丙氨酰-谷氨酰胺双肽对接受肠外营养的外科病人氮平衡、肠粘膜通透性和预后的影响

The impact of GLN-dipeptide of nitrogen bulance, Gut permeability and clinical outcome a randomized double blind clinical trail

目的评价丙氨酰-谷氨酰胺双肽的临床安全性及其对手术后病人氮平衡、肠粘膜通透性和临床预后的影响。方法接受腹部外科手术的120例病人，研究方案获得伦理委员会批准并都得到了病人的知情书面同意。采用双盲设计。二个中心的60例病人进行了临床安全性和临床预后的观察（每个中心各30例）。另外二个中心的60例病人进行了氮平衡、肠粘膜通透性、临床预后和临床安全性的观察。所有的病人都接受等氮（每天0．20g/kgBW）和等热卡（每天30kcal/kgBW）的肠外营养。研究组接受丙氨酸-谷氨酰胺双肽的补充（Dipeptiven，每天0．50g／kgBW，相当于谷氨酰胺每天0．34g/kgBW）。对临床生化指标、血浆氨基酸谱、氮平衡、肠粘膜通透性（lactulose/mannitolratio,L/M比值）进行测定。对病人的住院时间和与感染有关的并发症进行观察。统计分析采用Statview软件，进行方差分析或卡方检验，当P＜0．05认为差异有显著性。结果术前研究组和对照组具有可比性。手术前（AOD-3）研究组和对照组病人的L／M比值分别是0.047±0．029和0.058±0．049。在手术后第七天，研究组和对照组病人的L／M比值分别是0．097±0．063和0.132±0．081。二组Delta比较差异有显著性（P＝0．02）。手术后6天的累计氮平衡在研究组是144±145mg/kg，对?

Purpose: To evaluate the impact of alanyl-glutamine(Ala-Gln) - Supplemented parenteral nutrition (PN) on clinical safety, nitrogen balance, intestinal permeability, and clinical outcome in postoperativer patients. Methods One hundred twenty patients Undergoingmajor abdominal surgery were enrolled. Protocol was approved and informed consent obtatined. A double-blind protocol was impact used in Europe. The clinical safety and outcome were obserbed for 6o patients in 2 centers (30 each). Sixty Patients from 2 additional centers (30 each) were for clinical safety,,nitrogen balane,intestinal permeability, and clinical outcome. All Patients received impact (0. 2g/kg) body wt per day) and isocaloric (30 kcal/kg body wt per day) parenteral nutrition. The study group received Ala-Gln (Dipeptiven,Fresenius Kabi,Bad Homberg,Germany) GLN 0. 35g/kg perday. Clinical chemistry variables, plasma amino acids profile,nitrogen balance, intestinal permeability (lactulose/majnnitol ratio [L/M ratio]) were measured; hospital stay and infection rate were moi tored. Statview was used for analysis of variance (ANOVA) or X2 tests. Date were expressed as means±SD, and the significance level was P<0.05. Results The patients in both groups were comparable prior to the operation. Vital signs and clinical chemical parameters were similar between groups. L/M ratio was 0.047±0. 049 in study group before the operation(AOD-3). The L/M ratio was 0.132±0.081 in the seventh postoperative day. The difference of L/M ratio between groups was sighficant (P = 0.02). The Cumulative nitrogen balance values were - 5±l62mg/kg for 6 dsys in control and 144±145mg/kg for 6 days in study group (P = 0.004). All the patients recovered without incision infection. However, there were 3 cases that had infection related complications in the control group; the difference wasn't significant between groups. The hospital stay in the study group was 12. 5 days,which was 4 days less than that of the control group (P = 0.02). Conclusions: Ala-Gln-supple-mented PN was clinically safe, had better nitrogen balance, and maintained intestinal permeability patients in study group was better; it was significantly difterent from the control group.