Koch H H, Wudy A, Eberlein G, Quast C
Medizinische Klinik I, Klinikum Nürnberg, Germany.
Diabetes Nutr Metab. 1999 Jun;12(3):195-201.
This double-blind, placebo-controlled, cross-over study investigated whether acarbose therapy enables patients with Type 1 diabetes to administer insulin injections at the same time as meals without adverse glycaemic consequences, thus negating the need for an injection-meal interval (IMI). The valid-case population was 15. All patients were well controlled on insulin therapy and diet. Each patient underwent four 14-d treatment sequences: IMI of 0 min+acarbose; IMI of 30 min + acarbose; IMI of 0 min + placebo; IMI of 30 min + placebo. There was a 1-wk, placebo-controlled washout period between each treatment. A 50 mg acarbose or placebo tablet was taken with each of three meals for the first 3 d of each treatment; this was increased to 100 mg three times daily on the remaining 11 d. Blood samples were taken between 08.00 and 09.00 h at the end of each treatment sequence, during the fasting state and at the following times after breakfast: 30, 60, 120 and 180 min. The primary target variable was 1-hr postprandial blood glucose level after 14 d. The mean increase in 1-hr postprandial blood glucose level using an IMI of 0 min + acarbose was 51.1+/-53.2 mg/dl, compared with 46.6+/-50.4 mg/dl using a 30-min IMI + placebo. Data provided strong evidence that acarbose prevents the marked increase in postprandial glucose level normally observed when insulin is administered with a meal. Acarbose may thus be useful for patients with Type 1 diabetes who find IMIs inconvenient.
这项双盲、安慰剂对照、交叉研究调查了阿卡波糖治疗是否能使1型糖尿病患者在进餐时同时注射胰岛素而不产生不良血糖后果,从而无需注射-进餐间隔(IMI)。有效病例数为15例。所有患者均通过胰岛素治疗和饮食得到良好控制。每位患者接受四个为期14天的治疗序列:0分钟IMI+阿卡波糖;30分钟IMI+阿卡波糖;0分钟IMI+安慰剂;30分钟IMI+安慰剂。每次治疗之间有1周的安慰剂对照洗脱期。在每个治疗的前3天,每餐服用50毫克阿卡波糖或安慰剂片;在其余11天,剂量增加至每日三次,每次100毫克。在每个治疗序列结束时,于08:00至09:00之间、空腹状态以及早餐后以下时间点采集血样:30、60、120和180分钟。主要目标变量是14天后餐后1小时血糖水平。使用0分钟IMI+阿卡波糖时,餐后1小时血糖水平的平均升高为51.1±53.2毫克/分升,而使用30分钟IMI+安慰剂时为46.6±50.4毫克/分升。数据提供了强有力的证据表明,阿卡波糖可防止在进餐时注射胰岛素时通常观察到的餐后血糖水平显著升高。因此,阿卡波糖可能对觉得IMI不方便的1型糖尿病患者有用。