Hasenkam J M, Kimose H H, Knudsen L, Grønnesby H, Halborg J, Christensen T D, Attermann J, Pilegaard H K
Department of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital, Aarhus N, Denmark.
Eur J Cardiothorac Surg. 1997 May;11(5):935-42. doi: 10.1016/s1010-7940(97)01204-9.
Patients with mechanical heart valves require lifelong oral anticoagulant treatment which entails frequent blood sampling and dosage adjustment. The purpose of this study was to investigate the feasibility of letting heart valve operated patients manage blood specimen analysis and dosage adjustment themselves.
A total of 21 patients were enrolled in the study and followed for at least 9 months postoperatively. Immediately after the heart valve operation they were trained in operating a CoaguChek international normal ratio (INR) monitor to analyze capillary whole blood samples. Subsequently training in dosage adjustment was accomplished and all patients were considered fully capable of self management after 30 weeks. In the training period, parallel laboratory INR measurements were made at 3-4 week intervals for reference. A control group of 20 patients was matched, respectively, to the study group. The INR target range was 2.0-3.0.
Out of the 21 study patients 19 continued self management beyond 9 months. The median INR value obtained with the monitor was within therapeutic target range for all study patients and only 15 out of 20 control patients were within this range. The mean systematic deviation between laboratory and CoaguChek INR was 7.8% but each patient had a constant characteristic deviation from -11 to +21%. The study patients were within therapeutic target range 77% of the time compared with 53% for the control patients.
Self management of oral anticoagulation is feasible for selected patients and constitutes a significant service improvement compared with conventional management. The CoaguChek monitor seems sufficiently accurate and reliable for self testing and the treatment quality is comparable or even better than conventional management. Assessment of the rate of bleeding and thrombo-embolic events shall be settled in studies comprising larger number of patients.
机械心脏瓣膜患者需要终身口服抗凝治疗，这需要频繁采血和调整剂量。本研究的目的是调查让心脏瓣膜手术患者自行管理血样分析和剂量调整的可行性。
共有21名患者纳入本研究，并在术后至少随访9个月。心脏瓣膜手术后，立即对他们进行操作CoaguChek国际标准化比值（INR）监测仪分析毛细血管全血样本的培训。随后完成剂量调整培训，30周后所有患者均被认为完全具备自我管理能力。在培训期间，每隔3 - 4周进行一次平行实验室INR测量以供参考。将20名患者组成的对照组分别与研究组进行匹配。INR目标范围为2.0 - 3.0。
21名研究患者中有19名在9个月后继续自我管理。监测仪测得的INR中位数对所有研究患者而言均在治疗目标范围内，而20名对照患者中只有15名在此范围内。实验室与CoaguChek INR之间的平均系统偏差为7.8%，但每位患者有一个从 -11%到 +21%的恒定特征偏差。研究患者77%的时间处于治疗目标范围内，而对照患者为53%。
对于选定的患者，口服抗凝的自我管理是可行的，与传统管理相比，这是一项显著的服务改进。CoaguChek监测仪似乎足够准确和可靠用于自我检测，且治疗质量与传统管理相当甚至更好。出血和血栓栓塞事件发生率的评估应在纳入更多患者的研究中解决。
