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急性失代偿性心力衰竭患者静脉使用利尿剂不同给药策略的临床疗效与安全性:一项随机临床试验

Clinical effects and safety of different strategies for administering intravenous diuretics in acutely decompensated heart failure: a randomised clinical trial.

作者信息

Llorens Pere, Miró Òscar, Herrero Pablo, Martín-Sánchez Francisco Javier, Jacob Javier, Valero Amparo, Alonso Héctor, Pérez-Durá María José, Noval Antonio, Gil-Román José Juan, Zapater Pedro, Llanos Lucía, Gil Víctor, Perelló Rafel

机构信息

Emergency Department and Short-Stay Unit, Hospital General Universitario de Alicante, Alicante, Spain.

Emergency Department, Hospital Clinic de Barcelona; 'Emergencies: Processes and Pathologies' Research Group, IDIBAPS, Barcelona, Spain.

出版信息

Emerg Med J. 2014 Sep;31(9):706-13. doi: 10.1136/emermed-2013-202526. Epub 2013 Jun 22.

Abstract

BACKGROUND

The mainstay of treatment for acutely decompensated heart failure (ADHF) is intravenous diuretic therapy either as a bolus or via continuous infusion.

OBJECTIVES

We evaluated the clinical effects and safety of three strategies of intravenous furosemide administration used in emergency departments (EDs) for ADHF.

METHODS

We performed a multicentre, randomised, parallel-group study. Patients with ADHF were randomised within 2 h of ED arrival to receive furosemide by continuous infusion (10 mg/h, group 1) or boluses (20 mg/6 h, group 2; or 20 mg/8 h, group 3). The primary end point was total diuresis, and secondary end points were dyspnoea, orthopnoea, extension of rales and peripheral oedema, blood pressure, respiratory and heart rates, and pulse oximetry, which were measured at arrival and 3, 6, 12 and 24 h after treatment onset. We also measured serum creatinine, sodium and potassium levels at arrival and after 24 h.

RESULTS

Group 1 patients (n=36) showed greater 24 h diuresis (3705 mL) than those in groups 2 (n=37) and 3 (n=36) (3093 and 2670 mL, respectively; p<0.01), and this greater diuretic effect was observed earlier. However, no differences were observed among groups in the nine secondary clinical end points evaluated. Creatinine deterioration developed in 15.6% of patients, hyponatraemia in 9.2%, and hypokalaemia in 19.3%, with the only difference among groups observed in hypokalaemia (group 1, 36.3%; group 2, 13.5%; group 3, 8.3%; p<0.01).

CONCLUSIONS

In patients with ADHF attending the ED, boluses of furosemide have a smaller diuretic effect but provide similar clinical relief, similar preservation of renal function, and a lower incidence of hypokalaemia than continuous infusion.

TRIAL REGISTRATION NUMBER

This randomised trial was registered in the European Clinical Trial Database (EudraCT) with the reference number 2008-004488-20.

摘要

背景

急性失代偿性心力衰竭(ADHF)的主要治疗方法是静脉注射利尿剂,可采用大剂量推注或持续输注。

目的

我们评估了急诊科用于ADHF的三种静脉注射呋塞米给药策略的临床效果和安全性。

方法

我们进行了一项多中心、随机、平行组研究。ADHF患者在抵达急诊科后2小时内被随机分组,分别接受持续输注呋塞米(10mg/h,第1组)或大剂量推注(20mg/6h,第2组;或20mg/8h,第3组)。主要终点是总尿量,次要终点是呼吸困难、端坐呼吸、啰音范围和外周水肿、血压、呼吸和心率以及脉搏血氧饱和度,在入院时以及治疗开始后3、6、12和24小时进行测量。我们还在入院时和24小时后测量血清肌酐、钠和钾水平。

结果

第1组患者(n = 36)24小时尿量(3705mL)比第2组(n = 37)和第3组(n = 36)(分别为3093mL和2670mL)更多(p<0.01),且这种更大的利尿效果出现得更早。然而,在评估的九个次要临床终点中,各组之间未观察到差异。15.6%的患者出现肌酐恶化,9.2%出现低钠血症,19.3%出现低钾血症,各组之间唯一的差异出现在低钾血症方面(第1组,36.3%;第2组,13.5%;第3组,8.3%;p<0.01)。

结论

在急诊科就诊的ADHF患者中,呋塞米大剂量推注的利尿效果较小,但能提供相似的临床缓解、相似的肾功能保护,且低钾血症发生率低于持续输注。

试验注册号

该随机试验已在欧洲临床试验数据库(EudraCT)注册,注册号为2008 - 004488 - 20。

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