基于FAERS数据库的地诺孕素不良事件信号挖掘

Mining of dienogest adverse event signal based on FAERS database

目的挖掘美国FDA不良事件报告系统数据库(the FDA adverse event reporting system,FAERS)中地诺孕素上市后安全警戒信号,为临床安全用药提供参考。方法采用比例失衡分析法中的报告比值比法,检索FAERS数据库2004年1季度至2022年1季度收录的地诺孕素相关报告挖掘不良事件信号。利用国际医学用语词典术语集进行汉化及分析查询。结果以地诺孕素为首要怀疑药品的不良事件报告数共检测出790例报告,66个信号。安全信号表现为操作后肺栓塞、小脑卒中、混合性焦虑和抑郁障碍以及斯蒂尔病和静脉栓塞等。主要累及血管与淋巴管类疾病、呼吸系统、胸及纵隔疾病、各类损伤、中毒及操作并发症等系统器官。结论利用挖掘FAERS数据库可较全面深入地分析研究地诺孕素上市后的不良事件,为临床安全合理用药提供依据。临床应用地诺孕素时,应密切关注该药的血管与淋巴管类疾病,尽早采取干预措施,保证患者安全、有效用药。

Objective To explore the safety warning signals of dienogest in the FDA adverse event reporting system(FAERS)and to provide reference for clinical safe drug use.Methods The reports related to dienogest collected from the FAERS database from the first quarter of 2004 to the first quarter of 2022 were searched for adverse event signals by using the reporting odds ratio method in disproportionality analysis.The term set of the International Dictionary of Medical Terms was used for sinicization and analysis.Results The number of adverse event reports with dienogest as the primary suspect drug was 790 reports with 66 signals.The safety signals were pulmonary embolism after operation,cerebellar stroke,mixed anxiety and depression disorder,Steele's disease and venous embolism.It mainly involves vascular and lymphatic diseases,respiratory system,chest and mediastinal diseases,various injuries,poisoning and operational complications.Conclusion The FAERS database can be used to comprehensively analyze and study the adverse events of dienogest after marketing,and provide a basis for safe and rational clinical drug use.When using dienogest in clinic,we should pay close attention to the vascular and lymphatic diseases of the drug,and take intervention measures as soon as possible to ensure the safe and effective use of the drug.