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作 者:奚秋磊[1] 钦伦秀[2] 陶国清[3] 裘正军[4] 于吉人[5] 吴国豪[1] XI Qiu-lei;QIN Lun-xiu;TAO Guo-qing;QIU Zheng-jun;YU Ji-ren;WU Guo-hao(Zhongshan Hospital Affiliated to Fudan University,Shanghai 200032,China;Huashan Hospital Affiliated to Fudan University 9 Shanghai 200040,China;Wuxi Peopled Hospital,Wuxi 214043,China;Shanghai First Peopled Hospital,Shanghai 201620,China;The First Affiliated Hospital of Medical College ofZhejiang University,Hangzhou 310003,China)
机构地区:[1]复旦大学附属中山医院,上海200032 [2]复旦大学附属华山医院,上海200040 [3]无锡市人民医院,无锡214043 [4]上海市第一人民医院,上海201620 [5]浙江大学医学院附属第一医院,杭州310003
出 处:《中国新药杂志》2021年第18期1692-1697,共6页Chinese Journal of New Drugs
基 金:国家科技支撑项目:即配型多室输液袋关键技术及产品研发(2012BAI22B06)。
摘 要: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.
关 键 词:肠外营养 中长链脂肪乳/氨基酸/葡萄糖 工业化三腔袋
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