基于FAERS的多粘菌素B安全信号挖掘研究

目的:基于美国FDA不良事件报告系统(FAERS),对多粘菌素B的不良事件进行挖掘,为临床安全使用多粘菌素B提供参考.方法:下载2004年1季度至2019年4季度一共64季度的FAERS数据,经过MedEx药品名称标准化、MedDRA不良事件系统分类等数据清洗后,提取多粘菌素B相关不良事件,采用报告比值比法(ROR)和...

Data mining and safety analysis of polymyxin B based upon FAERS

OBJECTIVE To detect and analyze the adverse events of polymyxin B by FDA’s adverse event reporting system(FAERS) to provide rationales for its safe clinical dosing.METHODS A total of 64 quarters of FAERS data were downloaded from 2004 Q1 to 2019 Q4 and polymyxin B-related adverse events extracted after data cleaning of MedEx drug name standardization and MedDRA adverse event system classification.And signal detection was conducted by odds ratio(ROR) and proportional reporting ratio(PRR). RESULTS A total of 947 cases of polymyxin B adverse events were recorded,including 4 042 reported items.The ratio of male-to-female with adverse events was 0.8 and the median age 48 years.The US,Japan and Brazil were top three countries with the most reported cases.A total of 188 identical adverse event signals were detected,including 1 889 reported items.Examination,infections,invasive diseases,blood and lymphatic diseases,ophthalmic diseases and gastrointestinal diseases were the most frequently reported.And ADE detection signals were strongest in engraftment syndrome,engraft failure and hepatic vein occlusion. CONCLUSION During the dosing of polymyxin B,close attention should be paid to the occurrence of coagulation dysfunction,secondary infection and respiratory paralysis.And patients with hematological diseases and transplantation should also be closely watched for drug safety.