基于美国FAERS数据库多黏菌素B不良事件信号挖掘研究

Research on signal mining of adverse drug events of polymyxin B based on FAERS

摘要:

目的 基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库，挖掘并研究多黏菌素B的药物不良事件（ADE），为临床合理用药提供参考。方法 检索并下载FAERS数据库2004年第一季度至2023年第四季度的数据，筛选出多黏菌素B的ADE报告，采用报告比值比法（ROR）、比例报告比值比法（PRR）和综合标准法（MHRA）对多黏菌素B的ADE报告进行分析研究。结果 FAERS数据库中共收录294份多黏菌素B为首要怀疑药物的ADE，经过筛选，共挖掘出有效信号21个，ADE报告128份，共涉及12个系统器官分类（SOC），报告数量前三位分别为肾脏及泌尿系统疾病、各类神经系统疾病、各类损伤和中毒及操作并发症，信号强度最强的ADE是皮肤色素沉着过度，同时还挖掘出说明书未说明的ADE，如：皮肤色素沉着过度、医院内感染、横纹肌溶解、低钾血症、感染性休克等。结论 在应用多黏菌素B时，要重点关注肾脏及泌尿系统疾病、各类神经系统疾病、各类损伤和中毒及操作并发症、感染及侵染类疾病等ADE，及时采取防治措施，降低临床用药风险。

Abstract:

Objective Based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database in the United States. The aim of this study was to explore and study the adverse events (ADE) of polymyxin B, providing reference for rational clinical medication.Methods Retrieve and download FAERS database data from the first quarter of 2004 to the fourth quarter of 2023, Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and the Medicines And Healthcare Products Regulatory Agency (MHRA) were used to analyze the ADE reports of polymyxin B.Results A total of 294 ADE samples were extracted with polymyxin B as the primary suspected drug. After screening, 21 effective signals were excavated and 128 ADE reports were excavated, involving 12 system organ class (SOC). The top three reported cases were renal and urinary disorders, nervous system disorders, injury, poisoning and procedural complications. The strongest ADE signals were skin hyperpigmentation. It was also found that such ADE as skin hyperpigmentation, nosocomial infection, rhabdomyolysis, hypokalaemia and septic shock, etc., were not mentioned in the manual.Conclusion When using polymyxin B, attention should be paid to ADE such as renal and urinary disorders, nervous system disorders, injury, poisoning and procedural complications, infections and infestations, and timely prevention and control measures should be taken to reduce the risk of clinical use.