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布美他尼鼻喷雾剂:增强利尿反应及推进门诊心力衰竭护理的新方法?

Bumetanide nasal spray: a novel approach to enhancing diuretic response and advancing ambulatory heart failure care?

作者信息

Biegus Jan, Ponikowska Beata, Canonico Mario Enrico, Damman Kevin, Palazzuoli Alberto, Ambrosy Andrew P

机构信息

Institute of Heart Diseases, Wroclaw Medical University, Borowska 213, 50-556, Wroclaw, Poland.

Department of Pathophysiology, Wroclaw Medical University, Wrocław, Poland.

出版信息

Heart Fail Rev. 2025 May 13. doi: 10.1007/s10741-025-10517-y.

DOI:10.1007/s10741-025-10517-y
PMID:40360832
Abstract

Loop diuretics are the cornerstone of managing congestion in heart failure (HF). It is hypothesized that in heavily congested patients, gut edema may lead to lower bioavailability of oral drugs, including diuretics, which, in turn, may lead to insufficient diuresis. Intravenous (IV) loop diuretics are often required to achieve rapid diuresis due to their high plasma concentrations. However, reliance on IV administration limits options in ambulatory settings, where effective rescue therapies are needed. Bumetanide Nasal Spray (BNS) is a novel formulation designed to overcome absorption challenges and provide rapid, high bioavailability through intranasal administration. This mini-review summarizes the results of the recently presented bioavailability study of BNS conducted in healthy individuals, showing its bioequivalence to oral formulations. Lastly, the paper discusses the potential caveats and limitations of the trial and further perspectives.

摘要

袢利尿剂是治疗心力衰竭(HF)充血的基石。据推测,在严重充血的患者中,肠道水肿可能导致口服药物(包括利尿剂)的生物利用度降低,进而可能导致利尿不足。由于静脉注射(IV)袢利尿剂的血浆浓度高,常常需要使用它们来实现快速利尿。然而,在需要有效急救治疗的门诊环境中,依赖静脉给药限制了选择。布美他尼鼻喷雾剂(BNS)是一种新型制剂,旨在克服吸收难题,并通过鼻内给药提供快速、高生物利用度。本综述总结了最近在健康个体中进行的BNS生物利用度研究结果,表明其与口服制剂具有生物等效性。最后,本文讨论了该试验的潜在注意事项和局限性以及进一步的前景。

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Bumetanide nasal spray: a novel approach to enhancing diuretic response and advancing ambulatory heart failure care?布美他尼鼻喷雾剂:增强利尿反应及推进门诊心力衰竭护理的新方法?
Heart Fail Rev. 2025 May 13. doi: 10.1007/s10741-025-10517-y.
2
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本文引用的文献

1
Randomized Study Comparing a Novel Intranasal Formulation of Bumetanide With Oral and Intravenous Formulations.比较布美他尼新型鼻内制剂与口服和静脉制剂的随机研究。
Circulation. 2025 Mar 11;151(10):737-740. doi: 10.1161/CIRCULATIONAHA.124.072949. Epub 2024 Nov 18.
2
Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure: A Pilot Study (AT HOME-HF).避免使用皮下呋塞米治疗心力衰竭恶化:一项试点研究(AT HOME-HF)。
JACC Heart Fail. 2024 Nov;12(11):1830-1841. doi: 10.1016/j.jchf.2024.07.015. Epub 2024 Sep 11.
3
Decongestion in acute heart failure: Is it time to change diuretic-centred paradigm?
急性心力衰竭的利尿消肿:是否到了改变以利尿剂为中心的治疗模式的时候?
Eur J Heart Fail. 2024 Oct;26(10):2094-2106. doi: 10.1002/ejhf.3423. Epub 2024 Aug 21.
4
Loop diuretics in heart failure: The objective markers to guide the therapy are needed.心力衰竭中的袢利尿剂:需要用于指导治疗的客观标志物。
ESC Heart Fail. 2024 Aug;11(4):1816-1818. doi: 10.1002/ehf2.14920. Epub 2024 Jun 24.
5
Reduced congestion and improved response to a fluid/sodium challenge in chronic heart failure patients after initiation of sacubitril/valsartan: The NATRIUM-HF study.沙库巴曲缬沙坦治疗慢性心力衰竭患者后,减少充血并改善对液体/钠挑战的反应:NATRIUM-HF 研究。
Eur J Heart Fail. 2024 Jul;26(7):1507-1517. doi: 10.1002/ejhf.3265. Epub 2024 May 9.
6
The blunted loop diuretic response in acute heart failure is driven by reduced tubular responsiveness rather than insufficient tubular delivery. The role of furosemide urine excretion on diuretic and natriuretic response in acute heart failure.急性心力衰竭中利尿剂反应迟钝是由于管状反应性降低而非管状输送不足所致。呋塞米尿排泄在急性心力衰竭中利尿剂和利钠反应中的作用。
Eur J Heart Fail. 2023 Aug;25(8):1323-1333. doi: 10.1002/ejhf.2852. Epub 2023 May 1.
7
Association between intestinal oedema and oral loop diuretic resistance in hospitalized patients with acute heart failure.肠水肿与住院急性心力衰竭患者口服袢利尿剂抵抗的关系。
ESC Heart Fail. 2021 Oct;8(5):4067-4076. doi: 10.1002/ehf2.13525. Epub 2021 Jul 28.
8
Pathophysiology and Therapeutic Approaches to Acute Decompensated Heart Failure.急性失代偿性心力衰竭的病理生理学和治疗方法。
Circ Res. 2021 May 14;128(10):1468-1486. doi: 10.1161/CIRCRESAHA.121.318186. Epub 2021 May 13.
9
Global Differences in Characteristics, Precipitants, and Initial Management of Patients Presenting With Acute Heart Failure.全球急性心力衰竭患者特征、诱发因素和初始治疗的差异。
JAMA Cardiol. 2020 Apr 1;5(4):401-410. doi: 10.1001/jamacardio.2019.5108.
10
Renal tubular resistance is the primary driver for loop diuretic resistance in acute heart failure.肾单位肾小管阻力是急性心力衰竭中袢利尿剂抵抗的主要驱动因素。
Eur J Heart Fail. 2017 Aug;19(8):1014-1022. doi: 10.1002/ejhf.757. Epub 2017 Jan 19.