Singh Namrata, Mishra Sushil Kumar, Sachdev Vikas, Sharma Hanish, Upadhyay Ashish Datt, Arora Indu, Saraya Anoop
From the Departments of *Gastroenterology and Human Nutrition, and †Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
Pancreas. 2014 Aug;43(6):867-73. doi: 10.1097/MPA.0000000000000124.
The aim of this study is to evaluate the effect of oral glutamine (GL) supplementation on gut permeability and endotoxemia (surrogate end point) in patients with severe acute pancreatitis.
In a randomized controlled trial, patients were randomized to be given placebo or GL for 7 days. The primary outcome measures include the effect on gut permeability (assessed by lactulose/mannitol excretion in urine and endotoxemia assessed by endotoxin core antibodies type IgG and IgM (EndoCab IgG and IgM). The secondary outcome measures include infectious complications, mortality, total hospital/intensive care unit stay, C-reactive protein, and prealbumin levels.
Patients were assigned to GL (n = 41) and placebo (n = 39) groups. There was no change in gut permeability after the intervention. However, the EndoCab IgM levels increased significantly (33 [4, 175] to 40 [8, 350] GMU/mL; P = 0.0164) and the C-reactive protein levels decreased significantly (133 [1, 287] to 88 [1, 267] ng/mL; P = 0.0236) in the GL group. No difference was observed in infectious complication, prealbumin value, hospital/intensive care unit stay, and mortality in both groups.
No significant trend was identified for an effect of GL on gut permeability. Decreased inflammation and endotoxemia did not translate into reduced infectious complications in severe acute pancreatitis. However, the study was underpowered to detect the aforementioned difference (trial registration: CTRI/2009/000945).
本研究旨在评估口服补充谷氨酰胺（GL）对重症急性胰腺炎患者肠道通透性和内毒素血症（替代终点）的影响。
在一项随机对照试验中，患者被随机分为接受安慰剂或GL治疗7天。主要结局指标包括对肠道通透性的影响（通过尿中乳果糖/甘露醇排泄评估）以及通过内毒素核心抗体IgG和IgM（EndoCab IgG和IgM）评估的内毒素血症。次要结局指标包括感染性并发症、死亡率、总住院/重症监护病房住院时间、C反应蛋白和前白蛋白水平。
患者被分为GL组（n = 41）和安慰剂组（n = 39）。干预后肠道通透性无变化。然而，GL组中EndoCab IgM水平显著升高（从33 [4, 175] 升至40 [8, 350] GMU/mL；P = 0.0164），C反应蛋白水平显著降低（从133 [1, 287] 降至88 [1, 267] ng/mL；P = 0.0236）。两组在感染性并发症、前白蛋白值、住院/重症监护病房住院时间和死亡率方面未观察到差异。
未发现GL对肠道通透性有显著影响趋势。炎症和内毒素血症的降低并未转化为重症急性胰腺炎感染性并发症的减少。然而，该研究的效能不足以检测到上述差异（试验注册号：CTRI/2009/000945）。
