术后短期肠内营养在腹部手术病人应用的安全性和有效性观察

Clinical study on safety and efficacy of enteral nutritional suspension in patients after abdominal operations

目的:观察肠内营养混悬液(TPF-FOS)在腹部中等以上手术后病人中应用的安全性及有效性。方法:本文为前瞻性、多中心临床研究,腹部中等以上手术后病人管饲TPF-FOS连续5 d,术前和术后5 d观察病人血清蛋白水平、炎症反应、胃肠道反应发生率等,并记录不良事件。结果:入组121例病人,其中104例完成研究。术后肠内营养支持后血清前白蛋白与术前无明显变化[术前(190.32±72.38)mg/L比术后5 d EN(185.62±83.57)mg/L],血清白蛋白和转铁蛋白水平显著下降,全身炎症反应综合征发生率呈下降趋势(P=0.059)胃肠道发生率随管饲时间而呈下降趋势(第1天28.9%。比第5天22.3%)。与肠内营养制剂相关的不良事件少且大部分为轻度。血总胆固醇水平明显降低。结论:腹部中等以上手术后病人管饲TPF-FOS 5 d后,可维持与术前相当的血清前白蛋白水平,胃肠道反应发生率随管饲时间而呈下降趋势。

Objective To evaluate the safety and efficacy of enteral nutritional suspension（total protein fiber frutooligosaccharide, TPF-FOS） in patients after moderate to major abdominal operations.Methods In this prospective multicenter clinical study,patients after moderate to major abdominal operations received 5 days of tube feeding of TPFFOS postoperatively.Serum proteins,inflammation and incidence of gastrointestinal reactions were monitored.Adverse events during the study were recorded.Results One hundred and twenty-one patients were recruited,among which 104 completed the study.The levels of serum prealbumin after 5 days of enteral nutrition postoperatively did not change significantly in comparison with those of the preoperative baseline,while levels of serum albumin and transferrin decreased remarkably,with a decrease in the incidence of systemic inflammatory response syndrome（P=0.059）.Gastrointestinal reactions showed a tendency to decline with increase in the duration of tube feeding,and only a few adverse events were related to the enteral preparation,most of which had minor symptoms.Blood cholesterols declined significantly in comparison with the baseline.Conclusions After postoperatively 5 days of administration of enteral nutritional suspension in patients after moderate to major abdominal operations,the serum pre-albumin level could be maintained similar to that before the surgery,and the incidence of gastrointestinal reactions showed a tendency to decline along with the duration of tube feeding.