Volume 4,Issue 3
Objective: The purpose of this study was to evaluate the efficacy and safety of monosialotetrahexosylganglioside (GM1) in patients with acute ischemic stroke (AIS) based on real-world data. Methods: From March 2022 to January 2023, patients with AIS treated with GM1 were included in this study. Functional outcomes were assessed using the modified Rankin Scale (mRS) and the NIH Stroke Scale (NIHSS) at baseline and at 2, 6, and 10 weeks after treatment initiation. Safety was evaluated through adverse event (AE) monitoring. Results: A total of 1772 patients with AIS were collected for analysis after the exclusion of the exclusion criteria. GM1 treatment significantly improved functional outcomes. The mRS score decreased from a baseline of 1.32 to 0.97 at the third follow-up (mean reduction: 0.35 points, P < 0.05). The NIHSS score decreased from 5.14 to 2.32 (mean reduction: 2.82 points, P < 0.05). A total of 128 AEs were reported in 98 patients (5.5%). The majority of AEs were mild to moderate (124 events, 7.0%), with only 4 severe AEs (Grade 3, 0.2%) observed. No life-threatening or fatal AEs occurred. Conclusion: GM1 treatment significantly improves the mRS score and NIHSS score of AIS patients, and the safety is high. AIS patients showed obvious advantages in neurological function recovery after GM1 treatment, and these results provide a clinical basis for GM1 in the real diagnosis and treatment environment of AIS patients.