Eldor Amiram, Schwartz Joseph
Institute of Hematology, Tel-Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Pathophysiol Haemost Thromb. 2002 May-Jun;32(3):99-106. doi: 10.1159/000065212.
The efficacy of oral anticoagulants (OAC) in reducing the incidence of stroke in elderly patients with atrial fibrillation (AF) has been well documented. The intensity of OAC therapy and deviations in the prothrombin time (PT) are the strongest risk factor for bleeding complications in elderly patients. The aim of this study was to evaluate a more rigorous regulation of OAC by the use of a portable whole blood PT-monitor (CoaguChek) in elderly patients with AF (age 65-80 years). The study group consisted of 20 patients, of whom 17 were evaluable, which were trained to use to CoaguChek monitor and adjust their anticoagulant dose for 12 months. The control group, 20 patients matched for age, gender and the duration of OAC treatment, were tested in an anticoagulant clinic and their OAC dose was adjusted by a physician. To validate the PT-monitor results, the patients performed a total of 129 simultaneous venous blood PT tests at various time points. The correlation coefficient R(2) was 0.707 indicating the accuracy of the CoaguChek results. The self-managed patients perform more frequent measurements 46 +/- 8.9 vs. 15.7 +/- 3.1 PT tests per patient. They demonstrated a within the therapeutic range INR in 80.5% of the tests (95% confidence interval, 76.5-84.1%) as compared to 72.4% (95% confidence interval, 68.5-76.5%) in the control group (p = 0.057). The median value for all CoaguChek International Normalized Ratio (INR) recordings was within therapeutic range in the self-management group as well as in the control group. There were fewer INR results below or above the therapeutic range in the study group. None of the patients had hemorrhagic or thrombotic events during the study. Overall, the study group expressed high satisfaction from using the home monitor. We conclude that home PT monitoring and self-management of OAC are feasible in a motivated population of elderly patients with atrial fibrillation and are probably cost effective.
口服抗凝剂（OAC）在降低老年房颤（AF）患者中风发生率方面的疗效已有充分记录。OAC治疗强度及凝血酶原时间（PT）偏差是老年患者出血并发症的最强危险因素。本研究旨在评估通过使用便携式全血PT监测仪（CoaguChek）对老年房颤患者（年龄65 - 80岁）进行更严格的OAC管理。研究组由20名患者组成，其中17名可评估，他们接受培训使用CoaguChek监测仪并调整抗凝剂剂量，为期12个月。对照组为20名年龄、性别和OAC治疗时长匹配的患者，在抗凝门诊接受检测，其OAC剂量由医生调整。为验证PT监测仪结果，患者在不同时间点共进行了129次同步静脉血PT检测。相关系数R²为0.707，表明CoaguChek结果的准确性。自我管理组患者测量更频繁，每位患者平均进行46±8.9次PT检测，而对照组为15.7±3.1次。自我管理组80.5%的检测结果国际标准化比值（INR）处于治疗范围内（95%置信区间，76.5 - 84.1%），对照组为72.4%（95%置信区间，68.5 - 76.5%）（p = 0.057）。自我管理组和对照组所有CoaguChek国际标准化比值（INR）记录的中位数均在治疗范围内。研究组低于或高于治疗范围的INR结果较少。研究期间所有患者均未发生出血或血栓事件。总体而言，研究组对使用家用监测仪表示高度满意。我们得出结论，对于有积极性的老年房颤患者群体，家庭PT监测和OAC自我管理是可行的，且可能具有成本效益。
