Ifzaal Moazzma, Bughio Sharib Afzal, Rizvi Syed Ali Farhan Abbas, Muzaffar Maryam, Ali Rubia, Ikram Moeen, Murtaza Meer, Mirza Agha Muhammad Wali, Ans Hasaan Haider, Bucataru Lavinia, Ans Armghan Haider, Ahmed Raheel, Ahmed Mushood, Ayyan Muhammad, Rehman Muhammad Aemaz Ur
Acute Medicine Unit, University Hospital of North Midlands, UK.
Department of Medicine, Ziauddin Medical University, Karachi, Pakistan.
J Stroke Cerebrovasc Dis. 2025 Jul;34(7):108338. doi: 10.1016/j.jstrokecerebrovasdis.2025.108338. Epub 2025 May 3.
Data regarding the efficacy and safety of tenecteplase (TNK) in patients with acute ischemic stroke (AIS) who present outside the standard treatment window are limited. This study aims to evaluate the role of TNK at a dose of 0.25 mg/kg, in treating AIS patients in an extended time window.
Searches were performed up to February 15, 2025 in PubMed, Embase, and Cochrane Library to include randomized-controlled trials (RCTs) comparing TNK (0.25 mg/kg) to no thrombolysis in AIS patients presenting after 4.5 hours of symptom onset or wake-up AIS. The primary efficacy outcomes included a 3-month excellent functional outcome (mRS ⩽1), and a good functional outcome (mRS ⩽2). Secondary safety outcomes assessed included symptomatic intracranial hemorrhage (sICH), any ICH, and 3-month all-cause death. A random-effects model was used to calculate summary estimates.
6 RCTs were included (n = 1,955 patients) in the meta-analysis. The pooled analysis demonstrated a significantly improved excellent functional outcome on 90 days (OR = 1.35, 95 % CI: 1.12 to 1.64) with TNK administration compared to control. No statistically significant association was observed for the two groups regarding good functional outcome (OR = 1.16, 95 % CI: 0.94 to 1.44), all-cause death (OR = 1.11, 95 % CI: 0.82 to 1.49), sICH (OR = 1.79, 95 % CI: 0.94 to 3.39), and any ICH (OR = 1.21, 95 % CI: 0.96 to 1.53).
TNK administration in an extended time window for AIS patients leads to favorable neurological outcomes with a good safety profile.
关于替奈普酶（TNK）在超出标准治疗时间窗就诊的急性缺血性卒中（AIS）患者中的疗效和安全性的数据有限。本研究旨在评估剂量为0.25mg/kg的TNK在延长时间窗内治疗AIS患者中的作用。
截至2025年2月15日，在PubMed、Embase和Cochrane图书馆进行检索，纳入比较TNK（0.25mg/kg）与未进行溶栓治疗的随机对照试验（RCT），这些试验的研究对象为症状发作4.5小时后就诊的AIS患者或醒后卒中的AIS患者。主要疗效指标包括3个月时良好的功能结局（改良Rankin量表[mRS]≤1）和较好的功能结局（mRS≤2）。评估的次要安全性指标包括症状性颅内出血（sICH）、任何颅内出血以及3个月时的全因死亡。采用随机效应模型计算汇总估计值。
荟萃分析纳入了6项RCT（n = 1955例患者）。汇总分析表明，与对照组相比，使用TNK治疗可使90天时良好的功能结局显著改善（比值比[OR]=1.35，95%置信区间[CI]：1.12至1.64）。两组在较好的功能结局（OR = 1.16，95%CI：0.94至1.44）、全因死亡（OR = 1.11，95%CI：0.82至1.49）、sICH（OR = 1.79，95%CI：0.94至3.39）和任何颅内出血（OR = 1.21，95%CI：0.96至1.53）方面未观察到统计学上的显著关联。
在延长时间窗内给予AIS患者TNK可带来良好的神经功能结局且安全性良好。
