Results of a Multicenter Study on the Efficacy and Safety of Inosine Glycyl-Cysteinyl-Glutamate Disodium in the Treatment of Acute Ethanol Poisoning

Abstract

The article presents results of a multicenter, randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of inosine glycylcysteinyl-glutamate disodium (Molixan®) in the treatment of acute severe ethanol poisoning. The aim of the study To evaluate the efficacy and safety of inosine glycyl-cysteinyl-glutamate disodium in a new dosage regimen in the treatment of severe ethanol poisoning. Material and Methods The material of the study is the data of 133 patients with severe ethanol poisoning. Inclusion criteria: age from 18 to 60 years, 1–2 coma stage (Glasgow-Pittsburgh coma scale of 14–27), ethanol in the blood of more than 2.5%. The patients were randomized into 2 groups: the Study Drug group (SD group) — 67 patients who, in addition to the standard therapy, were injected with the study drug - inosine glycyl-cysteinyl-glutamate disodium in a dose of 3.0 mg/kg; and the Placebo group — 66 patients who, in addition to the standard therapy, were injected with 0.9% sodium chloride solution in a dose of 3.0 mg/kg. Comparative intergroup and intragroup analyses were carried out according to the main clinical, laboratory parameters and EEG monitoring data. Results The study showed a positive effect of the study drug — a reduction in the coma period was noted (from 137 (75; 180) minutes to 78 (50; 155) minutes (p<0.001)), higher values of the Glasgow-Pittsburgh scale were recorded after 3 and 6 hours from the start of the therapy (p<0.01), a reduction in the time of formation of EEG awakening patterns in patients with delta coma activity from 192.2 (161.9; 222.5) minutes to 112.5 (97.6; 127.6) minutes (p<0.001), a decrease in heart rate (p<0.02), a decrease in the number of complaints of weakness and dizziness (p<0.005), in patients with high ALT levels, the frequency of development and severity of tremor decreased (p<0.01). The hepatoprotective effect of the drug was revealed, it was manifested by a decrease in ALT (p<0.001), AST (p<0.001) and direct bilirubin (p<0.03); the effect of the drug on metabolic processes — a decrease in lactate (p<0.02), an increase in BE-ECF (p<0.01), glucose (p<0.01) 3 hours after drug administration, an increase in potassium after 24 hours (p<0.03). The analysis of safety data did not reveal statistically significant differences between the treatment groups, no serious adverse events were recorded. Conclusion The study demonstrated the efficacy and safety of inosine glycyl-cysteinyl-glutamate disodium (Molixan®) in the treatment of severe ethanol poisoning in a single dose of 3.0 mg/kg administered intravenously