Efficacy and safety of edaravone dexborneol for acute ischemic stroke: a meta-analysis

To evaluate the safety and efficacy of Edaravone Dexborneol in the treatment of acute ischemic stroke (AIS).

Randomized clinical trials (RCTs) and Prospective cohort study on Edaravone Dexborneol for AIS were retrieved from PubMed, Embase, Cochrane Library, Web of Science, and CNKI. The quality of included studies was assessed using the Cochrane risk of bias tool. Meta-analysis was performed using RevMan 5.2. Efficacy evaluation is based on the changes in the National Institutes of Health Stroke Scale (NIHSS) and mRS scores from baseline to 10-14 days after treatment, as well as the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90 days. Safety evaluation is based on the incidence of adverse events during treatment or within 3 months.

The meta-analysis included 54 studies. For efficacy evaluation: 1. Compared with the control group, the edaravone dexborneol (ED) treatment group showed a reduction in NIHSS score of 2.27, which was statistically significant (I ² = 93%, MD = -2.27, 95% CI:-2.61 to-1.94, p < 0.00001). Subgroup analysis based on the mean baseline NIHSS score categorized patients into mild-to-moderate, moderate-to-severe, and severe stroke subgroups. In the mild-to-moderate stroke subgroup: (I ² = 91%, MD = -1.92, 95% CI:-2.30 to-1.54, p < 0.00001.). In the moderate-to-severe stroke subgroup: (I ² = 94%, MD = -2.76, 95% CI: -3.72 to -1.79, p < 0.00001). In the severe stroke subgroup: (I ² = 80%, MD = -3.50, 95% CI: -4.76 to -2.24, p = 0.04). Patients with higher baseline NIHSS scores may have more pronounced functional improvement after ED treatment. 2. At 2 weeks after treatment, the ED group showed a reduction in mRS score of 0.93 compared with the control group, with statistical significance (I ² = 98%, MD = -0.93, 95% CI:-1.23 to-0.63, p < 0.00001). 3. For the proportion of patients achieving mRS = 0-1 at 90 days after treatment, 7 studies were included, with 4,925 patients in the ED group and 3,289 in the control group (I ² = 57%, RR = 1.10, 95% CI: 1.02 to 1.18, p = 0.01). The results indicate a statistically significant functional improvement at 90 days after ED treatment for acute cerebral infarction. Therefore, ED may achieve both short-term and long-term neurological improvement in acute ischemic stroke. For safety evaluation, there was no statistically significant difference in the incidence of adverse events between the ED group and the control group (RR = 0.99, 95% CI: 0.95 to 1.03, p = 0.60).

This meta-analysis provides evidence supporting the efficacy and safety of Edaravone Dexborneol for both short- and long-term treatment of acute ischemic stroke. It significantly reduced NIHSS and mRS scores at 10-14 days post-treatment and increased the proportion of patients achieving an mRS score of 0-1 at 90 days. Patients with higher baseline NIHSS scores may derive greater prognostic benefit from edaravone dexborneol therapy. Future multicenter, large-sample clinical studies are still needed to further validate the efficacy and safety of Edaravone Dexborneol.