Lazzaroni M, Ardizzone S, Imbimbo B P, Sangaletti O, Ghirardosi C, Bianchi Porro G
Int J Clin Pharmacol Ther Toxicol. 1987 Apr;25(4):218-21.
The purpose of this study is to investigate the effects of a single oral dose of 10 mg of mifentidine, a new H2-receptor antagonist, on unstimulated and pentagastrin-stimulated gastric acid secretion in healthy subjects. The study was carried out in a double-blind randomized, placebo controlled, cross-over design. Ten subjects were given both placebo and active drug, with a wash-out period of at least 3 days. Unstimulated acid secretion was measured in the period between 1 and 1.5 h after drug administration. Immediately thereafter, 2 micrograms/kg/h of pentagastrin was infused intravenously and pentagastrin-stimulated gastric acid secretion was determined for two subsequent hours. The volume of gastric secretion was significantly less after mifentidine than after placebo during the pentagastrin-stimulated period. Acid output was inhibited during unstimulated and pentagastrin-stimulated secretion by mifentidine by 45% and 39% of the placebo values, respectively. No adverse clinical or laboratory effects were noted during the study. The results of this study indicate that mifentidine, given as a single oral dose of 10 mg, inhibits effectively unstimulated and pentagastrin-stimulated acid secretion in healthy subjects.
本研究的目的是调查单次口服10毫克新型H2受体拮抗剂米芬替丁对健康受试者基础胃酸分泌和五肽胃泌素刺激的胃酸分泌的影响。本研究采用双盲随机、安慰剂对照、交叉设计进行。10名受试者分别服用安慰剂和活性药物,洗脱期至少为3天。在给药后1至1.5小时期间测量基础胃酸分泌。此后,立即以2微克/千克/小时的速度静脉输注五肽胃泌素,并在随后的两小时内测定五肽胃泌素刺激的胃酸分泌。在五肽胃泌素刺激期间,米芬替丁给药后的胃液分泌量明显低于安慰剂给药后。在基础胃酸分泌和五肽胃泌素刺激的胃酸分泌过程中,米芬替丁对胃酸分泌的抑制作用分别为安慰剂组的45%和39%。研究期间未观察到不良临床或实验室效应。本研究结果表明,单次口服10毫克米芬替丁可有效抑制健康受试者的基础胃酸分泌和五肽胃泌素刺激的胃酸分泌。