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体重指数对直接口服抗凝剂安全性和有效性的影响:一项回顾性研究。

Effects of body mass index on the safety and effectiveness of direct oral anticoagulants: a retrospective review.

机构信息

Department of Pharmacy, Parkview Health, 11109 Parkview Plaza Drive, Fort Wayne, IN, 46845, USA.

Department of Cardiology, Parkview Health, 11109 Parkview Plaza Drive, Fort Wayne, IN, 46845, USA.

出版信息

J Thromb Thrombolysis. 2019 Oct;48(3):359-365. doi: 10.1007/s11239-019-01857-2.

DOI:10.1007/s11239-019-01857-2
PMID:30963393
Abstract

BACKGROUND

The International Society on Thrombosis and Haemostasis recommends avoiding the use of direct oral anticoagulants (DOACs) in patients with a body mass index (BMI) greater than 40 kg/m or weight greater than 120 kg.

HYPOTHESIS

Higher BMI is associated with altered pharmacokinetics which may affect the safety and effectiveness for DOACs.

METHODS

Data were collected on 3458 patients taking a DOAC prior to admission to a Midwestern health system between February 2013 and August 2016. Of these, 43 patients had a thrombotic event and 70 patients had an overt bleeding event. Patients were stratified among the following three BMI groups: BMI < 30 kg/m, BMI 30-40 kg/m, and BMI > 40 kg/m.

RESULTS

There was no statistically significant difference between BMI groups for thrombotic events (p = 0.598) or for overt bleeding events (p = 0.065). The BMI < 30 kg/m had the highest occurrence rate of bleeding events. It was observed that bleeding occurrence decreased as the BMI groups increased. The BMI > 40 kg/m group had the lowest risk of bleeding events, and was the only group to have a higher occurrence rate of thrombotic events compared to bleeding events.

CONCLUSIONS

Among patients admitted to a single health system on DOAC therapy over a three-and-a-half-year period, obesity did not significantly correlate with thrombotic or overt bleeding complications. This study is limited as a single health system study with low overall event rates. A preliminary finding of this study showed a trend towards decreased bleeding frequency as BMI increased.

摘要

背景

国际血栓与止血学会建议,对于体重指数(BMI)大于 40kg/m2 或体重超过 120kg 的患者,避免使用直接口服抗凝剂(DOAC)。

假设

较高的 BMI 与改变的药代动力学有关,这可能会影响 DOAC 的安全性和有效性。

方法

在 2013 年 2 月至 2016 年 8 月期间,从中西部医疗系统入院的 3458 名服用 DOAC 的患者中收集数据。其中,43 名患者发生血栓事件,70 名患者发生显性出血事件。患者被分为以下三组 BMI:BMI<30kg/m2、BMI30-40kg/m2 和 BMI>40kg/m2。

结果

在血栓事件(p=0.598)或显性出血事件(p=0.065)方面,BMI 组之间没有统计学差异。BMI<30kg/m2 的出血事件发生率最高。观察到随着 BMI 组的增加,出血事件的发生率降低。BMI>40kg/m2 的出血事件发生率最低,并且是唯一与出血事件相比发生血栓事件发生率较高的组。

结论

在接受 DOAC 治疗的单一医疗系统患者中,在三年半的时间内,肥胖与血栓形成或显性出血并发症没有显著相关性。本研究存在局限性,因为这是一项单一的医疗系统研究,总体事件发生率较低。本研究的初步结果表明,随着 BMI 的增加,出血频率呈下降趋势。

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Evaluation of safety and efficacy outcomes of direct oral anticoagulants versus warfarin in normal and extreme body weights for the treatment of atrial fibrillation or venous thromboembolism.直接口服抗凝剂与华法林在正常体重和极端体重患者中治疗心房颤动或静脉血栓栓塞的安全性和有效性结果评估。
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