基于数据挖掘法分析3种超声造影剂不良反应信号  

Analysis of adverse reaction signals of three ultrasound contrast agents(Optison,Definity,and Lumason)using a data mining method

作　　者：宋勇 李东炫 王翔 李锐 Song Yong;Li Dongxuan;Wang Xiang;Li Rui(Department of Ultrasound,the Third Affliated Hospital of Chongqing Medical University,Chongqing 401120,China;Department of Pharmacy,the Third Affliated Hospital of Chongqing Medical University,Chongqing 401120,China)

机构地区：[1]重庆医科大学附属第三医院超声科,401120 [2]重庆医科大学附属第三医院药剂科,401120

出　　处：《中华医学超声杂志（电子版）》2024年第9期890-898,共9页Chinese Journal of Medical Ultrasound(Electronic Edition)

摘　　要：目的对3种超声造影剂(Optison、Definity、Lumason)的不良反应事件(ADE)进行分析和总结,为优化临床实践提供参考信息。方法提取美国食品药品监督管理局不良反应事件呈报系统(FARES)中26004年1月1日至2022年12月31日间有关Optison、Definity、Lumason的ADE报告,获取报告的基本特征。同时,应用报告比值比(ROR)法和英国药品和保健品管理局(MHRA)综合标准法对3种超声造影剂进行首选术语层级和标准MedDRA分析查询(SMQ)层级的药品不良反应(ADR)信号检测,评估其安全性。结果FAERS数据库中包含3种超声造影剂相关ADR报告1661份,其中Optison、Definity和Lumason相关ADE报告分别为31份、1523份和107份。总体来看,ADE报告中男性患者(811份)多于女性患者(693份),患者年龄集中在45岁及以上者(994份),而Lumason的死亡病例报告占比最高(8.41%)。在ADR信号检测中,Optison 1个首选术语、5个SMQ检测出阳性信号;Definity 58个首选术语、10个SMQ检测出阳性信号;Lumason 37个首选术语、10个SMQ检测出阳性信号。在首选术语层级ADR信号检测中,Definity检测到了3个(晕厥前期、发绀、刺激反应消失)说明书未记录的新信号,Lumason检测到了8个(苍白、晕厥前期、多汗、灼烧感、肺水肿、感觉热、肺栓塞、产品复溶质量问题)说明书未记录的新信号。在SMQ层级ADR检测结果提示,过敏反应相关疾病及休克病症是超声造影剂所共有的风险特性。结论3种超声造影剂均存在潜在的ADR风险,且不良反应症状之间存在共性与差异性。医务人员在超声造影检查中应严密监测患者,及时处置发生的ADR,保障患者医疗安全。Objective To analyze and summarize the adverse reactions associated with three ultrasound contrast agents(Optison,Definity,and Lumason),in order to provide reference information for optimizing clinical practice.Methods Adverse event(ADE)reports on Optison,Definity,and Lumason from January 1,2004 to December 31,2022 were extracted from the FDA Adverse Event Report System(FAERS),and the basic characteristics of the reports were obtained.The reporting odds ratio(ROR)method and the UK Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive standard method were used to detect the adverse drug reaction(ADR)signals at the preferred term(PT)level and the standard MedDRA query(SMQ)level to evaluate the safety of the three ultrasound contrast agents.Results The FAERS database contained 1661 ADR reports related to the three ultrasound contrast agents,with 31,1523,and 107 ADE reports related to Optison,Definity,and Lumason,respectively.Overall,there were more male patients(811)than female patients(693)in ADE reports,the main age group was 45 years and older(994),and Lumason had the highest percentage of fatal case reports(8.41%).In ADR signal detection,positive signals were detected in 1 PT and 5 SMQs for Optison,in 58 PTs and 10 SMQs for Definity,and in 37 PTs and 10 SMQs for Lumason.In the PT level ADR signal detection,3 new signals(pre-syncope,cyanosis,and loss of stimulus response)which were not recorded in the label were detected for Definity,and 8 new signals(pallor,pre-syncope,hyperhidrosis,burning sensation,pulmonary edema,heat sensation,pulmonary embolism,and product reconstitution quality problems)were detected for Lumason.The results of ADR detection at the SMQ level suggested that anaphylactic reaction-related diseases and shock disorders were risk characteristics shared by ultrasound contrast agents.Conclusion All three ultrasound contrast agents have potential ADR risks,and there are commonalities and differences among their ADR symptoms.Medical personnel should closely monitor patients during ul

关 键 词：超声造影剂 药物警戒 药物不良反应 数据挖掘 

分 类 号：R445.1[医药卫生—影像医学与核医学]