Wan Yi, Heneghan Carl, Perera Rafael, Roberts Nia, Hollowell Jennifer, Glasziou Paul, Bankhead Clare, Xu Yongyong
Department of Health Statistics, Fourth Military Medical University, Xi'an, China.
Circ Cardiovasc Qual Outcomes. 2008 Nov;1(2):84-91. doi: 10.1161/CIRCOUTCOMES.108.796185. Epub 2008 Nov 5.
To date, there has been no systematic examination of the relationship between international normalized ratio (INR) control measurements and the prediction of adverse events in patients with atrial fibrillation on oral anticoagulation.
We searched MEDLINE, EMBASE, and Cochrane through January 2008 for studies of atrial fibrillation patients receiving vitamin-K antagonists that reported INR control measures (percentage of time in therapeutic range [TTR] and percentage of INRs in range) and major hemorrhage and thromboembolic events. In total, 47 studies were included from 38 published articles. TTR ranged from 29% to 75%; percentage of INRs ranged from 34% to 84%. From studies reporting both measures, TTR significantly correlated with percentage of INRs in range (P<0.001). Randomized controlled trials had better INR control than retrospective studies (64.9% versus 56.4%; P=0.01). TTR negatively correlated with major hemorrhage (r=-0.59; P=0.002) and thromboembolic rates (r=-0.59; P=0.01). This effect was significant in retrospective studies (major hemorrhage, r=-0.78; P=0.006 and thromboembolic rate, r=-0.88; P=0.03) but not in randomized controlled trials (major hemorrhage, r=0.18; P=0.33 and thromboembolic rate, r=-0.61; P=0.07). For retrospective studies, a 6.9% improvement in the TTR significantly reduced major hemorrhage by 1 event per 100 patient-years of treatment (95% CI, 0.29 to 1.71 events).
In atrial fibrillation patients receiving orally administered anticoagulation treatment, TTR and percentage of INRs in range effectively predict INR control. Data from retrospective studies support the use of TTR to accurately predict reductions in adverse events.
迄今为止，尚未对国际标准化比值（INR）控制测量值与接受口服抗凝治疗的心房颤动患者不良事件预测之间的关系进行系统研究。
我们检索了截至2008年1月的MEDLINE、EMBASE和Cochrane数据库，以查找关于接受维生素K拮抗剂治疗的心房颤动患者的研究，这些研究报告了INR控制测量值（治疗范围内时间百分比[TTR]和处于范围内的INR百分比）以及大出血和血栓栓塞事件。总共从38篇已发表文章中纳入了47项研究。TTR范围为29%至75%；INR百分比范围为34%至84%。在报告了这两种测量值的研究中，TTR与处于范围内的INR百分比显著相关（P<0.001）。随机对照试验的INR控制优于回顾性研究（64.9%对56.4%；P=0.01）。TTR与大出血（r=-0.59；P=0.002）和血栓栓塞率（r=-0.59；P=0.01）呈负相关。这种效应在回顾性研究中显著（大出血，r=-0.78；P=0.006和血栓栓塞率，r=-0.88；P=0.03），但在随机对照试验中不显著（大出血，r=0.18；P=0.33和血栓栓塞率，r=-0.61；P=0.07）。对于回顾性研究，TTR提高6.9%可使每100患者年治疗中的大出血显著减少1例（95%CI，0.29至1.71例）。
在接受口服抗凝治疗的心房颤动患者中，TTR和处于范围内的INR百分比可有效预测INR控制情况。回顾性研究数据支持使用TTR准确预测不良事件的减少。
