基于FAERS数据库对氨氯地平和乐卡地平信号的检测与评价  

Detection and evaluation of the signals of amlodipine and lercanidipine based on FAERS database

作　　者：钟贵遵 张妮 王红力 陈思琪 龚莉 潘玲云 贾运涛[5] ZHONG Guizun;ZHANG Ni;WANG Hongli;CHEN Siqi;GONG Li;PAN Lingyun;JIA Yuntao(School of Pharmacy,Chongqing Medical University,Chongqing 400016,China;Dept.of Pharmacy,Army Medical Characteristic Center of PLA,Chongqing 400042,China;Key Lab of Researches on Transformation of Tumor Metastasis and Individualized Diagnosis and Treatment,Chongqing University Cancer Hospital,Chongqing 400030,China;Dept.of Pharmacy,Chongqing University Cancer Hospital,Chongqing 400030,China;Dept.of Pharmacy,Children’s Hospital Affiliated to Chongqing Medical University/Key Laboratory of Child Development Disease Research,Ministry of Education/National Science and Technology Cooperation Base of Major Child Development Diseases/Chongqing Key Laboratory of Pediatrics/National Clinical Medicine Research Center of Child Health and Diseases,Chongqing 400014,China)

机构地区：[1]重庆医科大学药学院,重庆400016 [2]中国人民解放军陆军特色医学中心药剂科,重庆400042 [3]重庆大学附属肿瘤医院肿瘤转移与个体化诊治转化研究重庆市重点实验室,重庆400030 [4]重庆大学附属肿瘤医院药学部,重庆400030 [5]重庆医科大学附属儿童医院药学部/儿童发育疾病研究教育部重点实验室/儿童发育重大疾病国家科技合作基地/儿科学重庆市重点实验室/国家儿童健康与疾病临床医学研究中心,重庆400014

出　　处：《中国药房》2022年第21期2647-2653,共7页China Pharmacy

基　　金：重庆市首批临床药学重点专科建设项目(No.渝卫办发〔2020〕68号);重庆医科大学未来医学青年创新团队发展支持计划项目(No.重医大发〔2022〕26号)。

摘　　要：目的对氨氯地平和乐卡地平药物不良事件(ADE)进行信号检测并评价。方法检索美国FDA不良事件报告系统(FAERS)数据库2004年1月1日至2021年9月30日收录的“氨氯地平”和“乐卡地平”所有ADE报告,采用报告比值比法和贝叶斯可信区间递进神经网络法检测ADE信号,筛选出重点系统内的中强信号及强信号进行分析。结果从FAERS数据库中提取得到以氨氯地平、乐卡地平为怀疑药物的ADE报告各249657、10558份,检出氨氯地平、乐卡地平安全信号分别为62、58个。两药同时检出外周水肿、低血压、直立性低血压、低血容量性休克等中强信号,以上均为两药常见的不良反应。较为特殊的ADE如下:呼吸系统、胸及纵隔疾病系统中,氨氯地平检出非心源性肺水肿强信号,乐卡地平检出静息时呼吸困难强信号;胃肠系统中,氨氯地平检出齿龈肥大强信号;皮肤及皮下组织类疾病系统中,两药均检出“血管炎相关”的中强信号,氨氯地平检出线状IgA病中强信号,乐卡地平检出大疱性皮炎中强信号;肾脏及泌尿系统疾病系统中,两药均检出急性肾损伤安全信号(氨氯地平检出中强信号,乐卡地平检出强信号);精神病类系统中,氨氯地平检出自杀既遂中强信号。低血压和急性肾损伤在两药报告数中均排在前2位。信息成分(IC)时间扫描图谱结果显示,2004-2021年,氨氯地平的非心源性肺水肿、自杀既遂信号IC值分别从0.76、-0.49增至4.48、1.95,置信区间分别从(-0.44,1.97)、(-1.01,0.03)缩窄至(4.24,4.72)、(1.90,2.01),提示信号稳定。结论临床使用氨氯地平和乐卡地平时,应警惕外周水肿、低血压、心律失常、肺水肿、牙龈增生、皮肤相关ADE、急性肾损伤及抑郁、自杀等风险。OBJECTIVE To detect and evaluate the signals of amlodipine and lercanidipine-induced adverse drug events(ADE).METHODS All ADE reports about“amlodipine”and“lercanidipine”were searched from FAERS database during Jan.1st,2004 to Sept.30th,2021.Reported odds ratio and Bayesian confidence propagation neural network were used to detect ADE signals.The moderately strong signals and strong signals in key systems were selected for analysis.RESULTS From FAERS database,249657 and 10558 reports were extracted with amlodipine and lercanidipine as suspect drugs,respectively.In this study,62 and 58 signals related to amlodipine and lercanidipine were detected respectively.At the same time,moderately strong signals of peripheral edema,hypotension,orthostatic hypotension and hypovolemic shock were detected in the two drugs,all of which were common adverse reactions of the two drugs.The special ADEs detected in this study were as follows:in the respiratory system,chest and mediastinal disease system,strong signals of non-cardiogenic pulmonary edema were detected for amlodipine,and strong signals of dyspnea at rest for lercanidipine;in gastrointestinal diseases,strong signals of gingival hypertrophy were detected only for amlodipine;in skin and subcutaneous tissue disease system,moderately strong signals related to“vasculitis”were detected for both drugs,moderately strong signals related to linear IgA disease were detected for amlodipine,and moderately strong signals related to bullous dermatitis were detected for lercanidipine;in the renal and urinary system disease system,the signals of acute renal injury were detected for both drugs(amlodipine was detected as a moderately strong signal,and lecardipine was detected as a strong signal);in the mental system,moderately strong signals related to suicide were detected for amlodipine.Both hypotension and acute renal injury ranked in the top two in the number of reports of the two drugs.The time scan results of the information component(IC)of this study showed that the IC va

关 键 词：氨氯地平 乐卡地平 药物不良事件 信号检测 安全用药 高血压 

分 类 号：R969.3[医药卫生—药理学] R972.4[医药卫生—药学]