免疫增强型肠内营养对血浆氨基酸、肠道通透性及临床结局的作用（一项纳入120例患者的随机、双盲、对照、多中心临床试验）

[The role of immune enhanced enteral nutrition on plasma amino acid, gut permeability and clinical outcome (a randomized, double blind, controlled, multi-center clinical trail with 120 cases)].

作者信息

Jiang Z M, Gu Z Y, Chen F L, Wang X R, Li Z J, Xu Y, Li R

机构信息

Department of Surgery, PUMC Hospital, CAMS, PUMC, Beijing 100730, China.

出版信息

Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2001 Oct;23(5):515-8.

PMID:12905875

Abstract

OBJECTIVE

To evaluate the role of arginine, RNA and omega 3 fatty acid enriched enteral nutrition.

METHODS

The study was designed as a prospective, randomized, double blind, multi-central trial. It was an isocaloric and isonitrogenous intake in both groups. The protocol was approved by the Ethic Committee and, written informed consents were obtained.

RESULTS

There were 120 patients enrolled in this protocol. After data were input to computer, open the code. 118 out of 120 patients completed the study and, 2 of them were dropped out. One is because the nasal jejunum tubes dropped and not willing to be replaced. Second patient had fistula of anastomosis on 4th days after operation. There were finally 60 patients in the study group and 58 in the control group. There were no liver or renal functions damage and, obvious adverse in both groups. Plasma amino acid profile: There was significant difference (delta) of plasma arginine levels pre- and after study [(33.7 +/- 58.5) mumol/L vs (-2.4 +/- 30.7) mumol/L] (P = 0.004). Intestinal Permeability (lactulose/mannitol ratio): The differences (delta) of lactulose/mannitol ratio pre- and after the study were 0.017 +/- 0.012 in study group and, 0.027 +/- 0.016 in control group. (P = 0.047). Immunological markers: Humoral immunity: The differences of IgM levels pre- and after the study were (0.6 +/- 0.4) g/L in study group and, (0.2 +/- 0.4) g/L in control group(P = 0.006). Cellular immunity: The differences (delta) of CD3 levels pre- and after the study were (3.8 +/- 5.2)% in study group and (0.3 +/- 6.5)% in control group (P = 0.01). In CD4, (3.4 +/- 5.3)% in study group and, (-0.3 +/- 5.7)% in control group (P = 0.032). Clinical Outcomes: There was no infection-related in study group and, 2 abdominal infection patients in control group. No significant difference was found between groups (P = 0.46). The hospital stays were (13 +/- 2.5) days in study group and, (14.5 +/- 3.0) days in control group (P = 0.004). The cost for full hospitalization was (15,122 +/- 6,279) Yuan in study group and, (17,403 +/- 7,091) Yuan in control group. There was 2,281 Yuan lower in study group (P = 0.07). The costs for nutritional drugs were (1,383 +/- 242) Yuan in study group and, (707 +/- 111) Yuan in control group. The difference was 676 Yuan higher in study (P = 0.001).

CONCLUSION

Immune enhanced enteral nutrition had better plasma arginine level, intestinal permeability marker, IgM, CD3 and CD4. Also had less hospital stay and, less totaled hospital cost in study group.

摘要

目的

评估富含精氨酸、RNA和ω-3脂肪酸的肠内营养的作用。

方法

本研究设计为一项前瞻性、随机、双盲、多中心试验。两组摄入的热量和氮量相等。该方案已获伦理委员会批准，并获得了书面知情同意书。

结果

本方案共纳入120例患者。数据录入计算机后揭盲。120例患者中有118例完成了研究，2例退出。1例是因为鼻空肠管脱落且不愿更换。另1例患者术后第4天出现吻合口瘘。最终研究组有60例患者，对照组有58例患者。两组均无肝肾功能损害及明显不良反应。血浆氨基酸谱：研究前后血浆精氨酸水平有显著差异（差值）[（33.7±58.5）μmol/L对（-2.4±30.7）μmol/L]（P = 0.004）。肠道通透性（乳果糖/甘露醇比值）：研究组研究前后乳果糖/甘露醇比值的差值为0.017±0.012，对照组为0.027±0.016。（P = 0.047）。免疫指标：体液免疫：研究组研究前后IgM水平的差值为（0.6±0.4）g/L，对照组为（0.2±0.4）g/L（P = 0.006）。细胞免疫：研究组研究前后CD3水平的差值为（3.8±5.2）%，对照组为（0.3±6.5）%（P = 0.01）。CD4方面，研究组为（3.4±5.3）%，对照组为（-0.3±5.7）%（P = 0.032）。临床结局：研究组无感染相关情况，对照组有2例腹部感染患者。两组间差异无统计学意义（P = 0.46）。研究组住院时间为（13±2.5）天，对照组为（14.5±3.0）天（P = 0.004）。研究组全住院费用为（15122±6279）元，对照组为（17403±7091）元。研究组低2281元（P = 0.07）。营养药物费用研究组为（1383±242）元，对照组为（707±111）元。研究组高676元（P = 0.001）。