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埃索美拉唑 20mg 在健康志愿者中比维持剂量雷贝拉唑、兰索拉唑或泮托拉唑提供更有效的胃酸控制。

Esomeprazole 20mg provides more effective intragastric Acid control than maintenance-dose rabeprazole, lansoprazole or pantoprazole in healthy volunteers.

机构信息

AstraZeneca R&D, Mölndal, Sweden.

出版信息

Clin Drug Investig. 2004;24(1):1-7. doi: 10.2165/00044011-200424010-00001.

Abstract

OBJECTIVE

A high proportion of patients with gastro-oesophageal reflux disease experience recurrence of symptoms within a year of initial treatment. The key to preventing relapse is an effective maintenance therapy that maintains intragastric pH >4. This study was conducted to compare the effects on intragastric pH of maintenance doses of four proton pump inhibitors: esomeprazole 20mg, lanso-prazole 15mg, rabeprazole 10mg and pantoprazole 20mg.

STUDY PARTICIPANTS AND METHODS

Three standardised, randomised, two-way crossover studies were performed in a total of 108 Helicobacter pylori-negative healthy subjects. Intragastric pH was monitored on day 5 of once-daily oral dosing. The percentage of time of a 24-hour period with intragastric pH >4 and 24-hour median pH were measured on day 5.

RESULTS

The mean percentage of time with intragastric pH >4 on day 5 was significantly longer following esomeprazole 20mg compared with either lansoprazole 15mg (esomeprazole 50.4% vs lansoprazole 43.0%, p = 0.026), rabeprazole 10mg (esomeprazole 59.8% vs rabeprazole 51.7%, p = 0.011) or pantoprazole 20mg (esomeprazole 59.6% vs pantoprazole 39.5%, p < 0.0001).

CONCLUSIONS

Maintenance dose esomeprazole 20mg provided greater acid control and maintained intragastric pH >4 for a longer period of time than maintenance dose lansoprazole 15mg, rabeprazole 10mg and pantoprazole 20mg in healthy subjects.

摘要

目的

相当比例的胃食管反流病患者在初始治疗后一年内会出现症状复发。预防复发的关键是采用有效的维持治疗,使胃内 pH 值>4。本研究旨在比较质子泵抑制剂四种维持剂量对胃内 pH 值的影响:埃索美拉唑 20mg、兰索拉唑 15mg、雷贝拉唑 10mg 和泮托拉唑 20mg。

研究参与者和方法

在总共 108 例幽门螺杆菌阴性的健康受试者中进行了三项标准化、随机、双交叉研究。在每日一次口服给药的第 5 天监测胃内 pH 值。在第 5 天测量 24 小时内胃内 pH 值>4 的时间百分比和 24 小时中位 pH 值。

结果

埃索美拉唑 20mg 组第 5 天胃内 pH 值>4 的时间百分比明显长于兰索拉唑 15mg 组(埃索美拉唑 50.4%比兰索拉唑 43.0%,p=0.026)、雷贝拉唑 10mg 组(埃索美拉唑 59.8%比雷贝拉唑 51.7%,p=0.011)或泮托拉唑 20mg 组(埃索美拉唑 59.6%比泮托拉唑 39.5%,p<0.0001)。

结论

在健康受试者中,维持剂量的埃索美拉唑 20mg 比维持剂量的兰索拉唑 15mg、雷贝拉唑 10mg 和泮托拉唑 20mg 提供了更好的酸控制,并能维持更长时间的胃内 pH 值>4。

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