Fitzmaurice D A, Murray E T, Gee K M, Allan T F, Hobbs F D R
Department of Primary Care and General Practice, Medical School, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
J Clin Pathol. 2002 Nov;55(11):845-9. doi: 10.1136/jcp.55.11.845.
The increase in numbers of patients receiving warfarin treatment has led to the development of alternative models of service delivery for oral anticoagulant monitoring. Patient self management for oral anticoagulation is a model new to the UK. This randomised trial was the first to compare routine primary care management of oral anticoagulation with patient self management.
To test whether patient self management is as safe, in terms of clinical effectiveness, as primary care management within the UK, as assessed by therapeutic international normalised ratio (INR) control.
Patients receiving warfarin from six general practices who satisfied study entry criteria were eligible to enter the study. Eligible patients were randomised to either intervention (patient self management) or control (routine primary care management) for six months. The intervention comprised two training sessions of one to two hours duration. Patients were allowed to undertake patient self management on successful completion of training. INR testing was undertaken using a Coaguchek device and regular internal/external quality control tests were performed. Patients were advised to perform INR tests every two weeks, or weekly if a dose adjustment was made. Dosage adjustment was undertaken using a simple dosing algorithm.
Seventy eight of 206 (38%) patients were eligible for inclusion and, of these, 35 (45%) declined involvement or withdrew from the study. Altogether, 23 intervention and 26 control patients entered the study. There were no significant differences in INR control (per cent time in range: intervention, 74%; control, 77%). There were no serious adverse events in the intervention group, with one fatal retroperitoneal haemorrhage in the control group. Costs of patient self management were significantly greater than for routine care (pound 90 v pound 425/patient/year).
These are the first UK data to demonstrate that patient self management is as safe as primary care management for a selected population. Further studies are needed to elucidate whether this model of care is suitable for a larger population.
接受华法林治疗的患者数量增加，促使人们开发出口服抗凝剂监测的替代服务模式。患者自我管理口服抗凝治疗在英国是一种新的模式。这项随机试验首次比较了口服抗凝治疗的常规初级保健管理与患者自我管理。
通过治疗性国际标准化比值（INR）控制评估，测试在英国患者自我管理在临床疗效方面是否与初级保健管理一样安全。
从符合研究入选标准的六个全科诊所接受华法林治疗的患者有资格进入研究。符合条件的患者被随机分为干预组（患者自我管理）或对照组（常规初级保健管理），为期六个月。干预包括两次时长为一至两小时的培训课程。患者在成功完成培训后可进行自我管理。使用Coaguchek设备进行INR检测，并定期进行内部/外部质量控制测试。建议患者每两周进行一次INR检测，如果进行了剂量调整则每周检测一次。使用简单的给药算法进行剂量调整。
206名患者中有78名（38%）符合纳入标准，其中35名（45%）拒绝参与或退出研究。共有23名干预组患者和26名对照组患者进入研究。INR控制方面无显著差异（处于目标范围的时间百分比：干预组为74%；对照组为77%）。干预组未发生严重不良事件，对照组有一例致命性腹膜后出血。患者自我管理的成本显著高于常规护理（每位患者每年90英镑对425英镑）。
这些是英国首批表明患者自我管理对于特定人群与初级保健管理一样安全的数据。需要进一步研究以阐明这种护理模式是否适用于更多人群。
