与内甲素受体对抗剂相关的肝损伤:基于FDA不良事件报告系统数据的药监测研究
Jinjian Gu1, Yuting Guo2, Bin Wu2
1West China School of Pharmacy, Sichuan University, Chengdu, Sichuan, China.
International journal of clinical pharmacy
|June 20, 2024
概括
像博森坦和马西森坦这样的内甲素受体对抗剂与药物诱导的肝损伤有关. 医疗保健提供者应监测肝功能,特别是高风险患者,由于这些风险.
科学领域:
- 药监和药物安全 药监和药物安全
- 肝病学 肝病学是一种肝病学.
- 临床药理学 临床药理学
背景情况:
- 内甲素受体抗剂 (ERA) 在临床上被广泛使用.
- 有关ERA的潜在肝毒性存在担忧.
研究的目的:
- 评估ERA与药物诱导性肝损伤 (DILI) 之间的关联.
- 利用FDA不良事件报告系统 (FAERS) 进行全面的药物监测.
主要方法:
- 分析了2004年1月至2022年12月的FAERS数据.
- 使用不成比例算法 (ROR,IC) 来检测DILI信号.
- 对DILI事件进行了年龄和性别分层分析.
主要成果:
- 博森坦和马西森坦与肝损伤有显著的关联.
- 博森坦与胆固醇,肝细胞损伤和严重的肝脏疾病有关.
- 马西与肝衰竭,胆固醇损伤和严重的肝脏疾病有关.
结论:
- 博森坦和马西森坦的使用需要监测肝损伤.
- 常规血清氨基转移酶监测建议在风险患者.
- 建议对ERA药物相互作用进行进一步调查.
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