重组人前尿激酶与阿替普酶在急性缺血性卒中4.5小时内的对比：随机对照试验的系统回顾和荟萃分析

IF 1.8 4区医学 Q3 NEUROSCIENCES

Journal of Stroke & Cerebrovascular Diseases Pub Date : 2025-07-05 DOI:10.1016/j.jstrokecerebrovasdis.2025.108392

Tallal Mushtaq Hashmi MBBS , Aimen Shafiq MBBS , Rohma Zia MBBS , Hadiah Ashraf MBBS , Muhammad Burhan MBBS , Mushood Ahmed MBBS , Ahmad Mesmar MBBS , Raheel Ahmed MRCP , Gregg C. Fonarow MD, FACC

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引用次数: 0

摘要

背景：组合人前尿激酶（rhPro-UK）已成为急性缺血性卒中（AIS）患者4.5小时内出现症状的潜在替代阿替普酶。该荟萃分析评估并比较了rhPro-UK与阿替普酶在该患者群体中的疗效和安全性。方法综合检索PubMed、Cochrane和Embase自成立至2025年11月30日，筛选在症状出现4.5小时内接受静脉注射rhPro-UK与阿替普酶治疗的AIS患者的符合条件的rct。采用RevMan Web进行随机效应meta分析。3项随机对照试验共纳入2,289例患者(rhPro-UK: 1141例；阿替普酶：1148)符合纳入标准。合并分析显示，rhPro-UK和阿替普酶在获得良好功能结局方面无显著差异(mRS 0-1, 90d: RR = 1.04, 95% CI = 0.98 - 1.10；P = 0.17)和良好的功能结局(90d时mRS 0-2: RR = 1.0, 95% CI = 0.96 ~ 1.05；P = 0.86)。早期神经系统改善（RR = 1.05, 95% CI = 0.96 ~ 1.15）、症状性颅内出血（RR = 0.52, 95% CI = 0.19 ~ 1.43）、全因死亡率（RR = 1.10, 95% CI = 0.64 ~ 1.91）和严重不良事件（RR = 0.92, 95% CI = 0.75 ~ 1.13）方面差异无统计学意义。结论：该荟萃分析发现，在急性缺血性卒中患者的功能结局、早期神经系统改善或安全性方面，rhPro-UK和阿替普酶之间没有统计学上的显著差异。rhPro-UK有望成为一种具有成本效益的替代方案，但需要进一步的大规模随机对照试验来证实其在AIS管理中的作用。

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Recombinant human pro-urokinase vs. alteplase within 4.5 hours of acute ischemic stroke: A systematic review and meta-analysis of randomized controlled trials

Background

Recombinant human pro-urokinase (rhPro-UK) has emerged as a potential alternative to alteplase for patients with acute ischemic stroke (AIS) presenting within 4.5 hours of symptom onset. This meta-analysis evaluates and compares the efficacy and safety of rhPro-UK with alteplase in this patient population.

Methods

A comprehensive search was conducted on PubMed, Cochrane and Embase from inception to November 30, 2025, to identify eligible RCTs comparing intravenous rhPro-UK with alteplase in AIS patients treated within 4.5 hours of symptom onset. A random-effects meta-analysis was conducted using RevMan Web.

Results

Three RCTs encompassing 2,289 patients (rhPro-UK: 1141; alteplase: 1148) met the inclusion criteria. The pooled analysis demonstrated no significant difference between rhPro-UK and alteplase in achieving excellent functional outcome (mRS 0-1 at 90d: RR = 1.04, 95 % CI = 0.98 to 1.10; P = 0.17) and good functional outcome (mRS 0-2 at 90d: RR = 1.0, 95 % CI = 0.96 to 1.05; P = 0.86). No statistically significant difference was observed for early neurological improvement (RR 1.05, 95 % CI 0.96 to 1.15), symptomatic intracranial hemorrhage (RR = 0.52, 95 % CI = 0.19 to 1.43), all-cause mortality (RR 1.10, 95 % CI 0.64 to 1.91) and severe adverse events (RR = 0.92, 95 % CI = 0.75 to 1.13).

Conclusion

This meta-analysis found no statistically significant differences between rhPro-UK and alteplase in terms of functional outcomes, early neurological improvement, or safety profiles in patients with acute ischemic stroke. rhPro-UK shows promise as a cost-effective alternative, but further large-scale RCTs are required to confirm its role in AIS management.

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来源期刊

Journal of Stroke & Cerebrovascular Diseases Medicine-Surgery

CiteScore

5.00

自引率

4.00%

发文量

583

审稿时长

62 days

期刊介绍： The Journal of Stroke & Cerebrovascular Diseases publishes original papers on basic and clinical science related to the fields of stroke and cerebrovascular diseases. The Journal also features review articles, controversies, methods and technical notes, selected case reports and other original articles of special nature. Its editorial mission is to focus on prevention and repair of cerebrovascular disease. Clinical papers emphasize medical and surgical aspects of stroke, clinical trials and design, epidemiology, stroke care delivery systems and outcomes, imaging sciences and rehabilitation of stroke. The Journal will be of special interest to specialists involved in caring for patients with cerebrovascular disease, including neurologists, neurosurgeons and cardiologists.