口服固酶5型抑制剂和青症:一个VigiBase分析
Behzad Abbasi1, Nathan M Shaw1,2,3, Jason L Lui1
1Department of Urology, University of California San Francisco, San Francisco, California, USA.
Pharmacoepidemiology and drug safety
|November 1, 2023
概括
固酶5型抑制剂 (PDE5i) 显示出不成比例地更高的青症事件信号,特别是在年轻的患者中. 与PDE5i相比,内药物总体上具有更强的priapism信号.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
背景情况:
- 勃起起因药物,包括固酶5型抑制剂 (PDE5i) 和洞内药物,广泛用于勃起功能障碍.
- 是与这些治疗相关的已知的不良药物反应.
- 了解比较风险概况对于患者安全至关重要.
研究的目的:
- 调查和比较与PDE5i相关的priapism事件的发生率和报告不成比例,与洞内药物相比.
- 为了确定特定的患者群体或药物剂,具有较高的危险的priapism.
主要方法:
- 利用了世界卫生组织的VigiBase数据库的个体病例安全报告.
- 分析了西尔德纳菲尔,塔达拉菲尔,阿瓦纳菲尔,瓦尔德纳菲尔,帕帕维林和阿尔普拉斯塔迪尔的不良药物反应.
- 雇佣了不成比例分析 (案例/非案例方法) 来计算报道对的概率比率 (ROR).
主要成果:
- 在133,819个不良药物反应事件中,有632个是前症 (PDE5i:0.41%,洞内药物:9.92%).
- 与PDE5i (ROR = 1.38) 相比,内药物表现出明显更强的青症不成比例信号 (ROR = 34.7),而不是PDE5i (ROR = 1.38).
- 较年轻的年龄组 (12-17岁和2-11岁) 显示PDE5i使用的ROR较高,特别是与西尔代纳菲尔,与18岁及以上的个人相比.
结论:
- PDE5i的使用与不成比例地更高的青春欲乱症报告信号有关,特别是在儿科和青少年群体中.
- 与PDE5i相比,内药物显示出明显更强烈的青症信号.
- 这项研究强调了需要仔细选择和监测患者的必要性,特别是在使用PDE5抑制剂的年轻人中.
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