Cai Xiaofang, Chen Jiana, Chen Maohua, Xia Xiaotong, Fang Guanhua, Zhang Jinhua
Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China.
Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, China.
Front Pharmacol. 2023 Aug 17;14:1235331. doi: 10.3389/fphar.2023.1235331. eCollection 2023.
Warfarin has a narrow therapeutic window and individual variation, and patients require regular follow-up and monitoring of the International Normalized Ratio (INR) for dose adjustment. The calculation method of Warfarin Dosing Calculator (WDC) software is based on the European and American populations, and its accuracy in the Chinese population is yet to be verified. This study was to evaluate the feasibility of applying Warfarin Dosing Calculator software intervention in a real-world clinical research setting in China. The pilot study divided the included patients after valve replacement into an experimental group and a control group, with 38 cases in each group. In the control group, the initial dose was fixed at 2.5 mg/d and the dose was adjusted empirically during the study period; in the experimental group, the Warfarin Dosing Calculator software was applied to guide the dosing, and patients in both groups were followed up for 3 months. Analysis of the incidence anticoagulation outcomes and excessive anticoagulation events in both groups. Kaplan-Meier survival curves were used to analyze the correlation between different dosing regimens and first International Normalized Ratio attainment, and Logrank tests were performed. The mean time required for first International Normalized Ratio compliance in the experimental group was 4.38 days less than in the control group, and the mean number of tests was 1.43 less ( < 05). Time in therapeutic range (TTR) was significantly higher in the experimental group than in the control group ( < 05). Kaplan-Meier survival curve analysis showed that the first International Normalized Ratio attainment rate was significantly higher in the experimental group than in the control group ( = 01). No major bleeding events occurred in either group, but other excessive anticoagulation events (INR>3.5 and minor bleeding) were significantly reduced in the experimental group compared with the control group ( < 05). Application of Warfarin Dosing Calculator software to guide individualized warfarin dosing may be better than a fixed dose of 2.5 mg/d. It may be shorten the time to first International Normalized Ratio attainment, and the attainment rate in the same time, and can better improve the mean Time in therapeutic range level value and reduce excessive anticoagulation events, which improves the safety of warfarin anticoagulation therapy in clinical practice. https://www.chictr.org.cn/showproj.html?proj=52793, ChiCTR2000032393.
华法林的治疗窗狭窄且存在个体差异，患者需要定期随访并监测国际标准化比值（INR）以调整剂量。华法林剂量计算器（WDC）软件的计算方法基于欧美人群，其在中国人群中的准确性尚待验证。本研究旨在评估在中国真实世界临床研究环境中应用华法林剂量计算器软件干预的可行性。该试点研究将纳入的瓣膜置换术后患者分为试验组和对照组，每组38例。对照组初始剂量固定为2.5mg/d，研究期间根据经验调整剂量；试验组应用华法林剂量计算器软件指导给药，两组患者均随访3个月。分析两组抗凝结局和抗凝过度事件的发生率。采用Kaplan-Meier生存曲线分析不同给药方案与首次达到国际标准化比值之间的相关性，并进行Logrank检验。试验组首次达到国际标准化比值所需的平均时间比对照组少4.38天，平均检测次数少1.43次（P<0.05）。试验组在治疗范围内的时间（TTR）显著高于对照组（P<0.05）。Kaplan-Meier生存曲线分析显示，试验组首次达到国际标准化比值的达标率显著高于对照组（P=0.01）。两组均未发生严重出血事件，但试验组与对照组相比，其他抗凝过度事件（INR>3.5和轻微出血）显著减少（P<0.05）。应用华法林剂量计算器软件指导华法林个体化给药可能优于固定剂量2.5mg/d。它可能缩短首次达到国际标准化比值的时间，并在同一时间内提高达标率，还能更好地提高平均治疗范围内时间水平值并减少抗凝过度事件，从而提高华法林抗凝治疗在临床实践中的安全性。https://www.chictr.org.cn/showproj.html?proj=52793, ChiCTR2000032393
