药物诱导的外科手术期间恶性高温症:基于食品和药物管理局不良事件报告系统 (FAERS) 数据库的现实研究
Zeguang Lu1, Minghai Huang2, Liying Liu1
1Department of Anesthesiology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
International journal of surgery (London, England)
|February 24, 2026
概括
恶性高温症 (MH) 是手术期间严重的药物不良反应. 这项研究分析了2005-2024年与药物相关的MH病例,确定了改善患者安全的关键触发因素和趋势.
科学领域:
- 麻醉学和外科手术期间的医学.
- 药监和药物安全 药监和药物安全
- 关键护理医学 关键护理医学
背景情况:
- 恶性高温症 (MH) 是一种已知的,严重的不良药物反应 (ADR),与特定麻醉剂有关.
- 目前还没有全面,最新的药物概况,这些药物可能会触发外科手术期间的MH.
- 了解这些触发因素对于防止手术期间患者出现严重后果至关重要.
研究的目的:
- 通过使用大型不良事件数据库,全面分析与外科手术期间恶性高温症 (MH) 相关的药物.
- 识别和量化涉及到MH事件的特定药物的风险信号,包括致命的结果.
- 分析随着时间的推移,MH报告的趋势,并为患者安全策略提供信息.
主要方法:
- 利用食品和药物管理局的不良事件报告系统 (FAERS) 数据库从2005年第一季度到2024年第四季度的报告.
- 收集和分析了与外科手术期间的MH和致命的MH结局相关的不良事件 (AE) 报告.
- 应用不成比例分析来识别与药物相关的MH信号,并对风险水平进行分类.
主要成果:
- 报告共有769例外科手术期间的MH病例,其中100例 (13%) 导致死亡.
- 在26种已识别的药物中,17种药物通过不成比例分析显示出阳性MH信号.
- 吸入麻醉剂是最常见的,其次是肌肉松剂; 赛沃弗兰, 异弗兰, 普罗波, 顺胆和芬太尼是最常见的触发剂. 与肌肉松剂相关的MH报告显示了日益增长的趋势.
结论:
- 本研究提供了药物诱导的外科手术期间的MH的详细概述,强调了持续警和个性化风险评估的必要性.
- 结果验证了已知的MH触发因素,并揭示了不断变化的风险模式,强调了更新安全协议的重要性.
- 根据FAERS数据分析,提出了可行的策略,以提高患者的安全性,并指导未来的麻醉学研究.
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