中长链脂肪乳氨基酸葡萄糖三腔袋与院内配制全合一肠外营养液临床应用比较

Comparison of the clinical application of Medium and Long Chain Fat Emulsion/Amino Acids/Glucose Injection with hospital-prepared all-in-one parenteral nutrient solution

目的:评价中长链脂肪乳/氨基酸(16)/葡萄糖(36%)电解质注射液用于腹部中等以上手术患者营养治疗的有效性和安全性。方法:采用多中心、随机、双盲、对照试验设计,纳入240例需肠外营养支持的腹部中等以上手术患者。试验组122例,给予中长链脂肪乳/氨基酸(16)/葡萄糖(36%)电解质注射液,对照组118例,给予与试验药"等氮等热量"、液体量相当的院内配制"全合一"肠外营养液,疗程为5 d。观察两组受试者治疗前后血清前白蛋白、视黄醇结合蛋白、超敏C反应蛋白、IL-6等疗效指标变化,监测体重、血常规、血生化、尿常规、凝血功能、生命体征、心电图、各系统不良反应等安全性指标,统计两组营养液配制时间,通过统计学分析比较两组的临床疗效。结果:两组患者疗效和安全性指标差异均无统计学意义(P>0.05),但试验组营养液配制时间明显小于对照组(P<0.000 1)。结论:中长链脂肪乳/氨基酸(16)/葡萄糖(36%)三腔袋与院内配制的"全合一肠外营养液"疗效相当,安全性相当,但三腔袋组营养液配制更便捷,三腔袋可比院内配制"全合一肠外营养液"单袋平均节约13 min。

Objective: To evaluate the efficacy and safety of Medium and Long Chain Fat Emulsion/Amino Acids(16)/Glucose(36%) Injection in nutritional therapy for patients receiving moderate or major abdominal surgery. Methods: Totally 240 cases of parenteral nutrition support patients receiving moderate or major abdominal surgery were enrolled in the randomized, double blind, multi-center, controlled study. The patients were randomized to be given Medium and Long Chain Fat Emulsion/Amino Acids(16)/Glucose(36%) Injection(n=122) or hospital-prepared all-in-one parenteral nutrient solution(n=118;nitrogen content, heat and liquid quantity as equal as the former) for 5 d. During the treatment process, the curative effect was observed, such as serum prealbumin(PA), retinol binding protein(RBP), hypersensitive C-reactive protein(hs-CRP) and IL-6;safety indicators such as weight, blood routine, blood biochemistry, urine routine, coagulation function, vital signs, electrocardiogram and adverse reactions of each system were monitored;the time spent for preparing the nutrient solution was calculated and the clinical efficacy was compared by statistical analysis. Results: There was no significant difference in efficacy and safety indicators between the two groups(P>0.05). However, the time spent for preparing the nutrient solution in the experimental group was significantly shorter than that in the control group(P<0.000 1). Conclusion: There is no significant difference in the curative effect and safety between the Medium and Long Chain Fat Emulsion/Amino Acids(16)/Glucose(36%) triple-chamber bag and the hospital-prepared all-in-one parenteral nutrient solution, but the former is more convenient to be prepared, which can save 13 minutes on average compared with the latter.