Sheraz Maheen, Asif Nawal, Khan Ariba, Khubaib Khan Muhammad, Maaz Bin Rehan Muhammad, Tayyab Amer Ch Muhammad, Sadain Khalid Ahmed, Oriana Alfieri Caterina, Bouyarden Elmehdi, Amine Ghenai Mohamed, Alareed Ahmad, Ahmed Raheel, Ahmed Mushood, Ehsan Muhammad
Department of Medicine, Continental Medical College, Lahore, Pakistan.
Department of Medicine, King Edward Medical University, Lahore, Pakistan.
J Stroke Cerebrovasc Dis. 2025 Jun;34(6):108300. doi: 10.1016/j.jstrokecerebrovasdis.2025.108300. Epub 2025 Mar 27.
Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality worldwide. While alteplase has been widely used for acute management, recent clinical trials suggest that tenecteplase (TNK) may offer improved clinical outcomes. This study aims to compare the efficacy and safety of TNK compared with alteplase.
A comprehensive literature search was conducted using PubMed, Embase and Cochrane Library from inception to October 2024 to identify randomized controlled trials that compared TNK at 0.25 mg/kg dosage with alteplase. Data about clinical outcomes was extracted from both groups and assessed by generating forest plots using the random-effects model and pooling odds ratios (ORs).
A total of 11 RCTs with 7,546 patients were included in the analysis. TNK showed statistically significant improvement in excellent functional outcome (mRS 0-1) compared with alteplase (OR= 1.14, 95 % CI= 1.03-1.25). No statistically significant difference was observed for good functional outcome (mRS 0-2) (OR= 1.11, 95 % CI= 0.9-1.25), early neurological improvement (OR=1.08, 95 % CI= 0.93-1.26), all-cause death (OR=0.99, 95 % CI= 0.81-1.19), symptomatic intracranial hemorrhage (OR=1.11, 95 % CI=0.81-1.52) and poor functional outcome (mRS=4-6) (OR=0.95, 95 % CI=0.79-1.14).
In patients with acute ischemic stroke, TNK demonstrated a significant advantage over alteplase in achieving excellent functional outcomes. The incidence of early neurological improvement, symptomatic intracranial hemorrhage, all-cause death, and poor functional outcome remained comparable across the two groups.
急性缺血性卒中（AIS）是全球发病和死亡的主要原因。虽然阿替普酶已广泛用于急性治疗，但最近的临床试验表明，替奈普酶（TNK）可能会改善临床结局。本研究旨在比较TNK与阿替普酶的疗效和安全性。
使用PubMed、Embase和Cochrane图书馆进行全面的文献检索，检索时间从数据库建立至2024年10月，以确定将0.25mg/kg剂量的TNK与阿替普酶进行比较的随机对照试验。从两组中提取有关临床结局的数据，并通过使用随机效应模型生成森林图和汇总比值比（OR）进行评估。
共有11项随机对照试验、7546例患者纳入分析。与阿替普酶相比，TNK在实现良好功能结局（改良Rankin量表[mRS]评分0-1）方面显示出统计学上的显著改善（OR=1.14，95%置信区间[CI]=1.03-1.25）。在良好功能结局（mRS评分0-2）（OR=1.11，95%CI=0.9-1.25）、早期神经功能改善（OR=1.08，95%CI=0.93-1.26）、全因死亡（OR=0.99，95%CI=0.81-1.19）、症状性颅内出血（OR=1.11，95%CI=0.81-1.52）和不良功能结局（mRS评分4-6）（OR=0.95，95%CI=0.79-1.14）方面未观察到统计学上的显著差异。
在急性缺血性卒中患者中，TNK在实现良好功能结局方面比阿替普酶具有显著优势。两组的早期神经功能改善、症状性颅内出血、全因死亡和不良功能结局的发生率仍然相当。
