在FDA不良事件报告系统 (FAERS) 数据库中对etoposide的药监测研究,现实世界说什么?
Zhiwei Cui1, Feiyan Cheng1, Lihui Wang1
1Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Frontiers in pharmacology
|November 13, 2023
概括
这项研究分析了现实世界的数据,以识别埃托波西德不良药物事件 (ADEs). 它发现了常见和意想不到的ADEs,大多数发生在治疗一个月内,突出男性和女性的风险.
科学领域:
- 药监和药物安全 药监和药物安全
- 瘤学和癌症治疗学 癌症治疗学
- 数据挖掘和健康信息学
背景情况:
- 乙胺是一种广泛使用的抗瘤药物,具有确定的临床试验数据.
- 对埃托波的现实世界不良反应数据有限,需要进一步调查.
- 了解现实世界药物不良事件 (ADEs) 对患者安全至关重要.
研究的目的:
- 在现实环境中评估和评价与埃托波相关的不良事件.
- 在FAERS数据库中使用数据挖掘来识别重要的ADEs.
- 分析与etoposide相关的发病时间和人口特异性风险.
主要方法:
- 分析了来自美国食品和药物管理局不良事件报告系统 (FAERS) 数据库的16.134.686份报告.
- 鉴定了9,892个与乙醇相关的不良药物事件 (ADEs).
- 应用了不成比例分析算法 (ROR,PRR,BCPNN,MGPS) 来确定显著的ADE和使用韦布尔分布分析的时间到发病.
主要成果:
- 确定了478个显著的不良事件,包括已知的事件 (血小板缺血,白血病,贫血,口炎,肺炎) 和意想不到的事件 (血小板微血管病,耳毒性,第二次原发性恶性瘤,毒性脏病,卵巢衰竭).
- 相关的ADEs发病的中位时间为10天,73.8%发生在第一个月内.
- 确定了特定的高风险信号:男性肺炎和心脏病发作;女性药物耐药性和耳毒性.
结论:
- 现实世界的数据挖掘揭示了与etoposide相关的预期和新的不良药物事件.
- 大多数与埃托波类药物相关的不良反应在治疗的第一个月内表现出来.
- 这些研究结果支持加强对埃托类药物治疗的临床监测和风险识别策略,考虑到人口特异性风险.
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