延长时间窗内治疗急性缺血性脑卒中的替奈普酶：系统综述和荟萃分析

IF 5.4 3区材料科学 Q2 CHEMISTRY, PHYSICAL

ACS Applied Energy Materials Pub Date : 2024-01-01 DOI:10.1177/17562864231221324

L. Palaiodimou, A. Katsanos, Guillaume Turc, Michele Romoli, Aikaterini Theodorou, R. Lemmens, Simona Sacco, G. Velonakis, C. Vlachopoulos, G. Tsivgoulis

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引用次数: 0

摘要

背景：有关在延长时间窗内对急性缺血性卒中（AIS）患者使用替奈普酶（TNK）的结果数据有限。目的：我们旨在评估目前有关替奈普酶疗效的证据：我们的目的是评估目前有关 0.25 mg/kg 剂量的 TNK 在延长时间窗治疗 AIS 的有效性和安全性的证据。设计：我们进行了一项系统性回顾和荟萃分析，包括所有可用的随机对照临床试验（RCT），这些试验比较了 TNK 0.25 mg/kg 与不溶栓治疗在延长时间窗（最后一次见井或目击发病后 >4.5 小时）出现的 AIS 患者的效果。数据来源和方法：通过检索 Medline、Scopus 和国际会议摘要确定符合条件的研究。预定义的疗效结果为 3 个月的极佳功能结果[定义为改良 Rankin 量表（mRS）评分⩽1；主要结果]、3 个月的良好功能结果（mRS ⩽2）、3 个月的残疾程度降低（所有 mRS 评分均降低⩾1 分）。我们将症状性颅内出血（sICH）、任何 ICH 和 3 个月死亡率作为安全性终点。我们采用随机效应模型计算风险比 (RR) 和常见几率比 (cOR)，并得出相应的 95% 置信区间 (CI)。结果：共纳入三项研究，包括556名接受TNK治疗的患者和560名对照组患者。与对照组相比，TNK 0.25 mg/kg与3个月的优良功能预后相关（RR = 1.17；95% CI = 1.01-1.36；I2 = 0%），而在3个月的优良功能预后（RR = 1.05；95% CI = 0.94-1.17；I2 = 0%）和残疾减少（调整后的cOR = 1.14；95% CI = 0.92-1.40；I2 = 0%）方面没有差异。各组间发生 sICH（RR = 1.67；95% CI = 0.70-4.00；I2 = 0%）、任何 ICH（RR = 1.08；95% CI = 0.90-1.29；I2 = 0%）和 3 个月死亡率（RR = 1.10；95% CI = 0.81-1.49；I2 = 0%）的风险相似。结论根据三项 RCT 的数据显示，TNK 在延长时间窗内治疗 AIS 的疗效增强，安全性良好，因此该领域正在进行的 RCT 显然得到了支持。试验注册：PROSPERO 注册号：CRD4202344870CRD42023448707。

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Tenecteplase for the treatment of acute ischemic stroke in the extended time window: a systematic review and meta-analysis

Background: Outcome data regarding the administration of tenecteplase (TNK) to acute ischemic stroke (AIS) patients presenting in the extended time window are limited. Objectives: We aimed to assess the current evidence regarding the efficacy and safety of TNK at a dose of 0.25 mg/kg for AIS treatment in the extended time window. Design: A systematic review and meta-analysis was conducted including all available randomized-controlled clinical trials (RCTs) that compared TNK 0.25 mg/kg versus no thrombolysis in AIS patients presenting in the extended time window (>4.5 h after last-seen-well or witnessed onset). Data sources and methods: Eligible studies were identified by searching Medline, Scopus, and international conference abstracts. The predefined efficacy outcomes of interest were 3-month excellent functional outcome [defined as the modified Rankin Scale (mRS) score ⩽1; primary outcome], 3-month good functional outcome (mRS ⩽ 2), 3-month reduced disability (⩾1-point reduction across all mRS scores). We determined symptomatic intracranial hemorrhage (sICH), any ICH and 3-month mortality as safety endpoints. A random-effects model was used to calculate risk ratios (RRs) and common odds ratios (cORs) with corresponding 95% confidence intervals (CIs). Results: Three RCTs were included comprising 556 patients treated with TNK versus 560 controls. TNK 0.25 mg/kg was associated with a higher likelihood of 3-month excellent functional outcome compared to controls (RR = 1.17; 95% CI = 1.01–1.36; I2 = 0%), whereas there was no difference regarding good functional outcome (RR = 1.05; 95% CI = 0.94–1.17; I2 = 0%) and reduced disability (adjusted cOR = 1.14; 95% CI = 0.92–1.40; I2 = 0%) at 3 months. The risks of sICH (RR = 1.67; 95% CI = 0.70–4.00; I2 = 0%), any ICH (RR = 1.08; 95% CI = 0.90–1.29; I2 = 0%) and 3-month mortality (RR = 1.10; 95% CI = 0.81–1.49; I2 = 0%) were similar between the groups. Conclusion: Based on data from three RCTs showing increased efficacy and a favorable safety profile of TNK in the treatment of AIS in the extended time window, continuing efforts of ongoing RCTs in the field are clearly supported. Trial registration: PROSPERO registration ID: CRD42023448707.

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来源期刊

ACS Applied Energy Materials Materials Science-Materials Chemistry

CiteScore

10.30

自引率

6.20%

发文量

1368

期刊介绍： ACS Applied Energy Materials is an interdisciplinary journal publishing original research covering all aspects of materials, engineering, chemistry, physics and biology relevant to energy conversion and storage. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrate knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important energy applications.