Pueyo-Val Javier, Avedillo-Salas Ana, Berdún-Viñegra Pablo, Pueyo-Val Olga María, Fanlo-Villacampa Ana, Navarro-Pemán Cristina, Lanuza-Giménez Francisco Javier, Ioakeim-Skoufa Ignatios, Vicente-Romero Jorge
Department of Pharmacology, Physiology and Legal and Forensic Medicine, Faculty of Medicine, University of Zaragoza, ES-50009 Zaragoza, Spain.
Anesthesia and Resuscitation Department, Cruces University Hospital, ES-48903 Barakaldo, Spain.
Pharmaceuticals (Basel). 2023 Aug 15;16(8):1161. doi: 10.3390/ph16081161.
This study aimed to determine the type of drugs reported as suspected of causing severe supraventricular arrhythmias from the Spanish Human Pharmacovigilance System database. A total of 1053 reports were analysed, of which 526 (50%) were on men and 516 (49%) were on women. The most affected age group was the over-65s, with 593 reports (56%). Of the 1613 drugs, those belonging to the cardiovascular system (ATC Group C) were the most numerous (414 reports, 26%), with digoxin being the most frequent drug (49 reports, 12%). Other common groups were antiinfectives for systemic use (ATC Group J; 306 reports, 19%), antineoplastic and immunomodulating agents (ATC Group L; 198 reports, 12%), and nervous system drugs (ATC Group N; 185 reports, 11%). The most common supraventricular arrhythmia was atrial fibrillation (561 reports, 51%). Regarding outcomes, 730 (66%) patients recovered, 76 (7%) did not recover, 25 (3%) recovered but with sequelae, and 23 (2%) resulted in death. This study revealed that certain drugs have reported to be associated more frequently to supraventricular arrhythmias as serious adverse reactions, especially in the older population. Proper clinical management and effective strategies to ensure medication appropriateness should always be considered to improve patient safety when prescribing drugs.
本研究旨在从西班牙人用药品不良反应监测系统数据库中确定被报告怀疑导致严重室上性心律失常的药物类型。共分析了1053份报告，其中526份（50%）涉及男性，516份（49%）涉及女性。受影响最严重的年龄组是65岁以上人群，有593份报告（56%）。在1613种药物中，属于心血管系统（ATC分类C组）的药物数量最多（414份报告，26%），地高辛是最常见的药物（49份报告，12%）。其他常见类别是全身用抗感染药（ATC分类J组；306份报告，19%）、抗肿瘤和免疫调节药（ATC分类L组；198份报告，12%）以及神经系统药物（ATC分类N组；185份报告，11%）。最常见的室上性心律失常是心房颤动（561份报告，51%）。关于转归，730名（66%）患者康复，76名（7%）未康复，25名（3%）康复但有后遗症，23名（2%）死亡。本研究表明，某些药物作为严重不良反应与室上性心律失常的关联更为频繁，尤其是在老年人群中。在开药时，应始终考虑适当的临床管理和有效的策略以确保用药合理性，从而提高患者安全性。
