Department of Pharmacy, Medical Supplies Center, Chinese PLA General Hospital, Beijing, 100853, China.
College of Pharmacy, Chongqing Medical University, Chongqing, 400016, China.
Eur J Clin Pharmacol. 2023 Jun;79(6):759-765. doi: 10.1007/s00228-023-03492-6. Epub 2023 Apr 11.
The purpose of this study was to analyze the occurrence characteristics, clinical manifestations, medication distribution, and incidence of drug-induced arrhythmias in a real-world inpatient population.
According to the inclusion and exclusion criteria as well as the ADR evaluation criteria, we retrospectively evaluated hospitalized patients in 2019 using the arrhythmia module of the Adverse Drug Event Active Surveillance and Assessment System-II (ADE-ASAS-II). A detailed analysis was performed on the demographic data, ADR manifestations, and medication distribution of 2097 patients with drug-induced arrhythmias and QT interval prolongation.
Of the 167,546 hospitalized patients, there were 1809 cases of drug-induced arrhythmias, with an incidence of 1.08%. The ADRs in 45.35% of positive patients occurred within 3 days after medication administration, and 46.73% of the patients were 65 years old or older. The predominant ADRs identified in this study were extrasystole, tachycardia, and QT interval prolongation, of which the incidence was 0.20%. Levofloxacin was the most involved drug, and levofloxacin-associated rates of incidence of arrhythmia and QT interval prolongation were 1.24% and 0.44%, respectively. The risk factors for drug-induced arrhythmias were male sex, advanced age, emaciation, obesity, and underlying illnesses such as cardiovascular diseases, diabetes mellitus, cerebrovascular diseases, and hepatic and renal inadequacy (P < 0.05).
The incidence of drug-induced arrhythmias was in the range of common, while QTc interval prolongation was occasional. It is necessary to pay attention to patients with risk factors.
本研究旨在分析真实世界住院人群中药物致心律失常的发生特点、临床表现、用药分布及致心律失常发生率。
根据纳入排除标准及药物不良反应（ADR）评价标准，采用第二代药物不良反应主动监测和评估系统（ADE-ASAS-II）的心律失常模块，回顾性分析 2019 年住院患者，对 2097 例药物致心律失常和 QT 间期延长患者的人口学资料、ADR 表现及用药分布进行详细分析。
在 167546 例住院患者中，发生药物致心律失常 1809 例，发生率为 1.08%。45.35%的阳性患者的 ADR 发生在用药后 3 d 内，46.73%的患者年龄在 65 岁及以上。本研究中主要的 ADR 是室性期前收缩、心动过速和 QT 间期延长，发生率分别为 0.20%。左氧氟沙星涉及的药物最多，其致心律失常和 QT 间期延长的发生率分别为 1.24%和 0.44%。药物致心律失常的危险因素为男性、高龄、消瘦、肥胖及心血管疾病、糖尿病、脑血管疾病、肝肾功能不全等基础疾病（P<0.05）。
药物致心律失常的发生率处于常见范围内，而 QTc 间期延长则偶见。有必要关注有危险因素的患者。
