高蛋白摄入对危重症癌症患者肌肉量及临床结局的影响：一项预设的符合方案分析
The Effects of Higher Protein Intake on Muscle Mass and Clinical Outcomes in Critically Ill Cancer Patients: A Prespecified Per-Protocol Analysis.
作者信息
Toloi Jerusa Marcia, Laranja Ana Carolina Gallo, Toledo Diogo Oliveira, Treml Ricardo Esper, Malbouisson Luiz Marcelo S, Manzanares William, Silva-Jr João Manoel
机构信息
Division of Anesthesiology, Postgraduate Program of Anesthesiology, Surgical Sciences and Perioperative Medicine, Faculty of Medicine, University of São Paulo, Av. Dr. Arnaldo 455, Sao Paulo 05403-000, Brazil.
Department of Nutrition, Barretos Cancer Hospital, R. Antenor Duarte Vilela 1331, Barretos 14784-400, Brazil.
出版信息
Nutrients. 2025 Aug 24;17(17):2742. doi: 10.3390/nu17172742.
BACKGROUND/OBJECTIVES: The optimal protein dose for critically ill cancer patients, especially for muscle mass preservation and survival, remains unclear. This study evaluated whether a higher protein intake, compared to usual intake, was associated with improved clinical outcomes in this population.
METHODS
This was a prospective analysis of critically ill adult cancer patients admitted to an oncological intensive care unit (ICU). Patients were initially assigned to receive protein prescriptions of either 1.5 or 2.0 g per kilogram per day (g/kg/day), but due to common limitations in achieving prescribed targets in this setting, a prespecified per-protocol analysis was conducted. After three days of exclusive nutritional therapy, patients were reclassified into two groups based on actual protein intake: >1.5 g/kg/day (higher intake group, IG) and ≤1.5 g/kg/day (usual intake group, CG). The primary outcome was muscle mass preservation, measured by quadriceps muscle thickness (QMT) via ultrasound on days 1, 7, and 14. Secondary outcomes included ICU survival, hospital and ICU length of stay, mechanical ventilation duration, dialysis requirement, and 60-day survival.
RESULTS
From June 2019 to September 2023, 117 patients were included. Following the planned interim analysis, the study was stopped after meeting the Pocock criterion for ICU survival ( = 0.0013). After reclassification, 68.4% ( = 80) were in the IG and 31.6% ( = 37) in the CG. ICU stay was similar (both medians 13 days), but the IG had shorter hospital stays [21.0 vs. 27.5 days, = 0.020], less QMT loss, and improved ICU (HR = 0.31, 95% CI 0.15-0.64), hospital (HR = 0.43, CI 0.23-0.80), and 60-day survival (HR = 0.43, CI 0.23-0.80), along with shorter ventilation duration (HR = 0.54, CI 0.30-0.99).
CONCLUSIONS
Higher protein intake (>1.5 g/kg/day) was associated with better muscle mass preservation and improved clinical outcomes in critically ill cancer patients.
背景/目的：危重症癌症患者的最佳蛋白质剂量，尤其是对于维持肌肉量和提高生存率而言，仍不明确。本研究评估了与常规摄入量相比，更高的蛋白质摄入量是否与该人群更好的临床结局相关。
方法
这是一项对入住肿瘤重症监护病房（ICU）的成年危重症癌症患者的前瞻性分析。患者最初被分配接受每天每千克1.5或2.0克（g/kg/天）的蛋白质处方，但由于在这种情况下实现规定目标存在常见限制，因此进行了预先指定的符合方案分析。在进行三天的单纯营养治疗后，根据实际蛋白质摄入量将患者重新分为两组：>1.5 g/kg/天（高摄入量组，IG）和≤1.5 g/kg/天（常规摄入量组，CG）。主要结局是通过在第1、7和14天经超声测量股四头肌厚度（QMT）来评估肌肉量的维持情况。次要结局包括ICU生存率、住院时间和ICU住院时间、机械通气时间、透析需求以及60天生存率。
结果
从2019年6月至2023年9月，共纳入117例患者。在进行计划中的中期分析后，在达到ICU生存的Pocock标准（P = 0.0013）后，研究停止。重新分类后，IG组占68.4%（n = 80），CG组占31.6%（n = 37）。ICU住院时间相似（中位数均为13天），但IG组的住院时间较短[21.0天对27.5天，P = 0.020]，QMT损失较少，并且ICU生存率（HR = 0.31，95%CI 0.15 - 0.64）、住院生存率（HR = 0.43，CI 0.23 - 0.80）和60天生存率（HR = 0.43，CI 0.23 - 0.80）均有所改善，同时机械通气时间也较短（HR = 0.54，CI 0.30 - 0.99）。
结论
更高的蛋白质摄入量（>1.5 g/kg/天）与危重症癌症患者更好的肌肉量维持和改善的临床结局相关。
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