Prourokinase for acute ischemic stroke: A meta-analysis of randomized controlled trials.

IF 1.4 4区医学 Q2 MEDICINE, GENERAL & INTERNAL

Medicine Pub Date : 2025-10-03 DOI:10.1097/MD.0000000000044837

Deekshitha Alla, Rakshna Ramsundar, Gitanjali Boppana, Thanmayee Tummala, Hanisha Reddy Kukunoor, Riva Jayesh Shah, Snigdha Mandava, Ruth Getaneh Bayeh, Naga Keerthi Gangavarapu, Ram Prasanjith Reddy, Venkata Chandra Sekhar Yelchuri

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引用次数: 0

Abstract

Background: Use of current thrombolytic agents, such as alteplase, is limited by risks such as intracranial hemorrhage, short half-life, and complex dosing regimens. These drawbacks hinder their optimal use in ischemic stroke treatment. Prourokinase (Pro-UK), with its fibrin specificity and favorable safety profile, offers a promising alternative. This meta-analysis aims to comprehensively evaluate its efficacy and safety in improving clinical outcomes for stroke patients.

Methods: A systematic literature review was conducted across PubMed, Scopus, and Web of Science from 1989 to 2024 in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data analysis and visualization were performed using ReviewManager (RevMan) with a random-effects model. Risk of bias was assessed using the Cochrane tool, publication bias using Egger's test, and cumulative meta-analysis via trial sequential analysis.

Results: A total of 5 randomized controlled trials comprising 3812 participants were included in this meta-analysis. The pooled analysis revealed that Pro-UK did not result in a statistically significant improvement in clinical outcomes among stroke patients, as measured by the National Institutes of Health Stroke Scale at 24 hours (mean difference = 0.06; 95% confidence interval [CI]: -0.09 to 0.21), the modified Rankin Scale (risk ratio [RR] = 0.99; 95% CI: 0.96-1.03), and the Barthel index (RR = 1.00; 95% CI: 0.99-1.01). Additionally, while there was a trend toward a reduction in systemic intracranial hemorrhage in the Pro-UK group, this finding did not reach statistical significance (RR = 0.86; 95% CI: 0.43-1.72).

Conclusion: While Pro-UK offers a theoretical advantage in reducing systemic bleeding due to its clot-specific action, current evidence does not significantly improve key clinical outcomes. The limited number and heterogeneity of existing randomized controlled trials underscore the need for more robust, large-scale trials to confirm its safety and efficacy in acute ischemic stroke.

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普罗激酶治疗急性缺血性卒中：随机对照试验的荟萃分析。

背景：目前使用的溶栓药物，如阿替普酶，受到颅内出血、半衰期短和给药方案复杂等风险的限制。这些缺点阻碍了它们在缺血性卒中治疗中的最佳应用。prorokinase （Pro-UK）具有纤维蛋白特异性和良好的安全性，是一种有希望的替代方案。本荟萃分析旨在全面评价其改善脑卒中患者临床结局的有效性和安全性。方法：根据系统评价和荟萃分析指南的首选报告项目，对1989年至2024年间的PubMed、Scopus和Web of Science进行系统文献综述。采用随机效应模型，采用ReviewManager （RevMan）软件进行数据分析和可视化。偏倚风险采用Cochrane工具评估，发表偏倚采用Egger检验，累积荟萃分析采用试验序列分析。结果：本meta分析共纳入5项随机对照试验，共3812名受试者。合并分析显示，通过美国国立卫生研究院卒中量表（National Institutes of Health stroke Scale）、修正Rankin量表（风险比[RR] = 0.99; 95% CI: 0.96-1.03）和Barthel指数（RR = 1.00; 95% CI: 0.99-1.01）测量，Pro-UK对卒中患者的临床结局没有统计学意义上的改善。此外，虽然Pro-UK组系统性颅内出血有减少的趋势，但这一发现没有统计学意义（RR = 0.86; 95% CI: 0.43-1.72）。结论：虽然Pro-UK由于其凝块特异性作用在减少全身性出血方面提供了理论上的优势，但目前的证据并没有显著改善关键的临床结果。现有的随机对照试验数量有限且具有异质性，因此需要进行更强大的大规模试验来证实其在急性缺血性卒中中的安全性和有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Medicine 医学-医学：内科

CiteScore

2.80

自引率

0.00%

发文量

4342

审稿时长

>12 weeks

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