与丸激素治疗相关的主要心血管不良事件:FAERS数据库的药监测研究
Hui Zhao1, Jun-Min Li2, Zi-Ran Li1
1Department of Pharmacy, Huashan Hospital, Fudan University, Shanghai, China.
Frontiers in pharmacology
|July 28, 2023
概括
替代疗法 (TRT) 可能会增加心肌梗塞和心肌病变的风险,但在患有并发症的患者中,对心脏病有好处. MACEs很罕见但严重,需要医疗保健提供者和患者的注意.
科学领域:
- 心血管医学 心血管医学
- 内分泌学 在内分泌学.
- 药物监督 药物监督 药物监督
背景情况:
- 对于男性特征至关重要,并用于治疗男性阴性腺症的替代疗法 (TRT).
- 关于TRT与主要不良心血管事件 (MACE) 之间的关联存在争议.
- 来自FAERS的现实世界不良事件数据为TRT的心血管安全概况提供了洞察力.
研究的目的:
- 使用FDA FAERS数据调查TRT和MACE之间的关联.
- 确定与TRT相关的特定MACE,并分析其报告中的趋势.
- 为了评估TRT关于心血管结果的风险益处概况.
主要方法:
- 对2004年1月至2022年12月的FAERS数据的分析.
- 使用数据挖掘协议,包括报告几率比率 (ROR) 和贝叶斯信任传播神经网络 (BCPNN).
- 调查了与TRT相关的MACEs的过度报告,考虑了发病率和年龄,并分析了药监信号趋势.
主要成果:
- 在28921名丸激素使用者 (平均年龄57岁) 中,确定了3057例MACE病例.
- 2014年出现了MACE的显著药监信号,包括心肌梗塞和心肌病变.
- TRT与心脏病发作和心肌病变的风险增加有关,但在患有TD,DM和高血压的患者中,对心律失常,衰竭和中风有潜在的益处.
结论:
- TRT与心血管事件有复杂的关系,增加了一些MACE的风险,同时可能有利于其他人.
- 与TRT相关的MACE很少发生,但可能导致死亡和残疾等严重后果.
- 与TRT相关的MACE报告不足可能是显著的,突出显示医疗保健专业人员和患者需要提高认识.
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