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重症监护幸存者的肌肉生长与合成代谢(GAINS)试验:一项先导性随机对照试验。

Muscle Growth and Anabolism in Intensive Care Survivors (GAINS) trial: a pilot randomised controlled trial.

作者信息

Anstey Matthew H, Rauniyar Rashmi, Fitzclarence Ethan, Tran Natalie, Osnain Emma, Mammana Bianca, Jacques Angela, Palmer Robert N, Chapman Andrew, Wibrow Bradley

机构信息

Department of Intensive Care, Sir Charles Gairdner Hospital, Perth, Australia.

School of Medicine, University of Western Australia, Perth, Australia.

出版信息

Acute Crit Care. 2022 Aug;37(3):295-302. doi: 10.4266/acc.2021.01767. Epub 2022 Jun 27.

DOI:10.4266/acc.2021.01767
PMID:35791659
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9475160/
Abstract

BACKGROUND

To explore the feasibility, safety, and potential benefits of administration of the anabolic steroid nandrolone to patients in the recovery phase from critical illness weakness.

METHODS

In this phase II, double blind, randomized, controlled trial, adult critically ill patients admitted to one of two tertiary Intensive Care Units in Western Australia for longer than 7 days with significant weakness were enrolled. Patients received nandrolone (200 mg males, 100 mg females) intramuscularly or placebo weekly for up to 3 weeks in addition to standard care. The primary outcome measures were improvement in grip strength, Medical Research Council muscle strength sum score, and functional activity level (Chelsea critical care assessment tool [CPAx]).

RESULTS

A total of 22 patients was enrolled between September 2017 and May 2019. No significant adverse events were detected. Median grip strength change was non-significantly greater in the nandrolone group (8.5 vs. 13.0, P=0.185), while hospital length of stay (36 vs. 26 days, P=0.023) and duration of mechanical ventilation (377 vs. 168, P=0.032) were lower. The discharge CPAx and intensive care unit mobility scores were higher in the nandrolone group, although there was no difference in the change in CPAx score (17.0 vs. 17.7, P=0.865). There were no changes in ultrasound-detected muscle thickness between the two groups.

CONCLUSIONS

In patients with prolonged critical illness, nandrolone appears to be safe. However, a larger study, potentially combined with resistance exercise, is needed to definitively address the potential benefits of nandrolone.

摘要

背景

探讨对危重症肌无力恢复期患者使用合成代谢类固醇诺龙的可行性、安全性及潜在益处。

方法

在这项II期双盲随机对照试验中,纳入了西澳大利亚州两家三级重症监护病房之一收治的成年危重症患者,这些患者因严重肌无力住院超过7天。除标准治疗外,患者每周接受一次诺龙(男性200毫克,女性100毫克)肌肉注射或安慰剂,共3周。主要结局指标包括握力改善情况、医学研究委员会肌肉力量总分及功能活动水平(切尔西危重症评估工具[CPAx])。

结果

2017年9月至2019年5月共纳入22例患者。未检测到明显不良事件。诺龙组握力变化中位数无显著增加(8.5对13.0,P = 0.185),而住院时间(36天对26天,P = 0.023)和机械通气时间(377对168,P = 0.032)较短。诺龙组出院时的CPAx和重症监护病房活动评分较高,尽管CPAx评分变化无差异(17.0对17.7,P = 0.865)。两组间超声检测的肌肉厚度无变化。

结论

对于危重症病程较长的患者,诺龙似乎是安全的。然而,需要开展一项规模更大的研究,可能结合抗阻运动,以明确诺龙的潜在益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b568/9475160/136281ce3ce5/acc-2021-01767f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b568/9475160/1cd98837bf4b/acc-2021-01767f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b568/9475160/136281ce3ce5/acc-2021-01767f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b568/9475160/1cd98837bf4b/acc-2021-01767f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b568/9475160/136281ce3ce5/acc-2021-01767f2.jpg

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