Objective To study the characteristics and influencing factors of adverse drug reactions(ADR)of Arsenious Acid Sodium Chloride Injection,and provide reference for promoting clinical rational drug use.Methods The ADR reports of 285 cases of Arsenious Acid Sodium Chloride Injection collected from January 1st,2005 to December 31st,2022 were analyzed retrospectively by searching the database of ADR monitoring system in Shandong Province.Results In 285 cases,the proportion of male patients was higher than that of female patients.People aged 45～64 account for a relatively high proportion;Adverse reactions mostly occurred within 2 weeks of medication.ADR mainly involves hepatobiliary,gastrointestinal,systemic and other multi-system and organ damages,and the risks of QT interval prolongation,fever and chest tightness are not mentioned in the instructions.Conclusion Drug marketing license holders should strengthen the research and evaluation of drug safety after marketing,improve the safety content of the instructions;Guide clinical rational medication and strictly follow the instructions for use;Strengthen medication monitoring for elderly patients,especially related indicators of the hepatobiliary system and cardiovascular system,and ensure the safety of drug use by the public.
关键词
亚砷酸氯化钠注射液/药品不良反应/安全用药
Key words
Arsenious Acid Sodium Chloride Injection/Adverse drug reaction(ADR)/Safe medication
维普
万方数据