国际标准化比值监测评估非瓣膜心房颤动患者华法林抗凝出血风险的研究

Bleeding risk assessmentduring anticoagulation therapy in patients with non-valvular atrial fibrillation by monitoring international standardization ratio

目的探讨应用国际标准化比值（International normalized ratio,INR）评估非瓣膜心房颤动（Non-valve atrial fibrillation,NVAF）患者华法林（warfarin）抗凝出血风险的临床应用价值。方法对2009年3月—2013年2月杭州市第三人民医院收治的应用华法林抗凝NVAF患者98例行回顾分析。98例NVAF患者华法林治疗过程中发生出血者21例,无出血者77例。分析比较出血与未出血患者平均INR有无差别。并采用INR受试者工作特征曲线（Receiver operator characteristic curve,ROC）评估NVAF患者华法林抗凝出血风险,拟合INR最佳cut-off值,并根据该值评价出血风险的敏感性和特异性。结果出血患者华法林用量与非出血患者差别无统计学意义,（2.61±1.63）mg/d vs.（2.83±1.74）mg/d,P〉0.05,但出血患者INR为3.60±0.88,显著高于非出血患者的2.72±0.76（P〈0.05）;INR判断出血的cut-off值为INR=2.66,该值下判断出血风险的敏感性为70.34%,特异性为79.62%,ROC曲线下面积（AUC）为0.77（95%CI：0.71-0.85）。结论 INR可作为评估NVAF患者华法林抗凝出血风险的重要指标,随INR增大患者出血风险明显增加。

Objective To evaluate the clinical efficacy of international normalized ratio（ INR） in the assessment of warfarinbleeding risk in patients with non-valvular atrial fibrillation（ NVAF）. Methods Ninety-eight cases with NVAF were retrospectively analyzed in third people＇s hospital of Hangzhou from Mar 2009 to Sep 2013. Among all patients,21 cases were with bleeding. The difference of INR was compared between the bleeding and non-bleeding group. The receiver operator characteristic curve（ ROC） was used to assess the bleeding risk of warfarinanticoagulant in patients with NVAF. The predicting sensitivity and specificity were calculated by the cut-off point. Results No statistical difference of warfarin dosage was found between the bleeding and non-bleeding group [（ 2. 61 ± 1. 63） mg / d vs.（ 2. 83 ± 1. 74） mg / d,P〉 0. 05],but the INR in the bleeding group was much higher than that in the non-bleeding group（3. 60 ± 0. 88 vs. 2. 72 ±0. 76,P〈 0. 05）. The sensitivity and specificity of INR in the predicting bleeding were 70. 34% and 79. 62% with the best cut-off point of INR = 2. 66. And the diagnosis efficacy of ROC was 0. 77 with its 95% confidence interval of 0. 71-0. 85. Conclusion INR can be used as an importantindex for evaluating warfarinanticoagulant bleeding risk in patients with NVAF which demonstrated that the higher the INR was the higher risk of bleeding.