Efficacy and safety of edaravone dexborneol in acute ischemic stroke: systematic review and meta-analysis of randomized controlled trials

Introduction Stroke is a leading cause of global morbidity and mortality, with acute ischemic stroke (AIS) accounting for most cases. Despite advancements in reperfusion therapies, many patients do not achieve sufficient reperfusion, necessitating effective neuroprotective interventions. This meta-analysis evaluates the efficacy and safety of Edaravone Dexborneol (ED) compared to standard therapies in AIS treatment. Methods A systematic review and meta-analysis were conducted according to PRISMA guidelines, including randomized controlled trials (RCTs) investigating ED in AIS. Primary outcomes included Modified Rankin Scale (mRS <= 1) at 90 days and changes in National Institutes of Health Stroke Scale (NIHSS) scores. Pooled effect sizes were calculated using random-effects models. Results Five RCTs with 2,535 patients (1,263 ED, 1,272 control) were included. ED significantly improved the odds of achieving mRS <= 1 at 90 days (OR = 1.47, 95% CI [1.25-1.74], p < 0.00001). While NIHSS score changes at 14 days were not significant (p = 0.35), ED showed significant improvement at 30 days (MD = -1.77, 95% CI [-2.82 to -0.72], p = 0.0009). ED also significantly reduced the risk of hemorrhagic transformation (OR = 0.47, 95% CI [0.24-0.92], p = 0.03) and mortality rates were lower in the ED group but not statistically significant (OR = 0.66, 95% CI [0.41-1.06], p = 0.08, I2 = 1%). Conclusion ED demonstrates significant neuroprotective benefits in AIS by improving functional outcomes and reducing the risk of hemorrhagic transformation. However, further studies with larger sample sizes must confirm these findings and optimize treatment protocols.