基于美国FAERS数据库的多黏菌素E相关药品不良事件信号挖掘研究

Signal Mining of Polycolistin E-Related Adverse Drug Events Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database

目的:挖掘多黏菌素E的药品不良事件(ADE)信号,识别出潜在的不良反应,为临床合理用药提供依据。方法:采用比例失衡法(ROR),对美国食品药品监督管理局不良事件报告系统(FAERS)数据库中2013年10月1日至2023年10月1日的所有多黏菌素E相关ADE报告进行信号挖掘。分析报告病例的基本情况;映射得到对应的系统器官分类(SOC),并与药品说明书记录的不良反应进行对比;对不同适应证患者的首选术语(PT)进行分析。结果:共检索得到的1432例次报告事项,挖掘到140个以多黏菌素E为怀疑药物的ADE信号。其中涉及21种SOC,主要为全身性疾病及给药部位各种反应(381例次,占26.61%),其次为肾脏及泌尿系统疾病(168例次,占11.73%)和呼吸系统、胸及纵隔疾病(125例次,占8.73%)。报告例次数排序靠前的ADE信号涉及耐药、急性肾损伤、病原体耐药等PT,多器官功能不全综合征、囊性纤维化等PT未被药品说明书收录;信号强度排序靠前的ADE信号涉及胆石性肠梗阻、巴特综合征、非血小板减少性紫癜等PT,且上述3种PT均未被药品说明书收录。结论:对基于美国FAERS数据库的多黏菌素E相关ADE信号进行挖掘和评价,可为临床安全用药提供依据。

OBJECTIVE:To explore the signal of adverse drug event(ADE)of polycolistin E and identify potential adverse drug reactions,so as to provide evidence for clinical rational drug use.METHODS:The signal mining of all ADE reports of polymyxin E from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from Oct.1st,2013 to Oct.1st,2023 was performed by using the ratio imbalance method(ROR).The basic situation of reported cases was analyzed.Systematic organ classification(SOC)was mapped and compared with the adverse drug reactions recorded in the drug instructions.The preferred language(PT)of patients with different indications was analyzed.RESULTS:A total of 1432 reported items were retrieved,and 140 ADE signals suspected of using polymyxin E as a drug were identified.There were 21 kinds of SOC involved,mainly systemic diseases and various reactions at the administration site(381 cases,26.61%),followed by kidney and urinary system diseases(168 cases,11.73%),respiratory system,chest and mediastinum diseases(125 cases,8.73%).The ADE signals with the highest ranking of reported cases included drug resistance,acute kidney injury,pathogen resistance and other PT,while multiple organ dysfunction syndrome,cystic fibrosis and other PT were not included in the drug instructions.The ADE signals with the highest signal intensity included gallstone intestinal obstruction,Bartell syndrome,non-thrombocytopenic purpura and other PT,and the above three PT were not included in the drug instructions.CONCLUSIONS:The mining and evaluation of polycolistin E-related ADE signals based on the FAERS database can provide basis for clinical safety of drug use.