Department of Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
Department of Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands; Department of Applied Health Research, University College London, London, UK.
Thromb Res. 2015 Jul;136(1):94-100. doi: 10.1016/j.thromres.2015.04.034. Epub 2015 May 2.
It has not been investigated how much the use of clinical factors in a dosing algorithm improves the percentage of time in therapeutic range (TTR). The present study aimed to compare the effect of dosing algorithms for acenocoumarol and phenprocoumon including clinical patient characteristics with standard care in the Netherlands.
The pre-EU-PACT study, an observational study in the Netherlands, was used to obtain standard care data. Data from the Dutch patients in the EU-PACT trial (comparing the use of a clinical algorithm with and without genetic information) was used for the clinical dosing algorithm.
For both acenocoumarol and phenprocoumon, the percentage of time in, below and above therapeutic International Normalized Ratio (INR) range during 12weeks after treatment initiation were assessed in both studies.
During the weeks 2-12, the clinical dosing algorithm of acenocoumarol (80 patients) led to a higher TTR (74.3% versus 68.0% in range 2.0-3.5, 95% Confidence interval [CI] difference: 0.5% to 11.8%), and a reduced percentage of time below INR 2 and above INR 3.5, compared with standard care (272 patients). For phenprocoumon, compared with standard care (484 patients), 80 patients treated by the dosing algorithm did not obtained a significantly higher TTR in range 2.0-3.5 or a lower percentage of time above 3.5, however, they spent more time with INR below 2.
The use of a clinical dosing algorithm for acenocoumarol seemed to improve the quality of anticoagulation therapy during the treatment of initial 2-12 weeks. For phenprocoumon, there was no statistically difference in anticoagulation control.
尚未研究在给药算法中使用临床因素会使治疗范围内时间百分比(TTR)提高多少。本研究旨在比较在荷兰,包括临床患者特征的新型抗凝剂华法林和苯丙香豆素给药算法与标准治疗的效果。
使用荷兰预 EU-PACT 研究中的观察性研究来获取标准治疗数据。来自荷兰 EU-PACT 试验(比较使用临床算法和无遗传信息)的患者数据被用于临床给药算法。
在两项研究中,评估治疗启动后 12 周内,新型抗凝剂华法林和苯丙香豆素的时间百分比(TTR)、低于治疗范围(INR)和高于治疗范围。
在第 2-12 周期间,与标准治疗相比,新型抗凝剂华法林的临床给药算法(80 例患者)导致 TTR 更高(INR 2.0-3.5 范围内分别为 74.3%和 68.0%,95%置信区间[CI]差值:0.5%至 11.8%),INR 低于 2 和高于 3.5 的时间百分比降低。对于苯丙香豆素,与标准治疗相比(484 例患者),80 例接受剂量算法治疗的患者在 INR 2.0-3.5 范围内未获得更高的 TTR,也没有更低的时间百分比超过 3.5,但他们的 INR 低于 2 的时间更多。
在治疗初始的 2-12 周期间,新型抗凝剂华法林的临床给药算法的使用似乎改善了抗凝治疗的质量。对于苯丙香豆素,抗凝控制没有统计学差异。