深圳市2014~2017年药物性肝功能异常ADR/ADE报告分析  

Analysis the Characteristics of Drug Induced Abnormal Liver Function Based on the Data of Adverse Drug Reactions/Events Reported in Shenzhen from 2014 to 2017

作　　者：何桂林 左丽 陈佳音 周学琴[1] 王茜 He Guilin;Zuo Li;Chen Jiayin;Zhou Xueqin;Wang Qian(Department of Pharmacy,Peking University Shenzhen Hospital,Shenzhen 518036,Guangdong,China;Department of Drugs Monitoring,Shenzhen Institute of Pharmacovigilance and Risk Management)

机构地区：[1]北京大学深圳医院药学部,广东深圳518036 [2]深圳市药物警戒和风险管理研究院

出　　处：《药物流行病学杂志》2020年第6期395-398,412,共5页Chinese Journal of Pharmacoepidemiology

基　　金：深圳市卫生计生系统科研项目(编号:SZFZ2017050)。

摘　　要：目的:探讨药物性肝功能异常的发生特点,为该病的预防与临床用药提供参考。方法:从深圳市2014~2017年32068份药品不良反应/事件(ADR/ADE)报告中筛选肝功能异常病例,采用回顾分析方法,对肝功能异常患者性别、年龄、发生时间等,涉及药物、类型分布、转归等进行统计分析。结果:共筛选出药物性肝功能异常报告704份,占32068份ADR/ADE报告的2.20%。18~39岁年龄段比例最高(53.41%),发生在2~7 d内的比例最高(36.22%),76.95%发生在用药1个月之内;涉及抗结核药物(39.08%)、抗恶性肿瘤及影响免疫功能药(22.11%)、抗菌药(11.92%);阿托伐他汀钙(35例次)和甲巯咪唑(20例次)在同类药物中发生肝功能异常例次较多。严重肝功能异常发生比例较高(50.15%),合并用药(40.79%)更易导致严重肝功能异常发生,但大多数病例经停药或对症处理后预后良好,仅45例患者需入院治疗,其中39例为严重病例。结论:应重视肝功能异常的监测。尽量避免联合使用易致肝功能异常的药物,发现异常及时处理。Objective:To explore the clinical features and regular patterns of drug induced abnormal liver function in order to provide reference for abnormal liver function prevention and clinical medication.Methods:Abnormal liver function reports,which screened from a total of 32068 ADR/ADE reports reported in Shenzhen city from 2014 to 2017,were analyzed in terms of the sex and age of patients,time to onset of ADR/ADE,the types and varieties of drugs involved,category distribution and outcome of ADR/ADE.Results:1149 cases of suspected drug in 704 abnormal liver function reports were screened out,which accounted for 2.20%.The proportion of abnormal liver function was the highest(53.41%)at the age of 18-39 years old.The highest proportion(36.22%)of the onset time of abnormal liver function was within 2 to 7 days after medications,and 76.95%occurred within 1 month.Most of the involving drugs were anti-tuberculosis drugs(39.08%),anti-tumor drugs and immunoregulatory drugs(22.11%),anti-bacterial drugs(11.92%),which accounted for 73.11%of the total cases.Atorvastatin(35 cases)and methimazole(20 cases)occurred the most abnormal liver function in the same class of drugs.Although severe abnormal liver function had higher incidence(50.15%),and combination of drugs was more likely to cause serious ADR/ADE,the most had good prognosis.Most of abnormal liver function improved markedly after stopping medicine or symptomatic treatment,but 45 patients need to be hospitalized,39 of them were serious.Conclusion:It should be payed more attention on the monitoring and reporting abnormal liver function.In clinical work,it is necessary to avoid the combination use of drugs that may cause liver dysfunction.Monitoring the liver function should be reinforced and treat in time in case of any abnormality,in order to avoid bad outcome.

关 键 词：肝功能异常 药品不良反应/事件 回顾性分析 药物警戒 

分 类 号：R595.3[医药卫生—内科学]