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右兰索拉唑与埃索美拉唑治疗胃食管反流病的疗效与安全性对比研究

Efficacy and safety comparative study of dexrabeprazole vs. esomeprazole for the treatment of gastroesophageal reflux disease.

作者信息

Abdo-Francis Juan M, Cabrera-Álvarez Guillermo, Martínez-Torres Héctor, Remes-Troche José M

机构信息

Endoscopy Department, Hospital Ángeles Acoxpa, Mexico City.

Comprehensive Liver and Gastroenterology Clinic, Morelos.

出版信息

Gac Med Mex. 2022;158(6):423-429. doi: 10.24875/GMM.M22000722.

DOI:10.24875/GMM.M22000722
PMID:36657136
Abstract

INTRODUCTION

A national survey in the general population showed that gastroesophageal reflux disease (GERD) is highly prevalent in Mexico.

OBJECTIVE

To compare the efficacy and safety of two isomers, dexrabeprazole (10 mg) vs. esomeprazole (20 mg), in the treatment of GERD for four weeks.

METHODS

Randomized, multicenter, prospective, double-blind phase III clinical trial in two groups that included 230 patients.

RESULTS

A statistically significant decrease in the severity of GERD symptoms (heartburn, regurgitation, epigastric pain and dysphagia), evaluated using a visual analogue scale, was observed with both treatments. Mean score for dexrabeprazole on Carlsson-Dent questionnaire at 28 days was 2.12, and for esomeprazole, 3.02. Both treatments were effective, with no statistically significant difference being recorded (p < 0.05). On SF-36 health questionnaire, both were observed to improve the quality-of-life score, with no significant difference being identified. Both drugs were well tolerated, and the adverse event incidence profile was low.

CONCLUSIONS

In the treatment of non-erosive GERD, the use of dexrabeprazole at 10 mg/day is as effective as esomeprazole 20 mg/day, with the advantage that the dose is lower with an appropriate safety profile.

摘要

引言

一项针对普通人群的全国性调查显示,胃食管反流病(GERD)在墨西哥极为普遍。

目的

比较两种异构体,即右兰索拉唑(10毫克)与埃索美拉唑(20毫克),治疗胃食管反流病四周的疗效和安全性。

方法

在两组中进行随机、多中心、前瞻性、双盲III期临床试验,共纳入230名患者。

结果

使用视觉模拟量表评估发现,两种治疗方法均使胃食管反流病症状(烧心、反流、上腹痛和吞咽困难)的严重程度有统计学意义的降低。在第28天时,右兰索拉唑在卡尔森-登特问卷上的平均得分是2.12,埃索美拉唑为3.02。两种治疗方法均有效,差异无统计学意义(p<0.05)。在SF-36健康问卷上,两者均使生活质量得分得到改善,差异无统计学意义。两种药物耐受性良好,不良事件发生率较低。

结论

在治疗非糜烂性胃食管反流病时,每天服用10毫克右兰索拉唑与每天服用20毫克埃索美拉唑效果相同,优势在于剂量更低且安全性良好。

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