[1]姚 惠,胡一鸣,王书第,等.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.[doi:10.3969/j.issn.1006-1959.2025.20.005]
　YAO Hui,HU Yiming,WANG Shudi,et al.Mining and Analysis of ADE Signals of Chemotherapy-related Paronychia Basedon American FAERS Database[J].Journal of Medical Information,2025,38(20):26-31.[doi:10.3969/j.issn.1006-1959.2025.20.005]
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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()

医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
38卷
期数:
2025年20期
页码:
26-31
栏目:
药学信息学
出版日期:
2025-10-15

文章信息/Info

Title:
Mining and Analysis of ADE Signals of Chemotherapy-related Paronychia Basedon American FAERS Database
文章编号:
1006-1959（2025）20-0026-06
作者:
姚 惠1; 胡一鸣1; 王书第1; 昌 翠1; 耿 晶1; 刘玉洁1; 杨小娟2
皖北煤电集团总医院药学部1，临床试验机构办公室2，安徽 宿州 234000
Author(s):
YAO Hui1;  HU Yiming1;  WANG Shudi1;  CHANG Cui1;  GENG Jing1;  LIU Yujie1;  YANG Xiaojuan2
Department of Pharmacy1, Office of Clinical Trial Institution2, Wanbei Coal-electricity Group General Hospital,Suzhou 234000, Anhui, China
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
Keywords:
Chemotherapy-associated paronychia;  Adverse drug event;  FAERS;  Reported odds ratio method;  Proportional ratio method
分类号:
R632.7
DOI:
10.3969/j.issn.1006-1959.2025.20.005
文献标志码:
A
摘要:
目的 基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库，识别诱发化疗相关甲沟炎（CAP）的高风险药物，为临床用药安全监测和CAP的防治提供循证依据。方法 通过建立CAP病例报告的纳入标准，筛选出截至2024年6月30日FAERS数据库收录的甲沟炎相关病例报告，通过报告比值比（ROR）法与比例报告比值（PRR）法进行药物不良事件（ADE）阳性信号的筛选。结果 FAERS数据库共收录3608例甲沟炎病例，其中，1967例符合纳入标准。在性别分布方面，男女比例相当（57.96% vs. 42.04%）；患者年龄主要集中在18~64岁（54.55%），女性平均年龄为（59.30±14.46）岁，男性为（61.02±14.89）岁。数据来源国家主要以日本（34.47%）、美国（15.25%）与法国（6.46%）为主，此外来自于中国的甲沟炎病例报告仅45例（2.29%）。报告的前20种药物中，排名前5位的药物分别为帕尼单抗（n=384）、氟尿嘧啶（n=241）、阿法替尼（n=238）、奥沙利铂（n=215）与西妥昔单抗（n=146）。按信号强度排序，前5位的药物分别为阿法替尼（PRR=394.85，ROR=427.56）、帕尼单抗（PRR=265.12，ROR=278.20）、拉帕替尼（PRR=151.78，ROR=156.70）、左亚叶酸钙（PRR=96.68，ROR=99.02）与奥希替尼（PRR=81.27，ROR=82.66）。其中仅4种药物的说明书中明确收录甲沟炎的药物，分别为帕尼单抗、阿法替尼、厄洛替尼与奥希替尼，1种药物说明书中指明可能存在诱发指甲病变，为曲妥珠单抗。结论 本研究不仅证实了与CAP显著关联的5种药物，还发现氟尿嘧啶、奥沙利铂等药物存在潜在的致CAP风险，为临床安全用药和个体化治疗策略制定提供了重要参考。
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.

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更新日期/Last Update: 1900-01-01