中国临床药理学杂志2025，Vol.41Issue(15)：2177-2182,6.DOI:10.13699/j.cnki.1001-6821.2025.15.014
基于不良事件报告系统数据库对未成年人使用生长激素类制剂的不良反应评价
Evaluation of adverse reactions on the use of growth hormone agents in minors based on FAERS database
摘要
Abstract
Objective To explore the adverse reactions of growth hormone drugs in minors in the real world,provide references for safe clinical use,and offer guidance for the launch of new long-acting preparations in China.Methods All information from ASCⅡ data packages in the Food and Drug Administration(FDA)Adverse event reporting system(FAERS)from January 1,2004 to September 30,2024 was extracted.Data cleaning was conducted using R language.The generic and brand names of growth hormone drugs were obtained from the FDA website as search terms to screen and retain adverse reaction reports of minors with growth hormone drugs as the primary suspect(PS).The report odds ratio(ROR)and proportional report ratio(PRR)methods were used for data mining of growth hormone drug reports.Results Among the 33 262 included reports,male patients outnumbered female patients,and the age was mainly concentrated between 4 and 18 years old.After screening with ROR and PRR methods,a total of 357 signals were obtained.After classification by system organ,they were mainly concentrated in general diseases and various reactions at the administration site,various examinations,nervous system diseases.Among them,the most frequently reported were injection site reactions,headache,vomiting,fever,joint pain,limb pain,etc.A total of 103 preferred term(PT)signals were mined in the 0-3 years old group,232 in the 4-11 years old group,and 261 in the 12-18 years old group.A total of 398 positive signals were detected in the male minor group,and 394 in the female group.Migraine,viral infection,celiac disease were only detected in the male group,while epileptic seizure,epilepsy,Cushing's syndrome,anorexia nervosa were only detected in the female group.The average induction time of adverse events of concern such as sudden death,scoliosis,tumors,and diabetes was relatively long.Conclusion This study effectively utilizes the ROR and PRR methods to mine adverse reaction signals of growth hormone drugs.There are differences in adverse reactions of growth hormone drugs among minors of different ages and genders.Before using growth hormone drugs clinically,a thorough assessment of the patient's medication should be conducted,and during treatment,the occurrence of adverse reactions should be closely monitored.Timely intervention should be carried out when abnormalities are detected.关键词
生长激素/FAERS/药物不良反应/数据挖掘/未成年人Key words
growth hormone/FAERS/adverse drug reactions/data mining/minors分类
医药卫生引用本文复制引用
杜雪亭,高玲娜,朱小丽,韩强,孟佳,王伟美,马红芳..基于不良事件报告系统数据库对未成年人使用生长激素类制剂的不良反应评价[J].中国临床药理学杂志,2025,41(15):2177-2182,6.基金项目
河北省2025年度医学科学研究课题计划(20251614) （20251614）
