症状出现4.5小时内不同剂量替奈普酶与阿替普酶治疗急性缺血性卒中的随机对照试验网络荟萃分析
Different doses of tenecteplase vs. alteplase for acute ischemic stroke within 4.5 hours of symptom onset: a network meta-analysis of randomized controlled trials.
作者信息
Liang Huo, Wang Xue, Quan Xuemei, Chen Shijian, Qin Bin, Liang Shuolin, Huang Qiuhui, Zhang Jian, Liang Zhijian
机构信息
Department of Neurology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Department of Neurology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
出版信息
Front Neurol. 2023 Jun 2;14:1176540. doi: 10.3389/fneur.2023.1176540. eCollection 2023.
BACKGROUND
The optimal dose of tenecteplase vs. alteplase for acute ischemic stroke (AIS) has yet to be established. Therefore, we included the latest randomized controlled trials (RCT) to assess the efficacy and safety of different doses of tenecteplase vs. alteplase for AIS within 4.5 hours of symptom onset.
METHODS
Literature was searched in PubMed, Cochrane Library, Embase, Web of Science, and clinical trial registries until February 12, 2023. Odds ratios (OR) with 95% credible intervals (CrI) were estimated using Bayesian network meta-analysis (NMA). Treatments were ranked based on efficacy and safety using the surface under the cumulative ranking curve (SUCRA).
RESULTS
Eleven RCTs with 5,475 patients were included. Tenecteplase 0.25 mg/kg and alteplase 0.9 mg/kg had significantly higher rates of excellent functional outcome (tenecteplase: OR, 1.85; 95% CrI, 1.44-2.37; alteplase: OR, 1.60; 95% CrI, 1.29-1.97) and good functional outcome (tenecteplase: OR, 1.54; 95% CrI, 1.19-1.98; alteplase: OR, 1.40; 95% CrI, 1.14-1.74) than placebo, despite an increased risk of symptomatic intracranial hemorrhage. Furthermore, the NMA (OR, 1.16; 95% CrI, 1.01-1.33) and the pairwise meta-analysis (OR, 1.16; 95% CI, 1.02-1.33; P = 0.03) indicated that tenecteplase 0.25 mg/kg was superior to alteplase 0.9 mg/kg in excellent functional outcome. Alteplase 0.9 mg/kg (OR, 2.54; 95% CrI, 1.45-8.08) significantly increased the risk of any intracranial hemorrhage compared with placebo. SUCRA results demonstrated that tenecteplase 0.25 mg/kg ranked first and tenecteplase 0.4 mg/kg ranked last in efficacy outcomes.
CONCLUSIONS
The NMA indicated that tenecteplase 0.25 mg/kg and alteplase 0.9 mg/kg are safe and significantly improve clinical outcomes in patients with AIS within 4.5 h of symptom onset. Furthermore, tenecteplase 0.25 mg/kg provides more benefit and has the potential to replace alteplase 0.9 mg/kg in AIS treatment.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/index.php, identifier: CRD42022343948.
背景
对于急性缺血性卒中（AIS），替奈普酶与阿替普酶的最佳剂量尚未确定。因此，我们纳入了最新的随机对照试验（RCT），以评估在症状发作4.5小时内，不同剂量替奈普酶与阿替普酶治疗AIS的疗效和安全性。
方法
检索了PubMed、Cochrane图书馆、Embase、科学网和临床试验注册库中的文献，检索截至2023年2月12日。使用贝叶斯网络荟萃分析（NMA）估计具有95%可信区间（CrI）的比值比（OR）。使用累积排名曲线下面积（SUCRA）根据疗效和安全性对治疗进行排名。
结果
纳入了11项RCT，共5475例患者。尽管症状性颅内出血风险增加，但替奈普酶0.25mg/kg和阿替普酶0.9mg/kg的良好功能结局率（替奈普酶：OR，1.85；95%CrI，1.44 - 2.37；阿替普酶：OR，1.60；95%CrI，1.29 - 1.97）和较好功能结局率（替奈普酶：OR，1.54；95%CrI，1.19 - 1.98；阿替普酶：OR，1.40；95%CrI，1.14 - 1.74）均显著高于安慰剂。此外，NMA（OR，1.16；95%CrI，1.01 - 1.33）和成对荟萃分析（OR，1.16；95%CI，1.02 - 1.33；P = 0.03）表明，替奈普酶0.25mg/kg在良好功能结局方面优于阿替普酶0.9mg/kg。与安慰剂相比，阿替普酶0.9mg/kg（OR，2.54；95%CrI，1.45 - 8.08）显著增加了任何颅内出血的风险。SUCRA结果表明，替奈普酶0.25mg/kg在疗效结局中排名第一，替奈普酶0.4mg/kg排名最后。
结论
NMA表明，替奈普酶0.25mg/kg和阿替普酶0.9mg/kg是安全的，并且在症状发作4.5小时内的AIS患者中显著改善了临床结局。此外，替奈普酶0.25mg/kg带来的益处更多，在AIS治疗中有可能替代阿替普酶0.9mg/kg。
系统评价注册
https://www.crd.york.ac.uk/PROSPERO/index.php，标识符：CRD42022343948。
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