基于FAERS数据库的美洛昔康不良反应信号挖掘研究  

Adverse drug reaction signal mining of meloxicam based on FAERS database

作　　者：谢昊 李若菲[1,2,3] 丁紫嫣 陈且昕 陈力 XIE Hao;LI Ruo-fei;DING Zi-yan;CHEN Qie-xin;CHEN Li(Department of Pharmacy/Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Sichuan University,Ministry of Education,Chengdu 610041;West China School of Pharmacy,Sichuan University,Chengdu 610041)

机构地区：[1]四川大学华西第二医院药学部/循证药学中心,成都610041 [2]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [3]四川大学华西药学院,成都610041

出　　处：《中南药学》2021年第8期1711-1716,共6页Central South Pharmacy

基　　金：四川省科技厅项目(No.2019JDR0163)。

摘　　要：目的通过对美洛昔康不良反应信号的挖掘分析,为临床合理安全用药提供依据。方法采用比例失衡法中的报告比值比法(ROR)和比例报告比值法(PRR)对美国FDA不良事件报告系统(FAERS)中美洛昔康2015年第一季度至2020年第二季度共22个季度的不良反应报告进行数据挖掘及分析。结果检索得到8147个以美洛昔康为首要怀疑药品的不良反应作为研究原始数据,对数据进行分析处理后得到203个有效信号,主要集中在各种肌肉骨骼及结缔组织疾病、全身性疾病及给药部位各种反应、胃肠系统疾病等方面。信号强度前20位的首选术语中未在说明书中出现的信号15个,未在说明书中出现的信号累及器官系统5个。结论美洛昔康临床应用时,应特别注意对胃肠道系统、全身性疾病的监测,关注药物相互作用,同时尽量避免在患有心血管疾病的患者中使用。Objective To provide the basis for rational drug use through the mining and analysis of adverse drug reaction signals of meloxicam.Methods The reporting odds ratio method and proportional reporting ratio method were used to mine and analyze the adverse reaction reports of meloxicam from the first quarter of 2015 to the second quarter of 2020,in the FDA adverse events reporting system.Results Totally 8147 adverse drug reactions with meloxicam as the primary suspected drug were retrieved as the original data.After analyzing and processing the data,203 effective signals were obtained,involving various musculoskeletal and connective tissue diseases,systemic diseases and various reactions of drug administration sites,gastrointestinal system diseases and so on.In the top 20 strong signals,15 did not appear in the instructio;5 organs and systems did not appear in the instruction as well.Conclusion In the clinical application of meloxicam,special attention should be paid to the monitoring of the gastrointestinal system,systemic diseases,and to drug interactions.The use of meloxicam in patients with cardiovascular diseases should be avoided.

关 键 词：美洛昔康 比例失衡法 不良反应信号 

分 类 号：R96[医药卫生—药理学]