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高龄急性缺血性脑卒中患者使用替奈普酶与阿替普酶的比较。

Tenecteplase versus alteplase after acute ischemic stroke at high age.

机构信息

Department of Neurology, Division of Medicine, Akershus University Hospital, Lorenskog, Norway.

Department of Neurology, Haukeland University Hospital, Bergen, Norway.

出版信息

Int J Stroke. 2021 Apr;16(3):295-299. doi: 10.1177/1747493020938306. Epub 2020 Jul 6.

Abstract

BACKGROUND

Stroke prevalence is increasing with age. Alteplase is the only agent approved for thrombolytic treatment for patients with ischemic stroke, including patients ≥80 years. In the present study, the aim was to compare efficacy and safety of tenecteplase and alteplase in patients ≥80 years.

METHODS

Data from the Norwegian Tenecteplase Stroke Trial, a randomized controlled trial comparing alteplase and tenecteplase, were assessed.

RESULTS

Of the 273 patients ≥80 years included, mean age was 85.5 years.In the intention-to-treat analyses, 43.1% receiving tenecteplase and 39.9% receiving alteplase reached excellent functional outcome (modified Rankin Scale score 0-1) after 3 months (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.70-1.85, p=0.59). No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65). Death within 3 months occurred in 18 patients (14.3%) in the tenecteplase group and in 21 (15.3%) in the alteplase group (p 0.84). After excluding stroke mimics, the proportion of patients with excellent functional outcome was 44.1% in the tenecteplase group and 34.4% in the alteplase group (OR 1.50 CI 0.90-2.52, p 0.12).

CONCLUSION

No differences in the efficacy and safety of tenecteplase versus alteplase in patients ≥80 years were identified.

TRIAL REGISTRATION

Clinicaltrials.gov (NCT01949948).

摘要

背景

随着年龄的增长,中风的发病率也在增加。阿替普酶是唯一批准用于治疗缺血性中风患者的溶栓药物,包括≥80 岁的患者。本研究旨在比较替奈普酶和阿替普酶在≥80 岁患者中的疗效和安全性。

方法

评估了挪威替奈普酶溶栓试验(一项比较阿替普酶和替奈普酶的随机对照试验)的数据。

结果

273 名≥80 岁的患者中,平均年龄为 85.5 岁。在意向治疗分析中,接受替奈普酶治疗的患者中有 43.1%,接受阿替普酶治疗的患者中有 39.9%,在 3 个月后达到良好的功能结局(改良 Rankin 量表评分为 0-1)(优势比(OR)为 1.14,95%置信区间(CI)为 0.70-1.85,p=0.59)。在两组治疗患者中,48 小时内症状性颅内出血的发生率没有显著差异(替奈普酶组 11 例(8.5%),阿替普酶组 10 例(7.0%),OR 1.23,95%CI 0.50-3.00,p=0.65)。替奈普酶组 18 例(14.3%)和阿替普酶组 21 例(15.3%)患者在 3 个月内死亡(p=0.84)。排除中风模拟病例后,替奈普酶组的良好功能结局比例为 44.1%,阿替普酶组为 34.4%(OR 1.50,95%CI 0.90-2.52,p=0.12)。

结论

在≥80 岁的患者中,替奈普酶与阿替普酶的疗效和安全性没有差异。

试验注册

Clinicaltrials.gov(NCT01949948)。

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