Objective: To retrospectively analyze the safety and efficacy of monosialotetrahexosylganglioside sodium (GM1) in the treatment of stroke, and to provide a reference for clinical rational drug use. Methods: This study was a multicenter, single-arm, retrospective, observational study, which recruited stroke patients who were treated with GM1 from January 1, 2020, to December 31, 2023, as the research subjects, analyzed their adverse events and grades, and performed chi-square test and t-test on NIHSS scores and Barthel before and after intervention. Compare the scores before and after. Results: A total of 4405 patients were enrolled, and the NIHSS score of the patients decreased and the Barthel score increased after GM1 intervention, and there was a significant statistical difference before and after intervention (P < 0.05). A total of 1635 patients had adverse events, and 99.4% were mild, and severe was not seen. Conclusion: In this study, GM1 has high safety and significant efficacy in the treatment of stroke, and results suggest potential for clinical application, subject to further validation.