银黄口服制剂安全性风险分析及思考  

Risks to Safety of Yinhuang Oral Preparation

作　　者：邵波 钟露苗 成雨竹 邓华 朱兰 SHAO Bo;ZHONG Lumiao;CHENG Yuzhu;DENG Hua;ZHU Lan(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China;Hunan Center for Drug Evaluation,Changsha Hunan 410000,China)

机构地区：[1]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100076 [2]湖南省药品审评与不良反应监测中心,湖南长沙410000

出　　处：《中国药物警戒》2025年第1期84-87,共4页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2018YFC1707409);湖南省自然科学基金部门联合基金项目(2023JJ60114)。

摘　　要：目的分析银黄口服制剂安全性风险,为临床合理用药提供参考。方法对国家药品不良反应监测系统数据库(2004年1月1日至2023年12月31日)、国内文献数据库(建库至2023年12月31日)中银黄口服制剂相关不良反应数据进行整理与分析。结果2004年1月1日至2023年12月31日,国家药品不良反应监测系统数据库共收到银黄口服制剂不良反应/事件病例报告8700例,其中标识为严重的报告197例(2.26%)。不良反应监测数据和文献报道显示,银黄口服制剂不良反应累及多个系统-器官,主要表现为腹泻、腹痛、腹部不适、恶心、呕吐、皮疹、瘙痒、头晕等,有严重过敏反应报告。2024年7月2日,国家药品监督管理局已对银黄口服制剂药品说明书进行统一修订。结论医务人员和患者应合理选用银黄口服制剂,提高安全用药意识;药品上市许可持有人应加强药物警戒,做好用药指导与宣传,保障患者用药安全。Objective To analyze the risk posed by Yinhuang oral preparation in order to provide a reference for proper clinical use.Methods Cases of adverse drug reactions(ADR)related to Yinhuang oral preparation retrieved from China’s ADR monitoring database(collected between 2004 and 2023)and domestic databases(from inception to December 31,2023)were sorted out and analyzed.Results Between January 1,2004 and March 31,2023,there were reports of a total of 8700 cases of adverse drug reactions/adverse events(ADR/AE)related to Yinhuang oral preparation in the database,including 197 severe cases(2.26%).The ADR/AE reports from the national ADR monitoring system and literature showed that the ADR of Yinhuang oral preparation involved multiple systems and organs,and that the manifestations of adverse reactions varied,depending on dosage forms.The clinical manifestations included diarrhea,abdominal pain,abdominal discomfort,nausea,vomiting,rash,pruritus,and dizziness.There were also reports of individual cases of severe allergic reactions.The drug label of Yinhuang oral preparation was upgraded as required by the National Medical Products Administration(NMPA)on July 2,2024.Conclusion Yinhuang oral preparation should be used with caution.Drug marketing authorization holders should strengthen pharmacovigilance and provide guidance to ensure safe medication.

关 键 词：银黄 口服制剂 药品不良反应 安全性 说明书 非处方药 

分 类 号：R974[医药卫生—药品] R994.11[医药卫生—药学]