基于 FAERS 数据库的富马酸替诺福韦二吡呋酯相关 药物不良反应的流行病学分析  

Epidemiological Analysis of Adverse Drug Reactions Related to Tenofovir Disoproxil Fumarate Based on the FAERS Database

作　　者：蔡海峰 潘晓军 CAI Hai-feng;PAN Xiao-jun(Department of Pharmacy,the Fifth People's Hospital of Wuxi,Wuxi Jiangsu 214000,China)

机构地区：[1]无锡市第五人民医院药剂科,江苏无锡214000

出　　处：《抗感染药学》2024年第11期1101-1107,1124,共8页Anti-infection Pharmacy

基　　金：江苏省药学会-天晴医院药学基金(编号:Q202037)。

摘　　要：目的:基于美国FDA不良事件报告系统(FDAAdverse Event Reporting System,FAERS)数据库,分析富马酸替诺福韦二吡呋酯(tenofovir disoproxil fumarate,TDF)相关药物不良反应的流行病学特点,为临床TDF的用药安全提供参考。方法:以“富马酸替诺福韦二吡呋酯(tenofovir disoproxil fumarate)”作为检索词,在FAERS数据库中检索2004年1月1日-2022年12月31日TDF相关药物不良事件(adverse drug event,ADE)的所有信息,分析TDF相关药物不良反应的流行病学特点。结果:在FAERS数据库中共检索到与TDF相关的ADE共69352例,其中2004-2019年从584例逐渐升至5329例,而2020年陡增至20997例,之后又迅速减少;69352例TDF相关ADE中,报告国主要为美国(47050例,占67.84%),报告的严重程度主要为“严重”(57989例,占83.62%),所涉患者的性别主要为男性(43746例,占63.08%),而其年龄主要集中于18~64岁(38802例,占55.95%);69352例ADE涉及113个ADE阳性信号和19个系统器官分类,其中报告数前3位的依次为肾脏及泌尿系统疾病(24168例)、各种肌肉骨骼及结缔组织疾病(23432例)和精神病类(11305例);此外,在69352例ADE中,有37个ADE信号未在TDF说明书中被提及,其中报告数前3位的依次为骨坏死(10286例)、流产(1043例)和维生素D缺乏(880例),而信号强度前5位的依次为蛋白质总量异常、骨坏死、线粒体中毒症、超声产前筛查异常、β2微球蛋白尿增加。结论:TDF相关ADE绝大多数表现较为严重,对于所涉例数较多尤其是未在TDF说明书中被提及的阳性信号,临床应加强安全用药监测,并积极采取预防和治疗措施,以保障患者的用药安全。Objective:To analyze the epidemiological characteristics of adverse drug reactions related to tenofovir disoproxil fumarate(TDF)based on the US FDA Adverse Event Reporting System(FAERS)database,and provide a reference for the clinical medication safety of TDF.Methods:By using"tenofovir disoproxil fumarate"as a key word,all information on TDF-related adverse drug events(ADEs)from January 1,2004 to December 31,2022 was searched in the FAERS database,to analyze the epidemiological characteristics of the TDF-related adverse drug reactions.Results:A total of 69352 cases of TDF-related ADEs were searched from the FAERS database,of which the number gradually increased from 584 in 2004 to 5329 in 2019,and then sharply increased to 20997 in 2020,and then decreased rapidly.Among the 69352 cases of TDF-related ADEs,the reporting country was mainly the United States(47050 cases,67.84%),the reported severity was mainly"serious"(57989 cases,83.62%),the sex of patients involved was mainly male(43746 cases,63.08%),and their ages were mainly in the range of 18-64 years old(38802 cases,55.95%).The 69352 ADEs involved 113 ADE positive signals and 19 system organ classes.The top three reported ADEs were renal and urinary disorders(24168 cases),musculoskeletal and connective tissue disorders(23432 cases),and psychiatric disorders(11305 cases).In addition,among the 69352 ADEs,37 ADE signals were not mentioned in the TDF package insert,of which the top three ADEs were osteonecrosis(10286 cases),miscarriage(1043 cases),and vitamin D deficiency(880 cases),and the top five signal intensities were abnormal total protein,osteonecrosis,mitochondrial poisoning,abnormal ultrasound prenatal screening,and increasedβ2 microglobulinuria.Conclusion:Most TDF-related ADEs are serious.For ADEs that involve a large number of patients,especially those with positive signals not described in the TDF package insert,safe medication monitoring should be strengthened clinically,and active preventive and therapeutic measures should be taken to ensure the safe

关 键 词：富马酸替诺福韦二吡呋酯 FDA不良事件报告系统 药物不良事件 流行病学特点 

分 类 号：R978.7[医药卫生—药品] R181.35[医药卫生—药学]