含橄榄油脂肪乳剂用于肠外营养的安全性和有效性研究  

Efficacy and safety profile of ClinOleic 20% in surgical patients requiring parenteral nutrition.

作　　者：吴国豪[1] 曹伟新[2] 蔡端[3] 全应军[1] 吴肇汉[1] 

机构地区：[1]复旦大学附属中山医院外科,上海200032 [2]上海交通大学医学院附属瑞金医院营养科,上海200025 [3]复旦大学附属华山医院外科,上海200040

出　　处：《中国实用外科杂志》2006年第7期527-529,共3页Chinese Journal of Practical Surgery

摘　　要：目的验证含橄榄油的脂肪乳剂在肠外营养中的安全性和有效性。方法2003年12月至2004年5月,复旦大学附属中山医院、上海交通大学医学院附属瑞金医院及复旦大学附属华山医院3个医疗中心,采用前瞻性、随机、双盲对照研究方法共对205例接受腹部中等程度以上手术的病人行5d全肠外营养支持。两组等热量[125·5kJ/(kg·d)]、等氮[0·20g/(kg·d)]。研究组应用20%克林诺,对照组应用20%英脱力匹特,脂肪乳剂用量[甘油三酯1g/(kg·d)]。研究期间检测血常规、肝肾功能、血脂、电解质等生物学指标。结果两组在不良事件发生率、人体测量值、生命体征、内脏蛋白浓度、血液学检查、肝肾功能、电解质、血脂数值方面差异均无显著性意义。结论含橄榄油脂肪乳剂-克林诺是肠外营养时一种新型、安全有效的脂肪乳剂。Objective To confirm the safety and nutritional efficacy of ClinOleic 20% through a pragmatic study allowing its use as an alternative to Intralipid 20%. Methods The study was performed as a multicenter,randomized,double-blinded,prospective,non-inferiority trial. Two hundred and five patients undergoing moderate abdominal surgery were randomly assigned to receive ClinOleic 20% and lntralipid 20% as part of their TPN regimen over 5 days. Daily parenteral intakes of energy nitrogen and lipid were equal in two groups. The nutrition regimen was given as an all-in-one mixture, delivered continuously over 20 hours per day for 5 consecutive days. Results Efficacy analysis showed that ClinOleic can be considered as efficient as Intralipid in providing energy to maintain albumin plasma concentrations. No serious adverse event was reported in the two groups. For hematology, renal, hepatic safety criteria and vital signs, no significant difference was observed between groups. No significant difference was observed concerning Cholesterol. For triglycerides, a statistically significant difference was observed between ClinOleic and Intralipid groups but the difference was not medically relevant and the means remained within the normal range. Conclusion ClinOleic is a new safe and efficient lipid emulsion for parenteral nutrition.

关 键 词：脂肪乳剂 橄榄油 肠外营养 

分 类 号：R6[医药卫生—外科学]