Department of Neurology, Hubei Provincial Hospital of Integrated Chinese and Western Medicine, Hubei University of Chinese Medicine, Wuhan, 430000, China.
Department of Neurology, People's Hospital of Dongxihu District of Wuhan Union Hospital, Wuhan, 430040, China.
Neurol Sci. 2023 Sep;44(9):3005-3015. doi: 10.1007/s10072-023-06801-0. Epub 2023 Apr 15.
We aimed to evaluate the available evidence on the efficacy and safety outcomes of intravenous tenecteplase (TNK) compared with intravenous alteplase(ALT) for patients with acute ischemic stroke (AIS) in randomized controlled trials (RCTs).
The MEDLINE/PubMed, Embase, Springer, Web of Science, Cochrane Collaboration database, China National Knowledge Infrastructure (CNKI) database, and Wanfang database were comprehensively searched for RCTs regarding the effects of TNK versus ALT among AIS patients in these English and Chinese electronic databases from inception dates to August 1, 2022. This meta-analysis followed PRISMA guidelines. Two reviewers independently retrieved RCTs and extracted relevant information. The methodological quality of the included trials was estimated using the Cochrane risk of bias tool. The pooled analyses were performed using RevMan 5.3 software. The primary outcome was functional outcome on the modified Rankin Scale (mRS) (range 0 to 5) and mortality at 90 days. The secondary outcomes included successful recanalization, early neurologic improvement < 48 h, any intracranial hemorrhage (ICH), and symptomatic ICH. The follow-up time of all studies was at least 3 months.
A total of nine RCTs involving 1958 patients in TNK group and 1731 patients in ALT group were finally included. For the efficacy outcomes, there were no significant differences between the two groups in terms of mRS score 0 ~ 2 (RR 1.00; 95% CI 0.88-1.13; P = 0.96), mRS score 0 ~ 1 (RR 1.03; 95% CI 0.96-1.10; P = 0.36), successful recanalization (RR 1.25; 95% CI 0.88-1.76; P = 0.21), and early neurologic improvement < 48 h (RR 1.08; 95% CI 0.92-1.26; P = 0.37). Similar results were seen for the safety outcomes, which have no statistical differences in terms of any ICH (RR 1.01; 95% CI 0.72-1.41; P = 0.96), symptomatic ICH (RR 1.19; 95% CI 0.81-1.76; P = 0.37), and mortality at 90 days (RR 0.99; 95% CI 0.83-1.19; P = 0.94).
Overall, the efficacy and safety outcomes of intravenous thrombolysis with TNK versus ALT for AIS were not statistically different. However, TNK at a dose of 0.25 mg/kg may be a reasonable alternative to ALT for thrombolysis.
我们旨在评估静脉注射替奈普酶（TNK）与阿替普酶（ALT）治疗急性缺血性脑卒中（AIS）患者的疗效和安全性结局的现有证据，这些研究均为随机对照试验（RCT）。
我们全面检索了 MEDLINE/PubMed、Embase、Springer、Web of Science、Cochrane 协作数据库、中国知网（CNKI）数据库和万方数据库，以获取关于 TNK 与 ALT 治疗 AIS 患者的 RCT 研究，检索时间为各数据库建库至 2022 年 8 月 1 日。本荟萃分析遵循 PRISMA 指南。两名评审员独立检索 RCT 并提取相关信息。使用 Cochrane 偏倚风险工具评估纳入试验的方法学质量。使用 RevMan 5.3 软件进行汇总分析。主要结局是改良 Rankin 量表（mRS）（范围 0~5）评分的功能结局和 90 天死亡率。次要结局包括再通成功、48 小时内早期神经改善 < 48 小时、任何颅内出血（ICH）和症状性 ICH。所有研究的随访时间均至少为 3 个月。
最终纳入了 9 项 RCT，TNK 组纳入 1958 例患者，ALT 组纳入 1731 例患者。对于疗效结局，两组在 mRS 评分 02（RR 1.00；95%CI 0.88-1.13；P=0.96）、mRS 评分 01（RR 1.03；95%CI 0.96-1.10；P=0.36）、再通成功（RR 1.25；95%CI 0.88-1.76；P=0.21）和 48 小时内早期神经改善 < 48 小时（RR 1.08；95%CI 0.92-1.26；P=0.37）方面无显著差异。安全性结局也有类似的结果，两组在任何 ICH（RR 1.01；95%CI 0.72-1.41；P=0.96）、症状性 ICH（RR 1.19；95%CI 0.81-1.76；P=0.37）和 90 天死亡率（RR 0.99；95%CI 0.83-1.19；P=0.94）方面均无统计学差异。
总体而言，静脉注射 TNK 与 ALT 治疗 AIS 的疗效和安全性结局无统计学差异。然而，TNK 剂量为 0.25mg/kg 可能是替代 ALT 进行溶栓治疗的合理选择。
