the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- inflammatory factor
研究概览
简要总结
Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral nutrition support on nutritional status, immunologic function and intestinal permeability of patients with chronic radiation intestinal injury.
Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group and glutamine-enriched TPN group. The patients were administered total parenteral nutrition for at least four weeks (two weeks pre-operation and two weeks post-operation). The nutritional status, immunologic function, plasma concentration of glutamine and intestinal permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2 weeks post-operation. Nutrition status was determined the plasma concentrations of hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to CD8+T cells ( CD4 +/CD8 +) was calculated, and serum IgA, IgM and IgG.The intestinal permeability was detected by the urinal ratio of lactulose and mannitol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic radiation enteritis
- •Need the operation
- •Malnutrition
排除标准
- •Hepatic failure
- •Kidney failure
- •Neoplasm recurrence
- •Serious cardiovascular/metabolic disease
- •Pregnancy and lactation
研究组 & 干预措施
placebo group
干预措施: Glutamine (Drug)
Glutamine group
干预措施: Glutamine (Drug)
结局指标
主要结局
inflammatory factor
时间窗: 2 weeks after the surgery
次要结局
未报告次要终点
研究者
Lei Zheng
Resident
Nanjing University School of Medicine
