凝血酶时间比值对非瓣膜性房颤患者服用达比加群酯后出血风险预测研究

Predictive Study of Thrombin Time Ratio on Bleeding Events in Nonvalvular Atrial Fibrillation Patients Receiving Dabigatran Etexilate

关键词:  达比加群酯  心房颤动  出血  凝血酶时间比

Key words:  dabigatran etexilate  atrial fibrillation  bleeding  thrombin time ratio

摘要:

目的 寻找新的抗凝参数以监测非瓣膜性房颤患者服用达比加群酯后的出血风险。方法 本研究为回顾性队列研究,以2018年11月—2019年10月接受达比加群酯110 mgbid治疗的非瓣膜性房颤患者为研究对象。通过比较长期使用组和初次使用组,出血组和未出血组间的临床统计学数据,筛选最佳监测指标。使用Logistic回归分析确定出血的相关影响因素,绘制ROC曲线并寻找最佳临界值以预测出血事件。结果 本研究共纳入了487例患者,在长期使用组中,出血事件的发生率为14.1%(35/249)。所有患者均进行了6项常规凝血功能检测,包括凝血酶时间/凝血酶时间比,活化部分凝血酶原时间/活化部分凝血酶原时间比,凝血酶原时间/国际标准化比值。通过Logistic回归分析确定凝血酶时间(thrombintime,TT)比值是与出血事件相关的唯一独立变量。使用TT比值区分患者有无发生出血,临界值为16.25,灵敏度为31.4%,特异性为94.0%,曲线下面积为0.65。结论 研究表明TT比值>16.25是出血的独立危险因素,可用于评估接受达比加群酯治疗的非瓣膜性房颤患者的出血风险。

Abstract:

OBJECTIVE To find a new parameter to monitor bleeding tendency after dabigatran etexilate medication in nonvalvular atrial fibrillation patients.METHODS There conducted a retrospective cohort study including nonvalvular atrial fibrillation patients receiving dabigatran etexilate 110 mg bid between November 2018 and October 2019. In order to screen the best monitoring indexes, the clinical data from the medical records were obtained and compared between the long-term use group and first-time use group, the bleeding group and the no bleeding group. Logistic regression analyses were used to determine the related factors of bleeding. ROC curve was drawn in order to find the best cut-off value to predict bleeding events.RESULTS Total of 487 patients were included and the incidence of bleeding events was 14.1%(35/249) in the long-term use group. Six routine coagulation examinations(thrombin time/thrombin time ratio, activated partial thromboplastin time/activated partial thromboplastin time ratio, prothrombin time/international normalized ratio) were assayed. Logistic regression analyses identified the thrombin time(TT) ratio as the only independent variable associated with bleeding events. When using TT ratio to distinguish patients with and without bleeding events, the cut-off value was 16.25, while sensitivity was 31.4% and specificity was 94.0%. The area under the curve was 0.65.CONCLUSION This study demonstrates that TT ratio>16.25 is an independent risk factor for bleeding, and which maybe useful for assessment of bleeding risk in nonvalvular atrial fibrillation patients with dabigatran etexilate therapy.