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1.中国科学技术大学附属第一医院(安徽省立医院)药学部,合肥;230036
2.精准药物制剂与临床药学安徽省重点实验室,合肥 230001
3.北京大学第三医院药学部,北京 100191
4.北京大学医学部药物评价中心,北京 100191
Published:30 October 2024,
Received:09 April 2024,
Revised:22 September 2024,
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邓晓媚,李会婷,门鹏等.替奈普酶治疗急性缺血性脑卒中的快速卫生技术评估 Δ[J].中国药房,2024,35(20):2541-2547.
DENG Xiaomei,LI Huiting,MEN Peng,et al.Tenecteplase in the treatment of acute ischemic stroke: a rapid health technology assessment[J].ZHONGGUO YAOFANG,2024,35(20):2541-2547.
邓晓媚,李会婷,门鹏等.替奈普酶治疗急性缺血性脑卒中的快速卫生技术评估 Δ[J].中国药房,2024,35(20):2541-2547. DOI: 10.6039/j.issn.1001-0408.2024.20.17.
DENG Xiaomei,LI Huiting,MEN Peng,et al.Tenecteplase in the treatment of acute ischemic stroke: a rapid health technology assessment[J].ZHONGGUO YAOFANG,2024,35(20):2541-2547. DOI: 10.6039/j.issn.1001-0408.2024.20.17.
目的
2
评价替奈普酶治疗缺血性脑卒中的有效性、安全性和经济性,为临床合理用药和相关决策提供依据。
方法
2
系统检索PubMed、Cochrane图书馆、中国知网、万方数据以及卫生技术评估机构等官方网站,收集替奈普酶治疗急性缺血性脑卒中的系统评价/Meta分析、药物经济学研究和卫生技术评估报告,检索时限均为建库起至2024年6月30日。提取资料和评价质量后,对纳入研究的结果进行描述性分析。
结果
2
共纳入31篇文献,包括28篇系统评价/Meta分析和3篇药物经济学研究。有效性方面,与阿替普酶相比,替奈普酶(0.25 mg/kg)可显著提高患者的早期神经功能改善率,且在90 d优良神经功能预后率、90 d良好神经功能预后率及血管再通率方面均不劣于阿替普酶。安全性方面,与阿替普酶相比,替奈普酶不会增加出血发生率、症状性颅内出血发生率、3个月全因死亡率及颅内出血发生率。经济性方面,国外研究结果显示,替奈普酶较阿替普酶具有经济学优势。
结论
2
与阿替普酶相比,替奈普酶治疗急性缺血性脑卒中的有效性和安全性均较好,且具有经济学优势。
OBJECTIVE
2
To assess the efficacy, safety and cost-effectiveness of tenecteplase in the treatment of acute ischemic stroke, and to provide a basis for clinical rational drug use and related decision-making.
METHODS
2
The related literature in the PubMed, the Cochrane Library, CNKI, Wanfang data and health technology assessment (HTA) databases were searched from the establishment of the database to June 30th, 2024. Systematic reviews/meta-analyses, pharmacoeconomic studies and HTA reports on tenecteplase in the treatment of acute ischemic stroke were collected. After data extraction and quality assessment, descriptive analysis of the included studies was carried out.
RESULTS
2
A total of 31 articles were included, involving 28 systematic reviews/meta-analysis and 3 pharmacoeconomic studies. In terms of effectiveness, compared with alteplase, tenecteplase (0.25 mg/kg) could significantly increase the early neurological improvement; the 90 d excellent neurological recovery rate, 90 d good neurological recovery rate, and recanalization were not inferior to alteplase. For safety, compared with alteplase, tenecteplase did not increase the incidence of hemorrhage, symptomatic intracranial hemorrhage, 3-month mortality, or intracranial hemorrhage. In terms of cost-effectiveness, foreign research results showed that tenecteplase had economic advantages over alteplase.
CONCLUSIONS
2
Compared with alteplase, tenecteplase is effective and safe in the treatment of acute ischemic stroke, and it is cost-effective.
替奈普酶急性缺血性脑卒中快速卫生技术评估有效性安全性经济性
acute ischemic strokerapid health technology assessmenteffectivenesssafetycost-effectiveness
GBD 2019 Stroke Collaborators. Global,regional,and national burden of stroke and its risk factors,1990-2019:a systematic analysis for the Global Burden of Disease Study 2019[J]. Lancet Neurol,2021,20(10):795-820.
中华医学会神经病学分会,中华医学会神经病学分会脑血管病学组. 中国急性缺血性脑卒中诊治指南2018[J]. 中华神经科杂志,2018,51(9):666-682.
Chinese Society of Neurology,Cerebrovascular Disease Group,Chinese Society of Neurology. Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018[J]. Chin J Neurol,2018,51(9):666-682.
国家“九五”攻关课题协作组. 急性脑梗死六小时以内的静脉溶栓治疗 [J]. 中华神经科杂志,2002,35(4):210-213.
Cooperating Group for National 95’s Project. Intravenous thrombolysis with urokinase for acute cerebral infarctions[J]. Chin J Neurol,2002,35(4):210-213.
张芮瑞,付锦. 尿激酶和阿替普酶静脉溶栓治疗急性脑梗死的临床研究进展[J]. 心血管康复医学杂志,2023,32(6):652-656.
ZHANG R R,FU J. Clinical research progress of intravenous thrombolysis of urokinase and alteplase in the treatment of acute cerebral infarction[J]. Chin J Cardiovasc Rehabil Med,2023,32(6):652-656.
POWERS W J,RABINSTEIN A A,ACKERSON T,et al. Guidelines for the early management of patients with acute ischemic stroke:2019 update to the 2018 guidelines for the early management of acute ischemic stroke:a guideline for healthcare professionals from the American Heart Association/American Stroke Association[J]. Stroke,2019,50(12):e344-e418.
WARNER J J,HARRINGTON R A,SACCO R L,et al. Guidelines for the early management of patients with acute ischemic stroke:2019 update to the 2018 guidelines for the early management of acute ischemic stroke[J]. Stroke,2019,50(12):3331-3332.
BERGE E,WHITELEY W,AUDEBERT H,et al. European Stroke Organisation(ESO)guidelines on intravenous thrombolysis for acute ischaemic stroke[J]. Eur Stroke J,2021,6(1):I-LXII.
中国医师协会神经内科医师分会脑血管病专家组. 急性缺血性卒中替奈普酶静脉溶栓治疗中国专家共识[J].中国神经精神疾病杂志,2022,48(11):641-651.
Cerebrovascular Disease Group of Neurology Subassociation of Chinese Medical Doctor Association. Chinese expert consensus on teneplase intravenous thrombolytic therapy for acute ischemic stroke[J]. Chin J Nerv Ment Dis,2022,48(11):641-651.
WARACH S J,DULA A N,JrMILLING T J. Tenecteplase thrombolysis for acute ischemic stroke[J]. Stroke,2020,51(11):3440-3451.
唐惠林,门鹏,翟所迪. 药物快速卫生技术评估方法及应用[J]. 临床药物治疗杂志,2016,14(2):1-4.
TANG H L,MEN P,ZHAI S D. Introducing and explo-ring the method of rapid review on drugs[J]. Clin Med J,2016,14(2):1-4.
门鹏,唐惠林,翟所迪. 沙格列汀治疗2型糖尿病的有效性、安全性和经济性的快速卫生技术评估[J]. 中国新药杂志,2015,24(23):2751-2755.
MEN P,TANG H L,ZHAI S D. Effectiveness,safety and economy of saxagliptin in type 2 diabetes:a rapid health technology assessment[J]. China Ind Econ,2015,24(23):2751-2755.
SHEA B J,REEVES B C,WELLS G,et al. AMSTAR 2:a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions,or both[J]. BMJ,2017,358:j4008.
HUSEREAU D,DRUMMOND M,AUGUSTOVSKI F,等. 卫生经济学评价报告标准共识2022(CHEERS 2022):卫生经济学评价报告指导意见更新版[J]. 英国医学杂志中文版,2022,25(8):460-465.
HUSEREAU D,DRUMMOND M,AUGUSTOVSKI F,et al. Consolidated health economic evaluation reporting standards 2022(CHEERS 2022) statement:updated reporting guidance for health economic evaluations[J]. BMJ Chin Ed,2022,25(8):460-465.
HAILEY D. Toward transparency in health technology assessment:a checklist for HTA reports[J]. Int J Technol Assess Health Care,2003,19(1):1-7.
WARDLAW J M,KOUMELLIS P,LIU M. Thrombolysis(different doses,routes of administration and agents)for acute ischaemic stroke[J]. Cochrane Database Syst Rev,2013,2013(5):CD000514.
HUANG X Y,MACISAAC R,THOMPSON J L,et al. Tenecteplase versus alteplase in stroke thrombolysis:an individual patient data meta-analysis of randomized controlled trials[J]. Int J Stroke,2016,11(5):534-543.
KHEIRI B,OSMAN M,ABDALLA A,et al. Tenecteplase versus alteplase for management of acute ische-mic stroke:a pairwise and network meta-analysis of randomized clinical trials[J]. J Thromb Thrombolysis,2018,46(4):440-450.
XU N,CHEN Z Q,ZHAO C S,et al. Different doses of tenecteplase vs alteplase in thrombolysis therapy of acute ischemic stroke:evidence from randomized controlled trials[J]. Drug Des Devel Ther,2018,12:2071-2084.
BURGOS A M,SAVER J L. Evidence that tenecteplase is noninferior to alteplase for acute ischemic stroke:meta-analysis of 5 randomized trials[J]. Stroke,2019,50(8):2156-2162.
THELENGANA A,RADHAKRISHNAN D M,PRASAD M,et al. Tenecteplase versus alteplase in acute ischemic stroke:systematic review and meta-analysis[J]. Acta Neurol Belg,2019,119(3):359-367.
韩永莉,夏盈峰,李敏,等. 不同剂量替奈普酶与阿替普酶静脉溶栓治疗急性缺血性脑卒中有效性及安全性的Meta分析[J]. 实用心脑肺血管病杂志,2019,27(1):19-24,29.
HAN Y L,XIA Y F,LI M,et al. Effectiveness and safety in treating acute ischemic stroke between different doses of tenecteplase and alteplase:a meta-analysis[J]. Pract J Card Cereb Pneumal Vasc Dis,2019,27(1):19-24,29.
KATSANOS A H,SAFOURIS A,SARRAJ A,et al. Intravenous thrombolysis with tenecteplase in patients with large vessel occlusions:systematic review and meta-analysis[J]. Stroke,2021,52(1):308-312.
OLIVEIRA M,FIDALGO M,FONTÃO L,et al. Tenecteplase for thrombolysis in stroke patients:systematic review with meta-analysis[J]. Am J Emerg Med,2021,42:31-37.
MA P J,ZHANG Y,CHANG L,et al. Tenecteplase vs. alteplase for the treatment of patients with acute ischemic stroke:a systematic review and meta-analysis[J]. J Neurol,2022,269(10):5262-5271.
KATSANOS A H,PSYCHOGIOS K,TURC G,et al. Off label use of tenecteplase for the treatment of acute ischemic stroke:a systematic review and meta-analysis[J]. JAMA Netw Open,2022,5(3):e224506.
REQUIAO L E,OLIVEIRA R S,REIS L S,et al. Short-term efficacy outcomes of tenecteplase versus alteplase for acute ischemic stroke:a meta-analysis of 5 rando-mized trials[J]. Neurol India,2022,70(4):1454-1459.
ABUELAZM M,SERI A R,AWAD A K,et al. The efficacy and safety of tenecteplase versus alteplase for acute ischemic stroke:an updated systematic review,pairwise,and network meta-analysis of randomized controlled trials[J]. J Thromb Thrombolysis,2023,55(2):322-338.
REHMAN A U,MOHSIN A,CHEEMA H A,et al. Comparative efficacy and safety of tenecteplase and alteplase in acute ischemic stroke:a pairwise and network meta-analysis of randomized controlled trials[J]. J Neurol Sci,2023,445:120537.
KOBEISSI H,GHOZY S,TURFE B,et al. Tenecteplase vs. alteplase for treatment of acute ischemic stroke:a systematic review and meta-analysis of randomized trials[J]. Front Neurol,2023,14:1102463.
ROSE D,CAVALIER A,KAM W,et al. Complications of intravenous tenecteplase versus alteplase for the treatment of acute ischemic stroke:a systematic review and meta-analysis[J]. Stroke,2023,54(5):1192-1204.
WEI H,FU B,YANG C,et al. The efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase for acute ischemic stroke:a systematic review and meta-analysis[J]. Neurol Sci,2023,44(9):3005-3015.
LIANG H,WANG X,QUAN X M,et al. 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[J]. Front Neurol,2023,14:1176540.
THE E Z,LIN N N,MATAR M,et al. Different dosing regimens of tenecteplase in acute ischemic stroke:a network meta-analysis of the clinical evidence[J]. Eur Stroke J,2023,8(1):93-105.
凤心雨,王敏,郭文军,等. 替奈普酶治疗急性缺血性脑卒中疗效及安全性的Meta分析[J]. 中国药房,2023,34(9):1119-1125.
FENG X Y,WANG M,GUO W J,et al. Efficacy and safety of tenecteplase in the treatment of acute ischemic stroke:a meta-analysis[J]. China Pharm,2023,34(9):1119-1125.
SALAMATULLAH H K,BASHRAHIL B,ALGHAMDI A M,et al. Efficacy and safety of tenecteplase in comparison to alteplase in acute ischemic stroke:a systematic review and meta-analysis of randomized controlled trials[J]. Clin Neurol Neurosurg,2023,233:107961.
SHEN Z Y,BAO N N,TANG M,et al. Tenecteplase vs. alteplase for intravenous thrombolytic therapy of acute ischemic stroke:a systematic review and meta-analysis[J]. Neurol Ther,2023,12(5):1553-1572.
ZHANG X,WAN T F,CHEN J,et al. Tenecteplase versus alteplase for patients with acute ischemic stroke:a meta-analysis of randomized controlled trials[J]. Aging(Albany NY),2023,15(24):14889-14899.
WANG Y,CAI X Y,FANG Q,et al. Efficacy and safety outcomes of tenecteplase versus Alteplase for thrombolysis of acute ischemic stroke:a meta-analysis of 9 rando-mized controlled trials[J]. J Neurol Sci,2024,458:122912.
MA Y,XIANG H N,BUSSE J W,et al. Tenecteplase versus alteplase for acute ischemic stroke:a systematic review and meta-analysis of randomized and non-randomized studies[J]. J Neurol,2024,271(5):2309-2323.
HUANG J,ZHENG H,ZHU X F,et al. Tenecteplase versus alteplase for the treatment of acute ischemic stroke:a meta-analysis of randomized controlled trials[J]. Ann Med,2024,56(1):2320285.
SINGH A,SINGH M P,GAIKWAD N R,et al. Tenecteplase versus alteplase in acute ischemic stroke:a systematic review and meta-analysis[J]. Ann Neurosci,2024,31(2):132-142.
WU N H,DOEPPNER T R,HERMANN D M,et al. Efficacy and safety of intravenous tenecteplase compared to alteplase before mechanical thrombectomy in acute ische-mic stroke:a meta-analysis[J]. J Neurol,2024,271(7):3928-3941.
GAO L,MOODIE M,MITCHELL P J,et al. Cost-effectiveness of tenecteplase before thrombectomy for ischemic stroke[J]. Stroke,2020,51(12):3681-3689.
HAJIAN K,ABDI DEZFOULI R,DARVISHI A,et al. Tenecteplase in managing acute ischemic stroke:a long-term cost-utility analysis in Iran[J]. Expert Rev Pharmacoecon Outcomes Res,2023,23(1):123-133.
GAO L,PARSONS M,CHURILOV L,et al. Cost-effectiveness of tenecteplase versus alteplase for stroke thrombolysis evaluation trial in the ambulance[J]. Eur Stroke J,2023,8(2):448-455.
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