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
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1.成都市金牛区人民医院西药剂科;2.四川大学华西第二医院药学部/循证药学中心;3.云南省第一人民医院/昆明理工大学附属医院药学部

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Research on signal mining of fluorouracil and capecitabine adverse events based on FAERS database
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Sichuan Provincial People''s Hospital Jinniu Hospital

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    摘要:

    目的:通过挖掘氟尿嘧啶和卡培他滨进行药物不良事件(Adverse Drug Events,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个季度中上述药物的报告,运用报告比值法(ROR法)和综合标准法(MHRA法)联合检验,再利用MedDRA术语集汉化及系统器官归类对结果标准化。结果:去重后检出信号654个,累及系统器官27个,其中氟尿嘧啶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,两种药物都显示出较强的相关性。区别在于氟尿嘧啶跟血液系统毒性、心脏相关毒性关联性更强,而卡培他滨跟皮肤相关毒性关联性更强。结论:检出信号与药品说明书大多数重合性较好,证明了研究方法的可靠性,同时还发现了说明书未出现的不良事件供临床参考。

    Abstract:

    Objective The Adverse Drug Events (ADE) signals of fluorouracil and capecitabine were mined 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, and the reported ratio method (ROR method) and the comprehensive standard method (MHRA method) were used to jointly test, and then use the MedDRA terminology set Chinese and System organ classification standardized the results.Results After deduplication, 654 ADE signals were detected, involving 27 system organs. Among them, fluorouracil was mainly concentrated in blood and lymphatic system diseases, systemic diseases and various reactions at the administration site, gastrointestinal system diseases and various nervous system diseases. Capecitabine mainly focuses 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 is that fluorouracil is more strongly associated with cardiac-related toxicity and hematological toxicity, while capecitabine is 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 method. At the same time, adverse events that do not appear in the instructions are also found for clinical reference.

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  • 收稿日期:2022-05-05
  • 最后修改日期:2022-10-20
  • 录用日期:2022-07-19
  • 在线发布日期: 2022-11-09
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