基于OpenFDA数据挖掘和分析司美格鲁肽的不良事件报告信号  

Adverse Drug Events Signal Mining and Analysis of Semaglutide Based on OpenFDA

作　　者：郭艳琼 彭晶[1] 李庆德[1] 郑锦坤[1] 何蓉蓉[1] Guo Yanqiong;Peng Jing;Li Qingde;Zheng Jinkun;He Rongrong(Department of Pharmacy,Yuebei People’s Hospital,Guangdong Shaoguan 512025,China)

机构地区：[1]粤北人民医院药学部,广东韶关512025

出　　处：《中国药师》2022年第3期475-478,共4页China Pharmacist

基　　金：广东省中医药局科研项目(编号=20211386);韶关市卫生健康科研项目(编号:Y20227)。

摘　　要：目的:对司美格鲁肽安全警戒信号进行挖掘与分析,为临床安全用药提供参考。方法:检索并提取美国食品药品管理局(FDA)不良事件报告系统(FAERS)2017年12月1日~2021年9月30日司美格鲁肽相关的药品不良事件(ADE)报告,并对相关数据进行分析。结果:提取得到的5 185 800份ADE报告中,以司美格鲁肽为怀疑药物的有8 005份。司美格鲁肽ADE报告数量逐年递增,报告者主要为消费者或非医务人员,报告国家前6位分别是美国、加拿大、英国、法国、丹麦和德国。经报告比值比法(ROR)检测得到56个药品不良反应(ADR)信号,累及13个系统器官分类(SOC),信号强度排前3位的ADR是嗳气(ROR=39.34)、视网膜病(ROR=31.83)和胰腺炎(ROR=20.55)。共有35个ADR信号和6个SOC尚未被说明书记载,排除假阳性和原发病相关信号,信号强度排前3位的ADR是食欲减退(ROR=6.36)、体质量降低(ROR=5.97)和摄食量减少(ROR=5.30)。结论:利用大数据对司美格鲁肽ADE相关信息进行全面、多维度的挖掘分析,为有效开展药学监护和及时处理相关ADR提供参考。Objective: To provide reference for rational and safe drug use in clinical practice through the mining and analysis of security alert signals of semaglutide. Methods: The adverse drug events(ADE) reports on semaglutide from December 01, 2017 to September 30, 2021 were retrieved based on the Adverse Event Reporting System(FAERS) database of U.S. Food and Drug Administration(FDA), and relevant data were extracted and analyzed. Results: A total of 5 185 800 reports were retrieved, and among them, there were 8 005 ADE reports were mainly induced by semaglutide. The number of ADE reports grew significantly, and the data were reported by consumers and non-medical personnel. The top six reporter countries were the United States, Canada, the Great Britain, France, Denmark and Deutschland. After the detection of top 100 ADE report by reporting odds ratio(ROR) method, 56 adverse drug reaction(ADR) signals related to 13 system organ class(SOC)were identified in total, and the top 3 ADRs in signal intensity were eructation(ROR=39.34), retinopathy(ROR=31.83) and pancreatitis(ROR=20.55). A total of 35 signals and 6 SOC were not mentioned in the latest label, and the top 3 ADRs in signal strength were decreased appetite(ROR=6.36), weight decreased(ROR=5.97) and hypophagia(ROR=5.30) after excluding false positive and primary disease-related signals. Conclusion: Based on the openFDA database, the ADE information can be comprehensively and multidimensionally mined and analyzed, which can provide reference for effective pharmaceutical care and timely treatment of adverse reactions, to promote clinical rational drug use.

关 键 词：司美格鲁肽 FDA不良事件报告系统 药物警戒 报告比值比法 安全用药 

分 类 号：R977.15[医药卫生—药品]