基于FAERS的未成年人使用四环素类药物的安全性评价  

Safety Evaluation of Tetracyclines in Children Based on the FAERS Database

作　　者：周晏曲 费皓天 汪成亮 陈力[1,2,3] ZHOU Yanqu;FEI Haotian;WANG Chengliang;CHEN Li(Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Sichuan University,Ministry of Education,Chengdu 610041,China;Ganzi People's Hospital,Sichuan Province,Ganzi 626000,China)

机构地区：[1]四川大学华西第二医院药学部,成都610041 [2]四川大学华西第二医院循证药学中心,成都610041 [3]四川大学华西第二医院出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [4]四川省甘孜州人民医院,甘孜626000

出　　处：《医药导报》2025年第5期801-811,共11页Herald of Medicine

摘　　要：目的检测<18岁人群使用四环素类代表性药物(四环素、米诺环素、替加环素及多西环素)的不良反应(ADR)信号,为临床安全用药提供参考。方法收集美国食品药品管理局(FDA)不良反应报告系统(FAERS)中2015年第一季度至2023年第二季度共34个季度4种四环素类药物相关药品不良反应事件(ADE)报告数据,按照年龄分组,采用报告比值比法(ROR)和综合标准法(MHRA)进行信号挖掘。结果FAERS数据库共检索到<18岁所有未成年人的报告367461份,四环素、米诺环素、替加环素及多西环素相关报告分别为43、583、40、501份;去重后共检出ADE信号280个,累及系统器官分类(SOC)22个。四环素集中在胃肠系统、各类神经系统疾病等;米诺环素集中在肝胆系统、内分泌系统、皮下及皮下组织类疾病等;替加环素集中在胃肠系统、全身性疾病及给药部位各种反应疾病等;多西环素集中在胃肠系统、精神病类、皮肤及皮下组织类疾病等。精神病类SOC在不良反应中均未累及。其中说明书未收录的不良反应包括米诺环素所致的失明、视神经乳头水肿;替加环素所致的高三酰甘油血症、急性胰腺炎;多西环素所致的贝尔氏麻痹、生长迟缓、失明、抑郁、自杀想法和焦虑。结论不同未成年人年龄分组中,4种四环素类药物之间ADR具有一定差异性,所有未成年使用四环素类药物需严格监查ADR,在关注该类药物对儿童牙齿和骨骼影响的同时,还应警惕其他ADE,如雅里希-赫克斯海默反应、痤疮、甲状腺炎、头痛等。新发现的累及SOC及ADE可为完善四环素类药物说明书不良反应可提供参考,以保障患者的治疗安全。Objective To detect the adverse drug reaction(ADR)signals of tetracycline representative drugs(tetracycline,minocycline,tigecycline,and doxycycline)in children,and to provide reference for safe clinical medication.Methods A total of 34 quarters of ADE report data related to four tetracyclines from the first quarter of 2015 to the second quarter of 2023 in the US FDA Adverse Event Reporting System(FAERS)were collected and grouped according to the age of minor children.The report odds ratio(ROR)method and the comprehensive standard method(MHRA)were used for signal mining.Results A total of 367461 reports were retrieved from the FAERS database for all minor children under 18 years old.There were 43,583,40 and 501 reports related to tetracycline,minocycline,tigecycline and doxycycline,respectively.A total of 280 ADE signals were detected after deduplication,involving 22 system organ classifications.Tetracycline was concentrated in the gastrointestinal system and various nervous systems.Minocycline was mainly in the hepatobiliary system,endocrine system,and subcutaneous and subcutaneous tissue diseases.Tigecycline was involved in the gastrointestinal system,systemic diseases and various reactive diseases at the administration site,Doxycycline was concentrated in the gastrointestinal system,mental illness,skin and subcutaneous tissue diseases.And it was found that psychosis was not involved in adverse reactions.Adverse reactions not included in the instructions include blindness and papilledema caused by minocycline,hypertriglyceridemia and acute pancreatitis caused by tigecycline,Bell's palsy,growth retardation,blindness,depression,suicidal thoughts and anxiety caused by doxycycline.Conclusions In different age groups of minor children,there are some differences in ADR among the four tetracycline drugs.ADR should be strictly monitored when using tetracycline drugs in all children.While paying attention to the effects of these drugs on children's teeth and bones,other ADE should also be vigilant,such as Jarisch-Herxhei

关 键 词：四环素 米诺环素 替加环素 多西环素 不良反应信号 美国食品药品管理局不良反应报告系统 

分 类 号：R978.14[医药卫生—药品] R969.3[医药卫生—药学]