Department of Internal Medicine, Washington University, St Louis, MO, USA.
Pharmacogenomics J. 2012 Oct;12(5):417-24. doi: 10.1038/tpj.2011.18. Epub 2011 May 24.
The risk of venous thromboembolism (VTE) is higher after the total hip or knee replacement surgery than after almost any other surgical procedure; warfarin sodium is commonly prescribed to reduce this peri-operative risk. Warfarin has a narrow therapeutic window with high inter-individual dose variability and can cause hemorrhage. The genetics-informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT) is a 2 × 2 factorial-design, randomized controlled trial designed to compare the safety and effectiveness of warfarin-dosing strategies. GIFT will answer two questions: (1) does pharmacogenetic (PGx) dosing reduce the rate of adverse events in orthopedic patients; and (2) is a lower target international normalized ratio (INR) non-inferior to a higher target INR in orthopedic participants? The composite primary endpoint of the trial is symptomatic and asymptomatic VTE (identified on screening ultrasonography), major hemorrhage, INR ≥ 4, and death.
静脉血栓栓塞症（VTE）的风险在全髋关节或全膝关节置换术后高于几乎任何其他手术；华法林钠通常用于降低围手术期的风险。华法林的治疗窗狭窄，个体间剂量差异大，可引起出血。预防深静脉血栓形成（DVT）的华法林基因信息学试验（GIFT）是一项 2×2 析因设计、随机对照试验，旨在比较华法林剂量策略的安全性和有效性。GIFT 将回答两个问题：（1）药物基因组学（PGx）剂量是否降低骨科患者的不良事件发生率；（2）较低的目标国际标准化比值（INR）是否不劣于骨科参与者的较高目标 INR？试验的综合主要终点是症状性和无症状性 VTE（通过筛查超声检查确定）、大出血、INR≥4 和死亡。
