摘要
目的 对比肠内、肠外营养对术后病人肠通透性等的影响。 方法 食道和胃肠道疾病需手术患者为研究对象。随机、对照、多中心临床研究 ,按随机表进入研究组及对照组 ,两组为等氮等热卡营养。研究计划经伦理委员会批准。所有病人均知情同意参加。 结果 安全性 :两组均无严重不良事件 ,但对照组有 5例肝功损害 ,研究组有 2例肝功损害 (P =0 .49)。替代 (surrogateefficacy)有效性终点指标 :(1)血浆谷氨酰胺 (GLN)的变化 :研究组术前 (5 76 .1± 73.6 ) μmol/L ,术后 (5 38.4± 78.6 ) μmol/L ,对照组术前(5 37.0± 99.5 ) μmo/L ,术后 (4 2 3.0± 6 9.0 ) μmo/L ,差值 (Delta ,△ )对比有显著性意义 (P =0 .0 0 2 9)。 (2 )肠通透性 (乳果糖 /甘露醇比值 )对比 :研究组乳果糖 /甘露醇比值增加 0 .0 18± 0 .0 14,对照组乳果糖 /甘露醇比值增加 0 .0 43± 0 .0 2 2 ,差值 (Delta ,△ )对比有显著性意义 (P =0 .0 0 0 1)。 (3)前白蛋白的变化 :研究组术前 (2 2 .2± 7.1)mg/dl,术后 (2 5 .0± 6 .4)mg/dl,对照组术前 (2 2 .5± 4.0 )mg/dl,术后 (2 2 .8± 6 .4)mg/dl,差值 (Delta ,△ )对比无显著性意义 (P =0 .14)。两组营养药费对比 (6天 ) :研究组 (6 75± 10 8)天 (人民币 ) ,对照组 (1934± 6
Objective To evaluate the role of enteral nutrition on glutamine level,gut permeability and cost/effect in post-operative patients. Methods 120 patients with normal viscera organ functions were enrolled when they fit requirements of the protocol.The Ethic Committee of Peking Union Medical College Hospital approved the protocol and the informed consents were obtained.It was a prospective,rando mized,controlled multiple center clinical trial.Traditional parenteral nutrition was used in the control group.An intact protein based enteral nutrition(Fresubin Neutral,Frsenius-Kabi,Germany)was used in the study group.It was isonitrogenic and isocalorie intake in both groups.Nitrogen intake (0.15 g±0.01)g·kg -1·d -1,Calorie (25±2)Kcal·kg -1·d -1.Enteral nutrition was given by tubing in the jieunum and the rate was controlled by EN pump.Parenteral nutrition was via a peripheral insert central catheter(PICC) and volumic infusion pump.Study was started on POD+3 and full dose from POD+5.All patients had 6 days full dose of EN or PN in different groups.The gut permeability was examined by L/M ratio by HPLC (Dianex),amino acid profile analyzed by amino acid auto-analyzer (Beckman),complications and cost were examed by physician and monitor.Statistical analysis was bone by software Stat View 4.5(SAS Co,Series number:STV 04171)on Mac G3.SOPs were documented for caring out this protocol with GCP requirements. Results There was no severe adverse event in both group,but there was 5 cases of patients with liver function disorder(6.6%)in control group and 2 cases in study group.Plasma glutamine level was less went-down in study group.In study group:pre(576.1±73.6)μmo/L,post(538.4±78.6) μmo/L,in control group:pre(537.0±99.46)μmo/L,post(423.0±69.0)μmo/L,the delta between groups were significant(P=0.0029).Gut permeability changes was less went-up in study group+0.018±0.014 Vs control group+0.043±0.022,(P=0.001).Pre-albumin in study group:pre(22.2±7.1)mg/dl,post(25.0±6.4)mg/dl,control group:Pre(22.5±4.0)mg/dl,post(22.8±6.4) mg/dl,the delta was not significant(P=0.14).No difference was found comparing the infection related complication and postoperative hospitalizing days between two groups(P=0.81).The cost of study group was 675±1.8 RMB,in control group was 1 934±665(RMB),There was significant difference(P=0.0001). Conclusions Enteral nutrition had lower cost and attenuated gut permeability increasing when compared with parenteral nutrition,it may related with maintaning glutamine levels in body fluid.
出处
《中国临床营养杂志》
2001年第1期7-11,共5页
Chinese Journal of Clinical Nutrition
基金
卫生部肠粘膜屏障重点项目
自然科学基金! (基金号 :3 9970 72 3 )
