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临床试验:抑酸治疗 Hispanic 成人胃食管反流病症状患者 - 埃索美拉唑、兰索拉唑和泮托拉唑的对照研究。

Clinical trial: gastric acid suppression in Hispanic adults with symptomatic gastro-oesophageal reflux disease - comparator study of esomeprazole, lansoprazole and pantoprazole.

机构信息

University of North Carolina School of Medicine, Chapel Hill, NC 27599-7080, USA.

出版信息

Aliment Pharmacol Ther. 2010 Jul;32(2):200-8. doi: 10.1111/j.1365-2036.2010.04335.x. Epub 2010 Apr 23.

Abstract

BACKGROUND

Hispanic-Americans are a rapidly growing population in the United States, yet gastro-oesophageal reflux disease (GERD) is not well studied in this population.

AIM

To compare the efficacy of esomeprazole, lansoprazole and pantoprazole in suppressing gastric acid, including the area of the 'acid pocket,' in Hispanics with GERD.

METHODS

In this open-label, 3-way crossover study, 83 Hispanics with symptomatic GERD were randomized to 1 of 6 possible treatment sequences of three 5-7-day dosing periods with esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg daily separated by 10-17-day washout periods. Intragastric pH was measured for 24 h using dual probes with a distal and proximal (area of the 'acid pocket') electrode.

RESULTS

Esomeprazole suppressed intragastric acid (pH >4.0) significantly longer over 24 h (primary end point) compared with lansoprazole and pantoprazole (P < 0.0001), and proximal gastric acid (pH >4.0) significantly longer over 24 h compared with lansoprazole (P < 0.05) and pantoprazole (P < 0.0001).

CONCLUSIONS

Esomeprazole was more effective than lansoprazole and pantoprazole in suppressing gastric acidity at both intragastric distal and proximal (area of the acid pocket) sites in Hispanics with GERD. Future studies are warranted to understand better the role of the acid pocket in GERD (Clinical trial numbers: D9612L00106; ClinicalTrials.gov: NCT00410592).

摘要

背景

西班牙裔美国人是美国人口增长最快的群体之一,但胃食管反流病(GERD)在这一人群中的研究并不充分。

目的

比较埃索美拉唑、兰索拉唑和泮托拉唑抑制胃酸的疗效,包括 GERD 西班牙裔患者的“酸口袋”区域。

方法

在这项开放标签、3 向交叉研究中,83 名有症状 GERD 的西班牙裔患者被随机分配到 6 种可能的治疗方案中的 1 种,即埃索美拉唑 40mg、兰索拉唑 30mg 和泮托拉唑 40mg,每日 1 次,每种药物治疗 5-7 天,洗脱期为 10-17 天。使用带有远端和近端(“酸口袋”区域)电极的双探头进行 24 小时胃内 pH 测量。

结果

埃索美拉唑在 24 小时内显著抑制胃酸(pH>4.0)(主要终点),效果明显长于兰索拉唑和泮托拉唑(P<0.0001),近端胃酸(pH>4.0)也明显长于兰索拉唑(P<0.05)和泮托拉唑(P<0.0001)。

结论

埃索美拉唑在 GERD 西班牙裔患者中抑制胃内远侧和近侧(酸口袋区域)胃酸的效果均优于兰索拉唑和泮托拉唑。需要进一步的研究来更好地了解酸口袋在 GERD 中的作用。(临床试验编号:D9612L00106;ClinicalTrials.gov:NCT00410592)。

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