Castell D, Bagin R, Goldlust B, Major J, Hepburn B
Esophageal Disorders Program, Medical University of South Carolina, Charleston, SC, USA.
Aliment Pharmacol Ther. 2005 Jun 15;21(12):1467-74. doi: 10.1111/j.1365-2036.2005.02513.x.
Many patients treated with a proton-pump inhibitor for gastro-oesophageal reflux disease or erosive oesophagitis still have substantial night-time gastric acidity. A previous trial of a new immediate-release omeprazole oral suspension suggested that nocturnal gastric acidity could be more effectively controlled with a bedtime dose of immediate-release omeprazole than with a delayed-release proton-pump inhibitor administered before dinner or at bedtime.
To compare the ability of immediate-release omeprazole with pantoprazole to control nocturnal gastric acidity, when they were dosed once daily and twice daily.
Thirty-six patients with nocturnal gastro-oesophageal reflux disease symptoms received immediate-release omeprazole and pantoprazole in this open-label, randomized-crossover trial. Median gastric pH, the percentage of time with gastric pH > 4 and the percentage of patients with nocturnal acid breakthrough, were evaluated with 24-h pH monitoring.
Repeated once daily (bedtime) dosing with immediate-release omeprazole suspension produced significantly better nocturnal gastric acid control than repeated once daily (predinner) or twice daily (prebreakfast and bedtime) dosing with pantoprazole delayed-release tablets (median pH: 4.7 vs. 2.0 and 1.7; percentage of time pH > 4: 55 vs. 27 and 34; nocturnal acid breakthrough: 53 vs. 78 and 75). Twice daily dosing (prebreakfast and bedtime) with immediate-release omeprazole 20 and 40 mg achieved the best night-time control of gastric acidity. Repeated once daily bedtime dosing with immediate-release omeprazole 40 mg and twice daily dosing with pantoprazole 40 mg gave similar 24-h pH control. No safety issues were associated with either drug in this trial.
Dosed once daily at bedtime, immediate-release omeprazole reduced nocturnal gastric acidity to a degree not observed with once daily dosing of delayed-release proton-pump inhibitors.
许多接受质子泵抑制剂治疗胃食管反流病或糜烂性食管炎的患者夜间仍有较高胃酸分泌。此前一项关于新型速释奥美拉唑口服混悬液的试验表明，睡前服用速释奥美拉唑比晚餐前或睡前服用缓释质子泵抑制剂能更有效地控制夜间胃酸分泌。
比较速释奥美拉唑与泮托拉唑每日一次和每日两次给药时控制夜间胃酸分泌的能力。
在这项开放标签、随机交叉试验中，36例有夜间胃食管反流病症状的患者接受了速释奥美拉唑和泮托拉唑治疗。通过24小时pH监测评估胃pH值中位数、胃pH值>4的时间百分比以及夜间酸突破患者的百分比。
每日一次（睡前）重复服用速释奥美拉唑混悬液比每日一次（晚餐前）或每日两次（早餐前和睡前）重复服用泮托拉唑缓释片能更有效地控制夜间胃酸分泌（pH值中位数：4.7对2.0和1.7；pH值>4的时间百分比：55%对27%和34%；夜间酸突破：53%对78%和75%）。每日两次（早餐前和睡前）服用20毫克和40毫克速释奥美拉唑能实现最佳的夜间胃酸控制。每日一次睡前重复服用40毫克速释奥美拉唑和每日两次服用40毫克泮托拉唑在24小时pH控制方面效果相似。本试验中两种药物均未出现安全问题。
睡前每日一次给药，速释奥美拉唑降低夜间胃酸分泌的程度是每日一次服用缓释质子泵抑制剂所未观察到的。
