Hagag Abdelmonam M, Kormod Muhammed E, Ads Mahmoud Elmwafy, El-Refaay Mennatullah A, Abozaid Omnia M, Ghanem Omar A, Yasser Mazen, Abdelmoaty Karim M, Khedr Alaa Mahmoud, Albers Gregory W
Faculty of Medicine, Zagazig University, As Sanafin Al Qibliyyah, Minya Al Qamh, Zagazig, Sharqia, Egypt.
Faculty of Medicine, Al-Azhar University, Cairo, Egypt.
Eur J Med Res. 2025 Aug 8;30(1):726. doi: 10.1186/s40001-025-02983-9.
Stroke was the second leading cause of death and the third leading cause of disability worldwide in 2019. Alteplase is an FDA-approved medication for the treatment of patients with ischemic stroke within 4.5 h. However, Tenecteplase is an alternative. We aimed to assess the safety, efficacy, and the best dose of tenecteplase vs alteplase.
We followed the PRISMA 2020 guidelines. We searched PubMed, Scopus, Web of Science, and the Cochrane Library until November 2024. We included RCTs that compared tenecteplase with alteplase in acute ischemic stroke patients within 4.5 h of onset. Relative risk, 95% CI, and random effects models were used. Our primary endpoints were excellent functional outcomes and mortality. An excellent functional outcome was defined as a modified Rankin Score of 0-1 at 90 days. The Risk of Bias 2 tool from Cochrane was used to assess the quality of the studies.
Thirteen RCTs met our inclusion criteria, including 9053 patients, 4416 of whom had tenecteplase. Six studies showed a low risk of bias, and the other 7 had some concerns either in their randomization process or in the deviation from the intended intervention. Tenecteplase 0.25 mg/kg had a significantly better performance in achieving excellent functional outcomes (p value 0.008), but no difference was observed in mortality rates (P value 0.37). On the other hand, no difference was observed in comparing either TNK 0.1 mg/kg or TNK 0.4 mg/kg versus alteplase in the reported outcomes. A meta-regression revealed that a reduction in the baseline NIHSS score had a significant effect on favorable functional outcomes (P value 0.025). Sensitivity analysis for outcomes comparing either TNK 0.25 mg/kg and TNK 0.1 mg/kg versus alteplase showed that no single study removal affected the significance of the study, while Kvistad 2022 and Logallo 2017 removal changed the significance of outcomes comparing TNK 0.4 mg/kg versus alteplase.
When compared with alteplase, 0.25 mg/kg tenecteplase is superior for achieving excellent functional outcomes and is not inferior in terms of major neurological improvement or death rates. TNKs at 0.25 mg/kg appear to be the optimal dose and a desirable alternative to alteplase.
CRD42024596896.
2019年，中风是全球第二大死因和第三大致残原因。阿替普酶是一种经美国食品药品监督管理局（FDA）批准用于治疗发病4.5小时内缺血性中风患者的药物。然而，替奈普酶是一种替代药物。我们旨在评估替奈普酶与阿替普酶相比的安全性、有效性和最佳剂量。
我们遵循PRISMA 2020指南。截至2024年11月，我们检索了PubMed、Scopus、科学网和考克兰图书馆。我们纳入了在发病4.5小时内将替奈普酶与阿替普酶用于急性缺血性中风患者的随机对照试验（RCT）。使用相对风险、95%置信区间和随机效应模型。我们的主要终点是良好的功能结局和死亡率。良好的功能结局定义为90天时改良Rankin评分0 - 1分。使用考克兰的偏倚风险2工具评估研究质量。
13项RCT符合我们的纳入标准，包括9053例患者，其中4416例使用替奈普酶。6项研究显示偏倚风险较低，另外7项在随机化过程或偏离预期干预方面存在一些问题。0.25mg/kg的替奈普酶在实现良好功能结局方面表现显著更好（p值0.008），但在死亡率方面未观察到差异（p值0.37）。另一方面，在报告的结局中，比较0.1mg/kg或0.4mg/kg的替奈普酶与阿替普酶时未观察到差异。一项Meta回归显示，基线美国国立卫生研究院卒中量表（NIHSS）评分降低对良好的功能结局有显著影响（p值0.025）。比较0.25mg/kg和0.1mg/kg的替奈普酶与阿替普酶的结局敏感性分析表明，没有一项研究的剔除影响研究的显著性，而剔除Kvistad 2022和Logallo 2017研究改变了比较0.4mg/kg替奈普酶与阿替普酶结局的显著性。
与阿替普酶相比，0.25mg/kg的替奈普酶在实现良好功能结局方面更优，在主要神经功能改善或死亡率方面并不逊色。0.25mg/kg的替奈普酶似乎是最佳剂量，是阿替普酶的理想替代药物。
国际前瞻性系统评价注册库（PROSPERO）注册号：CRD42024596896。
