Ansell Jack, Hirsh Jack, Hylek Elaine, Jacobson Alan, Crowther Mark, Palareti Gualtiero
From Boston University School of Medicine, Boston, MA.
Hamilton Civic Hospitals, Henderson Research Centre, Hamilton, ON, Canada.
Chest. 2008 Jun;133(6 Suppl):160S-198S. doi: 10.1378/chest.08-0670.
This article concerning the pharmacokinetics and pharmacodynamics of vitamin K antagonists (VKAs) is part of the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). It describes the antithrombotic effect of the VKAs, the monitoring of anticoagulation intensity, and the clinical applications of VKA therapy and provides specific management recommendations. Grade 1 recommendations are strong and indicate that the benefits do or do not outweigh the risks, burdens, and costs. Grade 2 recommendations suggest that the individual patient's values may lead to different choices. (For a full understanding of the grading, see the "Grades of Recommendation" chapter by Guyatt et al, CHEST 2008; 133:123S-131S.) Among the key recommendations in this article are the following: for dosing of VKAs, we recommend the initiation of oral anticoagulation therapy, with doses between 5 mg and 10 mg for the first 1 or 2 days for most individuals, with subsequent dosing based on the international normalized ratio (INR) response (Grade 1B); we suggest against pharmacogenetic-based dosing until randomized data indicate that it is beneficial (Grade 2C); and in elderly and other patient subgroups who are debilitated or malnourished, we recommend a starting dose of < or = 5 mg (Grade 1C). The article also includes several specific recommendations for the management of patients with nontherapeutic INRs, with INRs above the therapeutic range, and with bleeding whether the INR is therapeutic or elevated. For the use of vitamin K to reverse a mildly elevated INR, we recommend oral rather than subcutaneous administration (Grade 1A). For patients with life-threatening bleeding or intracranial hemorrhage, we recommend the use of prothrombin complex concentrates or recombinant factor VIIa to immediately reverse the INR (Grade 1C). For most patients who have a lupus inhibitor, we recommend a therapeutic target INR of 2.5 (range, 2.0 to 3.0) [Grade 1A]. We recommend that physicians who manage oral anticoagulation therapy do so in a systematic and coordinated fashion, incorporating patient education, systematic INR testing, tracking, follow-up, and good patient communication of results and dose adjustments [Grade 1B]. In patients who are suitably selected and trained, patient self-testing or patient self-management of dosing are effective alternative treatment models that result in improved quality of anticoagulation management, with greater time in the therapeutic range and fewer adverse events. Patient self-monitoring or self-management, however, is a choice made by patients and physicians that depends on many factors. We suggest that such therapeutic management be implemented where suitable (Grade 2B).
本文关于维生素K拮抗剂(VKA)的药代动力学和药效学,是美国胸科医师学会循证临床实践指南(第8版)的一部分。它描述了VKA的抗血栓形成作用、抗凝强度监测以及VKA治疗的临床应用,并提供了具体的管理建议。1级推荐力度较强,表明获益是否超过风险、负担和成本。2级推荐表明个体患者的价值观可能导致不同选择。(关于分级的完整理解,见Guyatt等人所著的“推荐分级”章节,《CHEST》2008年;133:123S - 131S。)本文的关键推荐如下:对于VKA给药,我们推荐开始口服抗凝治疗,大多数个体最初1或2天的剂量为5毫克至10毫克,随后根据国际标准化比值(INR)反应给药(1B级);在随机数据表明基于药物遗传学的给药有益之前,我们建议不要采用这种给药方式(2C级);对于老年及其他衰弱或营养不良的患者亚组,我们推荐起始剂量≤5毫克(1C级)。本文还包括针对INR未达治疗水平、INR高于治疗范围以及无论INR处于治疗水平还是升高时出现出血的患者管理的若干具体建议。对于使用维生素K纠正轻度升高的INR,我们推荐口服而非皮下给药(1A级)。对于有危及生命的出血或颅内出血的患者,我们推荐使用凝血酶原复合物浓缩物或重组凝血因子VIIa立即纠正INR(1C级)。对于大多数有狼疮抗凝物的患者,我们推荐治疗目标INR为2.5(范围2.0至3.0)[1A级]。我们建议管理口服抗凝治疗的医生以系统且协调的方式进行,包括患者教育、系统的INR检测、跟踪、随访以及与患者就结果和剂量调整进行良好沟通[1B级]。在经过适当选择和培训的患者中,患者自我检测或自我给药管理是有效的替代治疗模式,可提高抗凝管理质量,使处于治疗范围内的时间更长且不良事件更少。然而,患者自我监测或自我管理是患者和医生根据多种因素做出的选择。我们建议在合适的情况下实施这种治疗管理(2B级)。