与神经肌肉阻断剂相关的不良事件:FDA不良事件报告系统的不成比例分析
Liangxia Li1, Qianqian Xu1, Yarui Liu1
1Department of Pharmacy, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Frontiers in pharmacology
|August 8, 2024
概括
神经肌肉阻断剂 (NMBAs) 可以导致严重的不良事件,包括心脏骤停和过敏反应,强调在手术过程中需要仔细监测. 这项研究分析了FAERS数据,以确定NMBA安全信号.
科学领域:
- 药物监督 药物监督 药物监督
- 麻醉学 麻醉学
- 药品安全 药品安全
背景情况:
- 神经肌肉阻断剂 (NMBA) 对于外科手术至关重要,促进输管并优化手术条件.
- 确保NMBA的安全使用需要对其潜在的不良事件概况有充分的了解.
研究的目的:
- 识别和分析与常用的NMBA相关的不良事件 (AE) 信号.
- 为提高NMBA管理的临床安全提供参考.
主要方法:
- 利用美国食品和药物管理局不良事件报告系统 (FAERS) 数据库从2004年第一季度到2023年第三季度.
- 使用不成比例性分析 (ROR和BCPNN) 分析了atracurium,cisatracurium,rocuronium和vecuronium的分析报告.
- 根据"监管活动医学词典"中的首选术语 (PT) 识别出AE信号.
主要成果:
- 报告了超过11,500个与NMBA相关的副作用,其中罗库是报告最多的.
- 这四种NMBA都在心脏,免疫,呼吸和血管疾病方面显示出积极的安全信号.
- 确认了已知的副作用,如过敏反应和低血压,并确定了潜在的新信号,包括心室动,高血糖症,库尼斯综合征,应激心肌病,肝细胞损伤和高血症.
- 心脏骤停和过敏反应被确定为NMBA相关死亡的显著风险因素.
结论:
- 与NMBA相关的不良事件可能导致严重的临床结果.
- 这项研究为NMBAs的安全性概况提供了有价值的见解.
- 由于FAERS数据库固有的局限性,建议进行进一步的临床验证.
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