Defining Clinically Relevant Phenotypes of PPI Non-Responders

定义 PPI 无反应者的临床相关表型

基本信息

批准号：
8637997
负责人：
LAURIE A KEEFER
金额：
$ 33.6万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-04-01 至 2016-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8637997
关键词：
Accounting Acids Adult Adverse effects Affect Affective Agreement Anxiety Automobile Driving Awareness Behavior Clinic Clinical Clinical Trials Cognitive Data Development Diagnosis Diagnostic Diagnostic Procedure Equation Esophageal Event Failure Future Gastroesophageal reflux disease Generations Goals Gold Healthcare Heterogeneity Hypersensitivity Intervention Lead Logistic Regressions Medical Methods Modeling Monitor Operant Conditioning Operative Surgical Procedures Outcome Pathologic Patients Pharmaceutical Preparations Phenotype Population Population Heterogeneity Probability Protocols documentation Proton Pump Inhibitors Questionnaires Reflux Refractory Risk Symptoms Techniques Testing Visceral base clinical phenotype clinically relevant improved inhibitor/antagonist innovation novel population health preference response treatment strategy

项目摘要

DESCRIPTION (provided by applicant): Thirty to 50 percent of patients diagnosed with gastroesophageal reflux disease (GERD) are not satisfied with symptom control derived from proton pump inhibitors (PPI). This group of patients; PPI non-responders (PPI- NR), pursue further diagnostic procedures and interventions with low yield. This approach is problematic because symptoms are not related to pathologic reflux in at least 50% of PPI-NRs referred for ambulatory reflux testing and therefore it does not lead to improved outcomes or even inform us as to why a patient did not respond to PPI. The development of novel therapies for this group is limited by lack of agreement on the definition of a PPI responder and the lack of a model that accounts for the heterogeneity of continued symptom generation. Our goal is to validate a PPI-NR model that accounts for factors above and beyond pathologic reflux, reducing the need for low-yield ambulatory reflux monitoring and informing the development of novel treatments. Study 1 will provide an equation in which pre-test clinical and questionnaire data sufficiently enables probability estimation for each of 4 reflux phenotypes, derived from ambulatory reflux monitoring. Study 2 will yield a similar equation which will predict one's ability to withdraw PPI therapy when indicated.

描述（由申请人提供）：30％至50％的诊断为胃食管反流病（GERD）的患者对质子泵抑制剂（PPI）的症状控制不满意。这组患者； PPI非反应器（PPINR），采取进一步的诊断程序和较低产量的干预措施。这种方法是有问题的，因为症状与至少50％用于卧床反回测试的PPI-NRS中的病理反流无关，因此它不会导致改善的结果，甚至告知我们为什么患者为什么不对PPI做出反应。该组的新疗法的发展受到对PPI响应者的定义的一致性的限制，以及缺乏解释持续症状的异质性的模型。我们的目标是验证一个PPI-NR模型，该模型解释了高于病理反流的因素，从而减少了对低收益机反流监测的需求并告知新型治疗方法的发展。研究1将提供一个方程式，其中预测试临床和问卷数据足以实现4种回流表型中的每种概率估计，这些估计是由卧床反流监测得出的。研究2将产生类似的方程式，该方程将预测一个人在指示时撤回PPI治疗的能力。