基于FAERS数据库的吡非尼酮不良事件信号挖掘

Adverse drug event signal mining of pirfenidone based on FAERS database

目的挖掘吡非尼酮上市后的不良事件信号,为其临床合理用药提供依据。方法采用报告优势比(ROR)法和比例报告比(PRR)法对美国不良事件报告系统(FAERS)自建库至2021年9月所有的吡非尼酮,药品不良事件(ADE)报告进行数据挖掘分析。结果通过二次筛选共挖掘到105个有效信号,共涉及18个系统器官分类(SOC)。其中,说明书提及的信号64个,涉及的SOC主要包括胃肠道反应、皮肤毒性及神经系统疾病;药品说明书未提及的信号41个,涉及的SOC主要包括呼吸系统、胸及纵隔疾病、各类检查以及眼器官疾病等。结论吡非尼酮临床应用时,应特别注意对肺部及眼部情况监测,关注胃肠道反应,同时尽量减少紫外线暴露。

Objective To explore the adverse drug event(ADE)signals of pirfenidone after marketing and provide new evidence for its safe and rational use in clinic.Methods The reporting odds ratio(ROR)and proportional reporting ratio(PRR)were used to mine and analyze the adverse event reports of pirfenidone from the establishment of FDA Adverse Event Reporting System(FAERS)up to September 2021.Results After secondary screening,105 valid signals were obtained,involving 18 systems(SOC).Of them,64 signals were mentioned in the instructions,SOC involved including gastrointestinal reactions,skin toxicity and nervous system diseases;41 signals were not mentioned in the drug instructions,and SOC involved including respiratory,thoracic and mediastinal disorders,various examination,and eye disorders,etc.Conclusion In the clinical application of pirfenidone,special attention should be paid to the monitoring of the respiratory system,eye disorders and the gastrointestinal reactions.The ultraviolet exposure should be minimized during the use of pirfenidone.