背景:Sugammadex,一种选择性的类固醇神经肌肉阻断剂逆转剂,越来越多地用于神经肌肉功能的快速恢复。本研究旨在对sugammadex的安全性进行综合评价。
方法:提取2009年1月至2023年9月FDA不良事件报告系统(FAERS)数据库中报告的与sugammadex相关的不良事件(AE)。用四个衡量标准进行不相称性分析:报告优势比(ROR),比例报告比率(PRR),贝叶斯置信度传播神经网络(BCPNN),多项目伽玛泊松收缩器(MGPS)用于检测显著的不良事件。我们还检查了sugammadexFDA批准文件中缺少的意外AE,并根据EudraVigilance专家工作组开发的“重要医疗事件术语列表(IME列表)”的最新版本(26.1)对AE进行了分类。
结果:共有1452份报告与sugammadex相关。在首选术语(PT)级别,鉴定出98个与sugammadex相关的不良事件,包括“过敏反应”,\"心动过缓\",“支气管痉挛”和“心脏骤停”。其中,FDA官方标签中没有37个代表意外事件的代表,50个AE被认为是值得观察的IME。值得注意的是,标记中没有19个表示严重AE的PT,但需要进行IME监测,包括:\“Kounis综合征\”,“血管性水肿”,“无脉电活动”和“喉水肿”。
结论:该研究发现了与sugammadex相关的意外和潜在威胁生命的不良事件,快速逆转神经肌肉阻滞的有价值的药物。建议临床医生注意这些潜在的风险,特别是在患有过敏症或现有心血管或呼吸系统疾病的患者中。
BACKGROUND: Sugammadex, a selective steroidal neuromuscular blocking agent reversal agent, is increasingly employed for the rapid restoration of neuromuscular function. This study aimed to conduct a comprehensive evaluation of sugammadex\'s safety profile.
METHODS: Adverse events (AEs) related to sugammadex reported in the FDA Adverse Event Reporting System (FAERS) database from January 2009 to September 2023 were extracted. Disproportionality analysis with four measures: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were employed to detect significant AEs. We also inspected for unexpected AEs absent from the sugammadex FDA approval documentation and categorized AEs based on the latest version (26.1) of \'Important Medical Event Terms List (IME list)\' developed by the EudraVigilance Expert Working Group.
RESULTS: A total of 1452 reports were linked to sugammadex. At the preferred terms (PTs) levels, 98 sugammadex-related AEs were identified, including \"anaphylactic reaction\", \"bradycardia\", \"bronchospasm\" and \"cardiac arrest\". Among them, 37 representing unexpected events were absent from official FDA labeling, and 50 AEs were recognized as IME warranting observation. Notably, 19 PTs denoted serious AEs were absent from labeling yet needing IME surveillance, including: \"Kounis syndrome\", \"angioedema\", \"pulseless electrical activity\" and \"laryngeal edema\".
CONCLUSIONS: The study identified unexpected and potentially life-threatening AEs associated with sugammadex, a valuable agent for rapidly reversing neuromuscular blockade. Clinicians are advised to be mindful of these potential risks, particularly in patients with allergies or existing cardiovascular or respiratory conditions.