenecteplase for acute ischemic stroke based on data from the prospective, multicenter registry study of intravenous TNK for acute ischemic stroke in China (INTACT-China).
Methods A post-hoc analysis was conducted on patients from the INTACT-China study who had 90-day outcome data and complete baseline clinical information. According to the 90-day mRS score, patients were divided into the good outcome group (mRS score 0-1) and the poor outcome group (mRS score 2-6). Intergroup comparisons and multivariate logistic regression analysis were performed.
Results A total of 873 patients with acute ischemic stroke were included in this study, with 544 (62.3%) in the good outcome group and 329 (37.7%) in the poor outcome group. Univariate analysis indicated that age, smoking history, drinking history, history of hypertension, history of diabetes mellitus, history of atrial fibrillation, history of stroke, NIHSS score at admission, pre-onset mRS score, time from onset to admission, time from admission to treatment, receipt of endovascular therapy, and TOAST classification were associated with 90-day functional outcomes. Multivariate logistic regression analysis suggested that the NIHSS score at admission (OR 0.858, 95%CI 0.825-0.893, P<0.001), pre-onset mRS score (OR 0.427, 95%CI 0.258-0.705, P<0.001), and small artery occlusion stroke (OR 3.339, 95%CI 1.593-7.000, P<0.001) were independent predictors of outcomes after intravenous thrombolysis with tenecteplase in acute ischemic stroke.
Conclusions Lower NIHSS score at admission, lower pre-onset mRS score, and small artery occlusion stroke are independent predictors of the 90-day good functional outcome after intravenous thrombolysis with tenecteplase in patients with acute ischemic stroke. The proportion of patients achieving good functional outcome decreases with increasing stroke severity.

Key words: Acute ischemic stroke; Intravenous thrombolysis; Tenecteplase; Registry study; Predictor

中图分类号:

崔钰, 王璐, 陈会生. 急性缺血性卒中患者替奈普酶静脉溶栓治疗的良好预后影响因素分析[J]. 中国卒中杂志, 2026, 21(6): 712-718.

CUI Yu, WANG Lu, CHEN Huisheng. Analysis of Influencing Factors for Good Outcomes in Patients with Acute Ischemic Stroke Receiving Intravenous Thrombolysis with Tenecteplase[J]. Chinese Journal of Stroke, 2026, 21(6): 712-718.

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链接本文: https://www.chinastroke.org.cn/CN/10.3969/j.issn.1673-5765.2026.06.008

https://www.chinastroke.org.cn/CN/Y2026/V21/I6/712

参考文献

[1] FEIGIN V L，BRAININ M，NORRVING B，et al. World Stroke Organization：global stroke fact sheet 2025[J]. Int J Stroke，2025，20（2）：132-144.
[2] HILKENS N A，CASOLLA B，LEUNG T W，et al. Stroke[J]. Lancet，2024，403（10446）：2820-2836.
[3] 中华医学会神经病学分会，中华医学会神经病学分会脑血管病学组. 中国急性缺血性卒中诊治指南2023[J]. 中华神经科杂志，2024，57（6）：523-559.
Chinese Society of Neurology，Chinese Stroke Society. Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023[J]. Chin J Neurol，2024，57（6）：523-559.
[4] POWERS W J，RABINSTEIN A A，ACKERSON T，et al. Guidelines for the early management of patients with acute ischemic stroke：2019 update to the 2018 guidelines for the early management of acute ischemic stroke：a guideline for healthcare professionals from the American Heart Association/American Stroke Association[J/OL]. Stroke，2019，50（12）：e344-e418[2026-04-20]. https://doi.org/10.1161/STR.0000000000000211.
[5] MENON B K，BUCK B H，SINGH N，et al. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada（AcT）：a pragmatic，multicentre，open-label，registry-linked，randomised，controlled，non-inferiority trial[J]. Lancet，2022，400（10347）：161-169.
[6] WANG Y J，LI S Y，PAN Y S，et al. Tenecteplase versus alteplase in acute ischaemic cerebrovascular events（TRACE-2）：a phase 3，multicentre，open-label，randomised controlled，non-inferiority trial[J]. Lancet，2023，401（10377）：645-654.
[7] XIONG Y Y，WANG L Y，LI G S，et al. Tenecteplase versus alteplase for acute ischaemic stroke：a meta-analysis of phase Ⅲ randomised trials[J]. Stroke Vasc Neurol，2024，9（4）：360-366.
[8] 中国卒中学会，《中国卒中学会急性缺血性卒中再灌注治疗指南2024》编写组. 中国卒中学会急性缺血性卒中再灌注治疗指南2024[J]. 中国卒中杂志，2024，19（12）：1460-1478.
Chinese Stroke Association，Writing Group of Chinese Stroke Association Guidelines on Reperfusion Therapy for Acute Ischemic Stroke 2024. Chinese Stroke Association guidelines on reperfusion therapy for acute ischemic stroke 2024[J]. Chin J Stroke，2024，19（12）：1460-1478.
[9] 凌倚峰，程忻，杨璐萌，等. 急性缺血性卒中患者静脉溶栓治疗的临床预后影响因素分析[J]. 中华神经科杂志，2014，47（7）：449-454.
LING Y F，CHENG X，YANG L M，et al. Efficacy and outcome predictors of intravenous thrombolysis for patients with acute ischemic stroke[J]. Chin J Neurol，2014，47（7）：449-454.
[10] EMBERSON J，LEES K R，LYDEN P，et al. Effect of treatment delay，age，and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke：a meta-analysis of individual patient data from randomised trials[J]. Lancet，2014，384（9958）：1929-1935.
[11] LIU Y，LU G Z，LI D，et al. Tenecteplase thrombolytic therapy for acute ischaemic stroke in China：a real-world，multicentre，retrospective，controlled study[J]. Stroke Vasc Neurol，2025，10（4）：452-461.
[12] MARNAT G，GERSCHENFELD G，OLINDO S，et al. Incidence and predictors of intracranial hemorrhage after intravenous thrombolysis with tenecteplase[J]. Eur Stroke J，2024，9（4）：918-926.
[13] SUN L L，SONG L L，YANG J，et al. Smoking influences outcome in patients who had thrombolysed ischaemic stroke：the ENCHANTED study[J]. Stroke Vasc Neurol，2021，6（3）：395-401.
[14] ÁROKSZÁLLÁSI T，BALOGH E，ORBÁN-KÁLMÁNDI R，et al. Elevated blood alcohol concentration is associated with improved clinical outcomes of intravenous thrombolysis treatment in acute ischemic stroke patients—a retrospective study[J/OL]. J Clin Med，2023，12（6）：2238[2026-04-20]. https://doi.org/10.3390/jcm12062238.
[15] 吴国新，何家成，刘之钰，等. 静脉溶栓治疗急性缺血性脑卒中患者的临床预后影响因素[J]. 中国当代医药，2021，28（16）：79-81，92.
WU G X，HE J C，LIU Z Y，et al. Influencing factors of clinical prognosis in patients with acute ischemic stroke treated with intravenous thrombolysis[J]. China Modern Medicine，2021，28（16）：79-81，92.
[16] 李华，梁维，余振威. 急性缺血性脑卒中静脉溶栓预后的影响因素分析[J]. 中国实用神经疾病杂志，2018，21（1）：34-36.
LI H，LIANG W，YU Z W. Analysis of prognostic factors after intravenous thrombolysis in acute ischemic stroke[J]. Chin J Pract Nerv Dis，2018，21（1）：34-36.
[17] 吴建，孙翠兰. 影响急性卒中患者行阿替普酶静脉溶栓预后的相关因素分析[J]. 黑龙江医药科学，2021，44（2）：137-138.
WU J，SUN C L. Analysis of factors influencing the prognosis of acute stroke patients receiving intravenous alteplase thrombolysis[J]. Heilongjiang Medicine and Pharmacy，2021，44（2）：137-138.
[18] EHRLICH M E，LIANG L，XU H L，et al. Intravenous tissue-type plasminogen activator in acute ischemic stroke patients with history of stroke plus diabetes mellitus[J]. Stroke，2019，50（6）：1497-1503.
[19] 叶靖宇. 影响急性脑梗死患者阿替普酶静脉溶栓预后的相关因素探讨[J]. 医药前沿，2020，10（12）：65.
YE J Y. Exploration of related factors influencing the prognosis of acute cerebral infarction patients undergoing intravenous thrombolysis with alteplase[J]. Journal of Frontiers of Medicine，2020，10（12）：65.
[20] WNUK M，DRABIK L，DERBISZ J，et al. Prognostic significance of age in patients with acute ischaemic stroke treated with intravenous thrombolysis[J]. Neurol Neurochir Pol，2022，56（1）：81-88.
[21] VALKONEN K，MARTINEZ-MAJANDER N，SIBOLT G，et al. Recanalization treatment for acute ischemic stroke：3-month outcome before and after implementation of routine endovascular treatment[J/OL]. eNeurologicalSci，2022，27：100394[2026-04-20]. https://doi.org/10.1016/j.ensci.2022.100394.
[22] 甄志刚，张秋莲，张生，等. 急性缺血性脑卒中静脉溶栓患者预后与TOAST分型的相关性分析[J]. 现代中西医结合杂志，2019，28（31）：3478-3482.
ZHEN Z G，ZHANG Q L，ZHANG S，et al. Correlation analysis between prognosis and TOAST classification in patients with acute ischemic stroke undergoing intravenous thrombolysis[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine，2019，28（31）：3478-3482.
[23] 郑凤琦. 急性脑梗死患者rt-PA静脉溶栓治疗短期预后不良的影响因素[J]. 中国民康医学，2022，34（4）：7-10.
ZHENG F Q. Influencing factors of poor short-term prognosis in patients with acute cerebral infarction treated with rt-PA intravenous thrombolysis[J]. Medical Journal of Chinese People’s Health，2022，34（4）：7-10.
[24] 陈红芳，龚筱弦，徐冬娟，等. 治疗时间提前可改善缺血性脑卒中患者再灌注治疗的预后[J]. 浙江大学学报（医学版），2019，48（3）：247-253.
CHEN H F，GONG X X，XU D J，et al. Advanced treatment time improves outcomes of patients with ischemic stroke undergoing reperfusion therapy[J]. Journal of Zhejiang University（Medical Sciences），2019，48（3）：247-253.
[25] MISHRA N K，AHMED N，DAVALOS A，et al. Thrombolysis outcomes in acute ischemic stroke patients with prior stroke and diabetes mellitus[J]. Neurology，2011，77（21）：1866-1872.
[26] ZHANG K，LIU H B，ZONG C，et al. Intravenous thrombolysis versus early antiplatelet therapy in acute ischaemic stroke with small artery occlusion[J/OL]. Stroke Vasc Neurol，2025：svn-2025-004309[2026-04-20]. https://doi.org/10.1136/svn-2025-004309.
[27] FLURI F，HATZ F，RUTGERS M P，et al. Intravenous thrombolysis in patients with stroke attributable to small artery occlusion[J]. Eur J Neurol，2010，17（8）：1054-1060.
[28] NTAIOS G，MILIONIS H，VEMMOS K，et al. Small-vessel occlusion versus large-artery atherosclerotic strokes in diabetics：patient characteristics，outcomes，and predictors of stroke mechanism[J]. Eur Stroke J，2016，1（2）：108-113.
[29] MUSTANOJA S，MERETOJA A，PUTAALA J，et al. Outcome by stroke etiology in patients receiving thrombolytic treatment：descriptive subtype analysis[J]. Stroke，2011，42（1）：102-106.
[30] SARAF A，GILVAZ P C，RAMAKRISHNAN T C R，et al. Prospective observational cohort study of tenecteplase：results from the Indian registry in ischemic stroke-tenecteplase[J/OL]. J Am Heart Assoc，2024，13（23）：e036382[2026-04-20]. https://doi.org/10.1161/JAHA.124.036382.
[31] WU Z M，ZENG M Y，LI C，et al. Time-dependence of NIHSS in predicting functional outcome of patients with acute ischemic stroke treated with intravenous thrombolysis[J]. Postgrad Med J，2019，95（1122）：181-186.
[32] YOU S J，WANG Y N，WANG X，et al. Twenty-four-hour post-thrombolysis NIHSS score as the strongest prognostic predictor after acute ischemic stroke：ENCHANTED study[J/OL]. J Am Heart Assoc，2024，13（18）：e036109[2026-04-20]. https://doi.org/10.1161/JAHA.124.036109.
[33] ZHU L H，QIN Y，KANG T T，et al. Discharge NIHSS scores are predictive of poor 3-month outcomes in patients with acute ischemic stroke receiving intravenous thrombolysis[J/OL]. Ann Med，2026，58（1）：2610555[2026-04-20]. https://doi.org/10.1080/07853890.2025.2610555.
[34] SINGH N，ALMEKHLAFI M A，BALA F，et al. Effect of time to thrombolysis on clinical outcomes in patients with acute ischemic stroke treated with tenecteplase compared to alteplase：analysis from the AcT randomized controlled trial[J]. Stroke，2023，54（11）：2766-2775.
[35] WANG L Y，HAO M J，WU N，et al. Comprehensive review of tenecteplase for thrombolysis in acute ischemic stroke[J/OL]. J Am Heart Assoc，2024，13（9）：e031692[2026-04-20]. https://doi.org/10.1161/JAHA.123.031692.
[36] CAMPBELL B C V，MITCHELL P J，CHURILOV L，et al. Tenecteplase versus alteplase before thrombectomy for ischemic stroke[J]. N Engl J Med，2018，378（17）：1573-1582.