Thompson R G, Gottlieb A, Organ K, Koda J, Kisicki J, Kolterman O G
Amylin Pharmaceuticals, Inc., San Diego, California 92121, USA.
Diabet Med. 1997 Jul;14(7):547-55. doi: 10.1002/(SICI)1096-9136(199707)14:7<547::AID-DIA390>3.0.CO;2-U.
In order to determine the influence of a 5 h infusion of pramlintide compared to placebo on postprandial glucose, lactate, insulin, and C-peptide concentrations in patients with Type 2 diabetes, a single-blind, randomized, cross-over study was conducted in 24 patients; 12 treated with exogenous insulin and 12 managed with diet and/or oral hypoglycaemic agents. One hour after initiation of infusion, patients consumed a Sustacal test meal. The protocol was repeated on the following day with each patient receiving the alternate study medication. Pramlintide infusion in the insulin-treated patients resulted in statistically significant reductions in mean glucose, insulin, C-peptide, and lactate concentrations during the 4-h period after the Sustacal test meal. Pramlintide infusion also resulted in significant reductions of mean insulin, C-peptide, and lactate concentrations, but not glucose concentrations, in the patients treated with diet and/or oral hypoglycaemic agents. Within this latter group, reduction in postprandial glucose concentrations in individual patients correlated with glycated haemoglobin values. These results suggest that administration of pramlintide may improve glycaemic control in patients with Type 2 diabetes treated with insulin or poorly controlled on diet and/or oral hypoglycaemic agents.
为了确定与安慰剂相比，5小时输注普兰林肽对2型糖尿病患者餐后血糖、乳酸、胰岛素和C肽浓度的影响，对24例患者进行了一项单盲、随机、交叉研究；其中12例接受外源性胰岛素治疗，12例采用饮食和/或口服降糖药治疗。输注开始1小时后，患者食用了一种营养补充剂测试餐。次日重复该方案，每位患者接受另一种研究药物。在接受胰岛素治疗的患者中，输注普兰林肽导致在食用营养补充剂测试餐后4小时内，平均血糖、胰岛素、C肽和乳酸浓度出现统计学上的显著降低。在接受饮食和/或口服降糖药治疗的患者中，输注普兰林肽也导致平均胰岛素、C肽和乳酸浓度显著降低，但血糖浓度未降低。在后者组中，个体患者餐后血糖浓度的降低与糖化血红蛋白值相关。这些结果表明，普兰林肽给药可能改善接受胰岛素治疗或饮食和/或口服降糖药控制不佳的2型糖尿病患者的血糖控制。
