血管激素受体阻断剂和疑似药物诱导肝损伤的风险:在韩国使用基于电子健康记录的共同数据模型进行了一项回顾性队列研究
Hyunjoo Kim1,2, Nayeong Son1, Dahee Jeong1
1Department of Drug Safety Information, Korea Institute of Drug Safety and Risk Management, 14051, 6th FL, 30, Burim-ro 169beon-gil, Dongan-gu, Anyang, Gyeonggi-do, Republic of Korea.
Drug safety
|March 21, 2024
概括
与瓦尔沙坦相比,阿齐尔沙坦单疗显示药物诱导性肝损伤 (DILI) 的风险明显更高. 这项研究强调了现实世界的证据对于理解血管素受体阻断剂的不良药物反应的重要性.
科学领域:
- 药物监督 药物监督 药物监督
- 肝病学 肝病学是一种肝病学.
- 临床流行病学临床流行病学
背景情况:
- 血管激素受体抑制剂 (ARB) 是韩国常见的抗高血压药物.
- 在2021年确定了对阿齐尔沙坦诱导的肝损伤的国家补偿的需要.
- 有限的数据存在于ARBs和药物诱导性肝损伤 (DILI) 之间的关联.
研究的目的:
- 在特定的ARB中比较DILI的风险.
- 使用瓦尔沙坦作为参考比较药物.
- 从一个共同的数据模型数据库 (2017-2021) 中分析事件ARB用户.
主要方法:
- 追溯队列研究的设计.
- 根据处方的ARB分配给治疗组的患者.
- 根据国际DILI专家工作组标准定义的DILI.
- 考克斯回归和治疗权重的逆概率 (IPTW) 应用.
- 使用R.进行的分析.
主要成果:
- 包括来自20所大学医院的229,881名ARB用户.
- 原始DILI发病率从每1000人/年有15.6到82.8的变化.
- 奥尔梅沙坦使用者的DILI风险明显低于瓦尔萨坦使用者的DILI风险 (HR:0.73).
- 阿齐尔沙坦单疗使用者比瓦尔沙坦使用者有显著更高的DILI风险 (HR:6.55).
结论:
- 与瓦尔沙坦单疗相比,阿齐尔沙坦单疗与疑似DILI的风险更高.
- 这些发现强调了现实世界的证据在理解ARB相关的不良药物反应的价值.
- 进一步的研究可能会为ARB选择的临床实践指南提供信息.
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