Rosak C, Schwarz O, Althoff P H, Schöffling K, Schmidt F H
Dtsch Med Wochenschr. 1985 Dec 20;110(51-52):1975-80. doi: 10.1055/s-2008-1069123.
A double-blind, placebo-controlled, crossover-therapy study was carried out using intraindividual comparisons on 18 type II diabetics. All patients were secondary drug failure patients and had been on insulin-glibenclamide combination therapy for periods of 1-14 months. On the last day of each of the 2-week-treatment periods (insulin-glibenclamide [verum phase] versus insulin-placebo [placebo phase]) the patients received a standard breakfast equivalent to 100 g glucose. Medication was given 30 minutes before the standard breakfast. The blood glucose level during insulin-glibenclamide therapy was 35-45 mg/dl below that during insulin-placebo treatment at all time points investigated. Correspondingly, the glucose excretion was reduced by about 40% during the verum phase. beta-Hydroxybutyrate in serum and urine and glycosylated haemoglobin (HbA1) measurements made during the verum phase were also significantly lower. As expected, the insulin level in serum showed no change. In contrast, C peptide concentrations were significantly raised by 15-40% during the verum phase. Combination therapy with insulin and glibenclamide produced therefore a marked improvement in the metabolic status of C peptide-positive patients classified as secondary drug failure patients to oral therapy.
对18名II型糖尿病患者进行了一项双盲、安慰剂对照、交叉治疗研究,采用个体内比较。所有患者均为继发性药物失效患者,曾接受胰岛素-格列本脲联合治疗1至14个月。在每2周治疗期的最后一天(胰岛素-格列本脲[真药期]与胰岛素-安慰剂[安慰剂期]),患者接受相当于100克葡萄糖的标准早餐。在标准早餐前30分钟给药。在所有研究的时间点,胰岛素-格列本脲治疗期间的血糖水平比胰岛素-安慰剂治疗期间低35-45mg/dl。相应地,在真药期葡萄糖排泄减少了约40%。在真药期进行的血清和尿液中β-羟基丁酸以及糖化血红蛋白(HbA1)测量也显著降低。正如预期的那样,血清胰岛素水平没有变化。相比之下,在真药期C肽浓度显著提高了15-40%。因此,胰岛素和格列本脲联合治疗使被归类为口服治疗继发性药物失效患者的C肽阳性患者的代谢状况有了显著改善。