基于FAERS数据库维奈克拉不良事件信号挖掘  

Adverse event signals mining for venetoclax based on FDA Adverse Event Reporting System (FAERS)

作　　者：周洁 张晋萍 汪思亮[1,2] 刘梦颖 ZHOU Jie;ZHANG Jinping;WANG Siliang;LIU Mengying(Department of Pharmacy,Nanjing Drum Tower Hospital,School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Jiangsu Nanjing 210008,China;Department of Pharmacy,Nanjing Drum Tower Hospital Affiliated with Medical School of Nanjing University,Jiangsu Nanjing 210008,China)

机构地区：[1]南京鼓楼医院药学部,中国药科大学基础医学与临床药学学院,江苏南京210008 [2]南京大学医学院附属鼓楼医院药学部,江苏南京210008

出　　处：《中国医院药学杂志》2023年第23期2675-2679,2714,共6页Chinese Journal of Hospital Pharmacy

基　　金：南京鼓楼医院临床研究专项资金项目(编号:2022-LCYJ-PY-48);江苏省研究型医院学会精益化用药科研基金项目(编号:JY202113)。

摘　　要：目的:利用美国食品药品监督管理局不良事件报告系统(FAERS)数据库,分析维奈克拉(VEN)药物不良事件(ADE)的发生情况,为临床安全用药提供参考。方法:下载FAERS数据库2016年4月1日至2022年6月30日的数据,使用报告比值比法(ROR)、比例报告比值比法(PRR)以及综合标准法(MHRA)对VEN相关不良事件进行分析和风险信号监测。结果:共提取到19 177例以VEN为主要怀疑药物的病例。去除与药物无关和受原发病影响的ADE后,得到59个阳性ADE信号,涉及9个系统器官分类(SOC),报告量最多的SOC为全身性疾病及给药部位各种反应、各类检查、感染及侵染类疾病及血液及淋巴系统疾病。信号强度最高的ADE为肿瘤溶解综合征(TLS),还发现房颤、肺水肿、耳聋等未记录在VEN药品说明书中的ADE信号。结论:在VEN使用过程中,应密切关注患者TLS、血液系统疾病、感染等事件的发生,警惕说明书未提及的ADE信号,及时采取防治措施,降低临床用药风险。OBJECTIVE To evaluate the adverse drug event(ADE) of venetoclax(VEN) based on the FDA Adverse Event Reporting System(FAERS) database,so as to provide reference for the clinical use of VEN.METHODS Information in the FAERS database from April 1,2016 to June 30,2022 was downloaded.Reporting odds ratios(ROR),proportional reporting ratios(PRR),and medicines and healthcare products regulatory agency(MHRA) were used to detect the risk signals of VEN.RESULTS A total of 19 177 cases listing VEN as the primary suspect drug was recorded.After removing ADE unrelated to the target drug and affected by the primary disease,we obtained 59 positive ADE signals involving nine system organ class(SOC).The SOC with the largest reported amount were various reactions of systemic diseases and administration sites,all kinds of tests,infection and infestation diseases,and blood and lymphatic system diseases.The ADE with the highest signal intensity was the tumor lysis syndrome(TLS).The ADE signals of atrial fibrillation,pulmonary edema and deafness were not recorded in the VEN drug instructions.CONCLUSION During the use of VEN,close attention should be paid to the TLS,blood system diseases,and infections.We also should be alert for the occurrence of ADE signals not mentioned in the drug instructions,take preventive and treatment measures in time in order to lower clinical drug-induced risks.

关 键 词：维奈克拉 B细胞淋巴瘤因子-2抑制剂 FAERS 不良事件 

分 类 号：R979.1[医药卫生—药品]