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285例亚砷酸氯化钠注射液不良反应报告及风险因素分析

Analysis of ADR reports and risk factors of 285 cases of Arsenious Acid Sodium Chloride Injection
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摘要 目的研究亚砷酸氯化钠注射液药品不良反应(ADR)特点及风险因素,为促进临床合理用药提供参考。方法检索山东省药品不良反应监测系统数据库,对2005年1月1日至2022年12月31日收集的285例亚砷酸氯化钠注射液ADR报告进行回顾性分析。结果285例报告中,男性患者占比高于女性;从年龄上看,45~64岁人群占比较高;不良反应多发生在用药2周内;ADR主要累及肝胆、胃肠、全身性等多系统和器官损害,QT间期延长、发热、胸闷等风险在说明书中均未提及。结论药品上市许可持有人需加强上市后药品安全性研究与评价,完善说明书安全性内容;指导临床合理用药,严格按照说明书要求使用;加强老年患者用药监测,特别是肝胆系统、心血管系统的相关指标,保障公众用药安全。 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 1 st,2005 to December 31 st,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.
作者 霍艳飞 路长飞 谢彦军 许莉莉 常虹 孙春晓 李霞 HUO Yanfei;LU Changfei;XIE Yanjun;XU Lili;CHANG Hong;SUN Chunxiao;LI Xia(Shandong Center for Adverse Drug Reaction Monitoring,Jinan 250014,China)
出处 《药学研究》 CAS 2024年第7期723-728,共6页 Journal of Pharmaceutical Research
关键词 亚砷酸氯化钠注射液 药品不良反应 安全用药 Arsenious Acid Sodium Chloride Injection Adverse drug reaction(ADR) Safe medication
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