Abstract Background and aims Edaravone dexborneol is a neuroprotective agent with antioxidant and anti-inflammatory properties proposed to improve outcomes in acute ischemic stroke (AIS). We conducted a systematic review and meta-analysis to evaluate its efficacy and safety in adult AIS patients. Methods This review was conducted according to PRISMA 2020 and registered in PROSPERO (CRD420261276816). PubMed and Cochrane CENTRAL were searched through 17 November 2025 for randomized controlled trials comparing Edaravone dexborneol with placebo or edaravone alone in AIS. Functional outcome at 90 days (modified Rankin Scale, mRS) was assessed. Four RCTs (n = 2,268) were included. Random-effects meta-analysis was performed, and risk of bias was assessed using RoB 2. Results Across the four RCTs, Edaravone dexborneol significantly improved functional independence (mRS ≤1 at 90 days) compared with control therapy (pooled OR 1.46; 95% CI 1.24–1.71; p 0.001), with no detected heterogeneity (I2 = 0%). Subgroup analyses demonstrated consistent benefit across key clinical strata, including reperfusion-treated patients (intravenous thrombolysis or mechanical thrombectomy), higher baseline NIHSS severity, elderly populations (75 years), and patients with vascular risk factors. Safety outcomes showed no increased risk of serious adverse events or mortality. Risk of bias was low in three trials and showed some concerns in one open-label study. Conclusions Edaravone dexborneol significantly improves 90-day functional recovery in acute ischemic stroke with a favourable safety profile. Its consistent benefit across diverse clinical subgroups, including elderly and reperfusion-treated patients, supports its potential role as a broadly applicable neuroprotective adjunct in acute stroke management. Conflict of interest Himanshu Sharma: nothing to disclose. KH Reeta: nothing to disclose
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Himanshu Sharma
K H Reeta
European Stroke Journal
All India Institute of Medical Sciences
Mahatma Gandhi Dental College & Hospital
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Sharma et al. (Fri,) studied this question.
www.synapsesocial.com/papers/69fd7e5cbfa21ec5bbf069b9 — DOI: https://doi.org/10.1093/esj/aakag023.537