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.
Keywords: Alteplase; Recombinant human pro-urokinase; Stroke; Thrombolytic therapy.
Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.