澳大利亚阿德莱德大学Matthew J. Summers团队研究了重症患者肠内蛋白增加对患者预后的影响。该研究于2025年6月11日发表在《美国医学会杂志》上。

指南建议在危重疾病期间增加肠内蛋白，但对患者预后的影响尚不确定。该研究旨在确定增加肠内蛋白是否能增加存活和出院天数。该整群随机、交叉、开放标签试验于2022年5月23日至2023年8月23日在澳大利亚和新西兰的8个重症监护病房（ICU）招募接受肠内营养治疗的危重患者，最终随访时间为2023年11月21日。

研究组比较两种等热量肠内配方：增强蛋白（100 g蛋白/L）与常规蛋白（63 g蛋白/L）。ICU在12个月期间连续使用3个月的配方；4个ICU以扩增蛋白开始，4个以正常蛋白开始。主要观察指标为出院天数和第90天存活天数。次要结局包括幸存者在第90天离开索引医院的天数；第90天存活；有创通气、ICU和住院时间；气管切开术与新肾替代治疗的发生率和出院目的地。

研究组共纳入3397例患者(中位[IQR]年龄61（48-71）岁；2157[64%]男性)。在第90天，增强蛋白组脱离指标医院和存活的中位数（IQR）天数为62（0-77）天，普通蛋白组为64（0-77）天，调整后的组间中位数差异为1.97 （95% CI, 7.24 ~ 3.30）天（P = 0.46）。第90天，增强蛋白组1681例患者中有1221例（72.6%）存活，正常蛋白组1716例患者中有1269例（74.0%）存活（风险比0.99）。次要结局的组间差异包括：幸存者中位出院天数的差异为0.01 （95% CI, 1.94 ~ 1.96）天；有创通气的平均持续时间差异为6.8小时（95% CI, 3.0 ~ 16.5）；ICU住院时间（ICU存活出院时间）的病因特异性风险比为0.93 (95% CI, 0.88-1.00)，住院时间（存活出院时间）的病因特异性风险比为0.96 (95% CI, 0.90-1.02)；气管切开术的风险比为1.15 (95% CI, 0.66-2.01)，新的肾脏替代治疗的风险比为0.97 （95% CI, 0.81-1.16）。出院目的地相似。

研究结果表明，危重期肠内蛋白的增加并没有提高指标医院的出院天数和第90天的存活率。

附：英文原文

Title: Augmented Enteral Protein During Critical Illness: The TARGET Protein Randomized Clinical Trial

Author: Matthew J. Summers, Lee-anne S. Chapple, Amalia Karahalios, Rinaldo Bellomo, Marianne J. Chapman, Suzie Ferrie, Mark E. Finnis, Craig French, Sally Hurford, Nima Kakho, Matthew J. Maiden, Stephanie N. O’Connor, Sandra L. Peake, Jeffrey J. Presneill, Emma J. Ridley, An Tran-Duy, Patricia J. Williams, Paul J. Young, Sophie Zaloumis, Adam M. Deane, TARGET Protein Investigators and for the Australian and New Zealand Intensive Care Society Clinical Trials Group, Suzie Ferrie, Imogen Asser, Nerissa Brown, Lee-anne Chapple, Sarah Doherty, Mark Finnis, Mahni Foster, Kathleen Glasby, Rhea Louis, Fiona McDonald, Mark Plummer, Stephanie O’Connor, Justine Rivett, Matthew Summers, Sandra Peake, Catherine Kurenda, Srilatha Vemparala, Patricia Williams, Rinaldo Bellomo, Christine Choong, Glenn Eastwood, Kate Hamilton, Leah Peck, Helen Young, Deborah Barge, Alice Barrese, Kathleen Byrne, Adam Deane, Kate Fetterplace, Olivia Gigli, Matthew Maiden, Jeffrey Presneill, Brianna Tascone, Kym Wittholz, Samantha Bates, Craig French, Haindavi Muppa, Giang Nguyen, Stephanie Schembri, Stacey Hawker

Issue&Volume: 2025-06-11

Abstract:

Importance  Guidelines recommend augmenting enteral protein during critical illness, but the impact on patient outcomes is uncertain.

Objective  To determine whether augmenting enteral protein increases days alive and free from hospitalization.

Design, Setting, and Participants  This cluster randomized, crossover, open-label trial recruited critically ill patients receiving enteral nutrition from 8 intensive care units (ICUs) in Australia and New Zealand from May 23, 2022, to August 23, 2023, with final follow-up on November 21, 2023.

Intervention  Two isocaloric enteral formulae were compared: augmented protein (100 g protein/L) vs usual protein (63 g protein/L). ICUs used formulae sequentially for 3 months over a 12-month period; 4 ICUs commenced with augmented protein and 4 commenced with usual protein.

Main Outcomes and Measures  The primary outcome was the number of days free of admittance to the index hospital and alive at day 90. Secondary outcomes included days free of the index hospital at day 90 in survivors; alive at day 90; durations of invasive ventilation, ICU, and hospital admission; incidences of tracheostomy insertion and new kidney replacement therapy; and hospital discharge destination.

Results  A total of 3397 patients were included (median [IQR] age, 61 (48-71) years; 2157 [64%] male). The median (IQR) number of days free of the index hospital and alive at day 90 was 62 (0-77) days in the augmented protein group and 64 (0-77) days in the usual protein group, with an adjusted-for-period between-group median difference of 1.97 (95% CI, 7.24 to 3.30) days (P=.46). At day 90, a total of 1221 of 1681 patients (72.6%) were alive in the augmented protein group and 1269 of 1716 (74.0%) were alive in the usual protein group (risk ratio, 0.99 [95% CI, 0.95-1.03]). Between-group differences for secondary outcomes included the following: difference in median days free of hospital in survivors, 0.01 (95% CI, 1.94 to 1.96) days; difference in mean duration of invasive ventilation, 6.8 (95% CI, 3.0 to 16.5) hours; cause-specific hazard ratios for durations of ICU admission (time to live ICU discharge), 0.93 (95% CI, 0.88-1.00) and hospital admission (time to live hospital discharge), 0.96 (95% CI, 0.90-1.02); and risk ratio for tracheostomy, 1.15 (95% CI, 0.66-2.01) and new kidney replacement therapy, 0.97 (95% CI, 0.81-1.16). Discharge destinations were similar.

Conclusions and Relevance  Augmenting enteral protein during critical illness did not improve number of days free of the index hospital and alive at day 90.

DOI: 10.1001/jama.2025.9110

Source: https://jamanetwork.com/journals/jama/fullarticle/2835302