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埃索美拉唑治疗儿童糜烂性食管炎:一项国际性、多中心、随机、平行分组、双盲(针对剂量)研究。

Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study.

机构信息

Wayne State University, Detroit, MI, USA.

出版信息

BMC Pediatr. 2010 Jun 11;10:41. doi: 10.1186/1471-2431-10-41.

DOI:10.1186/1471-2431-10-41
PMID:20540767
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2904294/
Abstract

BACKGROUND

Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.

METHODS

Children aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux disease were randomized to esomeprazole 5 or 10 mg daily (< 20 kg) or 10 or 20 mg daily (> or = 20 kg) for 8 weeks. Patients with erosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.

RESULTS

Of 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis without erosive esophagitis. Of the 45 patients who had erosive esophagitis and underwent follow-up endoscopy, 89% experienced erosion resolution. Dilation of intercellular space was reported in 24% of patients with histologic examination.

CONCLUSIONS

Esomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in this pediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an important histologic marker of erosive esophagitis in children.

TRIAL REGISTRATION

D9614C00097; ClinicalTrials.gov identifier NCT00228527.

摘要

背景

质子泵抑制剂抑制胃酸分泌是成人胃食管反流病和糜烂性食管炎的标准治疗方法,并且越来越多地成为 1-17 岁儿童的一线治疗方法。我们评估了埃索美拉唑治疗小儿胃食管反流病的糜烂性食管炎的内镜愈合情况,并描述了食管组织学。

方法

1-11 岁内镜或组织学证实为胃食管反流病的儿童随机分为埃索美拉唑 5 或 10 mg/天(<20 kg)或 10 或 20 mg/天(≥20 kg),疗程 8 周。患有糜烂性食管炎的患者在 8 周后进行内镜检查以评估糜烂愈合情况。

结果

109 例患者中,49%有糜烂性食管炎,51%有组织学证据的反流性食管炎而无糜烂性食管炎。45 例有糜烂性食管炎并进行随访内镜检查的患者中,89%的患者的糜烂得到缓解。组织学检查报告 24%的患者存在细胞间隙扩张。

结论

埃索美拉唑(0.2-1.0mg/kg)可有效治愈小儿胃食管反流病患者的宏观和微观糜烂性食管炎。细胞间隙扩张可能是儿童糜烂性食管炎的重要组织学标志物。

试验注册

D9614C00097;ClinicalTrials.gov 标识符 NCT00228527。

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Prevalence of endoscopic findings of erosive esophagitis in children: a population-based study.儿童糜烂性食管炎内镜检查结果的患病率:一项基于人群的研究。
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