摘要
目的促进利奥西呱的临床安全、合理应用。方法收集美国食品和药物管理局不良事件报告系统(FAERS)自建库起至2022年3月31日利奥西呱的药品不良事件(ADE)报告,清洗数据,根据《ICH国际医学用语词典》25.0版(MedDRA 25.0)中的首选术语(PT)和系统器官分类(SOC)对ADE进行分类,采用报告比值比(ROR)法和比例报告比(PRR)法进行数据挖掘。结果获得以利奥西呱为首要怀疑药物的ADE报告6551份,其中男女比例约为1∶2.22,年龄段主要集中于≥60岁(54.24%),上报数量最多的国家为美国(84.69%),结局主要为死亡(33.86%)和住院治疗(33.83%)。挖掘到与药物治疗有关的ADE信号417个,涉及21个SOC,报告数排名前5的分别为胃肠道系统疾病(11.51%)、呼吸系统/胸及纵隔疾病(11.03%)、全身性疾病及给药部位各种反应(10.79%)、各类检查(10.07%)、各类神经系统疾病(8.87%),警戒信号排名前5的分别为肠梗阻、副鼻窦不适、缺铁性贫血、畏光、脑利尿钠肽升高;85.85%(358/417)的ADE信号在现有中文药品说明书中未提及,包括眼器官疾病、耳及迷路类疾病、肝胆系统疾病、良性/恶性及性质不明的肿瘤(包括囊状和息肉状)、免疫系统疾病、内分泌系统疾病等。结论临床应用利奥西呱前应做好评估,密切关注疾病进展,发生ADE应及时采取措施,降低临床用药风险。
Objective To promote the clinical safety and rational application of riociguat.Methods The adverse drug events(ADEs)reports in the Food and Drug Administration Adverse Event Reporting System(FAERS)were collected from its inception to March 31,2022,data cleaning was carried out,and the ADEs were classified according to the preferred terminology(PT)and system organ classification(SOC)in the ICH Medical Dictionary for Regulatory Activities 25.0(MedDRA 25.0).Data mining was conducted by the reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)method.Results A total of 6551 ADE reports were obtained,with riociguat as the primary suspected drug,with a male-to-female ratio of approximately 1∶2.22.The patients'ages were mainly concentrated at≥60 years old(54.24%),and the country with the highest number of ADE reports was the United States of America(84.69%).The main outcomes were death(33.86%)and hospitalization(33.83%).A total of 417 ADE signals related to medication were mined,involving 21 SOCs,among which the top five SOCs in terms of reports were gastrointestinal diseases(11.51%),respiratory/thoracic and mediastinal diseases(11.03%),systemic diseases and various reactions at the drug administration site(10.79%),various examinations(10.07%),and various neurological disease(8.87%);the top 5 SOCs in terms of warning signals were intestinal obstruction,paranasal sinus discomfort,iron-deficiency anemia,photophobia and increased brain natriuretic peptide.Precisely 85.85%(358/417)of ADE signals were not mentioned in the existing Chinese drug package inserts,including eye organ diseases,ear and labyrinth diseases,hepatobiliary system diseases,benign/malignant tumors and tumors of unknown nature(including cystic and polypoid tumors),immune system diseases,endocrine system diseases,etc.Conclusion Before the clinical application of riociguat,it is necessary to conduct an evaluation,closely monitor disease progression,and take timely measures to reduce the risk of clinical medication in the event of ADE.
作者
刘芳
陈静
张丽新
成华
LIU Fang;CHEN Jing;ZHANG Lixin;CHENG Hua(Beijing Luhe Hospital,Capital Medical University,Beijing,China 101149;Inner Mongolia Autonomous Region People's Hospital,Hohhot,Inner Mongolia,China 010017)
出处
《中国药业》
CAS
2023年第15期108-112,共5页
China Pharmaceuticals
基金
北京市通州区科技计划项目[KJ2021CX008-37]。
