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急性失代偿性心力衰竭重症患者的早期心脏康复:一项随机临床试验

Early Cardiac Rehabilitation for Critically Ill Patients With Acute Decompensated Heart Failure: A Randomized Clinical Trial.

作者信息

Wu Linjing, Li Jiahua, Zheng Yamin, Xue Mengmeng, Yan Wei, Sun Yongbin, Zhang Meiling, Li Qiaoyan, Zhang Jiahong, Jia Ying, Wang Yuli, Chen Yuan, Sun Guangyu, Liu Binbin, Dai Cuilian

机构信息

Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Fujian Branch of National Clinical Research Center for Cardiovascular Diseases, Xiamen, China.

出版信息

JAMA Netw Open. 2025 Jul 1;8(7):e2524141. doi: 10.1001/jamanetworkopen.2025.24141.


DOI:10.1001/jamanetworkopen.2025.24141
PMID:40736732
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12311714/
Abstract

IMPORTANCE: The optimal timing and approach for initiating cardiac rehabilitation (CR) in critically ill patients during the acute phase of acute decompensated heart failure (ADHF) remains uncertain. OBJECTIVE: To evaluate the effects of CR on physical function and rehospitalization for critically ill patients with ADHF admitted to the cardiac intensive care unit (CICU). DESIGN, SETTING, AND PARTICIPANTS: In this single-center, single-blind randomized clinical trial conducted in China, critically ill patients with severe ADHF admitted to the CICU were recruited between March 26, 2021, and September 1, 2022. All patients were followed up for 6 months, and investigators were blinded to the group assignment. INTERVENTIONS: After short-term therapy, participants were randomized 1:1 to an early progressive and personalized CR program for patients with ADHF (AHF-CR program) that was administered exclusively during the patients' CICU stay or to usual care. MAIN OUTCOMES AND MEASURES: The primary outcomes were Short Physical Performance Battery (SPPB) score at hospital discharge and 6-month all-cause rehospitalization rates. These outcomes were analyzed using an intention-to-treat approach including all patients after randomization. The Perme Intensive Care Unit Mobility (PERME) score was incorporated as an exploratory outcome during analysis to assess mobility status in critically ill patients. RESULTS: This study included 120 patients (mean [SD] age, 68.6 [12.3] years; 80 [66.7%] male). At randomization, pulmonary crackles were observed in 49 patients in the control group (81.7%) and 43 patients in the intervention group (71.7%). Additionally, 62 patients (51.7%) had an arterial partial pressure of oxygen to fraction of inspired oxygen ratio below 300 mm Hg. A total of 40 patients (33.3%) received intravenous vasoactive medications, and 87 (72.5%) received intravenous loop diuretics. The median difference in SPPB scores between groups was 1.0 (95% CI, 0-2.0; P = .16), which was not significant. Six-month rehospitalization rates were comparable between the control and intervention groups (16 [26.6%] vs 17 [28.3%]; hazard ratio, 1.00 [95% CI, 0.51-1.99]; P = .99). Exploratory analysis revealed that the intervention group had higher PERME scores, with a median between-group difference of 2.76 (95% CI, 0.77-4.74; adjusted P = .04). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of critically ill patients with ADHF, the AHF-CR program did not significantly improve SPPB scores or rehospitalization rates. However, it may offer potential physical benefits, including enhanced mobility. TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2100050151.

摘要

重要性:在急性失代偿性心力衰竭(ADHF)急性期的重症患者中启动心脏康复(CR)的最佳时机和方法仍不确定。 目的:评估CR对入住心脏重症监护病房(CICU)的ADHF重症患者身体功能和再住院率的影响。 设计、设置和参与者:在这项于中国进行的单中心、单盲随机临床试验中,招募了2021年3月26日至2022年9月1日期间入住CICU的重度ADHF重症患者。所有患者随访6个月,研究人员对分组情况不知情。 干预措施:经过短期治疗后,参与者按1:1随机分为接受专门在患者CICU住院期间实施的针对ADHF患者的早期渐进性和个性化CR计划(AHF-CR计划)或常规治疗。 主要结局和测量指标:主要结局为出院时的简短体能状况量表(SPPB)评分和6个月全因再住院率。这些结局采用意向性分析方法,包括随机分组后的所有患者。在分析过程中纳入了重症监护病房活动能力(PERME)评分作为探索性结局,以评估重症患者的活动状态。 结果:本研究纳入120例患者(平均[标准差]年龄,68.6[12.3]岁;80例[66.7%]为男性)。随机分组时,对照组49例患者(81.7%)和干预组43例患者(71.7%)出现肺部啰音。此外,62例患者(51.7%)的动脉血氧分压与吸入氧分数之比低于300 mmHg。共有40例患者(33.3%)接受静脉血管活性药物治疗,87例(72.5%)接受静脉袢利尿剂治疗。两组间SPPB评分的中位数差异为1.0(95%CI,-0.0至2.0;P = 0.16),无统计学意义。对照组和干预组的6个月再住院率相当(16例[26.6%]对17例[28.3%];风险比,1.00[95%CI,0.51至1.99];P = 0.99)。探索性分析显示,干预组的PERME评分更高,组间中位数差异为2.76(95%CI,0.77至4.74;校正P = 0.04)。 结论及相关性:在这项针对ADHF重症患者的随机临床试验中,AHF-CR计划未显著改善SPPB评分或再住院率。然而,它可能带来潜在的身体益处,包括增强活动能力。 试验注册:中国临床试验注册标识符:ChiCTR2100050151

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/182d/12311714/65856eac73e7/jamanetwopen-e2524141-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/182d/12311714/f6c7816c0b5f/jamanetwopen-e2524141-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/182d/12311714/65856eac73e7/jamanetwopen-e2524141-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/182d/12311714/f6c7816c0b5f/jamanetwopen-e2524141-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/182d/12311714/65856eac73e7/jamanetwopen-e2524141-g002.jpg

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本文引用的文献

[1]
A comprehensive assessment tool of acute-phase rehabilitation is associated with clinical outcomes in patients after cardiovascular surgery.

Heart Vessels. 2025-3

[2]
Early Exercise-Based Rehabilitation for Patients with Acute Decompensated Heart Failure: A Systemic Review and Meta-Analysis.

Rev Cardiovasc Med. 2022-10-21

[3]
Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper.

JACC Heart Fail. 2024-1

[4]
Frailty and long-term survival among patients in Australian intensive care units with metastatic cancer (FRAIL-CANCER study): a retrospective registry-based cohort study.

Lancet Healthy Longev. 2023-12

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Eur Heart J. 2023-10-1

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Eur Heart J. 2023-5-1

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Lancet Respir Med. 2023-6

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