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
  • 摘要:
      目的   探讨他克莫司（Tac）在儿童实体器官移植受者中的不良药物事件（ADE）特征。
      方法  研究数据来源于美国食品与药品监督管理局不良事件报告系统数据库，时间覆盖2004年第1季度至2023年第2季度，提取了以Tac为首要怀疑药物的儿童器官移植受者的ADE数据，运用比例失衡法对Tac与ADE之间的关联进行定量分析。分析Tac相关ADE的基本特征及信号强度。探究不同年龄儿童及不同移植器官类型的Tac相关ADE。
      结果  共筛选出1 443份涉及Tac的儿童ADE报告，其中心脏移植188例（13.0%）、肝移植668例（46.3%）、肾移植531例（36.8%）、肺移植56例（3.9%），儿童的中位年龄为10岁，ADE上报国家的前3位分别是美国、法国及英国，中国上报为26例，占比为1.8%。感染及侵染类疾病在Tac相关ADE报告中占比最高（20.96%），包括EB病毒及巨细胞病毒感染等。不同年龄段儿童的Tac相关ADE中感染及侵染类疾病均占据最大比例，但病原体种类存在差异。排斥反应、免疫抑制水平不稳定以及肾功能损伤也是各年龄段儿童常见的Tac相关ADE。心脏移植受者中以神经系统疾病的ADE为主，而肝移植和肾移植受者中感染及侵染类疾病更为常见，肺移植受者中的ADE以排斥反应最为常见。
      结论  Tac相关ADE在不同器官移植类型中呈现出不同的分布特点，需重视在儿童器官移植中进行个性化药物监测和风险评估，以优化Tac治疗并降低ADE风险。

     

    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.

     

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