BACKGROUND: Acute ischemic stroke (AIS) requires timely thrombolysis to restore perfusion and minimize neurological damage. Recombinant human prourokinase (rhPro-UK) has emerged as a promising alternative to alteplase, with potential efficacy and safety benefits within the critical 4.5-h treatment window. METHODS: Electronic databases, including PubMed, ScienceDirect, and Cochrane Central, were comprehensively searched from inception until December 2024. Risk ratios (RRs) with 95% confidence intervals were pooled for the dichotomous outcomes using a random effects model in Review Manager software. The heterogeneity among the included trials was evaluated using the I RESULTS: The final statistical analysis included 1179 participants in the rhPro-UK and 1148 in the tPA group. Excellent functional outcome (modified Rankin Scale [mRS] 0-1) (RR = 1.04, 95% CI: [0.98, 1.10]
p = 0.16) and good functional outcome (mRS 0-2) (RR = 1.00, 95% CI: [0.96, 1.05]
p = 0.90
I CONCLUSION: rhPro-UK demonstrated comparable efficacy to alteplase in achieving functional outcomes in AIS within 4.5 h, with no significant differences in mortality or neurological improvement. Although not statistically significant, a trend toward lower sICH risk with rhPro-UK highlights its potential safety advantage. More high-quality randomized clinical trials are required to confirm these findings.