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Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

2013年2月22日更新者：Nayoung Kim、Seoul National University Bundang Hospital

Predictive Factors of Response to Proton Pump Inhibitor Treatment in Patients With Gastroesophageal Reflux Disease Symptoms

Proton pump inhibitor (PPI) is widely used in patients with gastroesophageal reflux disease (GERD), however, some patients fail to respond to PPI therapy. Recent reporters suggest that depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses to a PPI treatments. Nevertheless, the predictive factors of response to PPI treatment still remain controversial. Therefore, the aims of this study were to investigate the efficacy of PPI therapy, and to evaluate the predictors of the PPI response in patients with symptomatic GERD by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

197

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

大韩民国
- Gyeonggi-do
  - Seongnam、Gyeonggi-do、大韩民国、463-707
    - Seoul National University Bundang Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年至 85年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be erosive reflux disease(ERD), non-erosive reflux disease (NERD) and even functional heartburn (FH).

描述

Inclusion Criteria:

Adult Subjects (From 16 to 85 years old)
The participants with GERD symptoms were treated a PPI therapy.
The participants completed a questionnaire. The questionnaire consisted of demographic data, GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).

Exclusion Criteria:

Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, peptic ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus) were excluded.
Patients who took the PPI therapy less than 4 weeks were excluded.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：病例对照
时间观点：追溯

团体/队列数

队列和干预

团体/队列
Erosive reflux disease (ERD)
Non-erovise reflux disease (NERD)
功能性胃灼热 (FH)

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Efficacy of PPI therapy in these erosive reflux disease (ERD), non-erosive reflux disease (NERD), and functional heartburn (FH) groups 大体时间：After 8 weeks of initial PPI administration	Responses of dyspeptic symptoms were classified into 4 sections, as follows: complete response (more than 80% of symptom resolution), satisfactory response (symptoms remained less than 50%), partial response (symptoms remained for more than 50%), and refractory response (unresponsive to the eradication therapy). Then, the symptom responses were classified into 2 groups: responder with complete or satisfactory subgroup, and non-responder with partial or refractory responder subgroup.	After 8 weeks of initial PPI administration

次要结果测量

结果测量	措施说明	大体时间
Predictors of the response to PPI treatment in patients with symptomatic GERD 大体时间：After 8 weeks of initial PPI administration	The participants were evaluated the predictors of PPI response by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).	After 8 weeks of initial PPI administration

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Seoul National University Bundang Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年7月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2013年2月21日

首先提交符合 QC 标准的

2013年2月22日

首次发布 (估计)

2013年2月25日

研究记录更新

最后更新发布 (估计)