基于FAERS数据库的艾曲波帕药物不良事件信号挖掘研究

Research on Signal Mining of Eltrombopag Adverse Events Based on FAERS Database

摘要: 目的：通过挖掘美国食品药品监督管理局不良事件呈报系统(FDA adverse event reporting system, FAERS)数据库中关于艾曲波帕(ETP)的相关数据，探讨该药潜在的不良反应，为临床安全用药提供依据。方法：提取FAERS数据库2017年第1季度至2022年第4季度共24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化。结果：共检出21,666次以ETP为首的不良事件(ADE)报告，检测得到18,761个有效ADE信号，共累及27个不同系统器官(SOC)，主要集中在各类检查、全身性疾病及给药部位各种反应、胃肠系统疾病等。结论：临床应用ETP药物时需监测患者血小板变化情况，密切监护患者生命体征；具有骨髓网状纤维化等相关基础疾病的患者需加强评估，以保证临床合理用药。

Abstract: Objective: To explore the potential adverse reactions of eltrombopag by (ETP) mining the FDA adverse event reporting system (FAERS) database to provide evidence for the safe use of these drugs in clinical settings. Methods: The reports of the above-mentioned drugs in the 24 quarters from the first quarter of 2017 to the fourth quarter of 2022 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: Totally 21,666 ADE with ETP as the primary suspected drug were retrieved as the original data. A total of 18,761 ADE signals were obtained from the ETP. The signals involved 27 different system organs (SOC). The ADEs of different ETP was mainly involved in “various types of tests”, “systemic disease and various reactions at the site of administration” and “gastrointestinal diseases”. Conclusion: The clinical use of ETP requires monitoring of blood and the vital signs of patients were closely monitored, white blood cell counts, ptients with underlying diseases such as myeloreticular fibrosis need to be evaluated to ensure rational drug use.