Christensen Thomas D, Johnsen Søren P, Hjortdal Vibeke E, Hasenkam J Michael
Department of Cardiothoracic and Vascular Surgery and Institute of Clinical Medicine, Skejby Sygehus, Aarhus University Hospital, DK-8200 Aarhus N, Denmark.
Int J Cardiol. 2007 May 16;118(1):54-61. doi: 10.1016/j.ijcard.2006.06.018. Epub 2006 Aug 7.
A number of randomized controlled trials have compared self-management of oral anticoagulant therapy with conventional management. However, the results have not appeared consistent and a systematic review and meta-analysis are therefore needed in order to evaluate self-management of oral anticoagulant therapy. The aim of this study was to evaluate the efficacy and safety of self-management of oral anticoagulant therapy for patients on long-term oral anticoagulant therapy.
A systematic review and meta-analysis including randomized controlled trials with highly selected patients comparing self-management of oral anticoagulant therapy with conventional treatment. Data were extracted in terms of study characteristics, quality of trials and outcome (death, minor and major complications (thromboembolic and bleeding events), and time within therapeutic INR target range).
Ten trials with a total of 2724 patients were included. Two of the trials could be classified as high quality trials. Considering all trials, self-management was associated with a reduced risk of death (relative risk (RR)=0.48, 95% confidence interval (CI) 0.29-0.79, p=0.004), major complications (RR=0.58, 95% CI 0.42-0.81, p=0.001) and with increasing time within therapeutic INR target range (weighted mean difference=6.53, 95% CI 2.24-10.82, p=0.003). No clear effect was found regarding minor complications (RR=0.98, 95% CI 0.49-1.99, p=0.96).
A majority of the existing trials have various methodological problems. However, self-management of oral anticoagulant therapy appeared at least as good and possible better than conventional management in highly selected patients.
多项随机对照试验比较了口服抗凝治疗的自我管理与传统管理。然而，结果并不一致，因此需要进行系统评价和荟萃分析以评估口服抗凝治疗的自我管理。本研究的目的是评估长期接受口服抗凝治疗的患者进行口服抗凝治疗自我管理的有效性和安全性。
进行一项系统评价和荟萃分析，纳入对经过严格筛选的患者进行随机对照试验，比较口服抗凝治疗的自我管理与传统治疗。根据研究特征、试验质量和结局（死亡、轻微和严重并发症（血栓栓塞和出血事件）以及处于治疗性国际标准化比值（INR）目标范围内的时间）提取数据。
纳入了10项试验，共2724例患者。其中2项试验可归类为高质量试验。综合所有试验来看，自我管理与死亡风险降低相关（相对风险（RR）=0.48，95%置信区间（CI）0.29 - 0.79，p = 0.004）、严重并发症风险降低相关（RR = 0.58，95% CI 0.42 - 0.81，p = 0.001），并且与处于治疗性INR目标范围内的时间增加相关（加权平均差=6.53，95% CI 2.24 - 10.82，p = 0.003）。未发现自我管理对轻微并发症有明显影响（RR = 0.98，95% CI 0.49 - 1.99，p = 0.96）。
大多数现有试验存在各种方法学问题。然而，在经过严格筛选的患者中，口服抗凝治疗的自我管理似乎至少与传统管理一样好，甚至可能更好。
