Demol P, Wingender W
Clinical Pharmacology, Bayer AG, Research Center, Wuppertal, FRG.
Scand J Gastroenterol Suppl. 1989;164:112-7. doi: 10.3109/00365528909091197.
The study is of double-blind crossover design. In the first part of the study, rioprostil (300 micrograms and 600 micrograms) is given orally with a solid breakfast to 9 healthy male volunteers. Both doses of rioprostil delay and reduce the 3-h postprandial GIP release. They also reduce the maximal postprandial insulin concentration, but only rioprostil (600 micrograms) reduces the 3-h integrated release of insulin significantly (by approximately 20%). Neither dose modifies the postprandial glucose gastrin levels significantly. In another study two groups of 6 volunteers are studied in parallel; they are given either rioprostil (600 micrograms) or a placebo each evening for 14 days. On the mornings before and on days 13 and 14 of the study the volunteers take a solid breakfast and blood glucose is measured 1 h and 2 h postprandially. The results show that no differences in the basal and postprandial glucose levels are observed. In conclusion, rioprostil given with a meal can reduce the insulin release but it does not change the postprandial blood glucose levels when given as a single dose or repeatedly in an evening dose. This study shows that rioprostil can be given to patients with diabetes.
该研究采用双盲交叉设计。在研究的第一部分,给9名健康男性志愿者在吃固体早餐时口服利奥前列素(300微克和600微克)。两种剂量的利奥前列素均延迟并减少餐后3小时的胃抑肽释放。它们还降低餐后最大胰岛素浓度,但只有利奥前列素(600微克)能显著降低胰岛素3小时的累积释放量(约20%)。两种剂量均未显著改变餐后葡萄糖胃泌素水平。在另一项研究中,两组各6名志愿者进行平行研究;他们每晚分别服用利奥前列素(600微克)或安慰剂,持续14天。在研究的第1天和第13、14天早晨,志愿者吃固体早餐,并在餐后1小时和2小时测量血糖。结果显示,未观察到基础血糖水平和餐后血糖水平有差异。总之,用餐时服用利奥前列素可减少胰岛素释放,但单剂量或每晚重复给药时不会改变餐后血糖水平。这项研究表明,糖尿病患者可以服用利奥前列素。