【摘要】 目的 从有效性、安全性、经济性、适宜性、创新性和可及性6个方面对替奈普酶用于急性缺血性卒中进行临床综合评价，以期为合理用药及卫生决策提供参考。方法 系统检索PubMed、Embase、the Cochrane Library、中国知网、万方数据知识服务平台、中国生物医学文献服务系统等数据库及卫生技术评估（HTA）相关网站，检索国家药品审评中心、药智网等专业网站以及国家药典、药品说明书等，筛选文献，提取数据。分别采用HTA Checklist、AMSTAR-2量表和CHEERS量表对纳入的HTA报告、系统评价/meta分析和经济学研究进行质量评价。结果 共纳入33篇文献，包括1篇HTA报告、28篇系统评价/meta分析和4篇药物经济学研究，文献质量总体良好。对于急性缺血性卒中患者，替奈普酶静脉溶栓在闭塞血管再通率、早期神经功能改善和恢复方面不劣于阿替普酶，且不增加颅内出血或死亡率。替奈普酶0.25 mg/kg组患者有效性及安全性更优，且花费更少。国内自主创新研发的替奈普酶给药方式更方便，满足临床诊疗需求。结论 对于适合静脉溶栓的急性缺血性卒中患者，替奈普酶有效性不劣于阿替普酶，且不增加不良事件，剂量选择0.25 mg/kg更优，创新性、适宜性及可及性良好。更多还原

【Abstract】 Objective To conduct a comprehensive clinical evaluation of tenecteplase for acute ischemic stroke from six dimensions: efficacy, safety, economy, suitability, innovation, and accessibility. Methods Systematic searches were performed in PubMed, Embase, the Cochrane Library, CNKI, Wanfang Data,SinoMed, and health technology assessment(HTA)datadases, as well as professional websites(e. g., National Center for Drug Evaluation, yaozhi), pharmacopoeias, and drug labels. Literature was screened, data were extracted. Quality assessments were conducted using the HTA Checklist, AMSTAR-2 scale, and CHEERS checklist to evaluate the methodological rigor of the included Health HTA reports, systematic reviews/meta-analyses, and economic evaluations. Results A total of 33 studies were included, involving 1 HTA reports, 28systematic review/meta analyses, and 4 pharmacoeconomic evaluations, with overall high methodological quality. For patients with acute ischemic stroke, intravenous tenecteplase demonstrated non-inferiority to alteplase in occluded vessel recanalization rates, early neurological improvement, and functional recovery, without increasing intracranial hemorrhage or mortality. The 0. 25 mg/kg dose of tenecteplase showed superior efficacy and safety at a lower cost. Domestically developed tenecteplase formulations offered more convenient administration, thereby better addressing clinical needs. Conclusion For acute ischemic stroke patients eligible for intravenous thrombolysis, tenecteplase is non-inferior to alteplase in efficacy without increasing adverse events. The dosage of 0. 25 mg/kg is optimal, with advantages in innovation, suitability, and accessibility.更多还原