药物遗传学指导与标准华法林剂量用于常规临床护理及其药物经济影响:随机对照临床试验
Aishwarya Anand1, Naveen C Hegde1, Pulkit Chhabra2
1Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Annals of hematology
|April 18, 2024
概括
药物遗传学测试 (PGT) 通过增加治疗范围的时间,与标准护理相比,显著改善了华法林治疗. 这种临床实用性和成本效益支持在低资源环境中实施PGT.
科学领域:
- 药物基因组学 药物基因组学
- 临床药理学 临床药理学
- 卫生经济学 卫生经济学
背景情况:
- 药物遗传测试 (PGT) 在高收入国家很常见,但其在低收入和中等收入国家 (LMICs) 的临床实用性和成本效益仍未得到充分研究.
- 华法林治疗需要仔细的剂量定位,而CYP2C9和VKORC1的遗传变异会影响患者的反应.
研究的目的:
- 评估PGT指导的华法林治疗与LMIC环境中的标准护理 (SOC) 的临床实用性和健康经济性.
- 为了比较关键的临床结果,包括治疗范围内的时间 (TTR) 和不良事件.
主要方法:
- 一项开放的随机对照试验比较了168名患者的PGT引导的华法林治疗与SOC.
- 对PGT手臂进行了CYP2C9*2,CYP2C9*3和VKORC1的遗传分析.
- 主要终点是90天内在治疗INR范围内度过的百分比时间;次要终点包括达到治疗INR的时间和不良事件.
主要成果:
- 与SOC手臂 (8.8%) 相比,PGT引导手臂的TTR中位数 (42.85%) 显著更高 (p < 0.00001).
- 在PGT组 (17.85天) 和SOC组 (33.92天) 中,达到治疗INR的时间较短 (p = 0.002).
- 不良事件是相似的,但PGT部门的终身支出较高,尽管它在低于1GDP的支付意愿门下被认为是具有成本效益的.
结论:
- 华法林的药物遗传测试在LMIC环境中显示出显著的临床疗效和成本效益.
- 建议将PGT作为临床调查的常规实施,以改善LMICs的华法林患者护理.
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