使用FAERS数据 (2004-2024) 对罗皮瓦卡因安全性的药监测评估
Congcong Lai1, Zengguang Bao1, Zenan Chen1
1Department of Anesthesiology, Xiangshan Hospital of TCM Medical and Health Group, Ningbo, China.
Medicine
|December 10, 2025
概括
罗皮瓦卡因是一种常见的局部麻醉剂,与安全问题有关,包括神经和心脏事件,主要是在使用后72小时内. 对不良事件 (AE) 的人口层面分析突出了需要进一步调查的潜在的性别特异性模式.
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:
- 罗皮瓦卡因 (ropivacaine) 是一种长效局部麻醉剂的广泛临床使用.
- 对于ropivacaine,在人口层面上仅有有限的安全数据.
- 需要对与罗皮瓦卡因相关的不良事件 (AE) 进行全面分析.
研究的目的:
- 使用美国食品和药物管理局不良事件报告系统 (FAERS) 分析和分类与罗皮瓦卡因相关的AE.
- 确定与罗皮瓦卡因相关的药物不良事件 (ADEs) 的重要安全信号和模式.
主要方法:
- 从FAERS (2004-2024) 中回顾提取罗皮瓦卡因ADE报告.
- 不成比例分析 (ROR,PRR,BCNN,EBGM) 用于评估AE协会.
- 韦布尔形状参数和卡普兰-梅尔方法用于时间到发病分析.
主要成果:
- 发现了1463个罗皮瓦卡因AE报告;检测到181个阳性ADEs.
- 常见的ADE包括麻醉并发症,霍纳综合征,延迟唤醒,局部麻醉系统毒性和单衰.
- 发病的中位时间为2天,观察到早期失败模式.
结论:
- 罗皮瓦卡因显著的安全信号,特别是神经和心脏事件在72小时内.
- 潜在的性别特异性报告模式需要进一步的临床研究.
- 现实世界的数据为有针对性的监测和对罗皮瓦卡因安全性的未来研究提供了证据.
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