阿尔佩利西布相关的不良事件:FDA不良事件报告系统数据库 (FAERS) 的药监测研究
Yun Li1, Hang Li2, Zhongyuan Xiang3
1Department of Pharmacy, Yueyang Central Hospital, Yueyang, 414000, Hunan, PR China.
Heliyon
|March 21, 2024
概括
这项研究分析了FDA的数据,以确定乳腺癌患者的alpelisib安全信号. 关键的不良事件发生在治疗的第一个月内,突出显示需要警监测.
科学领域:
- 药物监督和药物安全研究.
- 瘤学和乳腺癌治疗方法.
- 数据挖掘和不良事件的统计分析.
背景情况:
- 阿尔佩利西布 (Alpelisib) 是一种已批准用于治疗乳腺癌的药物.
- 评估alpelisib的安全概况对于患者护理至关重要.
- 利用药监数据库进行信号检测.
研究的目的:
- 识别和描述与alpelisib相关的安全信号.
- 提供对阿尔佩利西布不良事件 (AEs) 的广泛了解.
- 帮助减少阿尔佩利西布治疗期间AEs的风险.
主要方法:
- 美国食品和药物管理局药监数据库 (FAERS) 的数据挖掘.
- 对2019年第二季度至2022年第四季度的报告进行分析.
- 使用报告几率比率 (ROR) 的不成比例分析.
主要成果:
- 18,149份报告将阿尔佩利西布确定为可疑药物;分析了5,647名独特的患者.
- 受到影响的前10个系统器官类别 (SOC) 包括胃肠道,代谢,皮肤和神经系统疾病.
- 副作用的中位时间为13天;61.12%的副作用发生在治疗的第一个月内.
结论:
- 这项研究提供了对阿尔佩利西布相关的副作用的全面概述.
- 确定了新的首选术语 (PTs),包括便秘,消化不良和糖尿病酸性脂肪酸症.
- 副作用的早期发病 (30天内) 强调了及时临床干预的重要性.
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