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[直接口服抗凝剂治疗静脉血栓栓塞症患者轻微出血相关危险因素分析]

[Analysis of the Risk Factors Associated with Minor Bleeding in Patients with Venous Thromboembolism during Treatment with Direct Oral Anticoagulants].

作者信息

Sunaga Tomiko, Shimizu Tomomi, Nakamura Shoko, Takahashi Noriko, Higashino Mayumi, Matsui Mitsuki, Hozumi Tomomi, Ebato Mio, Suzuki Hiroshi, Kogo Mari, Watanabe Toru, Sasaki Tadanori

机构信息

Departmant of Hospital Pharmaceutics, School of Pharmacy, Showa University.

Department of Pharmacy, Showa University Fujigaoka Hospital.

出版信息

Yakugaku Zasshi. 2019;139(3):461-467. doi: 10.1248/yakushi.18-00026.

Abstract

Direct oral anticoagulants (DOACs) are safe and efficacious when compared to warfarin for patients with venous thromboembolism (VTE). However, bleeding is a major side effect of anticoagulant therapy in VTE patients. Discontinuation of the DOACs associated to adverse events such as bleeding. The HAS-BLED score predicts warfarin-associated hemorrhage. However, little is known about risk factors for DOAC-associated minor bleeding in VTE patients. We aimed to identify risk factors for minor bleeding in VTE patients that were treated with edoxaban, rivaroxaban, or apixaban. We retrospectively evaluated the data of 212 VTE patients who received treatment with a DOAC. The study endpoint was defined as the occurrence of minor bleeding. Logistic regression analysis was used to determine risk factors that were significantly associated with minor bleeding. A total of 36 (17.0%) patients experienced minor bleeding, with rates of 15.7%, 0%, and 21.3% for edoxaban, rivaroxaban, and apixaban, respectively. In the multivariate analysis, bleeding history or predisposition [odds ratio (OR) 6.083, 95% confidence interval (CI) 2.131-17.364, p=0.001] and cancer (OR 6.397, 95% CI 2.858-14.317, p<0.001) were significantly associated with minor bleeding. Bleeding history or predisposition and cancer were the most important risk factors for DOAC-induced minor bleeding in VTE patients in this study. To continue anticoagulant therapy of the DOACs, further management systems by minor bleeding risk factors for patients with VTE will be required.

摘要

与华法林相比,直接口服抗凝剂(DOACs)对静脉血栓栓塞症(VTE)患者是安全有效的。然而,出血是VTE患者抗凝治疗的主要副作用。停用DOACs与出血等不良事件相关。HAS - BLED评分可预测华法林相关出血。然而,关于VTE患者DOAC相关轻微出血的危险因素知之甚少。我们旨在确定接受依度沙班、利伐沙班或阿哌沙班治疗的VTE患者轻微出血的危险因素。我们回顾性评估了212例接受DOAC治疗的VTE患者的数据。研究终点定义为轻微出血的发生。采用逻辑回归分析来确定与轻微出血显著相关的危险因素。共有36例(17.0%)患者发生轻微出血,依度沙班、利伐沙班和阿哌沙班的发生率分别为15.7%、0%和21.3%。在多变量分析中,出血史或易感性[比值比(OR)6.083,95%置信区间(CI)2.131 - 17.364,p = 0.001]和癌症(OR 6.397,95% CI 2.858 - 14.317,p < 0.001)与轻微出血显著相关。出血史或易感性以及癌症是本研究中VTE患者DOAC诱导轻微出血的最重要危险因素。为了继续DOACs的抗凝治疗,将需要针对VTE患者的轻微出血危险因素建立进一步的管理系统。

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