器官移植2024，Vol.15Issue(4)：581-590,10.DOI:10.3969/j.issn.1674-7445.2024031
基于FAERS数据库的儿童实体器官移植受者应用他克莫司相关药物不良事件的研究
Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FAERS database
摘要
Abstract
Objective To investigate the characteristics of adverse drug event(ADE)related to tacrolimus(Tac)in pediatric solid organ transplant recipients.Methods The data were retrieved from the US Food and Drug Administration Adverse Event Reporting System database from the first quarter of 2004 to the second quarter of 2023.The ADE data of pediatric organ transplant recipients with Tac as the primary suspected drug were extracted.The relationship between Tac and ADE was quantitatively analyzed by proportional imbalance method.Basic characteristics and signal strength of ADE related to Tac were analyzed.ADE related to Tac in children of different ages and different types of organ transplantation were analyzed.Results A total of 1 443 children's ADE reports involving Tac were screened,including 188 cases(13.0％)of heart transplantation,668 cases(46.3％)of liver transplantation,531 cases(36.8％)of kidney transplantation and 56 cases(3.9％)of lung transplantation.The median age of children was 10 years old.The top three countries with ADE reporting were the United States,France and the United Kingdom.China reported 26 cases,accounting for 1.8％.Infection and infectious diseases accounted for the highest proportion(20.96％)in ADE related to Tac,including EB virus and cytomegalovirus infection,etc.Infection and infectious diseases occupied the largest proportion of ADE related to Tac in children of different ages,whereas the pathogen types were different.Rejection,unstable immunosuppression level and renal function damage were also common ADE related to Tac in children of all ages.Nervous system disease was the main ADE in heart transplant recipients,while infection and infectious diseases were more common in liver and kidney transplant recipients.Rejection was the most common ADE in lung transplant recipients.Conclusions ADE related to Tac possess different distribution characteristics in different types of organ transplantation.Extensive attention should be paid to individualized drug monitoring and risk assessment in pediatric organ transplant recipients,thereby optimizing Tac treatment and reducing the risk of ADE.关键词
实体器官移植/儿童/他克莫司/不良药物事件/感染/排斥反应/食物过敏/神经系统疾病Key words
Solid organ transplantation/Children/Tacrolimus/Adverse drug event/Infection/Rejection/Food allergy/Nervous system disease分类
临床医学引用本文复制引用
董博清,王婧雯,毕焕京,陈祖涵,路翠楠,薛武军,李杨,丁小明..基于FAERS数据库的儿童实体器官移植受者应用他克莫司相关药物不良事件的研究[J].器官移植,2024,15(4):581-590,10.基金项目
国家自然科学基金(82370802) （82370802）
创新药物上市后临床研究科研专项(WKZX2023CX190002) （WKZX2023CX190002）
西安交通大学医学"基础-临床"融合创新项目(YXJLRH2022049) （YXJLRH2022049）
