Brown D D, Juhl R P
N Engl J Med. 1976 Nov 4;295(19):1034-7. doi: 10.1056/NEJM197611042951902.
Employing a Latin-square design and single-dose studies of bioavailability in 10 normal human volunteers, we tested the hypothesis that antacids and kaolin-pectin might interfere with the bioavailability of orally administered digoxin. Cumulative six-day urinary digoxin excretion (expressed as the percentage of a 0.75-mg dose recovered) was: control, 40.1+/-3.0 (S.E.); aluminum hydroxide, 30.7+/-2.9; magnesium hydroxide, 27.1+/-2.4; magnesium trisilicate, 29.1+/-1.7; and kaolin-pectin 23.4+/-2.0. The differences in means were highly significant (F = 10.47, P less than 0.005). Further analysis (multiple comparison test) revealed that control differed significantly from each of the other treatments (alpha = 0.05), but there was no such difference between any of the other treatment groups. The decreased cumulative excretion produced by antacids and kaolin-pectin reflected a striking reduction in digoxin absorption associated with these compounds that was not related to alteration of gut transit time or to adsorption of digoxin to these gastrointestinal medications.
我们采用拉丁方设计并对10名正常人类志愿者进行单剂量生物利用度研究,以检验抗酸剂和高岭土果胶可能会干扰口服地高辛生物利用度这一假设。六天内累积的地高辛尿排泄量(以回收的0.75毫克剂量的百分比表示)为:对照组,40.1±3.0(标准误);氢氧化铝组,30.7±2.9;氢氧化镁组,27.1±2.4;三硅酸镁组,29.1±1.7;高岭土果胶组,23.4±2.0。均值差异具有高度显著性(F = 10.47,P < 0.005)。进一步分析(多重比较检验)显示,对照组与其他各治疗组均存在显著差异(α = 0.05),但其他治疗组之间不存在此类差异。抗酸剂和高岭土果胶导致的累积排泄量减少反映出与这些化合物相关的地高辛吸收显著降低,这与肠道转运时间的改变或地高辛对这些胃肠道药物的吸附无关。