MCKENDRY J B, LU F C, BICKERTON D, HANCHARYK G
Can Med Assoc J. 1965 May 22;92(21):1106-9.
Two lots of brand-name and three lots of non-proprietary tolbutamide products, the latter having been reported to be clinically ineffective, were compared in a double-blind study in 22 diabetic patients. Every patient took each of the five brands for two weeks. The dose range was 1 to 2 g. per day and the dose was kept constant in each patient throughout the five test periods. Statistical analyses of fasting, mid-morning and mid-afternoon blood sugar levels, mid-morning and mid-afternoon blood tolbutamide levels and levels of tolbutamide and its metabolite in 24-hour urine did not show any significant differences among the five products except for better control of fasting blood-sugar levels by one brand, nor did clinical observations reveal any differences.
在一项针对22名糖尿病患者的双盲研究中,对两批品牌名甲苯磺丁脲产品和三批非专利甲苯磺丁脲产品进行了比较,据报道后者临床无效。每位患者服用这五个品牌的产品各两周。剂量范围为每天1至2克,在整个五个测试期内,每位患者的剂量保持不变。对空腹、上午中段和下午中段血糖水平、上午中段和下午中段血液中甲苯磺丁脲水平以及24小时尿液中甲苯磺丁脲及其代谢物水平的统计分析表明,除一个品牌对空腹血糖水平控制更好外,这五种产品之间没有任何显著差异,临床观察也未发现差异。