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根据在比利时门诊护理中使用的不同处方指南,非维生素 K 拮抗剂口服抗凝剂的剂量是否合适。

Appropriateness of Non-vitamin K Antagonist Oral Anticoagulants Dosing According to Different Prescription Guides Used in Belgian Ambulatory Care.

机构信息

Research Group Cardiovascular Diseases, Department GENCOR (Genetics, Pharmacology and Physiopathology of Heart, Blood Vessels and Skeleton), University of Antwerp, Prinsstraat 13, 2000, Antwerp, Belgium.

Department of Cardiology, Antwerp University Hospital, Drie Eikenstraat 655, 2650, Edegem, Belgium.

出版信息

Clin Drug Investig. 2022 Sep;42(9):775-786. doi: 10.1007/s40261-022-01190-2. Epub 2022 Aug 20.

Abstract

BACKGROUND

Non-vitamin K antagonist oral anticoagulants (NOACs) are the preferred choice of anticoagulants to prevent stroke in most patients with atrial fibrillation (AF). NOAC's dosing algorithms are defined in the respective Summary of Product Characteristics (SmPC) but the European Heart Rhythm Association (EHRA) Practical Guide can also be used as it considers more complex clinical scenarios. Nevertheless, suboptimal dosing of NOACs compromises the efficacy and safety of this commonly prescribed therapy in the AF population. Clearer objectification of inappropriate dosing and its influencing factors is needed to optimise management of AF patients.

OBJECTIVES

The primary aim of this study was  to investigate whether there is a difference in the perceived appropriateness of NOAC dosing with respect to the SmPC or the 2018 EHRA Practical Guide in AF patients criteria and influencing factors. The secondary aim was to explore if there were differences in appropriateness of NOAC dosing between primary care and specialist care, and when using different renal function formulas.

METHODS

This retrospective study included AF patients treated with a NOAC in primary or in ambulatory specialist care in Antwerp (Belgium). Appropriateness of the NOAC dose was assessed according to the SmPC and 2018 EHRA recommendations. Univariate/multivariate analyses were performed to explore influencing factors for under- and overdosing of NOACs.

RESULTS

Of the included 294 AF patients, 19.4% and 15.6% received an inappropriate dose according to the SmPC and the 2018 EHRA Practical Guide respectively (p = 0.003). Perceived frailty and higher weight were associated with underdosing relative to the SmPC, while a higher body mass index and the use of drugs/alcohol were associated with underdosing relative to the EHRA 2018 recommendations. Lower renal function and treatment with other NOACs than apixaban were associated with relative overdosing compared to both standards.

CONCLUSIONS

Inappropriate NOAC dosing is present in almost twenty percent of AF patients according to the SmPC and requires further education of health care professionals and frequent reassessment of NOAC dosing. However, a significant lower prevalence of underdosing was present when judged by the 2018 EHRA criteria, likely reflecting decision making in complex AF patients. Perceived frailty, weight, renal function and type of NOAC are the main determinants of deviated dosing.

摘要

背景

在大多数患有心房颤动(AF)的患者中,非维生素 K 拮抗剂口服抗凝剂(NOAC)是预防中风的首选抗凝剂。NOAC 的剂量算法在各自的产品特性摘要(SmPC)中定义,但也可以使用欧洲心律协会(EHRA)实用指南,因为它考虑了更复杂的临床情况。然而,NOAC 的剂量不足会影响 AF 人群中这种常用治疗方法的疗效和安全性。需要更清楚地确定不适当的剂量及其影响因素,以优化 AF 患者的管理。

目的

本研究的主要目的是调查在 AF 患者标准中,根据 SmPC 或 2018 年 EHRA 实用指南,NOAC 剂量的感知适当性是否存在差异,以及影响因素。次要目的是探讨在初级保健和专科保健中,以及使用不同肾功能公式时,NOAC 剂量的适当性是否存在差异。

方法

本回顾性研究纳入了在安特卫普(比利时)接受初级或门诊专科治疗的 AF 患者,使用 NOAC。根据 SmPC 和 2018 年 EHRA 建议评估 NOAC 剂量的适当性。进行单变量/多变量分析以探讨影响 NOAC 剂量不足和过量的因素。

结果

在所纳入的 294 名 AF 患者中,根据 SmPC 和 2018 年 EHRA 实用指南,分别有 19.4%和 15.6%的患者剂量不当(p=0.003)。与 SmPC 相比,感知到的虚弱和更高的体重与剂量不足相关,而更高的体重指数和使用药物/酒精与相对于 EHRA 2018 建议的剂量不足相关。与两个标准相比,较低的肾功能和使用除阿哌沙班以外的其他 NOAC 与相对过量有关。

结论

根据 SmPC,近 20%的 AF 患者存在不适当的 NOAC 剂量,需要进一步对卫生保健专业人员进行教育,并经常重新评估 NOAC 剂量。然而,根据 2018 年 EHRA 标准,剂量不足的发生率显著降低,这可能反映了在复杂的 AF 患者中做出的决策。感知到的虚弱、体重、肾功能和 NOAC 类型是剂量偏差的主要决定因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c0b2/9392068/7443fd862a5a/40261_2022_1190_Fig1_HTML.jpg

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