第二代H1抗组胺药在老年患者中的心血管相关不良事件分析  

Analysis of cardiovascular related adverse events in older patients with second-generation H1-antihistamines

作　　者：刘钟桧 李佳菀 周双[2] 周颖[2] 刘新民[1] Liu Zhonghui;Li Jiayu;Zhou Shuang;Zhou Ying;Liu Xinmin(Department of Geriatrics,Peking University First Hospital,Beijing 100034,China;Department of Pharmacy,Peking University First Hospital,Beijing 100034,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]北京大学第一医院老年病内科,北京100034 [2]北京大学第一医院药剂科,北京100034 [3]中国药科大学基础医学与临床药学学院,南京211198

出　　处：《中华老年医学杂志》2025年第1期68-73,共6页Chinese Journal of Geriatrics

基　　金：中央高水平医院临床科研业务费资助(北京大学第一医院院内交叉研究专项,2024IR25);中央高校基本科研业务费资助(北大医学青年科技创新扬帆计划,BMU2024YFJHPY017)。

摘　　要：目的基于美国食品药品管理局不良反应报告系统(the Food and Drug Administration adverse event reporting system,FAERS)数据库对第二代H1抗组胺药在老年人群中的心血管相关不良事件进行信号挖掘与分析,为老年人临床用药安全提供参考。方法横断面研究,采用报告比值比、英国药品和健康产品管理局综合标准法、贝叶斯可信传播神经网络法和多项伽马泊松分布缩减法4种方法对FAERS数据库中2004年第一季度至2024年第一季度的第二代H1抗组胺药心血管相关不良事件信号进行检测,并在总体人群和老年人群(≥65岁)中进行亚组分析。结果本研究共收集到5种第二代H1抗组胺药(氯雷他定、地氯雷他定、西替利嗪、左西替利嗪、非索非那定)的1065例心血管相关不良事件报告,总体人群中,心悸均被检测为阳性信号,地氯雷他定还检测到心动过速和心电图QT间期延长为阳性信号。老年人群中,心悸和心电图QT间期延长被检测为阳性信号,且显示出比整体人群更高的信息成分(information component,IC)值和经验贝叶斯几何平均数(empirical Bayesian geometric mean,EBGM)值;氯雷他定和地氯雷他定在老年人中心电图QT间期延长也检测为阳性信号。结论心悸在第二代H1抗组胺药的心血管相关不良事件中检测为阳性信号,老年人还需要进一步关注心电图QT间期延长风险。Objective To conduct signal detection and analysis of cardiovascular-related adverse events associated with second-generation H1 antihistamines(sgAH)in the elderly population,utilizing the Food and Drug Administration adverse event reporting system(FAERS)database.The findings provide a reference for assessing the clinical drug safety of sgAH in the elderly.MethodsA cross-sectional study was conducted.Four methods were utilized to detect signals of cardiovascular-related adverse events associated with sgAHs in the FAERS database,covering the period from the first quarter of 2004 to the first quarter of 2024.These methods included the reporting odds ratio,the Medicines and Healthcare Products Regulatory Agency method,the Bayesian Confidence Propagation Neural Network method,and the multi-item gamma Poisson shrinker method.Subgroup analyses were performed on both the overall population and the elderly population(aged≥65).ResultsA total of 1065 reports of cardiovascular-related adverse events involving sgAHs such as loratadine,desloratadine,cetirizine,levocetirizine,and fexofenadine were collected.In the overall population,palpitations were identified as a positive signal,while desloratadine also demonstrated positive signals for tachycardia and prolonged electrocardiogram QT interval.In the elderly population,both palpitations and prolonged electrocardiogram QT interval were recognized as positive signals,exhibiting higher information component(IC)values and empirical Bayesian geometric mean(EBGM)values compared to the overall population.Furthermore,loratadine and desloratadine were also identified as positive signals for prolonged electrocardiogram QT interval in the elderly.ConclusionsPalpitations have been identified as a significant indicator of cardiovascular-related adverse events associated with sgAHs.Elderly patients should be particularly vigilant regarding the risk of prolonged QT intervals on electrocardiograms.

关 键 词：组胺H1拮抗剂 不良反应 心血管相关不良事件 

分 类 号：R969.3[医药卫生—药理学]