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雷贝拉唑 20mg 和泮托拉唑 40mg 单次剂量对胃内酸度和食管酸暴露 24 小时的影响:有夜间烧心史的胃食管反流病患者的随机研究。

Effects of a single dose of rabeprazole 20 mg and pantoprazole 40 mg on 24-h intragastric acidity and oesophageal acid exposure: a randomized study in gastro-oesophageal reflux disease patients with a history of nocturnal heartburn.

机构信息

Oklahoma Foundation for Digestive Research, Oklahoma City, OK, USA.

出版信息

Aliment Pharmacol Ther. 2010 May;31(9):991-1000. doi: 10.1111/j.1365-2036.2010.04255.x. Epub 2010 Feb 2.

Abstract

BACKGROUND

Nocturnal heartburn is common in patients with gastro-oesophageal reflux disease (GERD).

AIM

To compare the effects of single doses of rabeprazole 20 mg and pantoprazole 40 mg on 24-h intragastric acidity and oesophageal acid exposure (OAE).

METHODS

A total of 52 subjects with GERD and a >or=6-month history of heartburn were randomized into a blinded, 2 x 2 crossover trial. Subjects' intragastric pH was monitored in two 48-h study periods with 6- to 13-day washout between periods. Patients received placebo on day 1, a single dose of rabeprazole 20 mg or pantoprazole 40 mg on day 2, and standardized meals throughout.

RESULTS

The mean percentage time with intragastric pH >4 was significantly greater with rabeprazole vs. pantoprazole for the 24-h postdose interval (44.0% vs. 32.8%; P < 0.001). Significant differences were observed in the daytime (51.0% vs. 42.2%; P < 0.001) and nighttime (32.0% vs. 16.9%; P < 0.001). Rabeprazole was also significantly superior in other intragastric pH parameters. There was no statistical difference for OAE between treatments.

CONCLUSIONS

In GERD patients with nocturnal heartburn, rabeprazole 20 mg was significantly more effective than pantoprazole 40 mg in percentage time with intragastric pH >4 during the nighttime, daytime, and 24-h periods. Differences between treatments in OAE were not demonstrated. This trial is registered with http://clinicaltrials.gov, number NCT00237367.

摘要

背景

胃食管反流病(GERD)患者常出现夜间烧心。

目的

比较雷贝拉唑 20mg 和泮托拉唑 40mg 单剂给药对 24 小时胃内酸度和食管酸暴露(OAE)的影响。

方法

共有 52 例有 GERD 病史且烧心 >6 个月的患者被随机分为双盲、2×2 交叉试验。在两个 48 小时研究期间监测患者胃内 pH,两个期间之间有 6-13 天洗脱期。第 1 天给予安慰剂,第 2 天给予雷贝拉唑 20mg 或泮托拉唑 40mg 单剂给药,并在整个过程中给予标准餐。

结果

雷贝拉唑组与泮托拉唑组相比,24 小时胃内 pH >4 的时间百分比在给药后 24 小时内显著更高(44.0% vs. 32.8%;P < 0.001)。白天(51.0% vs. 42.2%;P < 0.001)和夜间(32.0% vs. 16.9%;P < 0.001)均观察到显著差异。雷贝拉唑在其他胃内 pH 参数方面也具有显著优势。两种治疗方法之间 OAE 无统计学差异。

结论

在夜间烧心的 GERD 患者中,雷贝拉唑 20mg 与泮托拉唑 40mg 相比,在夜间、白天和 24 小时内,胃内 pH >4 的时间百分比显著更高。两种治疗方法在 OAE 方面的差异未得到证实。该试验在 ClinicalTrials.gov 注册,编号为 NCT00237367。

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