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中国老年房颤患者非维生素K拮抗剂口服抗凝药使用不当的患病率、危险因素及预测:一项研究方案

Prevalence, risk factors, and prediction of inappropriate use of non-vitamin K antagonist oral anticoagulants in elderly Chinese patients with atrial fibrillation: A study protocol.

作者信息

Zhao Shu-Juan, Chen Bo-Ya, Hong Xue-Jiao, Liu Yin-Ping, Cai Hai-Xia, Du Song, Gu Zhi-Chun, Ma Pei-Zhi

机构信息

Department of Pharmacy, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, China.

Department of Cardiovascular Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, China.

出版信息

Front Cardiovasc Med. 2022 Aug 24;9:951695. doi: 10.3389/fcvm.2022.951695. eCollection 2022.

Abstract

BACKGROUND

Atrial fibrillation (AF) is an arrhythmia that is prevalent globally, and its incidence grows exponentially with aging. Non-vitamin K antagonist oral anticoagulants (NOACs) have been developed in recent years, and it challenges the supremacy of warfarin for thromboembolism prophylaxis in AF. Nevertheless, there are limited data specifically evaluating the real-life use of NOACs in elderly patients with AF in China.

METHODS

This is a national, multicenter, non-interventional, cross-sectional study that enrolls patients with AF aged 75 years and above from 31 institutions across China. Data were collected using the Hospital Information System. The primary outcomes include (1) profiles of NOAC use in the elderly; (2) frequency of inappropriate NOAC use based on guidelines and approved labeling recommendations; (3) exploring potential risk factors related to NOACs inappropriate use; and (4) creating a prediction tool for inappropriate NOACs use.

CONCLUSION

The results of this study reveal the prevalence, risk factors, and corresponding prediction tool of inappropriate NOACs use in older patients with AF in China, as well as provide valuable insights into the clinical application of NOACs in high-risk populations in the real-world setting.

CLINICAL TRIAL REGISTRATION

www.ClinicalTrials.gov, identifier: NCT05361889.

摘要

背景

心房颤动(AF)是一种在全球范围内普遍存在的心律失常,其发病率随年龄增长呈指数级上升。近年来,非维生素K拮抗剂口服抗凝药(NOACs)已被研发出来,它对华法林在房颤血栓栓塞预防方面的主导地位构成了挑战。然而,在中国,专门评估老年房颤患者中NOACs实际应用情况的数据有限。

方法

这是一项全国性、多中心、非干预性横断面研究,纳入了来自中国31家机构的75岁及以上房颤患者。数据通过医院信息系统收集。主要结局包括:(1)老年人使用NOACs的情况;(2)根据指南和批准的标签建议不适当使用NOACs的频率;(3)探索与不适当使用NOACs相关的潜在危险因素;(4)创建一个不适当使用NOACs的预测工具。

结论

本研究结果揭示了中国老年房颤患者中不适当使用NOACs的患病率、危险因素及相应的预测工具,同时为NOACs在现实环境中高危人群的临床应用提供了有价值的见解。

临床试验注册

www.ClinicalTrials.gov,标识符:NCT05361889。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d9ae/9449806/26c4ee5d88b9/fcvm-09-951695-g0001.jpg

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