摘要
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)和比例报告比值法(PRR)进行信号检测。结果:共提取到多粘菌素B不良事件报告记录947例,包含4 042个报告事项。发生不良事件的男女比值为0.8,患者中位年龄为48岁。美国、日本和巴西是报告例数最多的前3位国家。检测到不良事件信号188个,包含1 889项事件。各类检查、感染及侵袭类疾病、血液及淋巴系统疾病、眼器官疾病和胃肠系统疾病的报告事项最多。(移植物)植入综合征、(移植物)植入失败、肝静脉闭塞等的ADE信号最强。结论:使用多粘菌素B期间应关注患者的凝血功能、继发性感染和呼吸肌麻痹等不良事件的发生,特别应重视患有血液系统疾病和移植术后的患者,保障患者用药安全。
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.
作者
柏杨
魏春燕
陈昭阳
吴斌
BAI Yang;WEI Chun-yan;Chen Zhao-yang;WU Bin(Department of Pharmacy,West China Hospital,Sichuan University,Sichuan Chengdu 610041,China)
出处
《中国医院药学杂志》
CAS
北大核心
2021年第3期257-263,共7页
Chinese Journal of Hospital Pharmacy
