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重复血管闭塞刺激(RVOS)应用于多器官功能衰竭重症患者的安全性和可行性评估:一项初步随机对照试验

Safety and Feasibility Assessment of Repetitive Vascular Occlusion Stimulus (RVOS) Application to Multi-Organ Failure Critically Ill Patients: A Pilot Randomised Controlled Trial.

作者信息

Chhetri Ismita, Hunt Julie E A, Mendis Jeewaka R, Forni Lui G, Kirk-Bayley Justin, White Ian, Cooper Jonathan, Somasundaram Karthik, Shah Nikunj, Patterson Stephen D, Puthucheary Zudin A, Montgomery Hugh E, Creagh-Brown Benedict C

机构信息

Intensive Care Unit, Royal Surrey County Hospital, NHS Foundation Trust, Guildford GU2 7XX, UK.

Faculty of Health and Medical Sciences, School of Biosciences & Medicine, University of Surrey, Guildford GU2 7XH, UK.

出版信息

J Clin Med. 2022 Jul 6;11(14):3938. doi: 10.3390/jcm11143938.

DOI:10.3390/jcm11143938
PMID:35887701
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9316533/
Abstract

Muscle wasting is implicated in the pathogenesis of intensive care unit acquired weakness (ICU-AW), affecting 40% of patients and causing long-term physical disability. A repetitive vascular occlusion stimulus (RVOS) limits muscle atrophy in healthy and orthopaedic subjects, thus, we explored its application to ICU patients. Adult multi-organ failure patients received standard care +/- twice daily RVOS {4 cycles of 5 min tourniquet inflation to 50 mmHg supra-systolic blood pressure, and 5 min complete deflation} for 10 days. Serious adverse events (SAEs), tolerability, feasibility, acceptability, and exploratory outcomes of the rectus femoris cross-sectional area (RFCSA), echogenicity, clinical outcomes, and blood biomarkers were assessed. Only 12 of the intended 32 participants were recruited. RVOS sessions (76.1%) were delivered to five participants and two could not tolerate it. No SAEs occurred; 75% of participants and 82% of clinical staff strongly agreed or agreed that RVOS is an acceptable treatment. RFCSA fell significantly and echogenicity increased in controls ( = 5) and intervention subjects ( = 4). The intervention group was associated with less frequent acute kidney injury (AKI), a greater decrease in the total sequential organ failure assessment score (SOFA) score, and increased insulin-like growth factor-1 (IGF-1), and reduced syndecan-1, interleukin-4 (IL-4) and Tumor necrosis factor receptor type II (TNF-RII) levels. RVOS application appears safe and acceptable, but protocol modifications are required to improve tolerability and recruitment. There were signals of possible clinical benefit relating to RVOS application.

摘要

肌肉萎缩与重症监护病房获得性肌无力(ICU-AW)的发病机制有关,影响40%的患者并导致长期身体残疾。重复性血管闭塞刺激(RVOS)可限制健康受试者和骨科患者的肌肉萎缩,因此,我们探索了其在ICU患者中的应用。成年多器官功能衰竭患者接受标准治疗,每天两次接受或不接受RVOS{4个周期,每个周期为5分钟,将止血带充气至收缩压以上50 mmHg,然后5分钟完全放气},持续10天。评估了严重不良事件(SAE)、耐受性、可行性、可接受性以及股直肌横截面积(RFCSA)、回声性、临床结局和血液生物标志物等探索性结局。在计划招募的32名参与者中,仅招募到12名。RVOS疗程(76.1%)施用于5名参与者,2名无法耐受。未发生SAE;75%的参与者和82%的临床工作人员强烈同意或同意RVOS是一种可接受的治疗方法。对照组(n = 5)和干预组(n = 4)的RFCSA显著下降,回声性增加。干预组急性肾损伤(AKI)发生率较低,序贯器官衰竭评估(SOFA)总分下降幅度更大,胰岛素样生长因子-1(IGF-1)增加,而多配体蛋白聚糖-1、白细胞介素-4(IL-4)和肿瘤坏死因子受体II型(TNF-RII)水平降低。RVOS的应用似乎是安全且可接受的,但需要修改方案以提高耐受性和招募率。有迹象表明RVOS的应用可能具有临床益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8443/9316533/b18d766fa7e3/jcm-11-03938-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8443/9316533/7e42c2a502d0/jcm-11-03938-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8443/9316533/e4f797ec99dd/jcm-11-03938-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8443/9316533/b18d766fa7e3/jcm-11-03938-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8443/9316533/7e42c2a502d0/jcm-11-03938-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8443/9316533/e4f797ec99dd/jcm-11-03938-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8443/9316533/b18d766fa7e3/jcm-11-03938-g003.jpg

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