CAJ | 학술논문

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(surrogate efficacy)有效性终点指标：(1)血浆谷氨酰胺(GLN)的变化：研究组术前(576.1±73.6)μmol/L，术后(538.4±78.6)μmol/L，对照组术前(537.0±99.5)μmo/L，术后(423.0±69.0)μmo/L，差值(Delta,△)对比有显著性意义(P＝0．0029)。(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0.018±0.014，对照组乳果糖/甘露醇比值增加0.043±0.022，差值(Delta,△)对比有显著性意义(P=0．0001)。(3)前白蛋白的变化：研究组术前(22.2±7.1)mg/dl，术后(25.0±6.4)mg/dl，对照组术前(22.5±4.0)mg/dl，术后(22.8±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(675±108)天(人民币)，对照组(1 934±665)元(人民币)，两组相比差异有显著性意义(P＝0．0001)。结论等氮等热卡的基础上，肠内营养比肠外营养具有较高的血浆谷氨酰胺水平，较少肠通透性升高，较少费用。
목적대비장내、장외영양대술후병인장통투성등적영향。방법식도화위장도질병수수 술환자위연구대상。수궤、대조、다중심림상연구，안수궤표진입연구조급대조조，량조위등담등열잡영양。연구계화경윤리위원회비준。소유병인균지정동의삼가。결과안전성：량조균무엄중불량사건，단대조조유5례간공손해，연구조유2례간공손해(P=0.49)。체대(surrogate efficacy)유효성종점지표：(1)혈장곡안선알(GLN)적변화：연구조술전(576.1±73.6)μmol/L，술후(538.4±78.6)μmol/L，대조조술전(537.0±99.5)μmo/L，술후(423.0±69.0)μmo/L，차치(Delta,△)대비유현저성의의(P＝0．0029)。(2)장통투성(유과당/감로순비치)대비：연구조유과당/감로순비치증가0.018±0.014，대조조유과당/감로순비치증가0.043±0.022，차치(Delta,△)대비유현저성의의(P=0．0001)。(3)전백단백적변화：연구조술전(22.2±7.1)mg/dl，술후(25.0±6.4)mg/dl，대조조술전(22.5±4.0)mg/dl，술후(22.8±6.4)mg/dl，차치(Delta,△)대비무현저성의의(P=0.14)。량조영양약비대비(6천)：연구조(675±108)천(인민폐)，대조조(1 934±665)원(인민폐)，량조상비차이유현저성의의(P＝0．0001)。결론등담등열잡적기출상，장내영양비장외영양구유교고적혈장곡안선알수평，교소장통투성승고，교소비용。
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.