Clinical Pharmacy Anticoagulation Service, Aurora, Colorado 80011, USA.
Pharmacotherapy. 2012 Dec;32(12):1078-84. doi: 10.1002/phar.1139. Epub 2012 Oct 30.
To compare clinical and safety outcomes of warfarin therapy before and after implementation of a novel patient self-management (PSM) program in which patients received their venipuncture-derived international normalized ratio (INR) results through a secure online messaging system and adjusted their warfarin dosages and follow-up visits according to provided support tools.
Prospective, open-label, 3-month, pilot study.
Centralized clinical pharmacy anticoagulation service.
Forty-four patients with atrial fibrillation who were receiving warfarin for more than 6 months were enrolled in the trial between January 1, 2011, and February 28, 2011; 39 patients completed the trial. Patients acted as their own controls.
Patients received dosing decision support tools during a 2-hour live PSM training class. Those who then demonstrated proficiency in PSM assumed responsibility for their warfarin therapy management.
Outcomes of warfarin therapy were measured in each patient before and after implementation of the PSM program. Study variables included time in the therapeutic INR range (TTR), numbers of INR tests performed, and episodes of major bleeding or thrombosis. No significant difference in TTR occurred between the 90 days before PSM program participation and the 90 days of PSM (82.9% vs 81.2%, p=0.65). The mean number of INR tests performed for each patient increased from 2.97 before PSM program participation to 4.38 during PSM (p<0.01). No bleeding or thrombotic events occurred during the PSM phase.
Patients were trained to engage in PSM using support tools and venipuncture-derived INR results received by an online messaging system to adjust warfarin dosage and frequency of INR testing. No significant difference in TTR occurred in these patients before and during the PSM. This novel PSM model appears to be a feasible method of managing warfarin therapy in carefully selected patients; however, a larger, randomized controlled trial is needed to evaluate the safety and efficacy of the model and its effect on anticoagulation service workload.
比较新型患者自我管理（PSM）方案实施前后华法林治疗的临床和安全性结局。该方案中，患者通过安全的在线消息系统获取静脉采血获得的国际标准化比值（INR）结果，并根据提供的支持工具调整华法林剂量和随访。
前瞻性、开放标签、3 个月、试点研究。
集中式临床药学抗凝服务。
44 例患有心房颤动且接受华法林治疗超过 6 个月的患者参加了 2011 年 1 月 1 日至 2011 年 2 月 28 日的试验；39 例患者完成了试验。患者自身互为对照。
患者在 2 小时的 PSM 现场培训课程中接受剂量决策支持工具。那些表现出 PSM 熟练程度的患者则负责自己的华法林治疗管理。
在实施 PSM 方案前后，分别测量每位患者的华法林治疗结局。研究变量包括治疗 INR 范围（TTR）时间、INR 检测次数和大出血或血栓形成事件。在 PSM 方案参与前 90 天和 PSM 期间 90 天的 TTR 无显著差异（82.9%比 81.2%，p=0.65）。每位患者进行的 INR 检测次数从 PSM 方案参与前的 2.97 次增加到 PSM 期间的 4.38 次（p<0.01）。PSM 期间未发生出血或血栓形成事件。
患者接受了使用支持工具和通过在线消息系统接收静脉采血 INR 结果进行 PSM 的培训，以调整华法林剂量和 INR 检测频率。这些患者在 PSM 前后的 TTR 无显著差异。这种新型 PSM 模型似乎是一种管理经仔细选择的患者华法林治疗的可行方法；然而，需要更大的、随机对照试验来评估该模型的安全性和疗效及其对抗凝服务工作量的影响。
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