Johnson D A, Stacy T, Ryan M, Wootton T, Willis J, Hornbuckle K, Brooks W, Doviak M
Department of Medicine, Gastroenterology Division, Eastern Virginia Medical School, Norfolk, VA, USA.
Aliment Pharmacol Ther. 2005 Jul 15;22(2):129-34. doi: 10.1111/j.1365-2036.2005.02534.x.
Intragastric acid suppression is the most direct measure of the pharmacodynamic efficacy of proton pump inhibitors, which are the most effective drugs for acid-related diseases.
To compare the effectiveness of once and twice daily dosing of lansoprazole and esomeprazole in controlling intragastric acidity (target gastric pH > 4.0) over a 24-hour period.
In an open-label, two-way crossover study, 45 Helicobacter pylori-negative patients with gastro-oesophageal reflux disease were randomized to receive one of two regimens: 30 mg lansoprazole or esomeprazole 40 mg once daily. Intragastric pH was assessed by 24-hour pH monitoring on day 5 of each regimen. Dosing was increased to twice daily and pH was reassessed on day 10. Following a 14-day washout, patients were crossed over to the other medication and the dosage regimens and pH assessments were repeated.
Data were analysed from 35 patients who completed all scheduled assessments and had 24-hour monitoring for each end-point. Mean time pH > 4.0 and mean 24-hour pH were highest for esomeprazole 40 mg twice daily, followed by lansoprazole 30 mg twice daily, esomeprazole 40 mg once daily and lansoprazole 30 mg once daily. Esomeprazole 40 mg twice daily provided superior control of intragastric pH compared with either once or twice daily dosing of lansoprazole and once daily dosing of esomeprazole (P < 0.01). Esomeprazole 40 mg once daily was comparable with lansoprazole 30 mg twice daily and both were superior to lansoprazole 30 mg once daily (P < 0.01).
Response to acid suppression treatment depends on the treatment selected. Esomeprazole 40 mg twice daily provided better control of intragastric pH than all other regimens evaluated. Esomeprazole 40 mg daily, however, was comparable with lansoprazole 30 mg twice daily and superior to lansoprazole 30 mg once daily.
胃内酸抑制是质子泵抑制剂药效学疗效的最直接指标，质子泵抑制剂是治疗酸相关疾病最有效的药物。
比较兰索拉唑和埃索美拉唑每日一次和每日两次给药在24小时内控制胃内酸度（目标胃pH>4.0）的效果。
在一项开放标签、双向交叉研究中，45例幽门螺杆菌阴性的胃食管反流病患者被随机分为接受两种治疗方案之一：30毫克兰索拉唑或40毫克埃索美拉唑每日一次。在每种治疗方案的第5天通过24小时pH监测评估胃内pH。给药增加至每日两次，并在第10天重新评估pH。经过14天的洗脱期后，患者换用另一种药物，并重复给药方案和pH评估。
分析了35例完成所有预定评估并对每个终点进行24小时监测的患者的数据。每日两次服用40毫克埃索美拉唑时，pH>4.0的平均时间和24小时平均pH最高，其次是每日两次服用30毫克兰索拉唑、每日一次服用40毫克埃索美拉唑和每日一次服用30毫克兰索拉唑。与兰索拉唑每日一次或两次给药以及埃索美拉唑每日一次给药相比，每日两次服用40毫克埃索美拉唑对胃内pH的控制效果更佳（P<0.01）。每日一次服用40毫克埃索美拉唑与每日两次服用30毫克兰索拉唑相当，且两者均优于每日一次服用30毫克兰索拉唑（P<0.01）。
酸抑制治疗的反应取决于所选治疗方法。每日两次服用40毫克埃索美拉唑对胃内pH的控制效果优于所有其他评估方案。然而，每日服用40毫克埃索美拉唑与每日两次服用30毫克兰索拉唑相当，且优于每日一次服用30毫克兰索拉唑。
