药物与乳酸酸中毒的药品不良反应信号挖掘与分析  

Signal Mining and Analysis of Adverse Drug Events of Lactic Acidosis

作　　者：晏声蕾 陈加飞[1] 单雪峰[2] 王红梅[3] YAN Shenglei;CHEN Jiafei;SHAN Xuefeng;WANG Hongmei(Dept.of Pharmacy,People’s Hospital of Chongqing Banan District,Chongqing 401320,China;Dept.of Pharmacy,Bishan Hospital of Chongqing Medical University,Chongqing 402760,China;Dept.of Pharmacy,the First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China)

机构地区：[1]重庆市巴南区人民医院药剂科,重庆401320 [2]重庆医科大学附属璧山医院药学部,重庆402760 [3]重庆医科大学附属第一医院药学部,重庆400016

出　　处：《中国医院用药评价与分析》2023年第11期1387-1390,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：重庆市科卫联合医学科研项目(No.2020MSXM120)。

摘　　要：目的:分析导致乳酸酸中毒的药品不良事件报告,总结可能引起乳酸酸中毒的药物种类,以期为临床决策提供依据。方法:利用OpenVigil 2.1软件提取美国食品药品监督管理局不良事件报告系统(FAERS)数据库中的药品不良事件报告,提取时间为2004年第1季度至2022年第4季度,采用报告比值比法(ROR)和比例报告比值法(PRR)对数据进行分析,最后将药物按照不同系统分类。结果:共收集到18114份药物为首要怀疑的乳酸酸中毒不良事件报告,纳入分析最终得到31个不良反应信号,乳酸酸中毒不良反应信号频次排序居前5位的药物为二甲双胍、利奈唑胺、西格列汀、利格列汀和恩格列净,涉及药物类别主要为消化道和新陈代谢药物、心血管系统药物、系统用抗感染药物和神经系统药物。结论:多种药物可导致乳酸酸中毒,主要为消化道和新陈代谢药物、系统用抗感染药物。OBJECTIVE:To analyze the reports of adverse drug events of lactic acidosis,and to summarize the drugs categories that may cause lactic acidosis,so as to provide references for clinical decision-making.METHODS:Adverse drug event reports in the United States Food and Drug Administration Adverse Event Reporting System(FAERS)database were extracted by using OpenVigil 2.1 software for the drugs from the first quarter of 2004 to the fourth quarter of 2022,the data were analyzed by using reporting odd ratio(ROR)method and proportional reporting ratio(PRR)method,so that the drugs were finally classified according to different systems.RESULTS:A total of 18114 reports of adverse events of lactic acidosis with drugs as the first suspicion were collected,and 31 adverse reaction signals were finally obtained after analysis,the top 5 drugs ranked by the frequency of lactic acidosis adverse reaction signals were metformin,linezolid,sitagliptin,linagliptin and empagliflozin,and the drug categories involved were mainly digestive and metabolic drugs,cardiovascular system drugs,systemic use anti-infective drugs and neurologic drugs.CONCLUSIONS:Various drugs can cause lactic acidosis,mainly including digestive and metabolic drugs,and systemic anti-infective drugs.

关 键 词：乳酸酸中毒 报告比值比法 比例报告比法 不良反应信号 药品不良事件 

分 类 号：R969.3[医药卫生—药理学] R97[医药卫生—药学]