长效性淋巴激素释放激素类似物之间的不良事件概况差异:一个现实世界的药监测研究
Yuting Chen1,2, Weitao Lu3, Ruilian Liao4
1Department of Pharmacy, Guangzhou Red Cross Hospital of Jinan University, Guangzhou, Guangdong, China.
PloS one
|July 11, 2025
概括
长期作用的释放性荷尔蒙类似物 (GnRHa) 显示出不同的安全性. 布塞雷林和希斯特林具有明显的不良事件,儿童使用与较低的风险有关.
科学领域:
- 药物监督 药物监督 药物监督
- 内分泌学 在内分泌学.
- 在瘤学瘤学.
背景情况:
- 长效的淋巴激素释放激素类似物 (GnRHa) 广泛用于治疗前列腺癌,乳腺癌,子宫内膜异位症,子宫瘤和中部早发性青春期 (CPP) 等疾病.
- 现有的研究缺乏对不同GnRHa配方之间的现实安全概况进行全面比较.
研究的目的:
- 根据美国食品和药物管理局不良事件报告系统 (FAERS) 的数据,研究和比较各种长效GnRHa的不良事件 (AE) 概况.
主要方法:
- 在2004年1月至2023年9月的FAERS数据上,使用报告赔率比率 (ROR) 进行了不成比例分析.
- 单变量和多变量逻辑回归分析确定了与长效GnRHa相关的严重AEs的几率比率 (OR),考虑了各种暴露因素.
主要成果:
- 生殖系统和乳腺疾病是5种分析的GnRHa配方中最常见的副作用.
- 布塞雷林和希斯特林表现出不同的AE概况,布塞雷林与更多的胃肠道疾病有关,而希斯特林与增加的精神疾病有关.
- 后勤回归表明所有五种GnRHa的重大医疗事件风险增加,儿童患者 (<18岁) 与成人 (≥18岁) 相比,观察到的风险明显较低.
结论:
- 长效GnRHa药物的不良事件概况存在显著差异.
- 确定高风险患者群体和加强AE监测对于这些药物的安全临床使用至关重要.
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