心元胶囊致重度肝损伤1例及文献分析  

Analysis of One Case of Severe Liver Injury Induced by Xinyuan Capsule

作　　者：解燕 边原[2] 杜姗[2] XIE Yan;BIAN Yuan;DU Shan(Department of Pharmacy,Dongguan Songshan Lake Central Hospital,Dongguan Guangdong 523000,China;Department of Pharmacy,Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital,Chengdu Sichuan 610072,China)

机构地区：[1]东莞市松山湖中心医院药学部,广东东莞523000 [2]四川省医学科学院·四川省人民医院药学部,四川成都610072

出　　处：《中国药物警戒》2021年第4期361-364,372,共5页Chinese Journal of Pharmacovigilance

基　　金：四川省省级公益性科研院所基本科研业务专项课题(2018YSKY0017)。

摘　　要：目的分析1例心元胶囊致重度肝损伤的病例,探讨心元胶囊主要成分中制何首乌致肝损伤的一般规律和临床特点,为临床合理用药提供参考。方法对1例心元胶囊致肝损伤的病例进行报道,分析肝损伤与其成分中制何首乌的相关性;检索中国知网、万方数据、维普网建库至2019年11月30日发表的制何首乌及其制剂导致肝损伤的病例报道,提取病例信息进行统计分析。结果制何首乌及其制剂引发肝损伤排名前3位分别为制何首乌饮片(21%)、首乌片(18%)、灵芝益寿胶囊(16%);男女发病率为1.4∶1,以51~60岁的中年患者居多(30.5%);肝损伤类型以肝细胞损伤型为主(94.4%);肝损伤发生的时间跨度较大,以用药后1~3个月的发生率较高(61%);肝损伤经治疗后恢复好,平均恢复时间为(43.19±28.92)d。本例患者情况符合制何首乌及其制剂致肝损伤的一般规律和临床特点。结论心元胶囊及其他制何首乌制剂均可能导致肝损伤,临床医生和药师应密切关注,合理用药,减少和避免肝损伤的发生。Objective To report a case of severe liver injury caused by Xinyuan capsule and to explore the general rules and clinical characteristics of liver injury caused by Polygonum multiflorum in the main components of Xinyuan capsule,as to provide a reference for clinical rational drug use.Methods A case of liver injury caused by Xinyuan capsule was reported and analysed.Case reports of liver injury caused by Polygonum multiflorum and its preparations were retrieved and anaylsed.from CNKI,Wanfang Medical Database,and VIP full-text database.Results The top 3 liver injury induced by Polygonum multiflorum preparations were the Polygonum multiflorum decoction(21%),Shouwu Tablet(18%)and Ganoderma lucidum Yishou capsule(16%).The incidence rate of male and female was 1.4:1.Mostly middle-aged patients aged 51 to 60,accounting for 30.5%.The type of liver injury was mainly hepatocyte injury(94.4%).The time span of liver function injury occurred over a large period,and the incidence was 1 to 3 months after administration,accounting for 61%.Liver injury recovered well after treatment and the average recovery time was(43.19±28.92)days.The patient conditions to the general rules and clinical characteristics of liver injury caused by Polygonum multiflorum preparations.Conclusion Xinyuan capsules and other Polygonum multiflorum preparations can cause liver injury.Clinicians and pharmacists should pay close attention to rational use of drugs to reduce and avoid liver injury.

关 键 词：心元胶囊 制何首乌 药物性肝损伤 不良反应 文献分析 

分 类 号：R994.1[医药卫生—毒理学]