对博森坦的风险最小化措施的实施评估:一项回顾性研究
Daji Alyami1, Ahmed H Abdelazeem1,2, Adel A Alrwisan3
1Pharmacy Department, College of Pharmacy, Nursing and Medical Sciences, Riyadh Elm University, Riyadh, Saudi Arabia.
Expert opinion on drug safety
|August 22, 2024
概括
对博森坦肝脏监测的遵守率很低,只有60%的患者在治疗前进行了测试,大多数患者对每月测试的遵守率很低. 这突显了降低博森坦相关肝毒性风险的差距.
科学领域:
- 药物监督和药物安全监测.
- 临床实践中的肝毒性风险管理.
背景情况:
- 博森坦治疗存在肝脏不良反应的风险.
- 监管机构要求对博森坦采取特定的风险最小化措施 (RMM),包括对肝脏生物标志物进行测试.
研究的目的:
- 为了评估对博森坦治疗的强制性肝脏监测要求的遵守.
- 评估在博森坦治疗前和治疗期间实施肝损伤生物标志物检测的情况.
主要方法:
- 新使用博森坦的回顾性队列研究 (2016-2022年).
- 肝检测数据从实验室记录中收集.
- 坚持性定义为90天内开始前的测试和分类的每月测试坚持性 (低,中等,高).
主要成果:
- 该研究包括100名患者;71%是女性,平均年龄为25岁.
- 在博森坦开始前对肝脏检测的遵守率为60%.
- 大多数患者 (58.2%) 缺乏每月肝检测要求.
结论:
- 对于肝毒性监测,遵守博森坦风险最小化措施是不理想的.
- 结果为跟踪RMM实施和比较最小化策略提供了基准.
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