Re-evaluation of the Clinical Safety of Compound Porcine Cerebroside and Ganglioside Injection in 4239 Patients with Hemorrhagic Stroke
Objective:To evaluate the clinical safety of compound porcine cerebroside and ganglioside injection in 4239 patients with hemorrhagic stroke after the market,so as to provide reference for clinical rational drug use.Methods:From March 2020 to March 2021,a multi-center,prospective and non-controlled clinical study design method was used to analyze the basic situation,medication information,adverse drug reactions and disease outcome of 4239 patients with hemorrhagic stroke who used compound porcine cerebro-side and ganglioside injection in 46 medical institutions in China.Results:The average medication time of 4239 hemorrhagic stroke patients was(13.62±2.22)days.Only 13 cases were judged to be adverse drug reactions during medication,and the incidence of adverse reactions was 0.307％.The adverse drug reactions were mainly concentrated in gastrointestinal diseases and systemic diseases.Among the 4239 patients with hemorrhagic stroke,190 were cured,3109 improved,912 had no significant change,and 27 exacerbation,and 1 patient died.Among the 13 patients with adverse drug reactions,10 patients improved after treatment,and 3 patients showed no signifi-cant change after treatment.Among the 4239 patients with hemorrhagic stroke with different medication conditions,49.99％of the pa-tients used a dose of ≤6 mL,and 50.0％of the patients used a dose of ≥8 mL,and there was no significant difference in the incidence of adverse drug reactions between patients with different drug doses(P＞0.05).0.9％saline was the main vehicle type,followed by 5％glu-cose,and there was no statistical difference in the incidence of adverse drug reactions between different vehicle types(P＞0.05).81.17％of the patients did not flush the tube,17.65％of the patients flushed the tube,and 1.18％of the patients changed the infusion set,and there was no significant difference in the incidence of adverse drug reactions between different measures(P＞0.05).92.19％of the patients had no irrational drug use,there were irrational drug use in the 7.81％patients,and there was a statistically significant difference in the inci-dence of adverse drug reactions between the two(P＜0.05).Conclusion:The incidence of adverse reactions of compound porcine cerebro-side and ganglioside injection in 4239 patients with hemorrhagic stroke after the market was low and the risk was controllable.At the same time,the adverse reaction symptoms were known or common adverse reactions.
Compound porcine cerebroside and ganglioside injectionHemorrhagic strokeSafetyEvaluation
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