1439例药源性心律失常自发报告分析

Analysis of 1439 Cases of Drug-induced Arrhythmia

目的:了解药源性心律失常的发生规律及特点,为临床安全用药提供参考。方法:采用回顾性研究方法,提取我中心药品不良反应数据库中2008~2019年药源性心律失常的自发报告,剔除信息不全和无效报告后对报告一般情况、患者基本信息、药物类别、给药途径、心律失常类型、ADR治疗和转归等情况进行统计分析。利用Logistic回归分析方法筛选相关风险因素。结果:1439例药源性心律失常报告中,患者平均年龄为(55.17±21.20)岁,以45~64岁占比最高(35.72%);共涉及19类、387种药物,排名前5位的药物是右美托咪定(24.15%)、莫西沙星(16.18%)、重组人白介素-11(11.11%)、沙丁胺醇(10.39%)、胺碘酮(7.73%);心律失常类型多样,以心动过速(56.46%)和心动过缓(19.63%)为主。与非QT/QTc间期延长组相比,年龄>65岁(P=0.007)及患有心脑血管疾病(P=0.016)是QT/QTc间期延长患者的独立危险因素;治疗药物以抗心律失常药和抗过敏药为主。结论:莫西沙星和胺碘酮可导致多种类型的心律失常,重组人白介素-11以诱发心房颤动为主,右美托咪定主要为心动过缓,临床应加强用药监护;老年人和原患心脑血管疾病是药物导致QT/QTc间期延长的高风险因素,临床应予以重点关注;有必要开展重点品种主动监测研究,为临床提供用药参考。

Objective:To understand the regularity and characteristics of drug-induced arrhythmia,and to provide reference for clinical safety.Methods:The spontaneous reports of drug-induced arrhythmia from 2008 to 2019 were extracted from the adverse drug reaction report database of our monitoring center by retrospective study,and the general situation of reports,basic information of patients,drug categories,administration routes,arrhythmia types,ADR treatment and outcome were statistically analyzed after the incomplete and invalid reports were eliminated.The related risk factors were obtained by Logistic regression analysis.Results:The average age of 1439 arrhythmias was(55.17±21.20)years old,and the highest proportion was 35.72%between 45 and 64 years old.A total of 387 drugs were involved in 19 categories.The top 5 drugs were dexmedetomidine(24.15%),moxifloxacin(16.18%),recombinant human interleukin-11(11.11%),salbutamol(10.39%),and amiodarone(7.73%).There were various types of arrhythmia,with tachycardia(56.46%)and bradycardia(19.63%)as the main ones.Compared with non-QT/QTc interstitial prolongation group,age>65 years(P=0.007)and cardiovascular and cerebrovascular diseases(P=0.016)were independent risk factors for patients with prolonged QT/QTc.The treatment drugs were mainly antiarrhythmic drugs and antiallergic drugs.Conclusion:Moxifloxacin and amiodarone can lead to various types of arrhythmias.Recombinant human interleukin-11 is mainly used to induce atrial fibrillation,and dexmedetomidine is mainly used to induce bradycardia,so clinical medication monitoring should be strengthened.The elderly and primary cardiovascular and cerebrovascular diseases are the high risk factors for drug-induced prolongation of QT/QTc,which should be paid more attention to clinically.It is necessary to carry out targeted active monitoring research to provide reference for clinical medication.