中国药物警戒 ›› 2024, Vol. 21 ›› Issue (8): 925-930.
DOI: 10.19803/j.1672-8629.20240020

• 安全与合理用药 • 上一篇    下一篇

艾司洛尔不良反应/事件报告分析

赵俊1, 董丽2, 王洋3, 梁瑜1, 杨雪1, 李恩泽1,*   

  1. 1青岛大学附属医院药学部,山东 青岛 266003;
    2诸城市人民医院药剂科,山东 诸城 262200;
    3临沂市平邑县市场监督管理局,山东 平邑 273300
  • 收稿日期:2024-01-12 出版日期:2024-08-15 发布日期:2024-08-21
  • 通讯作者: *李恩泽,男,副主任药师,药品不良事件管理。E-mail: lezqd@126.com
  • 作者简介:赵俊,女,副主任药师,临床药理学。
  • 基金资助:
    山东省自然科学基金资助项目（2021QH205）; 山东省医学会临床科研专项基金-齐鲁专项（YXH2022ZX02051）

Adverse reaction/event reports of esmolol

ZHAO Jun1, DONG li2, WANG Yang3, LIANG Yu1, YANG Xue1, LI Enze1,*   

  1. 1Department of Pharmacy, the Affiliated Hospital of Qingdao University, Qingdao Shandong 266003, China;
    2Department of Pharmacy, Zhucheng People’s Hospital, Zhucheng Shandong 262200, China;
    3Pingyi County Market Supervision Administration Bureau, Pingyi Shandong 273300, China
  • Received:2024-01-12 Online:2024-08-15 Published:2024-08-21

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摘要： 目的 分析艾司洛尔不良反应/事件发生特点,为临床安全用药提供参考。方法 检索Web of Science、PubMed、Springer Link、中国知网、万方数据、维普网从建库至2023年10月31日中艾司洛尔致不良反应/事件个案报道,进行统计和分析,并基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据（2004年第1季度至2023年第4季度）进行挖掘验证其一致性。结果 文献检索共纳入14篇个案报道,14例患者发生艾司洛尔不良反应/事件;男性10例,女性4例;年龄15~94岁,平均年龄59.79岁;发生时间最短为立即发生,最长9 d;不良反应主要有癫痫发作、谵妄、低钠血症、心脏骤停、严重室性心律失常、多巴酚丁胺应激超声心动图假阳性冠状动脉痉挛等。美国FAERS数据库中艾司洛尔不良事件报告208例,发生不良事件559例次,累及系统--器官分类（SOC）21个;不良事件信号强度排序为：交界异位性心动过速、心搏出量降低、无脉性电活动、外渗、热射病、心室机能障碍、室颤、输液部位渗出、心源性休克、冠状动脉痉挛等,与文献收集的病例报告一致性较高。结论 艾司洛尔临床应用广泛,发生的不良反应/事件多为轻微且短暂,但有严重的且说明书未记载的不良反应/事件。建议临床使用时仍需谨慎,对不良反应/事件早期判断、及时停药、尽早给予相关对症处理。

关键词: 艾司洛尔, 神经系统, 低钠血症, 心脏, 药品不良事件, 药品不良反应, 美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）

Abstract: Objective To analyze the characteristics of esmolol-related adverse reactions/events so as to provide reference for safe drug use. Methods Case reports of esmolol-induced adverse reactions/events that were published between the inception and October 31, 2023 were retrieved from Web of Science, Pubmed, Springer Link, CNKI, Wanfang and VIP database. The consistency was verified by FAERS database between 2004 and 2023. Results A total of fourteen pieces of literature were included, involving fourteen patients who reported esmolol-related adverse reactions/events. These patients ranged in age from 15 to 94, with an average age of 59.79 years. The onset could take a few minutes or 9 days. The adverse reactions/events included seizures, delirium, hyponatremia, cardiac arrest, severe ventricular arrhythmia, and coronary artery spasm. A total of 208 patients with esmolol adverse events were detected in the FAERS database, with a total of 559 adverse events, involving 21 systematic organ classifications (SOCs). The signal was the strongest in case of junctional ectopic tachycardia, followed by decreased stroke volume, pulseless electrical activity, extravasation, heat attack, ventricular dysfunction, ventricular fibrillation, infusion site exudation, cardiogenic shock and coronary artery spasm, which was highly consistent with the case reports collected in literature. Conclusion Esmolol has been widely used in clinic, and most of the adverse reactions/events have been mild and transient. However, there are adverse reactions/events that are serious and left unmentioned in specifications. It is recommended that esmolol be used with caution, requiring early judgement of adverse effects, prompt discontinuation of the drug, and early administration of relevant symptomatic treatments.

Key words: esmolol, nervous system, hyponatraemia, cardiac, adverse drug event, adverse drug reaction, FAERS

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