Meng H C, Zayan M, Kahn S, Hirsch J D, Wolfe B M, Barbosa-Saldivar J L, Bradley D L
Acta Chir Scand Suppl. 1983;517:179-203.
A multicenter clinical study was done which directly compared efficacy and safety of Intralipid 10% and Intralipid 20%. Twenty-nine patients received the 10% concentration, 30 patients received the 20% concentration. Both groups of patients received equivalent amounts of calories, amino acids, dextrose and fat for seven day study periods. Analysis of nitrogen balance data showed that the two preparations were equally effective in maintaining nitrogen balance. Both concentrations of fat emulsion were effective in reversing or correcting the changes of essential fatty acid deficiency. Analysis of clinical laboratory data indicated that both preparations were equally well tolerated by the patients. No adverse effects attributed to the fat emulsions were observed.
开展了一项多中心临床研究,直接比较了10%英脱利匹特和20%英脱利匹特的疗效和安全性。29例患者接受10%浓度的制剂,30例患者接受20%浓度的制剂。两组患者在为期7天的研究期间接受等量的热量、氨基酸、葡萄糖和脂肪。氮平衡数据分析表明,两种制剂在维持氮平衡方面同样有效。两种浓度的脂肪乳剂均可有效逆转或纠正必需脂肪酸缺乏的变化。临床实验室数据分析表明,患者对两种制剂的耐受性相当。未观察到归因于脂肪乳剂的不良反应。