Höpfner M, Durani B, Spengler M, Fölsch U R
Department of Medicine, Christian-Albrechts-University, Kiel, Germany.
Arzneimittelforschung. 1997 Oct;47(10):1108-11.
In a single-centre, placebo-controlled, clinical study, the influence of an antacid containing magnesium hydroxide and aluminium hydroxide (Maalox 70; 10 ml) on the pharmacodynamics of the oral antidiabetic drug acarbose (Glucobay 100, Bay g 5421, CAS 56180; 100 mg) was tested in 24 healthy male volunteers. The drugs were given alone or in combination and were compared with placebo. Volunteers were randomized into four different treatment groups. The daily medication over 4 days was 1 x 1 placebo tablet, or 1 x 1 tablet containing 100 mg acarbose, or 1 x 1 tablet containing 100 mg acarbose plus 10 ml antacid suspension, or 1 x 1 placebo tablet plus 10 ml antacid suspension, interrupted by wash-out phases of 6-10 days between successive treatments. Efficacy was assessed on the basis of postprandial blood glucose and serum insulin levels after administration of 75 g sucrose, and was measured as maximal concentrations and 'area under the curve' (0-4 h). No influence of the antacid on the blood glucose and insulin-lowering effect of acarbose could be detected. Hence, there does not appear to be a significant interaction between acarbose and the antacid tested. Antacids similar to that tested do not need to be classified as a contraindication when used in combination with acarbose.
在一项单中心、安慰剂对照的临床研究中，对24名健康男性志愿者测试了一种含氢氧化镁和氢氧化铝的抗酸剂（胃仙-U 70；10毫升）对口服抗糖尿病药物阿卡波糖（拜糖平100，Bay g 5421，CAS 56180；100毫克）药效学的影响。药物单独或联合给药，并与安慰剂进行比较。志愿者被随机分为四个不同的治疗组。4天的每日用药为1片安慰剂，或1片含100毫克阿卡波糖的片剂，或1片含100毫克阿卡波糖加10毫升抗酸剂混悬液的片剂，或1片安慰剂加10毫升抗酸剂混悬液，连续治疗之间有6 - 10天的洗脱期。根据服用75克蔗糖后的餐后血糖和血清胰岛素水平评估疗效，并测量最大浓度和“曲线下面积”（0 - 4小时）。未检测到抗酸剂对阿卡波糖的血糖和降胰岛素作用有影响。因此，阿卡波糖与所测试的抗酸剂之间似乎没有显著相互作用。与所测试的抗酸剂类似的抗酸剂在与阿卡波糖联合使用时无需被列为禁忌。
