胰腺癌围手术期肠内外营养支持治疗的多中心、前瞻性随机对照研究

The role of perioperative enteral and parenteral nutrition treatment in pancreatic cancer： amulticenter, prospective randomized controlled trial

目的比较肠内营养和肠外营养支持治疗对胰腺癌围手术期患者的影响。方法采用多中心、前瞻性、随机对照研究方法对2007年1月至2008年12月实施胰十二指肠切除的胰腺癌围手术期患者进行评估。入选患者随机分为肠内营养治疗组（EN组）和肠外营养治疗组（PN组），对比观察2组患者在术后营养指标、并发症发生率及免疫功能状态等方面的变化。结果共人组200例患者，研究中脱落22例。EN组90例，PN组88例，2组患者的住院天数[分别为（23±13）、（27±24）d]、一般状态评分及生活质量评分差异均无统计学意义（P〉0．05）。EN组术后第7、10天前白蛋白水平分别为（69±16）、（80±22）mg／L，PN组分别为（67±19）、（70±11）mg／L，均显著低于术前水平[EN组（186±38）mg／L，PN组（179±37）mg／L]，差异有统计学意义（t=2．24、-2．13、-2．23、-2．20，P〈0．05），但2组间差异无统计学意义（P〉0．05）；白蛋白、前白蛋白、血红蛋白、总胆红素、尿素氮、血肌酐、血钾、血钠在2组患者问差异无统计学意义（P〉0．05）。术后第10天时，PN组血淋巴细胞总数[（0．687±0．065）×／L]、CD3＋CD4和CD3CD8淋巴细胞数[分别为（0．363±0．020）×109／L、（0．183±0．018）×109／L]，较术前及EN组明显降低，差异有统计学意义（t=-2．83-2．04，P〈0．05）。2组患者共35例出现术后并发症，各种并发症在2组问差异无统计学意义（P〉0．05）。结论与肠外营养相比，肠内营养并未降低胰腺癌围手术期并发症的发生率，但可以改善机体的营养免疫状态。

Objective To compare the two different nutritional supports, enteral nutrition and parenteral nutrition in the aspects of nutritional conditions, immune status, the incidence of perioperative complications and quality of life impacts in pancreatic cancer. Methods For the pancreatic cancer patients which panereaticoduodenectomy were performed from January 2007 to December 2008 in five high-volume medical centres, prospective, randomized controlled study was carried out. The enrolled patients were randomly divided into enteral nutritional group （EN group） and parenteral nutritional group （PN group ）. Related indicators, such as nutritional conditions, immune status, incidence of complications, general status and quality of life were assessed. Results The 200 patients were enrolled, while 178 cases which 90 patients in EN group and 88 patients in PN group were qualified to evaluate. The 22 cases were dropped out. For the mean hospital stay （ （23 ±13 ） days and （27 ± 24） days respcectively）, Karnofsky score and the life quality scoring, there are no statistical differences between the two groups. In post-operation day 7 and day 10, the prealbumin was （69 ±16） mg/L and （80 ±22） mg/L in EN group and it was （67±19） mg/L and （70 ± 11 ） mg/L in PN group, which are all significantly decreased than preoperational levels （（ 186 ±38） mg/L for enteral group and （ 179 ± 37） mg/L for parenteral group, t = - 2. 24, - 2. 13, - 2. 23, - 2. 20,all P 〈 0. 05 ） , but there was no statistically significant between the 2 groups （ P 〉 0. 05 ）. Other general indicators such as the albumin, hemoglobin, total bilirubin, blood urea nitrogen, serum creatinine, serum potassium and serum sodium, revealed no statistical differences in the 2 groups （ P 〉 0.05 ） ; The total lymphocytes, CD3＋ CD4＋ and CD; CD8＋ lymphocytes in PN group was （0. 687 ±0. 065） × 109/L, （0. 363 ± 0,029） 109/L, and （0. 183 ＋ 0.018） × 109/L respectively in post-operation day 10, which they are significantly decreased than in preoperational levels of PN group and the respective counterpart of EN group in post-operation daylO （ t = - 2. 04-2. 83, P 〈 0. 05 ）. The 35 patients were suffered from different complications in the 2 groups, but there was no statistical differences among them （ P 〉 0.05 ）. Conclusions Enteral nutritional support eould not decrease the incidence of perioperative complications in pancreatic cancer patient, but it can improve the immnnonutrition status in comparison with parenteral nutrition.