华法林剂量计算器的应用以指导个性化剂量与固定的剂量后的经验调整:试点研究
Xiaofang Cai1,2,3, Jiana Chen1,2, Maohua Chen1,2,4
1Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China.
Frontiers in pharmacology
|September 4, 2023
概括
华法林剂量计算器软件改善了华法林抗凝剂在中国患者通过减少时间达到治疗国际规范化比率 (INR) 和减少过度抗凝事件. 这种临床工具增强了华法林治疗的安全性和有效性.
科学领域:
- 药理学和治疗学 药理学和治疗学
- 临床药房 临床药房
- 医疗信息学 医疗信息学
背景情况:
- 华法林的剂量需要仔细监测,因为它的治疗窗口狭窄和个体变化,需要定期检查国际标准化比率 (INR).
- 基于欧洲/美国人口的现有华法林剂量计算器 (WDC) 软件需要在中国患者中验证准确性.
- 这项研究解决了需要验证WDC软件在真实世界的中国临床环境中的适用性.
研究的目的:
- 评估华法林剂量计算器 (WDC) 软件的可行性和临床实用性,用于指导华法林在中国患者群体中的剂量.
- 为了比较WDC软件引导的剂量方案与在进行门置换的患者中标准的固定剂量方案.
主要方法:
- 一项试点研究将76名门更换后患者随机分为试验组 (WDC软件引导剂量) 和对照组 (固定2.5毫克/天剂量,经验调整).
- 两组被跟踪了3个月,分析的重点是抗凝结结果和过度抗凝结事件.
- 使用Kaplan-Meier生存曲线和Logrank测试来评估首次INR遵守和实现率的时间.
主要成果:
- 与对照组 (p < 0.05) 相比,WDC组在较少的测试 (1.43 较少) 中显著更快地实现了第一个INR合规 (减少了4.38 天).
- 治疗范围中的时间 (TTR) 在WDC组显著更高 (p <0.05),第一个INR达到率也显著更高 (p = 0.01).
- 虽然没有发生重大出血,但WDC组的过度抗凝事件 (INR>3.5和轻微出血) 显著减少 (p <0.05).
结论:
- 华法林剂量计算器软件有效指导个性化的华法林剂量,在研究的中国人群中证明优于固定2.5毫克/天剂量.
- WDC软件应用程序缩短了治疗INR的时间,提高了达到率,提高了治疗范围的平均时间,并减少了过度的抗凝事件.
- 研究结果表明,WDC软件在临床实践中提高了华法林抗凝治疗的安全性和效率.
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