Objective:This study aimed to evaluate the prognostic impact of citicoline sodium capsules on patients with traumatic brain injury(TBI)and its safety.Methods:This study is a multicenter,single-arm,prospective,observat...Objective:This study aimed to evaluate the prognostic impact of citicoline sodium capsules on patients with traumatic brain injury(TBI)and its safety.Methods:This study is a multicenter,single-arm,prospective,observational study of brain trauma patients who met the inclusion criteria between March 2023 and June 2024 and who could be treated with citicoline sodium capsules after being evaluated by the investigator.The Glasgow Coma Scale(GCS)and Mini-Mental State Examination(MMSE),the incidence of adverse drug reactions/adverse events during treatment,and the abnormalities of safety tests with clinical evaluation significance were observed at 1 month and 2 months after treatment.Results:A total of 2806 patients,63.1%of whom were male,with an average age of 58.85 years old.The GCS and MMSE scores of the patients at 1 month and 2 months after treatment were significantly improved and were statistically significant,indicating that citicoline sodium had a significant effect on improving the state of consciousness and cognitive function of patients with TBI.Only 8 adverse reactions were reported in the study,all of which were mild gastrointestinal reactions and anaphylaxis,and did not lead to treatment interruption or serious consequences.Conclusion:Citicoline sodium has a significant therapeutic effect on patients with TBI and has good safety.展开更多
文摘Objective:This study aimed to evaluate the prognostic impact of citicoline sodium capsules on patients with traumatic brain injury(TBI)and its safety.Methods:This study is a multicenter,single-arm,prospective,observational study of brain trauma patients who met the inclusion criteria between March 2023 and June 2024 and who could be treated with citicoline sodium capsules after being evaluated by the investigator.The Glasgow Coma Scale(GCS)and Mini-Mental State Examination(MMSE),the incidence of adverse drug reactions/adverse events during treatment,and the abnormalities of safety tests with clinical evaluation significance were observed at 1 month and 2 months after treatment.Results:A total of 2806 patients,63.1%of whom were male,with an average age of 58.85 years old.The GCS and MMSE scores of the patients at 1 month and 2 months after treatment were significantly improved and were statistically significant,indicating that citicoline sodium had a significant effect on improving the state of consciousness and cognitive function of patients with TBI.Only 8 adverse reactions were reported in the study,all of which were mild gastrointestinal reactions and anaphylaxis,and did not lead to treatment interruption or serious consequences.Conclusion:Citicoline sodium has a significant therapeutic effect on patients with TBI and has good safety.
