Ming-yuan Xu ¹ Lan Li ^2* Bu Xu ^1* Shanfang Yuan ^1* Qin Zheng ^1* Wenjun Sun ^1*

• ¹ Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing, China
• ² Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Cangzhou, Hebei Province, China

Objective This study aimed to observe the effect of edaravone dexborneol (EDB) on the incidence of early post-stroke depression (PSD) and explore its inflammatory mechanisms. Methods A prospective, randomized controlled study was conducted from January 2022 to June 2023, involving patients with acute ischemic stroke (AIS) at the Neurology Department of the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine. The control group received routine treatment, while the experimental group received routine combined EDB treatment. The main outcome measures included PSD incidence, Patient Health Questionnaire (PHQ-9) and Hamilton Depression Scale (HAMD) scores on days 14 and 30, and inflammatory factor levels on day 14. Results A total of 93 patients were included in the study, 51 in the experimental group and 42 in the control group. On day 14, the PSD incidence was 13.7% in the experimental group, lower than 31.0% in the control group (95%CI 0.127 to 0.996; P = 0.044). Compared to the control group, the experimental group showed significantly lower concentrations of pro-inflammatory cytokines IL-1β (95%CI 3.353 to 5.184), IL-6 (95%CI 2.694 to 3.426), TNF-α (95%CI 4.985 to 12.196), IFN-γ (95%CI 0.163 to 0.451), MCP-1 (95%CI 0.335 to 0.787), IL-17A (95%CI 0.543 to 1.024), and IL-23p19 (95%CI 1.677 to 1.959)(all P < 0.001), and higher levels of anti-inflammatory cytokines IL-4 (95%CI -1.087 to -0.941), IL-10 (95%CI -6.125 to -1.662), and IL-13 (95%CI -6.078 to -2.953)(all P ≤ 0.001). On day 30, the PSD incidence in the experimental group was 15.7%, lower than 40.5% in the control group (95%CI 0.103 to 0.725; P = 0.007). Compared with the control group, the experimental group had lower PHQ-9 scores on day 14 (95%CI 0.034 to 1.577; P = 0.041) and day 30 (95%CI 0.018 to 1.573; P = 0.045), and also had lower HAMD scores on day 14 (95% CI 0.281 to 2.856; P = 0.018) and day 30 ( 95% CI 0.647 to 3.482; P = 0.005). Conclusion EDB could reduce the incidence of early PSD, reduce pro-inflammatory cytokine levels, and elevate anti-inflammatory cytokine levels, which was possibly related to the anti-inflammatory mechanism of EDB.