Dammann H G, Gottlieb W R, Walter T A, Dreyer M, Müller P, Simon B, Keohane P
Hepatogastroenterology. 1986 Oct;33(5):217-20.
To determine the potential efficacy of bedtime doses of the new furan H2 receptor antagonist nizatidine in the suppression of nocturnal acid secretion, this randomized, crossover, single-blind study was performed in 10 healthy male subjects. The actions of a single bedtime (21:00 hour) dose of the H2 receptor antagonists nizatidine (150 mg and 300 mg), ranitidine (300 mg) and cimetidine (800 mg), as well as placebo on nocturnal gastric acid and volume secretion (01:00 to 07:00 hours, and on overall 24 hour H+ ion concentration were studied. Compared with placebo, night-time (23:00 to 07:00 hours) H+ ion concentration was reduced by 70, 79, 95, and 76% (p less than 0.05-p less than 0.01). Nocturnal acid secretion, too, was significantly lower for the H2 blockers than for placebo (p less than 0.05-p less than 0.01). A significant reduction in night-time gastric volume secretion was observed in the hourly intervals from 04:00 to 07:00 hours and in total volume in the whole 6 hours period (p less than 0.05-p less than 0.01). Nizatidine 300 mg nocte, ranitidine and cimetidine significantly decreased H+ concentration for only 1 hour (08:00 to 09:00 hours, p less than 0.05-p less than 0.01) during the subsequent daytime period (08:00 to 13:00 hours). Since no significant pharmacodynamic differences between nizatidine 300 mg nocte, cimetidine 800 mg nocte and ranitidine 300 mg nocte were observed, it may be concluded that at the doses employed, these three H2-blockers will all be similarly effective in the acute therapy of peptic ulcer disease.
为确定新型呋喃类H2受体拮抗剂尼扎替丁睡前剂量在抑制夜间胃酸分泌方面的潜在疗效,对10名健康男性受试者进行了这项随机、交叉、单盲研究。研究了H2受体拮抗剂尼扎替丁(150毫克和300毫克)、雷尼替丁(300毫克)和西咪替丁(800毫克)以及安慰剂在睡前(21:00时)单剂量给药后对夜间胃酸和胃液分泌(01:00至07:00时)以及全天24小时H⁺离子浓度的影响。与安慰剂相比,夜间(23:00至07:00时)H⁺离子浓度分别降低了70%、79%、95%和76%(p<0.05 - p<0.01)。H2受体阻滞剂的夜间胃酸分泌也显著低于安慰剂(p<0.05 - p<0.01)。在04:00至07:00时的每小时时间段以及整个6小时期间的总体积中,观察到夜间胃容积分泌显著减少(p<0.05 - p<0.01)。尼扎替丁300毫克夜间给药、雷尼替丁和西咪替丁在随后的白天时间段(08:00至13:00时)仅1小时(08:00至09:00时)显著降低了H⁺浓度(p<0.05 - p<0.01)。由于未观察到尼扎替丁300毫克夜间给药、西咪替丁800毫克夜间给药和雷尼替丁300毫克夜间给药之间存在显著的药效学差异,因此可以得出结论,在所使用的剂量下,这三种H2受体阻滞剂在消化性溃疡疾病的急性治疗中疗效相似。