Signals mining and analysis of adverse drug events in minors using recombinant human growth hormone based on the FAERS database
10.12173/j.issn.1005-0698.202407021
- VernacularTitle: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
- Author:
Jiaxiao DONG
1
;
Yilei WANG
;
Xiuzheng LI
;
Jie LI
;
Yichun XU
;
Xiaodong XU
Author Information
1. 苏州大学附属张家港医院药剂科(江苏苏州 215000)
- Publication Type:Journal Article
- Keywords:
Recombinant human growth hormone;
Data mining;
Adverse drug events;
Minors;
Pharmacovigilance
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(2):157-165
- CountryChina
- Language:Chinese
-
Abstract:
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.
