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心力衰竭患者远程康复(TELEREH-HF)试验的基于病因学的亚组分析。

An aetiology-based subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial.

作者信息

Szalewska Dominika, Główczyńska Renata, Piotrowicz Ryszard, Kowalik Ilona, Pencina Michael J, Opolski Grzegorz, Zaręba Wojciech, Banach Maciej, Orzechowski Piotr, Pluta Sławomir, Irzmański Robert, Kalarus Zbigniew, Piotrowicz Ewa

机构信息

Chair and Clinic of Rehabilitation Medicine, Faculty of Health Sciences, Medical University of Gdańsk, Gdańsk, Poland.

1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

出版信息

ESC Heart Fail. 2021 Apr;8(2):1263-1273. doi: 10.1002/ehf2.13189. Epub 2021 Feb 1.

Abstract

AIMS

The aim of our study was to analyse the benefits of a 9 week hybrid comprehensive telerehabilitation (HCTR) programme in heart failure (HF) patients according to aetiology, as a subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial.

METHODS AND RESULTS

Overall, 555 (65.3%) patients with ischaemic (IS) and 295 (34.7%) patients with non-ischaemic (NIS) HF aetiology were randomized. There were no differences between the effect of HCTR and usual care (UC) on the primary outcome of number of days alive and out of the hospital in 26 months from the time of randomization in either aetiology (Wilcoxon-Mann-Whitney test), and no heterogeneity of effect between the aetiologies was noted (van Elteren test, P = 0.746). In Cox proportional hazards regression analysis, treatment was not independently associated with the secondary outcomes. For all-cause mortality, the adjusted hazard ratio for HCTR vs. UC was 0.90 (95% confidence interval, 0.54-1.51) in IS and 1.42 (95% confidence interval, 0.69-2.94) in NIS (P interaction = 0.316). Differences between HCTR and UC in terms of change in the 6 min walk test distance and cardiopulmonary exercise test time after 9 weeks reached statistical significance in the IS arm (P = 0.015 and P < 0.001, respectively), but not in the NIS arm; however, tests of heterogeneity indicated no statistically significant differences.

CONCLUSIONS

The trial showed no difference between HCTR and UC in the primary outcome of percentage of days alive and out of the hospital for either IS or NIS aetiology. Moreover, the magnitude of changes in the clinical and functional statuses of the HF patients did not differ by aetiology. HCTR might have had beneficial effects on the 6 min walk test distance and cardiopulmonary exercise test time after 9 weeks in the IS patients; however, the effect was not statistically significantly different from that observed in the NIS patients.

摘要

目的

作为心力衰竭患者远程康复(TELEREH-HF)试验的一项亚分析,我们研究的目的是根据病因分析为期9周的混合综合远程康复(HCTR)计划对心力衰竭(HF)患者的益处。

方法与结果

总体而言,555例(65.3%)缺血性(IS)心力衰竭患者和295例(34.7%)非缺血性(NIS)心力衰竭患者被随机分组。在随机分组后26个月内,HCTR与常规护理(UC)对两种病因的主要结局(存活且未住院天数)的影响均无差异(Wilcoxon-Mann-Whitney检验),且未观察到病因之间的效应异质性(van Elteren检验,P = 0.746)。在Cox比例风险回归分析中,治疗与次要结局无独立相关性。对于全因死亡率,IS组中HCTR与UC相比的调整后风险比为0.90(95%置信区间,0.54 - 1.51),NIS组为1.42(95%置信区间,0.69 - 2.94)(P交互作用 = 0.316)。9周后,IS组中HCTR与UC在6分钟步行试验距离和心肺运动试验时间变化方面的差异达到统计学显著性(分别为P = 0.015和P < 0.001),但NIS组未达到;然而,异质性检验表明无统计学显著差异。

结论

该试验表明,对于IS或NIS病因,HCTR与UC在存活且未住院天数百分比的主要结局方面无差异。此外,HF患者临床和功能状态变化的幅度不因病因而异。HCTR可能对IS患者9周后的6分钟步行试验距离和心肺运动试验时间有有益影响;然而,该效应与NIS患者观察到的效应在统计学上无显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0003/8006702/abd757f44ee6/EHF2-8-1263-g005.jpg

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