基于FAERS数据库的氟尿嘧啶和卡培他滨不良事件信号挖掘研究

Research on signal mining of fluorouracil and capecitabine adverse events based on FAERS database

摘要:

目的 挖掘氟尿嘧啶和卡培他滨的药物不良事件（ADE）信号，为安全用药提供参考。方法 提取FAERS数据库2017年第1季度至2021年第3季度共19个季度内上述药物的不良反应报告数据，采用报告比值比法（ROR）和综合标准法（MHRA）进行信号挖掘。结果 去重后共检出654个ADE信号，累及27个系统器官分类，其中氟尿嘧啶的ADE信号主要集中在血液及淋巴系统疾病、全身性疾病及给药部位各种反应、胃肠系统疾病和各类神经系统疾病等；卡培他滨的ADE信号主要集中在胃肠系统疾病、皮肤及皮下组织类疾病、全身性疾病及给药部位各种反应和血液及淋巴系统疾病等。在消化系统毒性方面，两种药物均显示出较强的相关性，区别在于氟尿嘧啶与血液系统毒性、心脏相关毒性关联性更强，而卡培他滨与皮肤相关毒性关联性更强。结论 检出的氟尿嘧啶和卡培他滨ADE信号中，大多数与药品说明书重合性较好，证明了本研究的可靠性。本研究还发现了药品说明书未记载的ADE，可供临床参考。

Abstract:

Objective To mine the adverse drug events (ADE) signals of fluorouracil and capecitabine to provide reference for safe medication.Methods The reports of the above-mentioned drugs in the 19 quarters from the first quarter of 2017 to the third quarter of 2021 were extracted from the FAERS database. The reporting odds ratio (ROR) and the medicines and healthcare products regulatory agency (MHRA) methods were used to mine the signals.Results After deduplication, 654 ADE signals were detected, involving 27 system organ classes. Among them, the ADE signals of fluorouracil were mainly concentrated in blood and lymphatic system diseases, systemic diseases and various reactions at the administration site, gastrointestinal system diseases and diseases of the nervous system. The ADE signals of capecitabine were mainly focused on gastrointestinal system diseases, skin and subcutaneous tissue diseases, systemic diseases and various reactions at the administration site, and blood and lymphatic system diseases. In terms of digestive system toxicity, both drugs showed strong correlations. The difference was that fluorouracil was more strongly associated with cardiac-related toxicity and hematological toxicity, while capecitabine was more strongly associated with skin-related toxicity.Conclusion Most of the detected signals have good coincidence with the drug instructions, which proves the reliability of the research. At the same time, adverse events that do not appear in the drug instructions are also found for clinical reference.