首页|285例亚砷酸氯化钠注射液不良反应报告及风险因素分析

285例亚砷酸氯化钠注射液不良反应报告及风险因素分析

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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.
Analysis of ADR reports and risk factors of 285 cases of Arsenious Acid Sodium Chloride Injection
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.

Arsenious Acid Sodium Chloride InjectionAdverse drug reaction(ADR)Safe medication

霍艳飞、路长飞、谢彦军、许莉莉、常虹、孙春晓、李霞

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山东省药品不良反应监测中心,山东 济南 250014

亚砷酸氯化钠注射液 药品不良反应 安全用药

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(7)
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