基于FAERS 数据库舒更葡糖逆转神经肌肉阻滞安全性研究

doi:10.19803/j.1672-8629.20220415

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (3): 321-325.
DOI: 10.19803/j.1672-8629.20220415

基于FAERS 数据库舒更葡糖逆转神经肌肉阻滞安全性研究

叶培¹, 张鹤巍², 吕强³, 叶小飞², 许金芳², 郭晓晶^2,*

¹复旦大学附属华东医院麻醉科,上海 200040;
²海军军医大学卫生勤务学系军队卫生统计学教研室,上海 200433;
³解放军92608部队医院麻醉科,上海 200940

收稿日期:2022-07-15 出版日期:2023-03-15 发布日期:2023-03-17
通讯作者: ^* 郭晓晶,女,博士,副教授,药物流行病学。E-mail：guoxiaojing1003@163.com
作者简介:叶培,男,硕士,临床合理用药。
基金资助:
国家自然科学基金资助项目（82073671、81703296）; 上海市公共卫生体系建设三年行动计划学科带头人计划（GWV-10.2-XD22）; 上海市卫生和计划生育委员会优秀青年医学人才培养计划（2018YQ47）; 上海市公共卫生体系建设三年行动计划优青计划（GWV-10.2-YQ33）

Safety of sugammadex for reversal of neuromuscular block based on FAERS database

YE Pei¹, ZHANG Hewei², LYU Qiang³, YE Xiaofei², XU Jinfang², GUO Xiaojing^2,*

¹Department of Anaesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China;
²Department of Health Statistics, Faculty of Health Service, Naval Medical University, Shanghai 200433, China;
³Department of Anaesthesia, Hospital 92608 of PLA, Shanghai 200940, China

Received:2022-07-15 Online:2023-03-15 Published:2023-03-17

摘要/Abstract

摘要： 目的基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库挖掘舒更葡糖导致的可疑不良事件信号,为临床合理用药提供参考。方法利用不相称测定分析法中的报告比值比法（ROR）对FAERS自2012年1月1日至2022年3月31日的数据进行信号检测。结果共获得1 379条以舒更葡糖为首要怀疑药物的不良事件记录,基于ROR法共获得130个可疑不良事件信号。其中信号强度较高的有神经肌肉阻滞复发（n=58,ROR₀₂₅: 79.67）、支气管痉挛（n=123,ROR₀₂₅: 71.47）、速发过敏反应（n=192,ROR₀₂₅: 44.47）、心动过缓（n=177,ROR₀₂₅: 38.32）、速发过敏反应性休克（n=85,ROR₀₂₅: 35.48）等。不同年龄组患者使用舒更葡糖后的常见不良事件类型不相同,0~17岁组不良事件信号总体强度最低。结论舒更葡糖相关不良事件主要涉及呼吸、心血管、免疫等系统,其中过敏性不良事件及心律失常与舒更葡糖的关联性较强,麻醉医生在使用该药物时应常规监测神经肌肉功能,并进行心电监护及血流动力学监测。

关键词: 舒更葡糖, 美国食品药品监督管理局, 不良事件报告系统, 不良事件, 信号挖掘, 神经肌肉阻滞逆转, 药物警戒

Abstract: Objective To retrieve the signals of suspected adverse events caused by sugammadex based on the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database so as to provide reference for clinical rational drug use. Methods The signals were detected using the ROR method in the disproportionality assay analysis of FAERS data collected from January 1, 2012 to March 31, 2022. Results A total of 1 379 records of adverse events associated with sugammadex were detected, and a total of 130 suspected adverse event signals were detected based on the ROR method. Recurrence of neuromuscular blockade (n=58,ROR₀₂₅: 79.67), bronchospasm (n=123,ROR₀₂₅: 71.47), anaphylactic reactions (n=192,ROR₀₂₅: 44.47), bradycardia (n=177,ROR₀₂₅: 38.32) and anaphylactic shock (n=85,ROR₀₂₅: 35.48) had higher signal intensities. The common adverse events following the use of sugammadex in patients of different age groups varied, and the overall intensity of adverse event signals was lower in the group aged 0 to 17. Conclusion Adverse events related to sugammadex mainly involve respiratory, cardiovascular and immune systems. Among other things, allergic events and arrhythmia are strongly associated with sugammadex. Anesthesiologists should routinely monitor neuromuscular function, ECG and hemodynamics when using sugammadex.

Key words: sugammadex, FDA, FAERS, adverse event, signal mining, neuromuscular block reversal, pharmacovigilance

中图分类号:

R971
R994.11

叶培, 张鹤巍, 吕强, 叶小飞, 许金芳, 郭晓晶. 基于FAERS 数据库舒更葡糖逆转神经肌肉阻滞安全性研究[J]. 中国药物警戒, 2023, 20(3): 321-325.

YE Pei, ZHANG Hewei, LYU Qiang, YE Xiaofei, XU Jinfang, GUO Xiaojing. Safety of sugammadex for reversal of neuromuscular block based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 321-325.

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基于FAERS 数据库舒更葡糖逆转神经肌肉阻滞安全性研究

Safety of sugammadex for reversal of neuromuscular block based on FAERS database

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