Guevara-Aguirre Jaime, Guevara-Aguirre Marco, Saavedra Jeannette, Bernstein Gerald, Rosenbloom Arlan L
Institute for Endocrinology Metabolism and Reproduction, Quito, Ecuador.
Diabetes Technol Ther. 2007 Aug;9(4):372-6. doi: 10.1089/dia.2006.0019.
The aim of this study was to compare the glucose pharmacodynamics after oral spray insulin (Oral-lyn , Generex Biotechnology, Toronto, ON, Canada) and subcutaneous (sc) injection of regular insulin in 10 subjects with type 1 diabetes mellitus (T1DM).
Basal therapy was twice-daily insulin glargine. Preprandial (30 min) regular insulin was given for 3 days, followed by 9 days of Oral-lyn, eight to 12 puffs immediately pre- and postprandially. Adjustments for glycemia were made using standard snacks and additional regular insulin or Oral-lyn. Peripheral glucose measurements were self-monitored in duplicate. Serum concentrations of fructosamine and hemoglobin A1c (HbA1c) were determined at the start and the end of the study period.
Average glucose concentrations (in mmol/L) for the 3-day regular insulin and 9-day Oral-lyn periods, respectively, were: pre-breakfast (B), 5.06 and 3.89; 1-h post-B, 8.39 and 7.67; post-B, 6.00 and 6.33; pre-lunch (L), 5.50 and 4.72; 1-h post-L, 7.83 and 7.89; 2-h post-L, 5.89 and 6.33; pre-dinner (D), 5.61 and 5.17; 1-h post-D, 7.22 and 7.83; and 2-h post-D, 6.11 and 6.67. Areas under the curve for both treatments were not significantly different (P = 0.6875). Fructosamine (mean +/- SD, 338.7 +/- 77.4 micromol/L and 321.7 +/- 63.4 micromol/L), and HbA1c (mean +/- SD, 7.5 +/- 1.5% and 7.2 +/- 1.2%) did not change significantly.
Regular insulin and Oral-lyn had similar glucodynamic effects in subjects with T1DM receiving twice-daily insulin analogue as baseline therapy. Intensive monitoring and timely corrections with additional snacks, additional sc regular insulin, or Oral-lyn puffs resulted in appropriate glycemic control as assessed by individual daily glycemic responses and, especially, normal preprandial glycemia. Protein glycation decreased, but not significantly.
本研究旨在比较10例1型糖尿病（T1DM）患者口服喷雾胰岛素（Oral-lyn，加拿大Generex生物技术公司，多伦多，安大略省）和皮下注射常规胰岛素后的葡萄糖药效学。
基础治疗为每日两次甘精胰岛素。给予餐时（30分钟）常规胰岛素治疗3天，随后给予Oral-lyn治疗9天，餐前和餐后立即喷8至12喷。使用标准零食以及额外的常规胰岛素或Oral-lyn进行血糖调整。外周血糖测量由患者自行重复监测。在研究期开始和结束时测定果糖胺和糖化血红蛋白（HbA1c）的血清浓度。
3天常规胰岛素治疗期和9天Oral-lyn治疗期的平均血糖浓度（mmol/L）分别为：早餐前（B），5.06和3.89；早餐后1小时，8.39和7.67；早餐后，6.00和6.33；午餐前（L），5.50和4.72；午餐后1小时，7.83和7.89；午餐后2小时，5.89和6.33；晚餐前（D），5.61和5.17；晚餐后1小时，7.22和7.83；晚餐后2小时，6.11和6.67。两种治疗的曲线下面积无显著差异（P = 0.6875）。果糖胺（均值±标准差，338.7±77.4 μmol/L和321.7±63.4 μmol/L）和HbA1c（均值±标准差，7.5±1.5%和7.2±1.2%）无显著变化。
在以每日两次胰岛素类似物作为基础治疗的T1DM患者中，常规胰岛素和Oral-lyn具有相似的葡萄糖动力学效应。通过额外的零食、额外的皮下常规胰岛素或Oral-lyn喷雾进行强化监测和及时校正，根据个体每日血糖反应评估，尤其是餐前血糖正常，可实现适当的血糖控制。蛋白质糖基化有所降低，但不显著。
