注射用七叶皂苷钠安全性风险分析及思考

目的 分析注射用七叶皂苷钠的安全性风险,为其安全使用提供参考.方法 对国家药品不良反应监测数据库、国内文献中不良反应报告及药品监管部门采取风险控制措施等相关资料信息进行整理与分析.结果 注射用七叶皂苷钠可致皮疹、瘙痒、静脉炎、过敏性休克、肝损害等不良反应;儿童和老年人也存在用药风险;临床应用需注意并做好相关防治措施.结...

Analysis and Consideration on Risk of Sodium Aescinate for Injection

Objective To analyze the risk of Sodium Aescinate for injection,so as to provide reference for clinical use safety.Methods The individual ADR(adverse drug reaction)cases in China adverse drug reaction database,domestic literatures,and the risk management measures by NMPA were analyzed.Results Data analysis showed that,the ADR of the Rash,pruritus,phlebitis,anaphylactic shock,liver damage et al.induced by Sodium Aescinate for injection and the risk of medication for children and the elderly should be concerned in clinical use and take relevant prevention and control measures.Conclusion Marketing authorization holders should take risk control measures such as revising the drug instructions for the identified risks and actively carry out post market study;hospitals should strengthen the rational use of drugs to avoid the occurrence of adverse reactions;institutions of monitoring and evaluation of adverse drug reactions should continuously strengthen the monitoring of adverse reactions to ensure the safety of drug users.