基于FAERS数据库的吡格列酮不良事件信号挖掘与分析  

Signals mining and analysis of adverse drug events of pioglitazone based on FAERS database

作　　者：李萍[1] 刘岩 杨天绎 赵琦瑶 李皎月 罗云鹏 戴金琳 黄子凡 张力[4] 杨晓晖[1] LI Ping;LIU Yan;YANG Tianyi;ZHAO Qiyao;LI Jiaoyue;LUO Yunpeng;DAI Jinlin;HUANG Zifan;ZHANG Li;YANG Xiaohui(Department of Nephrology and Endocrinology,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Key Laboratory of Chinese Internal Medicine of Ministry of Education,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 10070,China;Rutgers University,New Brunswick,New Jersey 08901,USA;Department of Scientific Research,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China)

机构地区：[1]北京中医药大学东直门医院肾病内分泌科,北京100700 [2]北京中医药大学东直门医院中医内科学教育部重点实验室,北京100700 [3]美国罗格斯大学,美国新泽西州新布朗斯维克08901 [4]北京中医药大学东方医院科研处,北京100078

出　　处：《药物流行病学杂志》2024年第12期1365-1374,共10页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金面上项目(81974541)。

摘　　要：目的挖掘吡格列酮的不良事件(ADE)信号,为临床安全用药提供参考。方法采用报告比值比法、贝叶斯置信区间递进神经网络法,对美国食品药品管理局不良事件报告系统(FAERS)数据库中2013年第1季度至2024年第2季度吡格列酮ADE报告进行数据挖掘与信号检测。结果经数据清理后,共收集到16904份以吡格列酮为首要怀疑药品的ADE报告。ADE报告集中于45岁及以上人群,以男性居多,主要上报国家为美国。共检测到180个ADE信号,涉及27个系统/器官分类,中等强度及以上ADE信号34个,其中未被药品说明书记载的ADE信号9个,分别是输尿管癌、尿道癌、胆囊肿瘤、肾盂恶性肿瘤、心包填塞、左心室功能障碍、肺水肿、膀胱炎、梦话。结论临床在应用吡格列酮时除密切关注体重增加、全身性水肿、心力衰竭外,还应关注左心室功能障碍、肺水肿、膀胱炎、心包填塞等未被药品说明书记载的潜在ADE,以保证用药安全。Objective To mine adverse drug event(ADE)signals of pioglitazone,and to provide references for the safe clinical use of the medication.Methods The reporting odds ratio(ROR)method and the Bayesian confidence propagation neural network(BCPNN)method were utilized to analyze pioglitazone ADE reports from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,spanning from the first quarter of 2013 to the second quarter of 2024.Results After data cleaning,a total of 16904 pioglitazone ADE reports were retrieved.The ADE reports primarily involved individuals over the age of 45,with a male predominance,and were mainly reported from the United States.After screening,180 ADE signals were identified,affecting 27 system-organ classes(SOC).Out of these,34 ADE signals were classified as medium to high risk,with 9 ADE signals not mentioned in the product labeling,including ureteral cancer,urethral cancer,gallbladder tumors,malignant tumors of the renal pelvis,pericardial tamponade,left ventricular dysfunction,pulmonary edema,cystitis,and somniloquy.Conclusion In addition to closely monitoring weight gain,systemic edema,and heart failure,clinical attention should be given to left ventricular dysfunction,pulmonary edema,cystitis,and pericardial tamponade ADEs that are not mentioned in the instructions,to ensure the safety of pioglitazone use in clinical practice.

关 键 词：吡格列酮 噻唑烷二酮类药物 药品不良事件 FAERS数据库 信号检测 药物警戒 

分 类 号：R969[医药卫生—药理学]