Evaluating the Efficacy and Safety of Edaravone-Dexborneol in Acute Ischemic Stroke: An Updated Systematic Review and Meta-Analysis of 7,846 Chinese Patients

To evaluate the safety and efficacy of Edaravone-Dexborneol as a neuroprotective agent in patients with acute ischemic stroke (AIS). 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 Edaravone-Dexborneol 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. Overall, 13 studies (5 cohort studies and 8 randomized controlled trials) involving 7,846 patients were included, demonstrating that Edaravone-Dexborneol 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 Edaravone-Dexborneol 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. Edaravone-Dexborneol 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. Edaravone-Dexborneol may show good functional outcomes, with improved mRS scores (0-1) at 90 days compared to Edaravone alone. Adverse events appear to be dose-dependent; however, further studies are needed to confirm these findings, with mid-range doses potentially balancing efficacy and safety. Small sample size and patient variability highlight the need for larger trials to explore long-term outcomes and optimize dosing.