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

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。

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

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) micromol/L vs (407 +/- 190) micromol/L)] (P < 0.01). IL-2 level, CD(4)/CD(8) 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, C(3)/C(4) 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 immunofunction, and using glutamine granules is safe.