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替奈普酶与阿替普酶用于急性缺血性卒中4.5小时内溶栓治疗的疗效与安全性研究

Tenecteplase and Alteplase for Thrombolysis of Acute Ischemic Stroke within 4.5 Hours: An Efficacy and Safety Study.

作者信息

Dhar Nikita, Kumar Mritunjai, Tiwari Ashutosh, Desai Ishita, Madhaw Govind, Kumar Niraj

机构信息

Department of Neurology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.

Department of Neurology, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India.

出版信息

Ann Indian Acad Neurol. 2022 Sep-Oct;25(5):897-901. doi: 10.4103/aian.aian_1127_21. Epub 2022 Jul 14.

Abstract

OBJECTIVE

To compare the efficacy and safety of thrombolysis using Tenecteplase (TNK) versus alteplase in acute ischaemic stroke (AIS) patients within 4.5-hour window period.

METHODS

This retrospective study involved the collection of data from consecutive AIS patients who underwent thrombolysis in the Department of Neurology at a tertiary care university hospital, between May 2018 to January 2021. Data including clinical history, neurological assessment using modified Rankin score (mRS), National Institutes of Health Stroke Scale (NIHSS), brain neuroimaging, treatment, and outcome details were collected. The primary efficacy outcome was the proportion of patients with good functional recovery (mRS of 0-2) at 90 days of follow-up.

RESULTS

Total of 42 patients with AIS underwent thrombolysis, of which 19 received alteplase and 23 got TNK. The median (range) onset to door time [120 (20-210) versus 120 (30-210) minutes; = 0.823] and median (range) onset to needle time [150 (60-255) versus 160 (50-240) minutes; = 0.779] were comparable in both alteplase and TNK groups, respectively. The primary outcome of good functional recovery (mRS ≤2) at 3 months was observed in more than half the patients in each group and was comparable ( = 0.701). Post-thrombolysis complications including cerebral haemorrhage (symptomatic or asymptomatic) were comparable between the two groups (31.6% vs 30.4%; = 0.936), except a significantly higher proportion of patients on TNK required mechanical ventilation (10.5% v/s 43.5%; = 0.019).

CONCLUSIONS

This study showed a comparable efficacy and safety profile of alteplase and TNK in thrombolysis of AIS throughout the 4.5 hours window period. Moreover, the ease of administration and better pharmacodynamic properties favors tenecteplase.

摘要

目的

比较替奈普酶(TNK)与阿替普酶在急性缺血性卒中(AIS)患者4.5小时时间窗内进行溶栓治疗的疗效和安全性。

方法

这项回顾性研究收集了2018年5月至2021年1月期间在一所三级大学医院神经内科接受溶栓治疗的连续AIS患者的数据。收集的数据包括临床病史、使用改良Rankin量表(mRS)、美国国立卫生研究院卒中量表(NIHSS)进行的神经学评估、脑神经影像学、治疗及结局细节。主要疗效结局是随访90天时功能恢复良好(mRS为0 - 2)的患者比例。

结果

共有42例AIS患者接受了溶栓治疗,其中19例接受阿替普酶治疗,23例接受TNK治疗。阿替普酶组和TNK组的中位(范围)发病至入院时间[120(20 - 210)分钟对120(30 - 210)分钟;P = 0.823]和中位(范围)发病至穿刺时间[150(60 - 255)分钟对160(50 - 240)分钟;P = 0.779]分别具有可比性。每组超过半数的患者在3个月时观察到功能恢复良好(mRS≤2)的主要结局,且具有可比性(P = 0.701)。溶栓后并发症包括脑出血(有症状或无症状)在两组间具有可比性(31.6%对30.4%;P = 0.936),但接受TNK治疗的患者中需要机械通气的比例显著更高(10.5%对43.5%;P = 0.019)。

结论

本研究表明,在4.5小时时间窗内对AIS进行溶栓治疗时,阿替普酶和TNK的疗效和安全性相当。此外,给药便利性和更好的药效学特性使替奈普酶更具优势。

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