基于FAERS数据库对超声造影剂注射用六氟化硫微泡上市后药品不良事件的信号挖掘  

Signal mining of post-marketing adverse drug events for the ultrasound contrast agent sulphur hexafluoride based on the FAERS database

作　　者：林娴 陈雪松 刘丽娟 任冉 徐晓红 LIN Xian;CHEN Xuesong;LIU Lijuan;REN Ran;XU Xiaohong(Department of Ultrasound Medicine,Affiliated Hospital of Guangdong Medical University,Guangdong 524001,China)

机构地区：[1]广东医科大学附属医院超声医学科,广东省湛江市524001

出　　处：《临床超声医学杂志》2024年第8期668-672,共5页Journal of Clinical Ultrasound in Medicine

基　　金：广东省医学科学技术研究基金项目(B2021148);湛江市非资助课题(200722114920577)。

摘　　要：目的基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库进行分析,挖掘超声造影剂注射用六氟化硫微泡的药品不良事件(ADE)信号,为临床安全用药提供参考。方法提取2015~2023年FAERS数据库所有上报的注射用六氟化硫微泡相关ADE报告,采用报告比值比(ROR)法、比例报告比值比(PRR)法、贝叶斯置信度置信递进神经网络法(BCPNN)和经验贝叶斯几何平均数(EBGM)算法对ADE进行分析,并挖掘其说明书未标注的ADE。结果共提取12178164份来自FAERS数据库的ADE报告,其中注射用六氟化硫微泡被确定为主要可疑药品的ADE报告为1079份。患者性别以男性为主(56.35%),上报国籍以美国为主(86.28%)。导致的ADE主要针对16个系统/器官分类,以各类神经系统疾病、全身性疾病及给药部位各种反应、呼吸系统、免疫系统疾病及心脏器官疾病为主,ADE风险信号与药品说明书基本一致。同时挖掘到了说明书未收录的不良反应,包括眼器官疾病、肾脏及泌尿系统疾病、耳及迷路类疾病、感染及侵染类疾病(ROR=0.61、0.36、0.72、0.03),但高风险信号均较低。严重ADE结局多为危及生命(23.2%)及住院治疗(23.04%),存在4.69%的死亡ADE报告情况。结论超声造影剂注射用六氟化硫微泡较为安全,实际应用存在部分说明书未收录的不良反应,建议临床实际应用过程中应严格把握禁忌证、注意事项及加强监护。Objective To conduct an analysis based on the U.S.food and drug administration adverse event reporting system(FAERS)to mine the adverse drug event signals of the ultrasound contrast agent sulphur hexafluoride,and to provide the reference for safe clinical use.Methods All reported sulphur hexafluoride adverse drug event reports(ADE)from 2015 to 2023 in the FAERS database were extracted,and the ADE were analyzed by the report-to-ratio(ROR)method,the proportionate report-to-ratio(PRR)method,the Bayesian confidence propagation neural network(BCPNN)method,the empirical Bayesian geometric mean(EBGM)algorithm,and the ADE that not labelled in the instructions were explored.Results A total of 12178164 ADE from the FAERS database were extracted.Of these ADE,sulphur hexafluoride was identified as the main suspected drug in 1079 ADE.Patient gender was predominantly male(56.35%)and reported nationality was predominantly American(86.28%).The resulting ADE were mainly for 16 system-organ classifications,with various neurological disorders,systemic disorders and various reactions at the site of administration,respiratory system,immune system disorders,and cardiac organ disorders being the main ones,and the ADE risk signals were generally consistent with the drug instructions.While adverse reactions not included in the instructions were extracted,including eye organ diseases,renal and urinary system diseases,ear and labyrinthine disorders and infections and invasive diseases(ROR=0.61,0.36,0.72,0.03),but the high risk signals were low.Severe ADE outcomes were mostly life-threatening(23.2%)and hospitalisation(23.04%),and there were 4.69% of fatal ADE.Conclusion Contrast agent sulphur hexafluoride is relatively safe,and the actual application of some of the instructions are not included in the adverse reactions,and it is recommended that contraindications,precautions,and supervision should be strictly grasped in the process of actual clinical application.

关 键 词：注射用六氟化硫微泡 FAERS数据库 药品不良事件 

分 类 号：R954[医药卫生—药学]