基于FAERS数据库芬戈莫德在多发性硬化患者中的肿瘤风险信号挖掘  

Data mining of cancer risk associated with fingolimod in multiple sclerosis patients:based on FAERS database

作　　者：张千 颜明明 赵晖 邱晓燕 钟明康 Qian ZHANG;Ming-Ming YAN;Hui ZHAO;Xiao-Yan QIU;Ming-Kang ZHONG(Department of Pharmacy,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院药剂科,上海200040

出　　处：《药物流行病学杂志》2023年第9期961-968,共8页Chinese Journal of Pharmacoepidemiology

基　　金：上海市“医苑新星”青年医学人才培养资助计划-临床药师项目[沪卫人事(2021)99]。

摘　　要：目的评估芬戈莫德在多发性硬化患者中潜在的肿瘤风险。方法提取美国食品药品管理局不良事件报告系统(FAERS)数据库2004年第一季度至2022年第四季度数据,采用报告比值比(ROR)法和信息成分(IC)法挖掘芬戈莫德在多发性硬化患者中潜在的肿瘤不良事件信号。结果获得1628例与芬戈莫德治疗多发性硬化患者有关的肿瘤不良事件报告,报告例次数排名前3位的肿瘤类别依次为皮肤和黏膜恶性肿瘤(527例次)、乳腺癌(89例次)和女性生殖器官癌(43例次)。信号分析显示,报告例次数排名前6位的肿瘤依次是基底细胞癌(189例次,ROR=5.67,ROR_(025)=4.91,IC_(025)=2.23)、恶性黑色素瘤(105例次,ROR=3.29,ROR_(025)=2.71,IC_(025)=1.39)、鳞状细胞癌(62例次,ROR=2.91,ROR_(025)=2.27,IC_(025)=1.12)、乳腺浸润性导管癌(53例次,ROR=8.62,ROR_(025)=6.56,IC_(025)=2.46)、皮肤鳞状细胞癌(45例次,ROR=3.58,ROR_(025)=2.67,IC_(025)=1.31)和子宫癌(37例次,ROR=4.09,ROR_(025)=2.96,IC_(025)=1.41)。结论芬戈莫德在多发性硬化患者中有广泛的潜在肿瘤不良事件风险,理解这一现象需要进一步的临床研究来探索,并建议服用芬戈莫德的患者进行皮肤科随访。Objective To evaluate the cancer risk associated with fingolimod for the treatment of multiple sclerosis(MS).Methods Data from the United States Food and Drug Administration Adverse Event Reporting System(FAERS)database from the first quarter of 2004 to the fourth quarter of 2022 were extracted.The reporting odds ratio(ROR)method and information components(IC)method were used to identify the association between fingolimod and potential cancer event reports in multiple sclerosis patients.Results A total of 1628 reports related to fingolimod in the treatment of multiple sclerosis were identified.Skin and mucous membrane cancer(527 items),breast cancer(89 items),and female genital cancer(43 items)were the top three cancers category in terms of report.The analysis showed that basal cell carcinoma(189 items,ROR=5.67,ROR_(025)=4.91,IC_(025)=2.23),malignant melanoma(105 items,ROR=3.29,ROR_(025)=2.71,IC_(025)=1.39),squamous cell carcinoma(62 items,ROR=2.91,ROR_(025)=2.27,IC_(025)=1.12),invasive ductal breast carcinoma(53 items,ROR=8.62,ROR_(025)=6.56,IC_(025)=2.46),cutaneous squamous cell carcinoma(45 items,ROR=3.58,ROR_(025)=2.67,IC_(025)=1.31)and cervix carcinoma(37 items,ROR=4.09,ROR_(025)=2.96,IC_(025)=1.41)were the top six cancer events in terms of report.Conclusion Fingolimod is associated with a much broader scope of potential cancer events in multiple sclerosis patients.Further clinical studies are required to explore a better understanding of this phenomenon,and dermatological follow-up is recommended for patients taking fingolimod.

关 键 词：芬戈莫德 肿瘤 药品不良事件 多发性硬化 FAERS数据库 数据挖掘 药物警戒 

分 类 号：R744.51[医药卫生—神经病学与精神病学] R969[医药卫生—临床医学]