初治非瓣膜性心房颤动患者华法林药物基因检测剂量的随机试验
A Randomized Trial of Pharmacogenetic Warfarin Dosing in Naïve Patients with Non-Valvular Atrial Fibrillation.
作者信息
Pengo Vittorio, Zambon Carlo-Federico, Fogar Paola, Padoan Andrea, Nante Giovanni, Pelloso Michela, Moz Stefania, Frigo Anna Chiara, Groppa Francesca, Bozzato Dania, Tiso Enrico, Gnatta Elisa, Denas Gentian, Padayattil Jose Seena, Padrini Roberto, Basso Daniela, Plebani Mario
机构信息
Department of Cardiac, Thoracic, and Vascular Sciences University of Padova, Padova, Italy.
Department of Medicine-DIMED, University of Padova, Padova, Italy.
出版信息
PLoS One. 2015 Dec 28;10(12):e0145318. doi: 10.1371/journal.pone.0145318. eCollection 2015.
UNLABELLED
Genotype-guided warfarin dosing have been proposed to improve patient’s management. This study is aimed to determine whether a CYP2C9- VKORC1- CYP4F2-based pharmacogenetic algorithm is superior to a standard, clinically adopted, pharmacodynamic method. Two-hundred naïve patients with non-valvular atrial fibrillation were randomized to trial arms and 180 completed the study. No significant differences were found in the number of out-of-range INRs (INR<2.0 or >3.0) (p = 0.79) and in the mean percentage of time spent in the therapeutic range (TTR) after 19 days in the pharmacogenetic (51.9%) and in the control arm (53.2%, p = 0.71). The percentage of time spent at INR>4.0 was significantly lower in the pharmacogenetic (0.7%) than in the control arm (1.8%) (p = 0.02). Genotype-guided warfarin dosing is not superior in overall anticoagulation control when compared to accurate clinical standard of care.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01178034.
未标注
有人提出根据基因型指导华法林给药以改善患者管理。本研究旨在确定基于CYP2C9 - VKORC1 - CYP4F2的药物遗传学算法是否优于标准的、临床采用的药效学方法。200例初治非瓣膜性心房颤动患者被随机分配至各试验组，180例完成研究。药物遗传学组（51.9%）和对照组（53.2%）在第19天后超出范围的国际标准化比值（INR<2.0或>3.0）数量（p = 0.79）以及处于治疗范围内的平均时间百分比（TTR）方面均未发现显著差异（p = 0.71）。药物遗传学组INR>4.0的时间百分比（0.7%）显著低于对照组（1.8%）（p = 0.02）。与准确的临床标准治疗相比，基于基因型指导的华法林给药在总体抗凝控制方面并不具有优势。
试验注册
ClinicalTrials.gov NCT01178034 。
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