Evaluating the efficacy and safety of Edaravone-Dexborneol in acute ischemic stroke: an updated systematic review and meta-analysis of 7,846 Chinese patients

Objective To evaluate the safety and efficacy of Edaravone-Dexborneol (EDB) as a neuroprotective agent in patients with acute ischemic stroke (AIS).Methods We conducted a comprehensive search in PubMed, Scopus, Web of Science, and Cochrane CENTRAL until January 22, 2026, including clinical trials and observational studies comparing EDB with edaravone monotherapy, standard treatment, and placebo. Data on functional recovery (Modified Rankin Scale [mRS], National Institutes of Health Stroke Scale [NIHSS], Barthel Index [BI]), safety outcomes, and mortality were extracted. A random effects model was used for statistical analysis.Results Overall, 13 studies (5 cohort studies and 8 randomized controlled trials) involving 7,846 patients were included, demonstrating that EDB significantly improved 90-day mRS scores (0–1) compared with edaravone alone (RD: 0.08, 95% CI: [0.03, 0.13], p = 0.001). When compared with standard treatment, NIHSS scores were significantly lower in the EDB group (MD: −2.18, 95% CI: [−3.75, −0.62], p = 0.006), and no significant difference was observed in mRS (0–1) or the risk of symptomatic intracranial hemorrhage (sICH). Safety outcomes showed a possible dose-dependent adverse event (AE), including hyperhomocysteinemia and hypokalemia.Conclusion EDB might be an effective treatment for improving functional recovery in patients with AIS and appears to have a relatively favorable safety profile. However, careful dosing is necessary to minimize AEs. Future research should focus on large-scale trials, long-term outcomes, and mechanistic studies to optimize treatment protocols.