基于FAERS数据库的蒽环类药物不良事件信号挖掘研究

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（FAERS）数据库中关于蒽环类药物（多柔比星、多柔比星脂质体，表柔比星、伊达比星、柔红霉素、米托蒽醌）的相关数据，探讨该药潜在的不良反应（ADR），为临床安全用药提供依据。方法 提取FAERS数据库中2017年第一季度至2021年第四季度共20个季度6种蒽环类药物的不良事件（ADE）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 共得到16 334例次以6种蒽环类药物为首要怀疑药物的ADE报告，检测得到1 654个有效ADR信号。其中，多柔比星（非脂质体，DOX）有效信号637个，多柔比星脂质体（PLD）有效信号441个，表柔比星（EPC）有效信号247个，柔红霉素（DAC）有效信号183个，伊达比星（IDC）有效信号87个，米托蒽醌（MT）有效信号59个。信号累及23个不同的系统器官分类（SOC），不同蒽环类药物的ADE主要累及血液及淋巴系统疾病、感染及侵染类疾病、心脏器官疾病等SOC。结论 蒽环类药物常见ADR累及的主要系统具有差异性，且不同药物之间与各系统ADR的关联强度不同。临床应用蒽环类药物时需关注血液及淋巴系统、心脏器官系统及神经系统相关指标的监测，以保证临床合理用药。

Signal mining of anthracyclines adverse events based on FAERS database

Objective To explore the potential adverse reactions of anthracyclines (doxorubicin, DOX; doxorubicin liposomal, PLD;epirubicin, EPC; idarubicin, IDC; daunorubicin, DAC; mitoxantrone, MT) by mining the FDA adverse event reporting system (FAERS) database to provide evidence for the safe use of these drugs in clinical settings.Methods Signal mining was performed by extracting adverse drug event (ADE) data for 6 anthracyclines from the FAERS database for a total of 20 quarters from the first quarter of 2017 to the fourth quarter of 2021 and by using the reporting odds ratio (ROR) and the medicines and healthcare products regulatory agency (MHRA) methods.Results Totally 16 334 ADEs with anthracyclines as the primary suspected drugs were retrieved as the original data. A total of 1 654 ADE signals were obtained from the 6 anthracyclines, including 637 from DOX, 441 from PLD, 247 from EPC, 183 from DAC, 87 from IDC and 59 from MT. The signals involved 23 different system organ classes (SOCs). The ADEs of different anthracyclines were mainly involved in the SOCs like blood and lymphatic disorders, infectious and invasive diseases and cardiac disorders.Conclusion There were differences in the major systems involved in the common ADEs of anthracyclines.The association intensity between different drugs and adverse reactions of each system were also different. Clinical application of anthracyclines requires monitoring the related indicators of blood and lymphatic system, heart organ system and nervous system to ensure rational medication.