来自FAERS和JADER数据库的GnRHas引起的不良事件的不成比例分析
Shupeng Zou1, Mengling Ouyang1, Yazheng Zhao1
1Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Frontiers in pharmacology
|July 19, 2024
概括
这项研究通过分析FDA和日本的不良事件数据库,确定了性腺激素释放激素类似物 (GnRHas) 的潜在新不良事件信号,突出了持续安全监测的必要性.
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:
- 激素释放性荷尔蒙类似物 (GnRHas) 对于治疗妇科疾病,早熟青春期和癌症至关重要.
- 确保GnRHas的现实安全性需要持续监测和分析不良事件 (AE).
研究的目的:
- 通过使用FDA不良事件报告系统 (FAERS) 和日本不良药事件报告 (JADER) 的数据,对与GnRHas相关的AE进行不成比例分析.
- 识别和描述潜在的新AE信号,并评估未列出的AE在各种GnRHas的临床优先级.
主要方法:
- 对FAERS和JADER数据 (2004-2023) 应用了两个调整的算法,以检测与GnRHa相关的AE信号.
- 使用统计分析系统 (SAS 9.4) 进行信号检测,包括调整报告几率比率 (aROR) 分析.
- 对可疑的首选术语 (PT) 进行了临床优先评估,并分析了严重与非严重的结果以及AE发病时间.
主要成果:
- 确定了许多可疑的leuprolide,goserelin和triptorelin的PT,其中一些PT在规格中没有列出.
- 观察到AE个人资料中的数据库特定差异,包括心力衰竭,糖尿病和自杀念头.
- 普罗利德显示严重AE的可能性更高 (例如,喘息,糖尿病,间歇性肺部疾病),一些PT显示出强有力的关联证据.
结论:
- 分析揭示了与GnRHas相关的可疑副作用,表明了潜在的新安全信号.
- 这些发现支持持续临床监测,强有力的药物监测和进一步调查GnRHa安全性概况的区域差异的需要.
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