Keywords
GM1
mRS score
NIHSS score
Submitted : 2025-12-09
Accepted : 2025-12-24
Published : 2026-01-08
Abstract
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.
References
Zhong J, Cao W, Zhou H, et al., 2024, Research Progress on Multisystem Complications Caused by Autonomic Dysfunction After Acute Ischemic Stroke. Journal of Shanghai Jiao Tong University (Medical Science), 44(7): 928–934.
Yang X, Li H, 2024, Research Progress on Contrast Agent Extravasation After Endovascular Treatment of Acute Ischemic Stroke. Modern Medicine and Health, 40(13): 2298–2301 + 2304.
Lu B, Sun N, Lu J, et al., 2024, Analysis of the Current Status of Quality of Life Survey and Related Influencing Factors of Acute Ischemic Stroke Patients. General Nursing, 22(14): 2722–2724.
Xu Y, Yao X, Luo H, 2024, Effects of Tetrahexoshave Ganglioside Sodium Monosialic Acid for Injection Combined With Xingnaojing Injection on Neurological Function and Inflammation in Stroke Patients. Clinical Rational Medicine, 17(24): 13–16.
Ren L, He H, Bai L, et al., 2023, Effects of Tetrahexoshave Ganglioside Monosialic Acid on Polyol Metabolism Pathway and Caudal Nerve Electrophysiological Changes in DPN Rats. Chinese Journal of Gerontology, 43(2): 414–418.
Sun W, Tian T, Wang G, et al., 2024, Effect of Alteplase Dose Selection Before Vascular Intervention in Macrovascular Occlusive Stroke on Recanalization Time, Reperfusion Grade, mRS Score, and Cost-Utility. Stroke and Neurological Disorders, 31(3): 242–246.
Hu D, Min F, Chen L, et al., 2024, Predictive Effectiveness of NIHSS Score and Daily Activity Level in the Risk of Constipation in Elderly Patients With First Stroke. Evidence-Based Nursing, 10(15): 2774–2778.
Yang J, 2022, Application of Tetrahexoshave Ganglioside Sodium Monosialic Acid Injection in Patients With Hypertensive Intracerebral Hemorrhage. Practical Integrative Medicine, 22(24): 5–8.
He L, Zhong Q, 2022, Clinical Study of Tetrahexoshave Ganglioside Combined With Rehabilitation Training in the Treatment of Stroke. Journal of Cardiovascular and Cerebrovascular Diseases of Integrative Traditional Chinese and Western Medicine, 20(17): 3107–3110.
Ye Y, Li X, 2022, Effects of Tetrahexoshave Ganglioside Monosialic Acid in the Treatment of Cerebral Infarction With Cognitive Dysfunction on Neurological Function and Serum NSE and sCD40L Levels in Patients. Cardiovascular Disease Prevention and Treatment Knowledge, 12(32): 33–36.
Cao J, Wang H, Huo K, et al., 2021, Effects of Tetrahexose Ganglioside Sodium Monosialic Acid Combined With Hypothermia on Serum Inflammatory Factors, Nerve Damage, and Neurobehavior in Neonatal HIE. China Maternal and Child Health Research, 32(11): 1649–1653.
Cheng Y, Gao H, 2022, Effects of Ganciclovir Combined With Tetrahexoshave Ganglioside Monosialic Acid on Clinical Symptoms, Neurotrophic Factors, and Immune Function in Children With Viral Encephalitis With Psychobehavioral Abnormalities. Journal of Practical Cardiovascular, Cerebropulmonary and Vascular Diseases, 30(1): 96–102.
Guo D, Wang M, 2002, Clinical Study on the Addition of GM₁ Monosialic Acid Ganglioside in the Treatment of Acute Ischemic Stroke. Chinese Clinical Neuroscience, 10(2): 190–191.
Li H, 2021, Efficacy Analysis of Tetrahexosate Ganglioside Sodium Combined With Butaphthalein in the Treatment of Ischemic Stroke. China Modern Pharmaceutical Application, 15(19): 180–182.
Zhang D, 2021, Observation on the Effect of Agatroban Combined With Tetrahexoshave Ganglioside Sodium Monosialic Acid in the Treatment of Acute Ischemic Stroke. Contemporary Medicine, 27(29): 6–8.