基于FAERS数据库的未成年人使用重组人生长激素不良事件信号挖掘与分析  

Signals mining and analysis of adverse drug events in minors using recombinant human growth hormone based on the FAERS database

作　　者：董家潇 王轶雷 李修政 李杰 徐益春 许晓东 DONG Jiaxiao;WANG Yilei;LI Xiuzheng;LI Jie;XU Yichun;XU Xiaodong(Department of Pharmacy,Zhangjiagang Hospital Affiliated to Soochow University,Suzhou 215000,Jiangsu Province,China;Department of Pharmacy,Taicang Hospital of Traditional Chinese Medicine,Suzhou 215000,Jiangsu Province,China;Department of Pharmacy,Kunshan Third People's Hospital,Suzhou 215000,Jiangsu Province,China;Department of Pharmacy,Yixing People's Hospital,Wuxi 214000,Jiangsu Province,China)

机构地区：[1]苏州大学附属张家港医院药剂科,江苏苏州215000 [2]太仓市中医院药剂科,江苏苏州215000 [3]昆山市第三人民医院药剂科,江苏苏州215000 [4]宜兴市人民医院药剂科,江苏无锡214000

出　　处：《药物流行病学杂志》2025年第2期157-165,共9页Chinese Journal of Pharmacoepidemiology

基　　金：苏州市科技局医疗卫生科技创新-应用基础研究(SKYXD2022001);江苏省药学会-天晴医院药学基金(Q202055)。

摘　　要：目的挖掘并分析重组人生长激素在未成年人群体中出现的不良事件(ADE)信号,为临床安全用药提供依据。方法从美国食品药品管理局不良事件报告系统(FAERS)数据库中检索2014年第3季度至2024年第2季度与重组人生长激素相关的ADE报告,采用《国际医学用语词典》对ADE报告进行标准化处理与分类,通过报告比值比法和贝叶斯置信区间递进神经网络法挖掘重组人生长激素与18岁以下未成年人之间的ADE信号。结果共检索到未成年人使用重组人生长激素的ADE报告33642份,剔除与ADE无关的信号(产品问题、社会问题等)后,最终得到358个ADE信号,涉及21个系统/器官分类。全身性疾病及给药部位各种反应和各类检查报告数最多,分别为3621个和3259个,其中心血管疾病相关的各类检查、精神病类、生殖系统及乳腺疾病等相关ADE信号未被药品说明书记载,包括血肌酐降低、血碱性磷酸酶升高、血红蛋白分布宽度减少、哭泣、攻击、性生殖腺发育不全等。结论未成年人使用重组人生长激素时,除了需注意血糖变化、脊柱侧凸等常见的ADE,还应关注患儿血常规指标变化、精神相关问题、生殖系统及乳腺疾病等潜在的ADE,以确保用药安全。Objective To mine and analyze adverse drug events(ADEs)signals in minors using recombinant human growth hormone(rhGH),and to provide reference for clinically safe use of drugs.Methods Based on the the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,the data of ADE reports related to rhGH from the third quarter of 2014 to the second quarter of 2024 were retrieved.The ADE reports were standardized and categorized using the Medical Dictionary for Regulatory Activities(MedDRA).The reporting odds ratio(ROR)method and Bayesian confidence propagation neural network(BCPNN)method were employed to mine and analyze ADE signals between rhGH and individuals under 18 years of age.Results A total of 33,642 ADE reports related to the use of rhGH in minors were retrieved.After excluding signals unrelated to ADEs(product issues,social issues,etc.),358 ADE signals were ultimately identified,involving 21 system organ lasses(SOCs).The most frequently reported ADEs were general disorders and administration site reactions(3,621 cases),as well as various laboratory test abnormalities(3,259 cases).Notably,ADE signals related to cardiovascular system tests,psychiatric disorders,and reproductive system and breast disorders,such as decreased serum creatinine,elevated alkaline phosphatase,reduced red blood cell distribution width,crying,aggression,and hypogonadism,were not documented in the drug package insert.Conclusion When administering rhGH to minors,in addition to monitoring common ADEs such as changes in blood glucose levels and scoliosis,attention should also be given to potential ADEs,including alterations in hematological parameters,psychiatric issues,and reproductive system and breast disorders,to ensure medication safety.

关 键 词：重组人生长激素 数据挖掘 药品不良事件 未成年人 药物警戒 

分 类 号：R977.1[医药卫生—药品]