医学信息2025，Vol.38Issue(20)：26-31,6.DOI:10.3969/j.issn.1006-1959.2025.20.005
基于美国FAERS数据库的化疗相关甲沟炎ADE信号的挖掘与分析
Mining and Analysis of ADE Signals of Chemotherapy-related Paronychia Based on American FAERS Database
摘要
Abstract
Objective To identify high-risk drugs that induce chemotherapy-related paronychia(CAP)based on the Food and Drug Administration Adverse Event Reporting System(FAERS)database,and to provide evidence-based basis for clinical drug safety monitoring and CAP prevention and treatment.Methods By establishing the inclusion criteria of CAP case reports,the reports of paronychia related cases included in the FAERS database as of June 30,2024 were screened out,and the positive signals of ADE were screened by the methods of reporting odds ratio(ROR)and proportional reporting ratio(PRR).Results A total of 3608 cases of paronychia were included in the FAERS database,of which 1967 cases met the inclusion criteria.In terms of gender distribution,the proportion of men and women was similar(57.96%vs.42.04%);the age of patients was mainly concentrated in 18-64 years old(54.55%).The average age of women was(59.30±14.46)years old,and that of men was(61.02±14.89)years old.The data sources were mainly from Japan(34.47%),the United States(15.25%)and France(6.46%).In addition,only 45 cases(2.29%)of paronychia cases were reported from China.Among the top 20 drugs reported,the top five drugs were panitumumab(n=384),fluorouracil(n=241),afatinib(n=238),oxaliplatin(n=215)and cetuximab(n=146).According to the signal intensity,the top five drugs were afatinib(PRR=394.85,ROR=427.56),panitumumab(PRR=265.12,ROR=278.20),lapatinib(PRR=151.78,ROR=156.70),calcium levofolinate(PRR=96.68,ROR=99.02)and osimertinib(PRR=81.27,ROR=82.66).Among them,only the instructions of 4 drugs clearly included the drugs for paronychia,which were panitumumab,afatinib,erlotinib and osimertinib,respectively.One drug instruction indicated that there may be induced nail lesions,which was trastuzumab.Conclusion This study not only confirmed five drugs with significant associations to CAP,but also identified previously unreported CAP risks associated with fluorouracil,oxaliplatin and other agents,providing critical evidence for clinical medication safety and personalized treatment strategies.关键词
化疗相关甲沟炎/药物不良事件/FAERS/报告比值比法/比例报告比值法Key words
Chemotherapy-associated paronychia/Adverse drug event/FAERS/Reported odds ratio method/Proportional ratio method分类
医药卫生引用本文复制引用
姚惠,胡一鸣,王书第,昌翠,耿晶,刘玉洁,杨小娟..基于美国FAERS数据库的化疗相关甲沟炎ADE信号的挖掘与分析[J].医学信息,2025,38(20):26-31,6.基金项目
宿州市卫生健康委科研项目(编号:SZWJ2024a051) （编号:SZWJ2024a051）
