Tutuian R, Katz P O, Bochenek W, Castell D O
Graduate Hospital, Esophageal Laboratory, Philadelphia, PA, USA.
Aliment Pharmacol Ther. 2002 Apr;16(4):829-36. doi: 10.1046/j.1365-2036.2002.01232.x.
Proton pump inhibitors have emerged as the most effective class of drugs for the treatment of gastro-oesophageal reflux. Pantoprazole is a proton pump inhibitor that has demonstrated high clinical efficacy.
To evaluate the effect of once-daily doses of pantoprazole, 10, 20 and 40 mg, on gastric acidity in healthy volunteers.
Thirty-six subjects received pantoprazole in a three-way crossover design study. Ambulatory 24-h intragastric pH and distal oesophageal pH were monitored at baseline and on the last day of each treatment period. The measured endpoints were the median intragastric and oesophageal pH, the percentage of time the intragastric pH < 4 and oesophageal pH < 4 and the area under the curve for gastric acidity over 24 h. Safety was evaluated by incidence and severity of adverse events.
Pantoprazole demonstrated a linear dose- dependent suppression of gastric acidity over the dose range 10-40 mg. The dose of 40 mg demonstrated a significantly greater response than the lower doses, particularly at night. All pantoprazole doses were well tolerated.
Pantoprazole demonstrates a dose-related effect in the range 10-40 mg once daily. The once-daily dose of 40 mg provides the highest and most consistent control of gastric pH, especially at night.
质子泵抑制剂已成为治疗胃食管反流最有效的一类药物。泮托拉唑是一种已显示出高临床疗效的质子泵抑制剂。
评估每日一次服用10毫克、20毫克和40毫克泮托拉唑对健康志愿者胃酸度的影响。
36名受试者在一项三交叉设计研究中接受泮托拉唑治疗。在基线期以及每个治疗期的最后一天监测24小时动态胃内pH值和食管远端pH值。测量的终点指标为胃内和食管pH值中位数、胃内pH值<4和食管pH值<4的时间百分比以及24小时胃酸度曲线下面积。通过不良事件的发生率和严重程度评估安全性。
在10 - 40毫克剂量范围内，泮托拉唑对胃酸度呈线性剂量依赖性抑制。40毫克剂量组的反应明显大于较低剂量组，尤其是在夜间。所有泮托拉唑剂量耐受性良好。
泮托拉唑每日一次服用时，在10 - 40毫克范围内呈现剂量相关效应。每日一次40毫克剂量能提供最高且最持续的胃pH值控制，尤其是在夜间。
