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利伐沙班用于新诊断非瓣膜性心房颤动患者口服抗凝治疗的评估

[Evaluation of oral anticoagulation with rivaroxaban, in patients with new onset non valvular atrial fibrillation].

作者信息

Neira Víctor, Corbalán Ramón, Pereira Jaime, Panes Olga, Garayar Bernardita, Aizman Andrés, Llevaneras Silvana, Villarroel Luis

机构信息

División de Enfermedades Cardiovasculares, Pontificia Universidad Católica de Chile, Santiago, Chile.

Departamento de Hematología y Oncología, Pontificia Universidad Católica de Chile, Santiago, Chile.

出版信息

Rev Med Chil. 2016 Sep;144(9):1103-1111. doi: 10.4067/S0034-98872016000900002.

Abstract

BACKGROUND

Atrial fibrillation (AF) generates a hypercoagulable state with an increased thrombin generation and raised levels of thrombin-antithrombin complexes, which results in a high risk of stroke and thromboembolism.

AIM

To evaluate the anticoagulant effect of rivaroxaban by anti-Xa factor activity and its correlation with thrombin-antithrombin complexes, thrombin generation and prothrombin time in patients newly diagnosed with non-valvular AF.

PATIENTS AND METHODS

Prospective study in patients with indication of anticoagulation. Demographic variables, cardiovascular risk factors, CHA2DS2-VASc and HAS-BLED scores were recorded. Blood samples were taken at baseline, at 3 and 24 hours after the administration of the drug and at 30 days. Rivaroxaban levels, anti-Xa activity, prothrombin time, thrombin generation and plasma levels of thrombin-antithrombin complexes were determined.

RESULTS

We studied 20 patients aged 76.3 ± 8.0 years (60% female) with a CHA2DS2-VASc score > 2 points. The anti-Xa factor activity correlated with rivaroxaban plasma levels at 3 hours (r = 0.61, p < 0.01), at 24 hours (r = 0.85, p < 0.01) and at 30 days (r = 0.99, p < 0.01), with prothrombin time at 3 hours (r = -0.86, p = 0.019) and at 30 days (r = -0.63, p = 0.02) and with a sustained decrease in thrombin generation at 30 days of follow-up (r = -0.74, p < 0.01). There was no correlation with thrombin-antithrombin complexes (r = -0.02, p = 0.83).

CONCLUSIONS

Rivaroxaban consistently inhibited the mild pro-coagulant state found in newly diagnosed non-valvular AF patients through the first 24 hours and this effect was maintained at 30 days. Plasma levels of the drug correlated with anti-Xa factor activity, thrombin generation and prothrombin time.

摘要

背景

心房颤动(AF)会产生高凝状态,凝血酶生成增加,凝血酶 - 抗凝血酶复合物水平升高,这会导致中风和血栓栓塞的高风险。

目的

通过抗Xa因子活性评估利伐沙班的抗凝效果,及其与新诊断的非瓣膜性AF患者的凝血酶 - 抗凝血酶复合物、凝血酶生成和凝血酶原时间的相关性。

患者和方法

对有抗凝指征的患者进行前瞻性研究。记录人口统计学变量、心血管危险因素、CHA2DS2 - VASc和HAS - BLED评分。在基线、给药后3小时和24小时以及30天时采集血样。测定利伐沙班水平、抗Xa活性、凝血酶原时间、凝血酶生成和凝血酶 - 抗凝血酶复合物的血浆水平。

结果

我们研究了20例年龄为76.3±8.0岁(60%为女性)、CHA2DS2 - VASc评分>2分的患者。抗Xa因子活性在3小时(r = 0.61,p < 0.01)、24小时(r = 0.85,p < 0.01)和30天(r = 0.99,p < 0.01)时与利伐沙班血浆水平相关,在3小时(r = -0.86,p = 0.019)和30天(r = -0.63,p = 0.02)时与凝血酶原时间相关,在随访30天时与凝血酶生成的持续降低相关(r = -0.74,p < 0.01)。与凝血酶 - 抗凝血酶复合物无相关性(r = -0.02,p = 0.83)。

结论

利伐沙班在最初24小时内持续抑制新诊断的非瓣膜性AF患者中发现的轻度促凝状态,且这种作用在30天时得以维持。药物的血浆水平与抗Xa因子活性、凝血酶生成和凝血酶原时间相关。

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