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CLOROTIC(联用袢利尿剂和噻嗪类利尿剂治疗失代偿性心力衰竭)试验中临床特征及预后的性别差异

Sex differences in clinical characteristics and outcomes in the CLOROTIC (combining loop with thiazide diuretics for decompensated heart failure) trial.

作者信息

Conde-Martel A, Trullàs J C, Morales-Rull J L, Casado J, Carrera-Izquierdo M, Sánchez-Marteles M, Llácer P, Salamanca-Bautista P, Manzano L, Formiga F

机构信息

Internal Medicine Department, Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain; Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.

Internal Medicine Department, Hospital d'Olot i Comarcal de la Garrotxa, Girona, Spain; Tissue Repair and Regeneration Laboratory (TR2Lab), Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IrisCC), Barcelona, Spain.

出版信息

Rev Clin Esp (Barc). 2024 Feb;224(2):67-76. doi: 10.1016/j.rceng.2023.11.003. Epub 2024 Jan 11.

DOI:10.1016/j.rceng.2023.11.003
PMID:38215973
Abstract

AIMS

The addition of hydrochlorothiazide (HCTZ) to furosemide improved the diuretic response in patients with acute heart failure (AHF) in the CLOROTIC trial. Our aim was to evaluate if there were differences in clinical characteristics and outcomes according to sex.

METHODS

This is a post-hoc analysis of the CLOROTIC trial, including 230 patients with AHF randomized to receive HCTZ or placebo in addition to an intravenous furosemide regimen. The primary and secondary outcomes included changes in weight and patient-reported dyspnoea 72 and 96 h after randomization, metrics of diuretic response and mortality/rehospitalizations at 30 and 90 days. The influence of sex on primary, secondary and safety outcomes was evaluated.

RESULTS

One hundred and eleven (48%) women were included in the study. Women were older and had higher values of left ventricular ejection fraction. Men had more ischemic cardiomyopathy and chronic obstructive pulmonary disease and higher values of natriuretic peptides. The addition of HCTZ to furosemide was associated to a greatest weight loss at 72/96 h, better metrics of diuretic response and higher 24-h diuresis compared to placebo without significant differences according to sex (all p-values for interaction were not significant). Worsening renal function occurred more frequently in women (OR [95%CI]: 8.68 [3.41-24.63]) than men (OR [95%CI]: 2.5 [0.99-4.87]), p = 0.027. There were no differences in mortality or rehospitalizations at 30/90 days.

CONCLUSION

Adding HCTZ to intravenous furosemide is an effective strategy to improve diuretic response in AHF with no difference according to sex, but worsening renal function was more frequent in women.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov: NCT01647932; EudraCT Number: 2013-001852-36.

摘要

目的

在CLOROTIC试验中,氢氯噻嗪(HCTZ)联合呋塞米可改善急性心力衰竭(AHF)患者的利尿反应。我们的目的是评估根据性别在临床特征和结局方面是否存在差异。

方法

这是对CLOROTIC试验的事后分析,包括230例AHF患者,这些患者被随机分配接受HCTZ或安慰剂,同时接受静脉注射呋塞米治疗方案。主要和次要结局包括随机分组后72小时和96小时体重的变化以及患者报告的呼吸困难、利尿反应指标以及30天和90天的死亡率/再住院率。评估了性别对主要、次要和安全性结局的影响。

结果

111名(48%)女性纳入研究。女性年龄更大,左心室射血分数值更高。男性缺血性心肌病和慢性阻塞性肺疾病更多,利钠肽值更高。与安慰剂相比,呋塞米联合HCTZ在72/96小时时体重减轻更多,利尿反应指标更好,24小时尿量更高,且根据性别无显著差异(所有交互作用的p值均无统计学意义)。女性肾功能恶化的发生率高于男性(比值比[95%置信区间]:8.68[3.41 - 24.63])(比值比[95%置信区间]:2.5[0.99 - 4.87]),p = 0.027。30/90天时死亡率或再住院率无差异。

结论

静脉注射呋塞米联合HCTZ是改善AHF利尿反应的有效策略,且根据性别无差异,但女性肾功能恶化更常见。

临床试验注册

Clinicaltrials.gov:NCT01647932;欧洲临床试验数据库编号:2013 - 001852 - 36。

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