基于FDA不良事件报告系统 (FAERS) 的中国β-阻断剂使用趋势和安全性探索的现实研究
Yilong Yan1,2, Wenshuo An1,2, Shenghui Mei1,2
1Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, 119 Nansihuan West Road, Fengtai District, Beijing, P. R. China.
BMC pharmacology & toxicology
|November 15, 2024
概括
在中国,甲醇占据了贝塔抑制剂处方的统治地位,主要针对老年人. 像BRASH综合征和急性损伤这样的新风险需要注意更安全的β-阻断剂使用.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
- 药品安全 药品安全
背景情况:
- β抑制剂是必不可少的心血管药物,临床指导方针不断变化.
- 在个性化β抑制剂治疗和确保患者安全方面存在挑战.
- 了解处方模式和不良事件对于合理使用至关重要.
研究的目的:
- 分析中国的β-阻断剂处方频率和模式.
- 为了识别与β-阻断剂相关的潜在不良药物反应风险信号.
- 在临床实践中提供优化β抑制剂治疗的证据.
主要方法:
- 通过医院处方分析合作项目利用了来自中国的处方数据 (2018年1月至2023年6月).
- 分析了来自FDA不良事件报告系统 (FAERS) 的药物不良反应报告.
- 监管活动的雇员医学词典 (MedDRA) 用于不良事件的分类和信号检测的比例失衡方法.
主要成果:
- 在中国,美托普罗罗尔占比为贝塔抑制剂处方的62.2%.
- 老年人 (65.7%) 和男性 (57.0%) 患者是主要的接受者.
- 观察到大量的非标签使用,例如,治疗高血压的sotalol (18.25%) 和治疗心痛的esmolol (12.94%) 和心力衰竭 (14.98%).
- 新发现的不良反应包括BRASH综合征 (美托普罗罗尔,卡维迪罗尔),急性损伤 (比索普罗罗尔),早产儿并发症 (拉贝塔罗尔) 和睡眠障碍 (普罗兰诺罗尔).
结论:
- 梅托普罗罗尔是中国市场领先的β-阻断剂.
- 新出现的不良反应,包括使用比索普罗罗尔的急性损伤和使用美托普罗罗尔和卡维迪罗尔的BRASH综合征,需要临床警.
- 需要进一步的研究来解决非标签处方和优化β-阻断剂的安全性.
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