肠内给予谷氨酰胺治疗烧伤随机临床试验。
A Randomized Trial of Enteral Glutamine for Treatment of Burn Injuries.
机构信息
From the Clinical Evaluation Research Unit (D.K.H., L.O.-R.) and the Research Institute (A.G.D.), Kingston Health Sciences Centre, and the Departments of Critical Care Medicine (D.K.H., L.O.R.) and Public Health Sciences (D.K.H.), Queen's University, Kingston, ON, the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Université Laval, and the Population Health and Optimal Health Practices Unit (Trauma-Emergency-Critical Care Medicine) and the Canada Research Chair in Critical Care Neurology and Trauma, Centre Hospitalier Universitaire de Québec-Université Laval Research Center, Quebec, QC (A.F.T.), the Department of Surgery, Division of Plastic Surgery, Department of Immunology, and Institute of Medical Science, University of Toronto, Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre, and Sunnybrook Research Institute, Toronto (M.G.J.), and the Departments of Medicine and Anesthesiology (S.B.) and the Department of Nutrition, Faculty of Medicine (D. Garrel), University of Montreal, Montreal - all in Canada; the University of Iowa, Iowa City (L.W.); Mercy Hospital Burn Center, Mercy Hospital, St. Louis (J.A.P.); Joseph M. Still Research Foundation, Augusta, GA (B.F.); Legacy Oregon Burn Center and Oregon Health and Science University, Portland (N.E.); Internal Medicine, Centro Nacional de Quemaduras y Cirugía Reconstructiva, Asunción, Paraguay (D. Grau); UT Southwestern Medical Center, Dallas (S.M.), and Joint Base San Antonio-Fort Sam Houston, San Antonio (J.M.G.) - both in Texas; University of Tennessee Health Science Center and Firefighters Burn Center, Memphis (S.R.V.); the Department of Hand, Plastic, and Reconstructive Surgery, Burn Trauma Center, BG Trauma Center Ludwigshafen, University of Heidelberg, Heidelberg (G.H.), and the Department of Anesthesiology, Intensive Care Medicine, and Pain Therapy, University Hospital Würzburg, Würzburg (C.S.) - both in Germany; Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham (N.M.), Mersey Regional Burn Centre, St. Helens and Knowesley NHS Trust, Whiston Hospital, Prescot (K.S.), Manchester Metropolitan University, Manchester (K.S.), and Plastic Surgery and Burns, Chelsea and Westminster Hospital London, London (D.C.) - all in the United Kingdom; Arizona Burn Center Valleywise Health, Maricopa Medical Center, Phoenix (K.F.); the Department of Surgical Sciences, Plastic Surgery, Uppsala University, and the Burn Center, Department of Plastic and Maxillofacial Surgery, Uppsala University Hospital, Uppsala, Sweden (F.H.); Connecticut Burn Center, Yale New Haven Health/Bridgeport Hospital, Bridgeport (A.S.); and Centro Traumatologico Ortopedico, Azienda Ospedaliera Universitaria, Città della Salute e della Scienza di Torino, Turin, Italy (N.D.).
出版信息
N Engl J Med. 2022 Sep 15;387(11):1001-1010. doi: 10.1056/NEJMoa2203364. Epub 2022 Sep 9.
BACKGROUND
Glutamine is thought to have beneficial effects on the metabolic and stress response to severe injury. Clinical trials involving patients with burns and other critically ill patients have shown conflicting results regarding the benefits and risks of glutamine supplementation.
METHODS
In a double-blind, randomized, placebo-controlled trial, we assigned patients with deep second- or third-degree burns (affecting ≥10% to ≥20% of total body-surface area, depending on age) within 72 hours after hospital admission to receive 0.5 g per kilogram of body weight per day of enterally delivered glutamine or placebo. Trial agents were given every 4 hours through a feeding tube or three or four times a day by mouth until 7 days after the last skin grafting procedure, discharge from the acute care unit, or 3 months after admission, whichever came first. The primary outcome was the time to discharge alive from the hospital, with data censored at 90 days. We calculated subdistribution hazard ratios for discharge alive, which took into account death as a competing risk.
RESULTS
A total of 1209 patients with severe burns (mean burn size, 33% of total body-surface area) underwent randomization, and 1200 were included in the analysis (596 patients in the glutamine group and 604 in the placebo group). The median time to discharge alive from the hospital was 40 days (interquartile range, 24 to 87) in the glutamine group and 38 days (interquartile range, 22 to 75) in the placebo group (subdistribution hazard ratio for discharge alive, 0.91; 95% confidence interval [CI], 0.80 to 1.04; P = 0.17). Mortality at 6 months was 17.2% in the glutamine group and 16.2% in the placebo group (hazard ratio for death, 1.06; 95% CI, 0.80 to 1.41). No substantial between-group differences in serious adverse events were observed.
CONCLUSIONS
In patients with severe burns, supplemental glutamine did not reduce the time to discharge alive from the hospital. (Funded by the U.S. Department of Defense and the Canadian Institutes of Health Research; RE-ENERGIZE ClinicalTrials.gov number, NCT00985205.).
背景
谷氨酰胺被认为对严重损伤的代谢和应激反应有有益的影响。涉及烧伤和其他重病患者的临床试验表明，谷氨酰胺补充的益处和风险存在相互矛盾的结果。
方法
在一项双盲、随机、安慰剂对照试验中，我们将在入院后 72 小时内的深二度或三度烧伤（根据年龄，影响 10%至 20%的全身表面积）的患者分为两组，每天接受 0.5 克/公斤体重的经肠给予谷氨酰胺或安慰剂。试验药物每 4 小时通过喂养管或每天三次或四次口服，直到最后一次植皮手术后 7 天、从急性护理病房出院或入院后 3 个月，以先到者为准。主要结局是从医院存活出院的时间，数据截止到 90 天。我们计算了存活出院的亚分布危险比，其中考虑了死亡作为竞争风险。
结果
共有 1209 名严重烧伤患者（平均烧伤面积为 33%的全身表面积）接受了随机分组，1200 名患者纳入分析（谷氨酰胺组 596 名，安慰剂组 604 名）。谷氨酰胺组从医院存活出院的中位时间为 40 天（四分位距，24 至 87），安慰剂组为 38 天（四分位距，22 至 75）（存活出院的亚分布危险比，0.91；95%置信区间[CI]，0.80 至 1.04；P=0.17）。谷氨酰胺组 6 个月死亡率为 17.2%，安慰剂组为 16.2%（死亡风险比，1.06；95%CI，0.80 至 1.41）。未观察到两组间严重不良事件存在实质性差异。
结论
在严重烧伤患者中，补充谷氨酰胺并未缩短从医院存活出院的时间。（由美国国防部和加拿大卫生研究院资助；RE-ENERGIZE ClinicalTrials.gov 编号，NCT00985205）。
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