替奈普酶与阿替普酶静脉溶栓桥接机械取栓治疗合并大血管闭塞急性缺血性脑卒中患者效果比较OA
Comparison of functional outcomes between tenecteplase and alteplase as bridging thrombolysis prior to mechanical throm-bectomy for acute ischemic stroke patients with large vessel occlusion
目的:比较替奈普酶与阿替普酶静脉溶栓桥接机械取栓(以下称取栓)治疗合并大血管闭塞急性缺血性脑卒中(AIS)患者的疗效和安全性.方法:采用回顾性队列研究设计,纳入2022年12月至2025年3月急性卒中质量评估与管理在线数据库(来源于CASE-Ⅱ研究,NCT04487340)发病24 h内接受替奈普酶或阿替普酶静脉溶栓桥接取栓治疗的合并大血管闭塞AIS患者,分别设为替奈普酶组和阿替普酶组.为平衡组间差异,研究基于年龄、性别、入院至溶栓时间(DNT)、入院至穿刺时间(DPT)及发病至入院时间进行1:4倾向评分匹配,并采用二元logistic回归模型(分类变量)和一般线性模型(连续型变量)比较两组3个月神经功能和安全性事件差异.此外,对发病至溶栓时间(ONT)不超过4.5 h的患者进行敏感性分析,并基于年龄、性别、基线美国国立卫生研究院卒中量表(NIHSS)评分、血管闭塞部位、DNT和DPT进行亚组分析,评估替奈普酶或阿替普酶静脉溶栓桥接取栓对患者3个月神经功能独立的影响.结果:共收集到1505例患者的资料,其中替奈普酶组250例,阿替普酶组1255例.替奈普酶组与阿替普酶组3个月神经功能差异均无统计学意义(均P>0.05),但替奈普酶组3个月全因死亡率低于阿替普酶组(OR=0.676,95％CI:0.470～0.972,P=0.032).倾向评分匹配后,替奈普酶组224例,阿替普酶组767例.两组3个月神经功能和安全性事件差异仍均无统计学意义(均P>0.05).敏感性分析结果显示,在ONT不超过4.5 h的患者中,替奈普酶组与阿替普酶组3个月神经功能和安全性事件差异均无统计学意义(均P>0.05).亚组分析结果显示,在各亚组人群中,替奈普酶组与阿替普酶组3个月神经功能独立差异均无统计学意义(均P>0.05).结论:替奈普酶与阿替普酶静脉溶栓桥接取栓应用于合并大血管闭塞AIS患者的3个月神经功能和安全性事件相似.
Objective:To compare the efficacy and safety of tenecteplase versus alteplase as bridging intravenous thrombolysis before mechanical thrombectomy in acute ischemic stroke(AIS)patients with large vessel occlusion.Methods:In this retrospective cohort study,data were extracted from the Acute Stroke Patients for Stroke Management Quality Evaluation online database(CASE-Ⅱ,NCT04487340).Patients with AIS and large vessel occlusion who received tenecteplase or alteplase followed by mechanical thrombectomy within 24 hours of symptom onset from December 2022 to March 2025 were included.The patients were divided into the tenecteplase group and the alteplase group.Propensity score matching(1∶4)was performed based on age,sex,door-to-needle time(DNT),door-to-puncture time(DPT),and onset-to-door time.Binary logistic regression and general linear models were used to compare 3-month functional and safety outcomes.Sensitivity analysis was conducted for patients with onset-to-needle time(ONT)≤4.5 h,and subgroup analyses were performed based on age,sex,baseline National Institutes of Health Stroke Scale(NIHSS)score,occlusion site,DNT and DPT.Results:Among 1505 enrolled patients,250 received tenecteplase and 1255 received alteplase.No significant differences were observed in 3-month functional outcomes between the two groups(all P>0.05).However,the tenecteplase group had lower 3-month all-cause mortality(OR=0.676,95%CI:0.470-0.972,P=0.032).After matching,224 tenecteplase-treated and 767 alteplase-treated patients were included.There were no significant differences in functional or safety outcomes between the two groups(all P>0.05).Sensitivity analysis showed that among patients with an onset-to-needle time(ONT)≤4.5 hours,there were no statistically significant differences in 3-month functional or safety outcomes between the tenecteplase group and the alteplase group(all P>0.05).Subgroup analyses indicated that no statistically significant differences in 3-month functional independence were observed across all subgroups(all P>0.05).Conclusion:In AIS patients with large vessel occlusion undergoing bridging thrombolysis before mechanical thrombectomy,tenecteplase and alteplase showed comparable 3-month functional and safety outcomes.
施政浩;杨建生;卢振产;蔡耀杰;朱益;黄龚春;朱晖;楼敏;程建华
温州医科大学附属第一医院神经内科,浙江 温州 325000浙江大学医学院附属第二医院神经内科,浙江 杭州 310009湖州市中心医院神经内科,浙江 湖州 313000诸暨市人民医院神经内科,浙江 绍兴 311800宁波市医疗中心李惠利医院神经内科,浙江 宁波 315000平湖市第一人民医院神经内科,浙江 嘉兴 314200长兴县人民医院神经内科,浙江 湖州 313100浙江大学医学院附属第二医院神经内科,浙江 杭州 310009温州医科大学附属第一医院神经内科,浙江 温州 325000
医药卫生
急性缺血性脑卒中大血管闭塞替奈普酶阿替普酶机械取栓临床结局安全性回顾性研究
Acute ischemic strokeLarge vessel occlusionTenecteplaseAlteplaseMechanical thrombectomyClinical outcomeSafetyRetrospective study
《浙江大学学报（医学版）》 2026 (2)
121-128,8
浙江省医学会临床医学专项资金(2023ZYC-A194)浙江省基础公益研究计划(LY23H090011)This study was supported by Zhejiang Medical Association Clinical Research Fund (2023ZYCA194) and Basic Public Welfare Research Program of Zhejiang Province (LY23H090011)
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