基于FAERS对慢性乙肝一线药物不良事件的分析  

Analysis of Adverse Drug Events in First-line of Chronic Hepatitis B Based on FAERS

作　　者：蔡泽芳 陈郁 周阳 罗千古[1] CAI Zefang;CHEN Yu;ZHOU Yang;LUO Qiangu(Department of Pharmacy,the Fifth Affliated Hospital of Sus Yat-Sen University,Zhuhai,Guangdong 519000,China)

机构地区：[1]中山大学附属第五医院药学部,广东珠海519000

出　　处：《今日药学》2023年第5期362-368,共7页Pharmacy Today

摘　　要：目的基于FAERS数据库对慢性乙型肝炎一线治疗药物恩替卡韦ETV、富马酸替诺福韦酯TDF和富马酸丙酚替诺福韦TAF的不良反应信号进行分析比较,为临床合理用药提供参考。方法提取3种慢性乙肝一线治疗药物自上市以来至2022年第二季度的AE报告,使用比例失衡法对ADR信号进行挖掘、比较、分析。结果检索出ETV的AE报告23748份,TDF共313011份,TAF共93276份,男性均多于女性,年龄集中分布于18~75岁间,主要上报国家是美国;发生严重的AE结局占16.92%~50.30%。ADE报告数前20位的PT中,ETV主要涉及各类检查、肝胆系统疾病、感染及侵袭类疾病、肾脏及泌尿疾病等;TDF主要涉及各种肌肉骨骼及结缔组织疾病、肾脏及泌尿系统疾病、精神病类等;TAF主要涉及各种肌肉骨骼及结缔组织疾病、肾脏及泌尿系统疾病、精神病类等。ETV还检出乳酸性酸中毒、喉头红斑、垂体梗死等新的不良反应信号;TDF和TAF均检出焦虑、快感缺失及情绪困扰等精神病类新的风险信号。结论经分析比较后可得,药物ADR风险信号累及的主要系统与说明书一致,证明研究的可靠性。3种药物均检出新的不良反应风险信号,且3种药物ADR具有一定的差异性,此项研究可为临床提供参考,促进合理用药。OBJECTIVE To analyze and compare the adverse reaction signals of entecavir,tenofovir disoproxil fumarate and Tenofovir Alafenamide fumarate,the preferred drugs of chronic hepatitis B(CHB)nucleoside(acid)analogs,based on the FAERS database,providing a reference for clinical rational drug use.METHODS TThe AE reports of three chronic hepatitis B first-line treatment drugs were extracted since their launch to the second quarter of 2022,the ratio imbalance method was used to mine,compare and analyze the ADR signals.RESULTSSA total of 23748 AE reports of ETV,313011 of TDF,and 93276 of TAF were retrieved.Males were more than females,and the age was mainly distributed between 18-75 years old.The main reporting country was the United States.Serious AE outcomes accounted for 16.92%-50.30%.Among the top 20 PTs by number of ADE reports,ETV was mainly involved in various examinations,hepatobiliary system diseases,infection and invasion diseases,kidney and urinary diseases,etc.TDF was mainly involved in various musculoskeletal and connective tissue diseases,kidney and urinary system diseases,psychiatric diseases,etc.TAF was mainly involved in various musculoskeletal and connective tissue diseases,kidney and urinary system diseases,psychiatric diseases,etc.ETV also detected new adverse reaction signals such as lactic acidosis,laryngeal erythema,and pituitary infarction.Both TDF and TAF detected new risk signals of psychosis such as anxiety,anhedonia and emotional distress.CONCLUSION After analysis and comparison,it can be concluded that the main systems involved in ADR risk signals are consistent with the instruction manual,which proves the reliability of the research.New adverse reaction risk signals are detected for the three drugs,and the ADRs of the three drugs have certain differences.This study can provide clinical reference and promote rational drug use.

关 键 词：FAERS数据库 恩替卡韦 富马酸替诺福韦酯 富马酸丙酚替诺福韦 不良反应信号 

分 类 号：R979.9[医药卫生—药品]