所有缺血性中风都应该改用Tenecteplase吗?证据和后勤。

IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY
Keith W Muir
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引用次数: 0

摘要

最近的临床试验提供了强有力的证据,证明0.25mg/kg的替普酶比0.9mg/kg的替普酶在4.5小时内治疗急性缺血性卒中无劣效性。综合数据荟萃分析表明,tenecteplase在90天的优秀(修改的Rankin量表0或1)结局方面可能具有优势。与阿替普酶相比,不太复杂的单次静脉滴注替奈普酶带来了显著的后勤效益。实际应用数据表明,减少了从门到针和从门到穿刺的时间,并可能改善临床结果。避免使用输液泵和监测减少了对资源的需求,并促进了医院间的转诊。由于其物流优势,指南更倾向于tenecteplase而不是alteplase。向tenecteplase过渡的服务需要考虑对所有相关工作人员(医疗、护理、药房)进行教育和培训,并应解决医生的关切。使用25mg剂量的中风特异性替奈普酶是非常可取的,以尽量减少可能因使用心脏剂量的替奈普酶而引起的剂量错误的机会。阿替普酶的一些适应症外使用得到了积极的随机对照试验数据的支持(醒来和未知发作的卒中,以及在发病后4.5-9小时成像支持的晚窗使用),而替奈普酶的等效数据则不那么确凿。比较tenecteplase与对照组的试验数据提供了唤醒/未知发作卒中和晚时间窗的相关安全性数据,一些疗效数据支持tenecteplase在晚时间窗的应用。考虑到0.25mg/kg替奈普酶生物学上相似的疗效和安全性的证据权重,以及剂量错误的可能性,不建议将阿替普酶保留用于标签外适应症。阿替普酶的一些适应症外使用得到了积极的随机对照试验数据的支持(醒来和未知发作的卒中,以及在发病后4.5-9小时成像支持的晚窗使用),而替奈普酶的等效数据则不那么确凿。比较tenecteplase与对照组的试验数据提供了唤醒/未知发作卒中和晚时间窗的相关安全性数据,一些疗效数据支持tenecteplase在晚时间窗的应用。考虑到0.25mg/kg替奈普酶生物学上相似的疗效和安全性的证据权重,以及剂量错误的可能性,不建议将阿替普酶保留用于标签外适应症。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Should we switch to tenecteplase for all ischemic strokes? Evidence and logistics.

Recent clinical trials provide robust evidence of non-inferiority of tenecteplase 0.25 mg/kg over alteplase 0.9 mg/kg in acute ischemic stroke treated within 4.5 h of time last known well. Aggregate data meta-analysis suggests likely superiority of tenecteplase with respect to excellent (modified Rankin Scale 0 or 1) outcomes at 90 days. Less complex single intravenous bolus administration of tenecteplase brings significant logistical benefits compared to alteplase. Real-world implementation data demonstrate reduced door-to-needle and door-to-puncture times, and potentially improved clinical outcomes. Avoiding the need for infusion pumps and monitoring reduces resource requirements and facilitates inter-hospital transfer. Guidelines favor tenecteplase over alteplase due to its logistical advantages. Transitioning services to tenecteplase requires consideration of education and training for all relevant staff (medical, nursing, pharmacy) and should address physician concerns. Use of stroke-specific tenecteplase 25 mg dose vials is strongly preferable to minimize the chance of dosing errors that might arise from use of cardiac-dose tenecteplase. Some off-label uses of alteplase are supported by positive randomized controlled trial data (wake-up and unknown onset stroke, and imaging-supported late window use 4.5-9 h after onset) while equivalent data for tenecteplase are less conclusive. Trial data comparing tenecteplase to control give relevant safety data for both wake-up / unknown onset stroke and for late time windows, and some efficacy data favor tenecteplase in a late time window. Given the weight of evidence for biologically similar efficacy and safety of tenecteplase 0.25 mg/kg, and potential for dosing errors, retention of alteplase for off-label indications should not be recommended.

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来源期刊
International Journal of Stroke
International Journal of Stroke 医学-外周血管病
CiteScore
13.90
自引率
6.00%
发文量
132
审稿时长
6-12 weeks
期刊介绍: The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.
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