肠内或肠外营养对手术后病人的氮平衡、肠通透性、血浆氨基酸及费用等的影响(60例随机、对照、多中心临床研究)

The impact of enteral nutrition for post-operative patients on nitro gen balance, gut permeability and cost/effect(60 cases randomized, controlled, m ulti center clinical trial)

目的 观察肠内营养、肠外营养对手术后病人的的氮平衡、肠通透性、费用等影响。 对象和方法 随机、对照、多中心临床研究。 6 0例合乎计划要求的食道、胃、结肠道手术的患者为对象。按随机表进入研究组或对照组 ,两组为等氮等热卡营养摄入。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 (1)安全性 :两组均无严重不良事件 ,对照组有 2例肝功损害 ,研究组无肝功损害 (P =0 .19)。 (2 )替代 (Surrogateefficacy)有效性指标 (Endpointmarkers) (1)氮平衡 :研究组累积氮平衡为 (10 8±10 7)mg·kg-1·6d-1,对照组累积氮平衡为 (94± 143)mg·kg-1·6d-1,两组无显著性差异 ,P =0 .6 75。 (2 )氨基酸谱 :两组血浆氨基酸的变化主要是谷氨酰胺 (GLN)在治疗前后的差值 (delta)有差异。研究组为 (-2 0 .1± 6 1.0 ) μmol/L ,对照组谷氨酰胺为 (- 10 6 .5± 79.2 ) μmol/L ,有显著性差异 ,P =0 .0 0 2。 (3)肠粘膜通透性结果 :两组在治疗前和治疗后 ,乳果糖 /甘露醇值差值 (delta)有不同。研究组增加 0 .0 2 0± 0 .0 12 ,对照组增加 0 .0 40± 0 .0 17,有显著性差异 ,P =0 .0 0 1。 (4)营养液药费 :研究组病人术后第三天至第九天的营养液药费明显低于对照组。研究组 :10 16± 110元 (人民币 )

Objective To evaluate the impact of entera l nutrition for post operative patients on nitrogen balance, gut permeability a nd cost/effect with the control group.60 consecutive patients undergoing the es ophagus or gastrointestinal tract operation were randomized into the study gro up or the control group. Methods Standard traditional pa renteral nutrition were used in the control group. Enteral nutrition (Harmonic M, Nutrichem, Germany) was used in the study group. The nitrogen and calorie int ake in both groups were same. Results Safety: no importa nt adverse event in both groups.There were two patients in the control group hav ing liver function impaired(6.6%). Surrogate end point and clinical outcome:(1)N itrogen balance:study group: Cumulative nitrogen balance (108.3±107.4)mg·kg -1·6d -1 Control group: Cumulative nitrogen balance (94.6±143.3) mg· kg -1·6d -1. No statistical significance, P =0.675.(2)The pre and poststudy difference of the serum GLN (delta):Study group: GLN(-20±60) mol/L; Control group:GLN(-106±79)mol/L;reaching the statistical significance, P = 0.006.(3) Gut mucosa permeability: The pre and poststudy difference of the lact ofrucotose/mannitol (delta):Study group:increased by(0.020±0.012);Control group :increased by (0.040±0.017);reaching the statistical significance, P =0.001.( 4)The total hospitalization cost:study group:(17 716±11 024)RMB,Control group:( 21 453±7 999)RMB,no statistical significance, P =0.138.(5)The cost of nutrit ional drugs:Study group:(1 016±110) RMB,Control group:(3 135±463) RMB,reaching the statistical significance, P =0.0001.(6)No infective complication was obs erved in both groups during the therapy. (7)No difference of the postoperative h ospitalizing days between the groups, P =0.925. Conclusions Enteral nutrition for post operative patients had better nitrogen balan ce, less increasing gut permeability and lower cost in this randomized controlle d muti center clinical trial.