Sels J P, Nauta J J, Menheere P P, Wolffenbuttel B H, Nieuwenhuijzen Kruseman A C
Department of Internal Medicine, University Hospital Maastricht, The Netherlands.
Br J Clin Pharmacol. 1996 Oct;42(4):503-6. doi: 10.1046/j.1365-2125.1996.44216.x.
In this double-blind, cross-over, placebo-controlled, randomized study, possible extraintestinal effects of miglitol, an absorbable alpha-glucosidase inhibitor, were investigated. Sixteen healthy male volunteers underwent two 75 g oral glucose tolerance tests with concomitant administration of miglitol or placebo. Peak and post-peak areas under the curve values for blood glucose, serum insulin and serum C-peptide after miglitol were not different from those found after placebo. The post-peak AUC-ratio (AUC (peak, 180 min) on miglitol/AUC (peak, 180 min) on placebo) was for glucose 1.15 (CI 0.94-1.40, P = 0.16), for insulin 1.12 (CI 0.95-1.33, P = 0.17) and for C-peptide 0.98 (CI 0.81-1.18, P = 0.82). It is concluded that miglitol exerts no clinically relevant extraintestinal effects on glucose control.
在这项双盲、交叉、安慰剂对照的随机研究中,对可吸收的α-葡萄糖苷酶抑制剂米格列醇可能的肠外效应进行了研究。16名健康男性志愿者接受了两次75克口服葡萄糖耐量试验,同时给予米格列醇或安慰剂。米格列醇给药后血糖、血清胰岛素和血清C肽的曲线下峰值及峰后面积值与安慰剂给药后的值无差异。峰后AUC比值(米格列醇的AUC(峰值,180分钟)/安慰剂的AUC(峰值,180分钟)),葡萄糖为1.15(95%置信区间0.94 - 1.40,P = 0.16),胰岛素为1.12(95%置信区间0.95 - 1.33,P = 0.17),C肽为0.98(95%置信区间0.81 - 1.18,P = 0.82)。结论是,米格列醇对血糖控制没有临床相关的肠外效应。