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转换为替奈普酶用于中风患者的静脉溶栓治疗:来自德国一家大型中风中心的经验。

Switch to tenecteplase for intravenous thrombolysis in stroke patients: experience from a German high-volume stroke center.

作者信息

Sekita Alexander, Siedler Gabriela, Sembill Jochen A, Schmidt Manuel, Singer Ludwig, Kallmuenzer Bernd, Mers Lena, Bogdanova Anna, Schwab Stefan, Gerner Stefan T

机构信息

Department of Neurology, University Hospital Erlangen, Schwabachanlage 6, 91054, Erlangen, Germany.

Department of Neuroradiology, University Hospital Erlangen, Schwabachanlage 6, 91054, Erlangen, Germany.

出版信息

Neurol Res Pract. 2025 May 5;7(1):28. doi: 10.1186/s42466-025-00388-x.

Abstract

BACKGROUND

Tenecteplase (TNK) offers promising efficacy and safety data for intravenous thrombolysis (IVT) in acute ischemic stroke (AIS) and pharmacological advantages over alteplase (rt-PA), justifying its gradual adoption as primary thrombolytic agent. At our tertiary care center, we transitioned from rt-PA to TNK, providing valuable real-world insights into this process, including its use beyond the 4.5-hour time window.

METHODS

We retrospectively analyzed our stroke registry to compare clinical and procedural data from AIS patients treated with rt-PA (up to 6 months before transition) and those treated with TNK (up to 6 months after transition, starting June 2024). Primary endpoints included treatment metrics, such as door-to-needle (DTN), door-to-imaging (DTI), imaging-to-needle (ITN), door-to-groin and door-to-recanalization times. Safety outcomes comprised rate of any intracranial hemorrhage (ICH), symptomatic ICH (sICH), parenchymatous hematoma type 2 (PH 2) and post-thrombolysis angioedema. A semiquantitative questionnaire evaluated satisfaction with TNK and changes in lysis behavior among nurses and physicians 3 months post-implementation.

RESULTS

During the twelve-month period (December 1, 2023 - November 30, 2024), 276 patients underwent IVT. Median DTN times were significantly shorter with TNK (n = 138) compared to rt-PA (n = 138) (TNK 27 min [IQR 19-39] vs. rt-PA 34 min [IQR 25-62]; p = 0.011). No significant differences were observed in safety outcomes, including any ICH (TNK 9% vs. rt-PA 6%; p = 0.30), sICH (2% vs. 1%; p = 0.31), PH 2 rates (1% in both groups), or angioedema (3% vs. 1%; p = 0.18). Staff satisfaction with TNK was high, citing advantages in preparation, administration, and time efficiency. Importantly, no changes in lysis behavior were reported following the transition.

CONCLUSIONS

Transitioning to TNK in routine practice at a tertiary care center seems feasible with reduced ITN and consequently DTN times. Functional outcomes at discharge were comparable without significant difference in the rate of (s)ICH. Overall, the transition to TNK was well-received by medical staff, highlighting TNK's practical advantages in acute stroke care.

TRIAL REGISTRATION

N.A.

摘要

背景

替奈普酶(TNK)在急性缺血性卒中(AIS)静脉溶栓(IVT)方面显示出有前景的疗效和安全性数据,且与阿替普酶(rt-PA)相比具有药理学优势,这使其逐渐被采用作为主要溶栓药物。在我们的三级医疗中心,我们从rt-PA转换为TNK,为这一过程提供了宝贵的真实世界见解,包括其在4.5小时时间窗之外的使用情况。

方法

我们回顾性分析了我们的卒中登记数据,以比较接受rt-PA治疗(转换前长达6个月)和接受TNK治疗(转换后长达6个月,从2024年6月开始)的AIS患者的临床和程序数据。主要终点包括治疗指标,如门到针(DTN)、门到影像(DTI)、影像到针(ITN)、门到腹股沟和门到再通时间。安全结局包括任何颅内出血(ICH)、症状性ICH(sICH)、2型实质性血肿(PH 2)和溶栓后血管性水肿的发生率。一份半定量问卷评估了实施3个月后护士和医生对TNK的满意度以及溶栓行为的变化。

结果

在十二个月期间(2023年12月1日至2024年11月30日),276例患者接受了IVT。与rt-PA(n = 1

38)相比,TNK(n = 138)组的中位DTN时间显著缩短(TNK为27分钟[四分位间距19 - 39],rt-PA为34分钟[四分位间距25 - 62];p = 0.011)。在安全结局方面未观察到显著差异,包括任何ICH(TNK为9%,rt-PA为6%;p = 0.30)、sICH(2%对1%;p = 0.31)、PH 2发生率(两组均为1%)或血管性水肿(3%对1%;p = 0.18)。工作人员对TNK的满意度很高,提到了在配制、给药和时间效率方面的优势。重要的是,转换后未报告溶栓行为有变化。

结论

在三级医疗中心的常规实践中转换为TNK似乎是可行的,ITN缩短,因此DTN时间也缩短。出院时的功能结局相当,(s)ICH发生率无显著差异。总体而言,向TNK的转换受到医务人员的好评,突出了TNK在急性卒中治疗中的实际优势。

试验注册

无。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b11b/12051303/e0a2d9589dc3/42466_2025_388_Figa_HTML.jpg

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