Sjögren Vilhelm, Ekici Rifat, Faergemann Erik, Björck Fredrik
Department of Public Health and Clinical Medicine, Umeå University, Sweden.
Department of Geriatrics, Neurology and Rehabilitation, Sundsvall County Hospital, Sundsvall, Sweden.
IBRO Neurosci Rep. 2023 Mar 7;14:353-357. doi: 10.1016/j.ibneur.2023.03.001. eCollection 2023 Jun.
Tenecteplase (TNK-tPA) has several benefits over alteplase (tPA) in treatment of acute ischaemic stroke. Randomised controlled trials have shown promising results. In June 2017, the Stroke Unit at Sundsvall County Hospital switched from tPA to TNK-tPA in standard clinical practice. This study examines the effects of that shift.
All thrombolysis treatments performed during the first twenty-four months with TNK-tPA (168) were compared to the last twenty-four months with tPA (191). Data were collected from patient records. Follow-up time was 30 days. Co-primary outcomes were death and symptomatic intracranial haemorrhage (SICH). Secondary outcomes were types of intracerebral bleeding and cause of death. Tertiary outcome was door-to-needle time (DNT).
Treatment groups were of comparable age (75.7 ± 0.2 years). tPA-treated patients had an NIHSS (National Institutes of Health Stroke Scale) score of 9.2 versus 7.5 for TNK-tPA. Patients older than 80 had more severe strokes (median NIHSS 9 versus 5). SICH occurred in 6 (3.6 %) patients in the TNK-tPA group and in 2 (1.0 %) treated with tPA, odds ratio (OR) 3.41 (0.70-16.7). Numbers for death were 21 (12.5 %) and 31 (15.2 %), OR 0.77 (0.46-1.29), meaning no statistically significant differences in primary outcomes. There were no significant differences in secondary outcomes. Predominant cause of death was cerebral infarction. DNT with tenecteplase was shorter: mean 44 versus 26, and median 35 versus 19 min.
Switching from alteplase to tenecteplase was associated with shorter time to treatment. To draw certain conclusions regarding safety or efficacy would require a larger material.
在急性缺血性中风的治疗中,替奈普酶(TNK-tPA)相较于阿替普酶(tPA)具有多项优势。随机对照试验已显示出有前景的结果。2017年6月,松兹瓦尔县医院的卒中单元在标准临床实践中从tPA改用TNK-tPA。本研究考察了这一转变的影响。
将使用TNK-tPA进行溶栓治疗的前二十四个月内的所有病例(168例)与使用tPA的后二十四个月内的病例(191例)进行比较。数据从患者病历中收集。随访时间为30天。共同主要结局为死亡和症状性颅内出血(SICH)。次要结局为脑内出血类型和死亡原因。三级结局为门到针时间(DNT)。
治疗组年龄相当(75.7±0.2岁)。接受tPA治疗的患者美国国立卫生研究院卒中量表(NIHSS)评分为9.2分,而接受TNK-tPA治疗的患者为7.5分。80岁以上患者中风更严重(NIHSS中位数为9分对5分)。TNK-tPA组有6例(3.6%)患者发生SICH,tPA治疗组有2例(1.0%),比值比(OR)为3.41(0.70 - 16.7)。死亡人数分别为21例(12.5%)和31例(15.2%),OR为0.77(0.46 - 1.29),这意味着主要结局无统计学显著差异。次要结局也无显著差异。主要死亡原因是脑梗死。使用替奈普酶的DNT更短:均值为44分钟对26分钟,中位数为35分钟对19分钟。
从阿替普酶改用替奈普酶与更短的治疗时间相关。要得出关于安全性或疗效的确切结论则需要更大规模的样本。