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从中西部农村卒中网络中的阿替普酶转换为替奈普酶治疗急性缺血性卒中:规划、实施、安全性和结局。

Transition from alteplase to tenecteplase for treatment of acute ischemic stroke in a rural stroke network of the Midwest: Planning, execution, safety, and outcomes.

机构信息

Brain and Spine Institute, Southern Illinois Healthcare, Carbondale, IL, United States; Southern Illinois University School of Medicine, Carbondale, IL, United States.

Brain and Spine Institute, Southern Illinois Healthcare, Carbondale, IL, United States.

出版信息

Clin Neurol Neurosurg. 2024 Dec;247:108633. doi: 10.1016/j.clineuro.2024.108633. Epub 2024 Nov 10.

Abstract

PURPOSE

This study aims to document the transition from alteplase to tenecteplase within a rural stroke network in the Midwest. It emphasizes the planning and execution of the transition, and evaluates safety and outcomes of tenecteplase compared to alteplase one year after the adoption of the new thrombolytic.

METHODS

This is a retrospective observational study of patients who were treated with thrombolytic therapy for suspected acute ischemic stroke at Southern Illinois Healthcare rural stroke network between July 2017 and July 2024. For each patient, demographics, past medical history, clinical presentation, National Institutes of Health Stroke Scale (NIHSS), and laboratory values were reviewed. Type of thrombolytic was noted. Door-to-needle time (DTN) and complications of thrombolytic therapy including symptomatic ICH (sICH) were reviewed. The primary outcome was the rate of sICH after administration of thrombolytic therapy. Secondary outcomes included target DTN ≤ 60 minutes and modified Rankin Scale (mRS) 0-2 at 30 days.

RESULTS

Out of 279 patients treated with thrombolytics, 215 (77 %) received alteplase, and 64 (23 %) received tenecteplase. The two groups were severity matched, and did not differ in terms of demographics or baseline comorbidities. Median DTN (IQR) was comparable between alteplase and tenecteplase, in minutes ((50 (40-69) vs. 53 (37-65)). In three distinct regression models for each of the predetermined outcomes, accounting for markers of stroke severity, the type of thrombolytic was not associated with development of sICH (OR 1.59, SE 1.445, p = 0.61), target DTN ≤ 60 min (OR 0.996, SE 0.304, p = 0.988), nor mRS 0-2 at 30 days (OR 1.086, SE 0.446, p = 0.842).

CONCLUSIONS

In our population, safety and outcome of thrombolytic therapy for acute ischemic stroke did not differ based on the type of thrombolytic used. Our study highlights the planning and execution of the transition from alteplase to tenecteplase, with challenges faced and lessons learned, and supports the use of tenecteplase in real-world rural practice.

摘要

目的

本研究旨在记录中西部农村卒中网络中从阿替普酶向替奈普酶的转变情况。它强调了转变的规划和执行,并评估了新溶栓药物采用一年后替奈普酶与阿替普酶相比的安全性和结果。

方法

这是一项回顾性观察性研究,纳入了 2017 年 7 月至 2024 年 7 月期间在南伊利诺伊医疗保健农村卒中网络中接受溶栓治疗疑似急性缺血性卒中的患者。对每位患者的人口统计学、既往病史、临床表现、美国国立卫生研究院卒中量表(NIHSS)和实验室值进行了回顾。记录溶栓药物的类型。评估门到针时间(DTN)和溶栓治疗并发症,包括症状性脑出血(sICH)。主要结局是溶栓治疗后 sICH 的发生率。次要结局包括目标 DTN≤60 分钟和 30 天改良 Rankin 量表(mRS)0-2 分。

结果

在接受溶栓治疗的 279 例患者中,215 例(77%)接受阿替普酶治疗,64 例(23%)接受替奈普酶治疗。两组严重程度匹配,在人口统计学或基线合并症方面无差异。阿替普酶和替奈普酶的中位数 DTN(IQR)相似,分钟数分别为(50(40-69)比 53(37-65))。在针对每个预定结局的三个不同回归模型中,考虑到卒中严重程度的标志物,溶栓药物的类型与 sICH 的发生无关(OR 1.59,SE 1.445,p=0.61)、目标 DTN≤60 分钟(OR 0.996,SE 0.304,p=0.988)或 30 天 mRS 0-2 分(OR 1.086,SE 0.446,p=0.842)。

结论

在我们的人群中,急性缺血性卒中溶栓治疗的安全性和结局不因溶栓药物的类型而异。本研究强调了从阿替普酶向替奈普酶的转变的规划和执行,包括所面临的挑战和经验教训,并支持在真实世界的农村实践中使用替奈普酶。

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