基于文献的中药肝损伤药物流行病学特征分析  

Analysis of pharmacoepidemiological characteristics of liver injury in traditional Chinese medicine based on literature

作　　者：朱日然[1] 张丛惠 化晓凯[2] 王惠 张晶晶 鞠建峰[1] ZHU Riran;ZHANG Conghui;HUA Xiaokai;WANG Hui;ZHANG Jingjing;JU Jianfeng(Pharmaceutical Department,The Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250014,China;Pharmaceutical Department,The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250001,China)

机构地区：[1]山东中医药大学附属医院药学部,山东济南250014 [2]山东中医药大学第二附属医院药学部,山东济南250001

出　　处：《药学研究》2024年第8期742-747,752,共7页Journal of Pharmaceutical Research

基　　金：2023年全国中药特色技术传承人才培训项目(No.T20234832005);山东省药品化妆品不良反应监测哨点课题(No.2022SDADRKY12);山东中医药学会临床药学科研专项基金(No.SDACM202203);山东省药品化妆品不良反应监测哨点课题(No.2023SDADRKY47)。

摘　　要：目的分析中药致肝损伤的流行病学特征,为临床安全、合理使用中药以及开展中药肝损伤药物警戒工作提供参考。方法以“中药”“肝损伤”“肝毒性”“致”“诱发”“例”等为关键词,分别检索中国知网、万方数据、维普数据文献数据库,收集中药相关肝损伤的个案报道,提取患者性别、年龄、原患疾病、药物、生化指标、临床表现等信息,通过一般描述性统计、临床表现词频共现分析、Apriori算法,对中药肝损伤的发生规律及风险因素进行分析。结果共纳入文献241篇,涉及患者268例,其中男性124例,女性144例,平均年龄(48.99±15.45)岁,各年龄段中51~60岁高发;肝损伤类型、严重程度分别以肝细胞损害型、重度为主,骨科、皮肤科用药出现肝损伤及重度肝损伤例数相对较多,用药时长主要集中在31~90 d,且此时间段内出现重度肝损伤的例数最多。结论临床医务人员需高度警惕中药肝损伤,降低中药肝损伤发生风险,保障患者用药安全。Objective To analyze the epidemiological characteristics of traditional Chinese medicine induced liver injury,and to provide reference for clinical safety and rational use of traditional Chinese medicine and pharmacovigilance for traditional Chinese medicine liver injury.Methods Using"traditional Chinese medicine","liver injury","liver toxicity","caused","induced"and"case"as key words,China National Knowledge Network,Wanfang data and VIP data literature database were respectively searched to collect the case reports of TCM related liver injury,and extract the information of patients′gender,age,original disease,drugs,biochemical indexes and clinical manifestations.The occurrence rule and risk factors of liver injury with traditional Chinese medicine were analyzed by general descriptive statistics,word frequency co-occurrence analysis of clinical manifestations and Apriori algorithm.Results A total of 241 literatures were included,involving 268 patients,of which 124 were males and 144 were females,with an average age of(48.99±15.45)years old,and the incidence was high in all ages from 51 to 60 years old.The type and severity of liver injury were mainly hepatocyte injury type and severity respectively.There were relatively more cases of liver injury and severe liver injury caused by drugs in orthopedics and dermatology.The duration of medication was mainly concentrated in 31 to 90 days,and the number of cases with severe liver injury was the highest during this period.Conclusion Clinical medical staff should be highly alert to traditional Chinese medicine liver injury,reduce the risk of traditional Chinese medicine liver injury,and ensure the safety of traditional Chinese medicine use.

关 键 词：中药 肝损伤 药物流行病学 特征分析 

分 类 号：R181.35[医药卫生—流行病学]