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心力衰竭住院患者住院期间呼吸困难状况的变化及出院后与健康相关的生活质量:来自EVEREST试验的结果。

Changes in Dyspnea Status During Hospitalization and Postdischarge Health-Related Quality of Life in Patients Hospitalized for Heart Failure: Findings From the EVEREST Trial.

作者信息

Ambrosy Andrew P, Khan Hassan, Udelson James E, Mentz Robert J, Chioncel Ovidiu, Greene Stephen J, Vaduganathan Muthiah, Subacuis Haris P, Konstam Marvin A, Swedberg Karl, Zannad Faiez, Maggioni Aldo P, Gheorghiade Mihai, Butler Javed

机构信息

From the Duke University Medical Center, Durham, NC (A.P.A., R.J.M., S.J.G.); Department of Medicine, Emory University School of Medicine, Atlanta, GA (H.K.); Division of Cardiology, Tufts Medical Center and Tufts University School of Medicine, Boston, MA (J.E.U., M.A.K.); Duke Clinical Research Institute, Durham, NC (R.J.M.); Institute of Emergency for Cardiovascular Diseases 'Prof. C.C. Iliescu', University of Medicine and Pharmacy Carol Davila, Bucuresti, Romania (O.C.); Division of Cardiology, Brigham and Women's Hospital, Boston, MA (M.V.); Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (H.P.S., M.G.); Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); Department of Cardiology, INSERM, Nancy University, University de Lorraine, Nancy, France (F.Z.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); and Stony Brook Heart Institute, Stony Brook, NY (J.B.).

出版信息

Circ Heart Fail. 2016 May;9(5). doi: 10.1161/CIRCHEARTFAILURE.115.002458.

DOI:10.1161/CIRCHEARTFAILURE.115.002458
PMID:27140204
Abstract

BACKGROUND

Dyspnea is the most common symptom among hospitalized patients with heart failure and represents a therapeutic target. However, the association between short-term dyspnea relief and postdischarge clinical outcomes and health-related quality of life (HRQOL) remains uncertain.

METHODS AND RESULTS

A post hoc analysis was performed of the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST) trial, which enrolled 4133 patients within 48 hours of admission for heart failure with an ejection fraction ≤40%. Physician-assessed dyspnea was recorded on a daily basis from baseline until discharge or day 7 as none, seldom, frequent, or continuous. Patient-reported dyspnea was measured using a 7-point Likert scale, and patients experiencing moderate or marked dyspnea improvement on day 1 were classified as early responders. The Kansas City Cardiomyopathy Questionnaire summary score, which ranges from 0 to 100, was collected postdischarge at week 1. The primary outcome was unfavorable HRQOL, defined a priori as a Kansas City Cardiomyopathy Questionnaire score <45. Secondary outcomes included 30-day all-cause mortality, and all-cause and cause-specific hospitalizations. The final analytic cohort included 1567 patients discharged alive with complete HRQOL data. Patients were 66.0±12.7 years old and had a mean ejection fraction of 25±8%. Physician-assessed dyspnea was rated as frequent or continuous in 1399 patients (90%) at baseline, which decreased to 250 patients (16%) by discharge, whereas patient-reported early dyspnea relief was reported by 610 patients (40%). The median Kansas City Cardiomyopathy Questionnaire score at week 1 was 50 (35, 65). All-cause mortality was 3.0%, and all-cause hospitalization was 20.5% within 30 days of discharge. Physician-assessed and patient-reported dyspnea was not independently associated with HRQOL, all-cause mortality, or all-cause or cause-specific hospitalization.

CONCLUSIONS

In-hospital physician-assessed, and patient-reported dyspnea was not independently associated with postdischarge HRQOL, survival, or readmissions. Although dyspnea relief remains a goal of therapy for hospitalized patients with heart failure with reduced ejection fraction, this measure may not be a reliable surrogate for long-term patient-centered or hard clinical outcomes.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00071331.

摘要

背景

呼吸困难是住院心力衰竭患者最常见的症状,也是一个治疗靶点。然而,短期呼吸困难缓解与出院后临床结局及健康相关生活质量(HRQOL)之间的关联仍不确定。

方法与结果

对托伐普坦在心衰中的血管加压素拮抗作用疗效:结局研究(EVEREST)试验进行事后分析,该试验纳入了4133例入院48小时内的射血分数≤40%的心力衰竭患者。从基线到出院或第7天,每天记录医生评估的呼吸困难情况,分为无、很少、频繁或持续。患者报告的呼吸困难采用7分李克特量表进行测量,第1天呼吸困难有中度或明显改善的患者被归类为早期缓解者。出院后第1周收集堪萨斯城心肌病问卷总结评分,范围为0至100分。主要结局是不良HRQOL,预先定义为堪萨斯城心肌病问卷评分<45分。次要结局包括30天全因死亡率、全因及特定病因住院率。最终分析队列包括1567例存活出院且有完整HRQOL数据的患者。患者年龄为66.0±12.7岁,平均射血分数为25±8%。基线时,1399例患者(90%)的医生评估呼吸困难为频繁或持续,出院时降至250例患者(16%),而610例患者(40%)报告了患者报告的早期呼吸困难缓解。第1周堪萨斯城心肌病问卷评分中位数为50(35,65)。出院后30天内全因死亡率为3.0%,全因住院率为20.5%。医生评估和患者报告的呼吸困难与HRQOL、全因死亡率或全因及特定病因住院率无独立关联。

结论

住院期间医生评估和患者报告的呼吸困难与出院后HRQOL(健康相关生活质量)、生存率或再入院率无独立关联。尽管呼吸困难缓解仍然是射血分数降低的住院心力衰竭患者的治疗目标,但这一指标可能不是以患者为中心的长期或硬性临床结局的可靠替代指标。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00071331。

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