与巴克洛芬相关的神经不良事件:基于FDA不良事件报告系统的不成比例分析
Ni Zhang1, Tingting Jiang1, Yanping Li1
1Department of Pharmacy, The Daping Hospital of Army Medical University, Chongqing, China.
SAGE open medicine
|April 30, 2025
概括
巴克洛芬是一种肌肉松剂,与神经系统不良事件 (nAEs) 有关,特别是在未成年人中,通过内注射. 警和早期监测对于安全的临床应用至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 神经学 神经学
- 临床药理学 临床药理学
背景情况:
- 巴克洛芬是一种被广泛使用的肌肉松剂.
- 神经学不良事件 (nAEs) 是与巴克洛芬使用相关的潜在风险.
- 了解nAE概况对于安全的临床应用至关重要.
研究的目的:
- 分析巴克洛芬的神经学不良事件 (nAE) 概况.
- 通过不成比例性分析,识别与巴克洛芬使用相关的特定NAE.
- 告知临床医生关于改善患者安全的潜在风险.
主要方法:
- 对FDA不良事件报告系统 (FAERS) 数据库的不成比例分析.
- 包括2004年1月至2023年6月的巴克洛芬相关不良事件报告.
- 使用报告几率比率 (ROR) 和贝叶斯信心传播神经网络 (BCPNN) 进行信号检测.
主要成果:
- 确定了9305例与巴克洛芬相关的nAE病例,其中21.74%是严重不良事件 (SAE).
- 儿科患者 (<18岁) 和静脉内给药显示报告频率更高.
- 有意义的信号包括昏昏欲睡,,昏迷,状态,全身性性-克隆性发作,脑脊液泄漏,内低血压,认知障碍,代谢性脑病和肌细胞结核.
结论:
- 临床医生必须意识到与巴克洛芬相关的潜在神经系统不良事件.
- 早期对nAEs的监测至关重要,特别是在儿科患者群体和治疗的初始阶段.
- 虽然不成比例性分析是有价值的,但对巴克洛芬相关的NAE的持续警仍然至关重要.
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