摘要
目的:挖掘与分析布格替尼潜在的药品不良反应信号,为临床安全用药提供参考。方法:基于美国FDA不良事件报告系统(FAERS),提取布格替尼自美国上市至2023年第二季度的药品不良事件(ADE)数据,采用比例失衡法对提取数据进行统计分析,筛选出符合判定条件的有效ADE信号,与药品说明书中记载的不良反应进行对比,并结合文献个案报道,挖掘未被记录的潜在药品不良反应。结果:共提取以布格替尼为主要怀疑对象的ADE报告2521份,女性所占比例(49.35%)高于男性所占比例(38.52%),年龄主要分布于41~65岁(29.27%)和大于65岁(21.98%),报告年份以2018年以后为主,呈逐年递增趋势,上报国家以美国为主(49.66%)。共挖掘到72个有效ADE信号,其中腹泻、恶心、血肌酸磷酸激酶升高、咳嗽的报告频次较高,与说明书记录一致。结论:该研究在布格替尼药品说明书的基础上挖掘到34个新的潜在不良反应,并提示了超说明书用药和剂量调整的注意事项,保障了患者用药安全。
OBJECTIVE To provide clinical safety supports for brigatinib through mining its potential adverse drug reaction signals.METHODS Based upon the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS),adverse drug event(ADE)data of brigatinib were retrieved from the listing date to the second quarter in 2023.Proportional imbalance method was utilized for examining the extracted data.The potential adverse drug reaction signals were identified along with ADEs in package insert and case reports in the literature.RESULTS A total of 2521 ADE reports related to brigatinib as a primary suspect drug were extracted.There was a higher proportion of females(49.35%)than males(38.52%).The age groups were distributed between 41 to 65 years(29.27%)and over 65 years(21.98%).The reporting years were largely clustered after 2018.There was a yearly rising trend and the major reporting country was United States(49.66%).A total of 72 effective ADE signals were identified.Diarrhea,nausea,elevation of blood creatine phosphokinase and cough were frequent.It was consistent with the descriptions of package insert.CONCLUSION This study has identified 34 new potential ADEs based upon package insert of brigatinib.It offers suggestions for off-label usage and dosage adjustments to ensure patient safety.
作者
臧美彤
孟帅
张洁
宋晓坤
ZANG Meitong;MENG Shuai;ZHANG Jie;SONG Xiaokun(Department of Pharmacy,Tianjin Medical University Cancer Institute&Hospital,National Clinical Research Center for Cancer,Tianjin Municipal Clinical Research Center for Cancer,Tianjin Municipal Key Laboratory of Cancer Prevention&Therapy,Tianjin 300060,China)
出处
《中国医院药学杂志》
CAS
北大核心
2024年第15期1790-1794,共5页
Chinese Journal of Hospital Pharmacy
基金
天津市教委科研计划项目(编号:2019KJ187)
天津市医学重点学科(专科)建设项目(编号:TJYXZDXK-009A)
天津医科大学肿瘤医院药检放专项基金(编号:Y2212)。
