埃索美拉唑治疗儿童糜烂性食管炎:一项国际、多中心、随机、平行组、双盲(剂量)研究。
Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study.
作者信息
Tolia Vasundhara, Youssef Nader N, Gilger Mark A, Traxler Barry, Illueca Marta
机构信息
*Wayne State University, Detroit, MI †Atlantic Health, Morristown, NJ ‡Baylor College of Medicine, Houston, TX §AstraZeneca LP, Wilmington, DE.
出版信息
J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94.
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 (≥ 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.
背景
使用质子泵抑制剂抑制胃酸是成人胃食管反流病和糜烂性食管炎的标准治疗方法,并且越来越成为1至17岁儿童的一线治疗方法。我们评估了埃索美拉唑对患有胃食管反流病幼儿糜烂性食管炎的内镜下愈合情况,并描述了食管组织学特征。
方法
年龄在1至11岁、经内镜或组织学确诊为胃食管反流病的儿童被随机分为两组,体重<20kg的儿童每日服用5或10mg埃索美拉唑,体重≥20kg的儿童每日服用10或20mg埃索美拉唑,疗程8周。患有糜烂性食管炎的患者在8周后接受内镜检查以评估糜烂的愈合情况。
结果
109例患者中,49%患有糜烂性食管炎,51%有反流性食管炎的组织学证据但无糜烂性食管炎。在45例患有糜烂性食管炎并接受随访内镜检查的患者中,89%的患者糜烂消失。组织学检查显示24%的患者存在细胞间隙增宽。
结论
埃索美拉唑(0.2 - 1.0mg/kg)可有效治愈该患有胃食管反流病的儿科人群中的宏观和微观糜烂性食管炎。细胞间隙增宽可能是儿童糜烂性食管炎的一个重要组织学标志物。