谷氨酰胺颗粒对创伤患者免疫功能影响的多中心、随机、双盲对照研究  

Effects of glutamine granules on immunofunction in trauma patients: a double-blind randomized controlled,multi-center clinical trail with 120 patients

作　　者：彭曦[1] 尤忠义[1] 黄显凯[2] 张才全[3] 贺光照[4] 全竹富[5] 解伟光[6] 

机构地区：[1]第三军医大学西南医院烧伤研究所,创伤,烧伤与复合伤国家重点实验室,重庆400038 [2]第三军医大学大坪医院创伤中心 [3]重庆医科大学第一附属医院普外科 [4]重庆医科大学第一附属医院烧伤科 [5]南京军区总医院普外科 [6]南京军区总医院烧伤科

出　　处：《中华外科杂志》2005年第17期1123-1126,共4页Chinese Journal of Surgery

摘　　要：目的观察服用谷氨酰胺(GLN)颗粒对创伤、烧伤及大手术患者免疫功能的影响及可能发生的不良反应.方法采用随机、双盲、安慰剂平行对照法,将受试患者分为谷氨酰胺组(GLN组)和安慰剂对照组(P组),每组60例,两组患者采用等氮、等热量的营养支持.GLN组口服或管饲 GLN 0.5 g·kg-1·d-1,对照组使用同等剂量的安慰剂(甘氨酸),疗程为7 d.比较两组患者血浆GLN浓度和各项免疫指标的变化,并观察患者肝肾功能的变化及不良反应发生情况.结果伤后患者血浆GLN浓度、多形核粒细胞(PMN)吞噬能力、淋巴细胞亚型比值(CD4/CD8)、白细胞介素2(IL-2)水平明显低于正常值,而免疫球蛋白和补体C3、C4含量变化不明显.与P组相比,GLN组患者用药7 d后血浆GLN浓度明显增高[(593±185)μmol/L和(407±190)μmol/L],增幅达45.7%(P<0.01),GLN组免疫球蛋白A(IgA)含量、IL-2水平、CD4/CD8及PMN吞噬率明显高于P组(P<0.05～0.01),而免疫球蛋白G、M(IgG、IgM)及补体C3、C4含量、血尿常规及肝、肾功能两组差异无统计学意义(P>0.05).少数患者出现轻微不良反应,如恶心、腹泻和便秘等,两组间差异无统计学意义(P>0.05).结论服用GLN颗粒能显著提高血浆GLN浓度,明显减轻伤后免疫抑制,提高机体免疫功能,临床应用无明显不良反应.Objective To evaluate the effect of glutamine granules on immunofunction in severe burns and trauma patients. Methods One hundred and twenty patients with severe burns, multiple trauma and post operation who met the requirements of the protocol joined this double-blind randomized controlled, multi-center clinical trail. Patients were randomly divided into two groups ： placebo control group （ P group, 60 patients） and glutamine granules treatment group （GLN group, 60 patients）. There was isonitrogenous and isocaloric intake in both groups. GLN and P group patients had been given glutamine granules or placebo （glycine） at 0. 5 g·kg^-1 ·d^-1 for 7 days, respectively. The level of plasma glutamine and some index of immunofunction were determined, and the complication and side effect were also observed. Results After 7 days of taking glutamine granules orally, plasma GLN concentration was significantly higher than that in P group[ （593 ± 185）μmol/L vs （407 ± 190）μmol/L） ] （P 〈0.01）. IL-2 level,CD4/CDs ratio, PMN swallow ratio in GLN group were significantly higher than those in P group （ P 〈 0. 05 - 0.01 ）, but the concentration of IgG, IgM, C3/C4 were not significantly different when compared with P group （P 〉 0. 05 ）. In addition, the occurrence of side effect in both groups was seldom. Conclusion Taking glutamine granules could increase plasma GLN concentration, enhance body i mmunofunction, and using glntamine granules is safe.

关 键 词：谷氨酰胺 免疫功能 多中心临床研究 创伤 谷氨酰胺颗粒 机体免疫功能 双盲对照研究 创伤患者 功能影响 随机 

分 类 号：R641[医药卫生—外科学] R285.5[医药卫生—临床医学]