随机临床试验：识别对短期埃索美拉唑治疗消化不良有反应者 - 一项随机、安慰剂对照研究。

Randomised clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomised, placebo-controlled study.

机构信息

Department of General Practice, The Panum Institute, University of Copenhagen, Denmark.

出版信息

Aliment Pharmacol Ther. 2011 Jan;33(1):41-9. doi: 10.1111/j.1365-2036.2010.04501.x. Epub 2010 Oct 29.

DOI:10.1111/j.1365-2036.2010.04501.x

PMID:21083590

Abstract

BACKGROUND

Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable.

AIM

To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment.

METHODS

Eight hundred and five uninvestigated, primary care patients with upper GI symptoms that were considered to be acid-related were randomised to 2 weeks' treatment with esomeprazole 40 mg or placebo. The study population was divided into a model sample (N = 484) and a validation sample (N = 321). We developed a therapeutic index to predict PPI response from the model sample and tested this in the validation sample.

RESULTS

Response to PPI was found in 68% of patients (44% in placebo arm). Bothersome heartburn and early satiety were associated with increased likelihood of PPI response, whereas dull abdominal pain, pain relieved by bowel movements and nausea in women were associated with a decreased likelihood of PPI response. Patients in the validation sample could be classified as having a 'very high' (n = 55), 'high' (n = 123), 'medium' (n = 78) or 'low' (n = 65) probability of PPI response. The therapeutic gains over placebo were 55%, 31%, 20% and 22%, respectively.

CONCLUSIONS

In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968).

摘要

背景

质子泵抑制剂 (PPI) 治疗消化不良的反应是不可预测的。

目的

确定与埃索美拉唑反应相关的症状，以便针对患者进行经验性治疗。

方法

805 名未经调查的、有上胃肠道症状的初级保健患者，这些症状被认为与酸有关，被随机分配接受 2 周埃索美拉唑 40mg 或安慰剂治疗。研究人群分为模型样本（N=484）和验证样本（N=321）。我们从模型样本中开发了一个治疗指数来预测 PPI 反应，并在验证样本中进行了测试。

结果

在 68%的患者中（安慰剂组为 44%）发现了对 PPI 的反应。令人烦恼的烧心和早饱与 PPI 反应的可能性增加有关，而钝痛、腹痛缓解、排便后疼痛和女性恶心与 PPI 反应的可能性降低有关。验证样本中的患者可分为 PPI 反应“非常高”（n=55）、“高”（n=123）、“中”（n=78）或“低”（n=65）的可能性。与安慰剂相比，治疗增益分别为 55%、31%、20%和 22%。