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利伐沙班血浆浓度与老年非瓣膜性心房颤动合并肺部感染患者的临床结局。

Rivaroxaban Plasma Concentration and Clinical Outcomes on Older Patients with Non-valvular Atrial Fibrillation and Pulmonary Infection.

机构信息

Department of Pharmacy, Fifth People's Hospital of Shanghai, Shanghai, China.

Department of General Practice, Fifth People's Hospital of Shanghai, Shanghai, China.

出版信息

Am J Cardiovasc Drugs. 2024 Jan;24(1):129-139. doi: 10.1007/s40256-023-00622-4. Epub 2023 Dec 24.

Abstract

INTRODUCTION

Infection may induce thrombotic and hemorrhagic events; however, it is currently unclear whether the inflammatory response affects the coagulation function and the clinical efficacy and safety of rivaroxaban in older patients with non-valvular atrial fibrillation (NVAF).

OBJECTIVE

This project aimed to assess the effectiveness and safety of the non-vitamin K antagonist oral anticoagulant rivaroxaban in older patients with NVAF complicated by infection, and to provide a basis for possible drug dose adjustment.

METHODS

A total of 152 NVAF patients aged ≥ 65 years admitted to the Fifth People's Hospital of Shanghai from June 2020 to May 2022 were included in this prospective, observational study. The changes in steady-state plasma concentration of rivaroxaban and FXa inhibition rate were compared between patients with and without infection, and the impact on the occurrence of infection, thrombotic events, and bleeding events was compared through 1-year follow-up.

RESULTS

Our results showed that patients in the infection group had abnormal inflammation markers, as well as an increased occurrence of bleeding and thrombotic events during hospitalization and follow-up. The high incidence of bleeding events in patients was closely related to the occurrence of infection, lymphocyte reduction, and increased neutrophil-lymphocyte ratio. The increase in thrombotic events was related to a decrease in rivaroxaban plasma concentration. Bleeding events in patients taking anticoagulant drugs are not necessarily due to drug accumulation.

CONCLUSIONS

Timely control of infection, assessment of bleeding and thrombotic risks, and selection of appropriate anticoagulation treatment strategies should be made in older NVAF patients who develop pulmonary infection.

CLINICAL TRIALS REGISTRATION

Chinese Clinical Trial Registry Number ChiCTR2000033144.

摘要

简介

感染可能会引起血栓形成和出血事件;然而,目前尚不清楚炎症反应是否会影响凝血功能以及非瓣膜性心房颤动(NVAF)老年患者使用利伐沙班的临床疗效和安全性。

目的

本研究旨在评估新型口服抗凝剂利伐沙班在 NVAF 合并感染的老年患者中的有效性和安全性,并为可能的药物剂量调整提供依据。

方法

前瞻性观察研究共纳入 2020 年 6 月至 2022 年 5 月期间上海第五人民医院收治的 152 例年龄≥65 岁的 NVAF 患者。比较感染患者和无感染患者稳定态血浆利伐沙班浓度和 FXa 抑制率的变化,通过 1 年随访比较对感染、血栓形成事件和出血事件发生的影响。

结果

结果显示,感染组患者炎症标志物异常,住院及随访期间出血和血栓形成事件发生率增加。患者出血事件高发生率与感染、淋巴细胞减少和中性粒细胞/淋巴细胞比值增加密切相关。血栓形成事件的增加与利伐沙班血浆浓度的降低有关。服用抗凝药物的患者发生出血事件不一定是由于药物蓄积。

结论

对于发生肺部感染的 NVAF 老年患者,应及时控制感染,评估出血和血栓形成风险,并选择合适的抗凝治疗策略。

临床试验注册

中国临床试验注册中心 ChiCTR2000033144。

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