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莫沙必利联合质子泵抑制剂治疗胃食管反流病的前瞻性随机双盲研究。

Effects of the Addition of Mosapride to Gastroesophageal Reflux Disease Patients on Proton Pump Inhibitor: A Prospective Randomized, Double-blind Study.

机构信息

Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

出版信息

J Neurogastroenterol Motil. 2013 Oct;19(4):495-502. doi: 10.5056/jnm.2013.19.4.495. Epub 2013 Oct 7.

Abstract

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) which are the most effective agents for the treatment of gastroesophageal reflux disease (GERD), have been known to delay gastric emptying. Mosapride has been used as prokinetics by accelerating gastric emptying. We evaluated the efficacy of mosapride to prevent PPI-induced delayed gastric emptying in a prospective randomized, double-blind and placebo-controlled trial.

METHODS

Thirty patients who were diagnosed as GERD and had normal gastric emptying were included in this study. PPI monotherapy group was treated with placebo drug in addition to pantoprazole and PPI plus mosapride group was treated with mosapride in addition to pantoprazole for 8 weeks. Gastric emptying scan and questionnaires about GERD and dyspeptic symptoms were assessed by scoring before and after treatment. To evaluate the changes of gastrointestinal endocrine hormones by PPI which are associated gastric acid secretion and gastric motility, fasting plasma gastrin and cholecystokinin were taken at weeks 0 and 8.

RESULTS

Half gastric emptying time was increased (P = 0.023) in PPI monotherapy group, and there were no significant changes in PPI plus mosapride group. Plasma gastrin level increased in PPI monotherpay group (P = 0.028) and there were no significant changes in PPI plus mosapride group. Plasma cholecystokinin level was not changed after treatment in both groups. GERD symptoms were improved after treatment in both groups, and postprandial bloating and nausea were improved in PPI plus mosapride group.

CONCLUSIONS

Mosapride showed to be effective in preventing delayed gastric emptying and the increase in plasma gastrin level induced by PPI treatment, but did not show prominent clinical symptom improvements.

摘要

背景/目的:质子泵抑制剂(PPIs)是治疗胃食管反流病(GERD)最有效的药物,已知其可延迟胃排空。莫沙必利通过加速胃排空被用作促动力药物。我们评估了莫沙必利预防 PPI 引起的胃排空延迟的疗效,这是一项前瞻性随机、双盲和安慰剂对照试验。

方法

本研究纳入了 30 名被诊断为 GERD 且胃排空正常的患者。PPI 单药治疗组除了泮托拉唑外还给予安慰剂药物,PPI 加莫沙必利组除了泮托拉唑外还给予莫沙必利治疗,疗程均为 8 周。在治疗前后通过评分评估胃排空扫描和 GERD 和消化不良症状问卷。为了评估与胃酸分泌和胃动力相关的 PPI 引起的胃肠内分泌激素的变化,在第 0 周和第 8 周采集空腹血浆胃泌素和胆囊收缩素。

结果

PPI 单药治疗组的半胃排空时间增加(P = 0.023),而 PPI 加莫沙必利组无明显变化。PPI 单药治疗组血浆胃泌素水平升高(P = 0.028),而 PPI 加莫沙必利组无明显变化。两组治疗后血浆胆囊收缩素水平均无变化。两组治疗后 GERD 症状均改善,PPI 加莫沙必利组餐后腹胀和恶心改善。

结论

莫沙必利可有效预防 PPI 治疗引起的胃排空延迟和血浆胃泌素水平升高,但对临床症状的改善无明显作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ca0/3816184/474de4c0de5f/jnm-19-495-g001.jpg

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