对阿帕胺的真实世界不成比例分析:FDA不良事件报告系统的数据挖掘
Zhihong Fang1, Zhiqiang Xu2, Wei Zhu2
1Department of General Surgery, The Affiliated Wuxi Children's Hospital of Nanjing Medical University, Wuxi, Jiangsu, China.
Frontiers in pharmacology
|June 21, 2023
概括
这项研究分析了现实世界的阿帕胺安全数据,确定了皮疹和疲劳等常见副作用. 这些发现有助于医生改善阿帕胺在前列腺癌治疗中的安全性.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 现实世界的证据.
背景情况:
- 阿帕胺是一种新型药物,已获批准用于前列腺癌 (PCa) 治疗.
- 现实世界的安全数据对于了解临床试验之外的药物概况至关重要.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 提供了一个有价值的数据来源.
研究的目的:
- 评估阿帕胺的现实安全性.
- 使用数据挖掘来识别与阿帕胺相关的潜在不良事件 (AE).
- 为了提高临床警和改善阿帕胺治疗期间的患者安全.
主要方法:
- 使用了FAERS数据,用于2018年第一季度至2022年第一季度的阿帕胺相关的AE报告.
- 采用不成比例分析,特别是报告概率比率 (ROR),以检测安全信号.
- 定义一个信号为ROR的95%置信区间下限>1与至少3报告的AE.
主要成果:
- 分析了4156份阿帕胺报告,确定了100个显著不成比例的首选术语 (PT).
- 经常报告的副作用包括皮疹,疲劳,腹,发热,跌倒,体重减轻和高血压.
- 最突出的器官系统类别 (SOC) 是"皮肤和皮下组织疾病",主要是皮肤学AEE (dAE).
- 其他显著的信号包括状角质炎,乙氨基酸细胞数量的增加,细菌性肺炎,肺结核和水.
结论:
- 这项研究提供了关于阿帕胺安全概况的强有力的现实世界证据.
- 这些发现强调了监测皮肤学不良事件和其他特定AE的重要性.
- 提高认识可以帮助临床医生和药剂师优化阿帕胺的使用和患者护理.
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