药物诱导性妇产不良:FDA不良事件报告系统数据库的数据挖掘和分析
Xiuli Yang1, Xiaochun Zheng1, Miaomiao Zhang1,2
1Center for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, Zhejiang, People's Republic of China.
Clinical epidemiology
|September 16, 2024
概括
这项研究分析了30265例妇产不适症病例,发现神经系统药物,特别是RISPERIDONE,是最相关的. 时间至发病分析表明,大多数顶级妇产不良诱导药物的早期发生.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 药物诱导的妇产不良是一种影响患者健康的重大不良事件.
- 了解药物相关性对于临床管理和患者安全至关重要.
- 食品和药物管理局的不良事件报告系统 (FAERS) 数据库是药监监管的宝贵资源.
研究的目的:
- 在FAERS数据库中对妇产不良报告进行探索性分析.
- 为了确定最常与药物诱导性妇产不全相关的药物.
- 为了研究顶级涉及的药物的发病时间特征.
主要方法:
- 对2004年1月至2023年12月的FAERS数据进行分析.
- 使用报告的几率比率 (ROR) 来检测药物信号的不成比例分析.
- 逻辑回归用于风险因素评估和韦布尔形状参数测试用于时间到发病分析.
主要成果:
- 鉴定了30,265例妇产不良,其中85.50%与神经系统药物有关,特别是RISPERIDONE (80.81%).
- 最强烈的妇产的信号包括瑞斯佩里 (ROR 602.38),杜塔斯特 (ROR 17.18) 和螺旋乳 (ROR 15.8).
- 后勤回归显示,成年人与儿科患者的风险较低,风险更高,体重增加. 韦布尔分析表明,大多数顶级药物的早期发作.
结论:
- 神经系统的药物,特别是瑞斯佩里,与药物诱导的妇产不适有很强的关联.
- 了解风险因素,如年龄和体重,以及早期发病时间模式,有助于临床识别.
- FAERS数据分析提供了有价值的见解,以改善药物安全性和患者护理,以改善妇产不良.
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