基于FAERS的伊马替尼相关皮肤不良反应信号挖掘与分析

doi:10.3969/j.issn.2095-1264.2024.05.16

首页 > 过刊浏览>2024年第5期 >621-626. DOI:10.3969/j.issn.2095-1264.2024.05.16

基于FAERS的伊马替尼相关皮肤不良反应信号挖掘与分析
DOI:
                        10.3969/j.issn.2095-1264.2024.05.16
                    
作者:
                        
                        
                    
作者单位:1.重庆医科大学药学院，重庆，400016;2.华中科技大学同济医学院附属协和医院 药学部，湖北 武汉，430022;3.重庆医科大学附属第一医院 药学部，重庆，400016
作者简介:宫竹君，女，硕士研究生，药师，研究方向为临床药学。
通讯作者:袁拥华，女，博士，硕士研究生导师，研究方向为临床药学。
中图分类号:R730.6;R969.3
基金项目:中国药学会医院药学专委会青年人才项目（CPA-Z05-ZC-2021-003）；重庆医科大学“基于一流专业的临床药学实践课程创新团队”（重医大发【2022】26号）。

Signal mining and analysis of imatinib-related cutaneous adverse reactions based on FAERS

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1.College of Pharmacy, Chongqing Medical University, Chongqing, 400016, China;2.Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, Hubei, China;3.Department of Pharmacy, the First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China

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摘要:

目的基于美国FDA不良事件报告系统（FAERS）挖掘并分析伊马替尼相关皮肤不良反应信号，为临床安全用药提供参考。方法利用《国际医学用语词典》（MedDRA）查询系统器官分类（SOC）为皮肤及皮下组织类疾病的首选语（PT），提取数据库中相关病例，数据去重后，采用报告比值比（ROR）法和比例报告比值（PRR）法进行信号检测与分析。结果提取到伊马替尼相关皮肤及皮下组织类疾病的药物不良事件（ADE）报告2 797份，其中，女性患者较多（55.27%），年龄分布以45~64岁为主（24.60%），严重不良结局占28.20%。检出40个可疑ADE信号，其中信号强度较高的有坏死性脂膜炎（n=7， ROR=121.33， 95% CI： 49.47~297.60）、假卟啉症（n=21， ROR=31.21， 95% CI： 19.85~49.08）、皮肤脆弱（n=23， ROR=18.75， 95% CI： 12.28~28.64）、角化不全（n=11， ROR=22.70， 95% CI： 12.26~42.04）、皮肤色素减退（n=22， ROR=11.56， 95% CI： 7.54~17.72）等。此外，本研究还发现了20个说明书中未提及的ADE，包括皮肤脆弱、角化不全、坏疽性脓皮病、坏死性脂膜炎、棘皮症等。结论伊马替尼与较多皮肤不良反应相关，对于说明书未提及的ADE，临床医生在使用时应警惕并及时识别，以保证患者安全用药。

Abstract:

Objective To explore and analyze the signals of imatinib-associated cutaneous adverse drug reactions based on American FDA Adverse Event Reporting System (FAERS), and to provide reference for safe drug use in clinical practice.Methods Using Medical Dictionary for Regulatory Activities (MedDRA) to query the preferred terms (PT) of the system organ classes (SOC) as skin and subcutaneous tissue disorders, and extracting the relevant cases from the FAERS. After deduplication of the data, the signals were detected and analyzed by reporting odds ratio (ROR) method and proportional reporting ratio (PRR) method.Results A total of 2 797 related adverse drug events (ADEs) reports were obtained. Most of them were female patients (55.27%). The age distribution was mainly 45~64 years old (24.60%). Reports with serious adverse outcome accounted for 28.20%. The signal detection results showed that ROR method and PRR method detected 40 suspicious ADE signals at the same time, among which the signals with high intensity were necrotizing panniculitis (n=7, ROR=121.33, 95% CI: 49.47~297.60), pseudoporphyria (n=21, ROR=31.21, 95% CI: 19.85~49.08), skin fragility (n=23, ROR=18.75, 95% CI: 12.28~28.64), parakeratosis (n=11, ROR=22.70, 95% CI: 12.26~42.04), skin hypopigmentation (n=22, ROR=11.56, 95% CI: 7.54~17.72) etc. In addition, 20 ADEs not mentioned on the drug label were found, including skin fragility, parakeratosis, pyoderma gangrenosum, necrotizing panniculitis and acanthosis.Conclusion Imatinib was associated with many skin adverse reactions, and clinicians should be vigilant and timely identify the ADEs not yet mentioned on the drug label when using imatinib, so as to ensure safe medication for patients.