Luo Jia-Xin, Li Zuo-Qiao, Meng Zi-Zhen, Dong Qian, Liu Xue-Yun, Yang Tian-Nan, Wang Zi-Jie, Wu Xiao-San, Li Qi
Department of Neurology, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230601, China.
Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
J Stroke Cerebrovasc Dis. 2025 Sep;34(9):108408. doi: 10.1016/j.jstrokecerebrovasdis.2025.108408. Epub 2025 Jul 29.
Only a minority of stroke patients are eligible for intravenous thrombolysis (IVT) within the standard 4.5-hour window. The safety and efficacy of IVT beyond this time frame remain insufficiently researched.
To evaluate the efficacy and safety following IVT in patients with AIS (4.5-24 hours).
The systematic review was registered in PROSPERO (CRD420251019740). Inclusion criteria included randomized clinical trials that examined outcomes, mortality, and complications in patients with AIS comparing IVT vs Best Medical Treatment (BMT). The risk of bias in the included studies was evaluated using the revised tool for assessing risk of bias. Meta-analyses assessed efficacy (excellent outcomes, functional independence) and safety (symptomatic intracranial hemorrhage [sICH], mortality) using a random-effects model.
A total of six randomized clinical trials with 1884 initially enrolled patients were included in the analysis. Higher excellent outcome rates were observed in the IVT group (RR, 1.25; 95 % CI, 1.11-1.41). No significant differences were found in functional independence (RR, 1.14; 95 % CI, 0.98-1.32), sICH (RR, 1.91; 95 % CI, 0.85-4.33), or 90-day all-cause mortality (RR, 1.02; 95 % CI, 0.81-1.29). There was considerable heterogeneity among the studies included in the functional independence outcome (I² = 40.8 %, τ² = 0.01); however, no heterogeneity was observed for other outcomes (I² = 0, τ² = 0).
These findings suggest that IVT with tenecteplase or alteplase may enhance 90-day excellent outcomes in patients with late-window acute ischemic stroke without significantly increasing the risk of sICH or mortality.
只有少数中风患者符合在标准4.5小时时间窗内进行静脉溶栓（IVT）的条件。在此时间框架之外进行IVT的安全性和有效性仍研究不足。
评估急性缺血性卒中（AIS）患者（4.5 - 24小时）接受IVT后的疗效和安全性。
该系统评价已在PROSPERO（CRD420251019740）注册。纳入标准包括比较IVT与最佳药物治疗（BMT）的、检查AIS患者结局、死亡率和并发症的随机临床试验。使用修订后的偏倚风险评估工具评估纳入研究的偏倚风险。荟萃分析使用随机效应模型评估疗效（良好结局、功能独立性）和安全性（症状性颅内出血[sICH]、死亡率）。
共有六项随机临床试验、1884名初始入组患者纳入分析。IVT组观察到更高的良好结局率（RR，1.25；95%CI，1.11 - 1.41）。在功能独立性（RR，1.14；95%CI，0.98 - 1.32）、sICH（RR，1.91；95%CI，0.85 - 4.33）或90天全因死亡率（RR，1.02；95%CI，0.81 - 1.29）方面未发现显著差异。功能独立性结局纳入的研究之间存在相当大的异质性（I² = 40.8%，τ² = 0.01）；然而，其他结局未观察到异质性（I² = 0，τ² = 0）。
这些发现表明，使用替奈普酶或阿替普酶进行IVT可能会提高晚期急性缺血性卒中患者90天的良好结局，而不会显著增加sICH或死亡率风险。
