Clinical Efficacy and Safety Reevaluation of Compound Porcine Cerebroside and Ganglioside Injection in the Treatment of Patients with Spinal Cord Injury:A Report of 611 Cases
Objective:The purpose of this study was to investigate the clinical efficacy and safety of compound porcine cerebro-side and ganglioside injection in the treatment of patients with spinal cord injury(SCI).Methods:From April 2020 to April 2021,A total of 611 patients with SCI were treated with compound porcine cerebroside and ganglioside injection in 46 grade A hospitals of level Ⅱ or higher level in different regions of China were selected as the research objects in a prospective,multi-center and non-control manner.The prognosis and the incidence of adverse events were analyzed through monitoring the patients'baseline characteristics and medication.Results:The effective rate of treatment in this study was 68.25％(417/611).After treatment,the incidence of adverse events was 5.57％,most of the adverse events were mild to moderate(5.57％),and the outcome was good(4.74％).The damages mainly included systemic damage(1.64％),gastrointestinal system damage(1.31％),and other damage(1.47％).There was no significant difference in the incidence of adverse drug events among patients with different baseline characteristics such as gender,age,American Spinal Injury Association(ASIA)grades,damaged site,education level and previous histories(P＞0.05).There was no significant difference in the incidence of adverse drug events between patients with or without the first use of compound porcine cerebroside and ganglioside injection,different solvent types of compound porcine cerebroside and ganglioside injection,and different administration methods(P＞0.05).The incidence of adverse drug events in patients with rational and irrational drug use was statistically significant(P＜0.05).Conclusion:The incidence of adverse events in patients with SCI treated with compound porcine cerebroside and ganglioside injection is low.The patients'symptoms are mild and the prognosis is good.The occurrence of adverse events is mostly related to irrational drug use,which deserves attention during med-ication.
Spinal cord injuryCompound porcine cerebroside and ganglioside injectionEfficacySafety
NETL
NSTL
万方数据
