基于FDA不良事件报告系统的利奥西呱不良事件信号挖掘与分析  

Signal Mining and Analysis of Riociguat-related Adverse Events Based on FDA Adverse Events Reporting System

作　　者：杨健[1] 郭丽萍 万盟[1] 赵拯[1] YANG Jian;GUO Liping;WAN Meng;ZHAO Zheng(Department of Pharmacy,the Affiliated Nanjing Hospital of Nanjing Medical University,Nanjing First Hospital,Nanjing 210006,China)

机构地区：[1]南京医科大学附属南京医院(南京市第一医院)药学部,南京210006

出　　处：《药学与临床研究》2023年第5期448-453,共6页Pharmaceutical and Clinical Research

摘　　要：目的:挖掘和分析利奥西呱上市后的不良事件信号,为临床安全合理用药提供参考。方法:将FDA不良事件报告系统中2013年10月1日~2022年12月31日的原始数据导入SAS 9.4软件,采用报告比值比法以及英国药品和保健产品管理局综合标准法对利奥西呱不良事件信号进行挖掘,分层分析考察不同性别、年龄和体重的人群服用利奥西呱发生不良事件的差异。结果:以利奥西呱为主要可疑药物的不良事件报告共计10528份,不良事件发生的中位时间为183 d。共挖掘出305个不良事件信号,涉及20个系统和器官分类,发生频次较高的不良事件信号与药品说明书基本一致。说明书未记载的不良事件包括肠道梗阻、食管炎、反应迟缓、听觉障碍等。女性患者出现头痛、心悸和颌骨疼痛的概率显著高于男性,而男性患者发生咯血的概率显著高于女性。18~64岁的患者发生头痛、心悸、颌骨疼痛和咯血概率显著高于64岁以上患者,而后者出现外周水肿(肿胀)、舒张压降低和贫血的概率显著增加。结论:临床使用利奥西呱时,应关注性别和年龄对不良事件的影响,以及说明书未载入的不良事件,加强药学监护。Objective:To provide reference for clinical safe and rational use of riociguat through signal mining and analysis of post-marketing adverse events.Methods:The raw data from the FDA adverse events reporting system from October 1,2013 to December 31,2022 were imported into the SAS 9.4 software.The reporting odds ratio(ROR)and the Medicines and Healthcare Products Regulatory Agency Method(MHRA)were used to mine the adverse event signals of riociguat.The impact of gender,age and weight on the occurrence of adverse events were investigated through stratified analysis.Results:A total of 10,528 adverse events were reported with riociguat as the primary suspect drug,and the median time to the onset of adverse events was 183 days.A total of 305 adverse event signals were excavated,involving 20 system organ classes.The adverse event signals with high frequency were basically consistent with the drug labels.Adverse events not described in the instructions included intestinal obstruction,sluggishness,oesophagitis,auditory disorder,etc.Female patients were significantly more likely to experience headache,palpitations and jaw pain,while male were notably more likely to suffer haemoptysis.Patients aged 18 to 64 years were significantly more likely to experience headache,palpitations,jaw pain and haemoptysis than patients over 64 years old,while the latter had a significantly high incidence of peripheral oedema(swelling),decreased diastolic blood pressure and anemia.Conclusion:The occurrence of adverse events of riociguat has gender and age differences,and clinical attention should be paid to adverse events not described in the instructions,and pharmaceutical monitoring should be strengthened if necessary.

关 键 词：利奥西呱 肺动脉高压 FDA不良事件报告系统 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]