随机临床试验：高剂量酸抑制治疗慢性咳嗽 - 一项双盲、安慰剂对照研究。

Randomised clinical trial: high-dose acid suppression for chronic cough - a double-blind, placebo-controlled study.

机构信息

Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, 27599-7080, USA.

出版信息

Aliment Pharmacol Ther. 2011 Jan;33(2):225-34. doi: 10.1111/j.1365-2036.2010.04511.x. Epub 2010 Nov 17.

DOI:10.1111/j.1365-2036.2010.04511.x

PMID:21083673

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3073617/

Abstract

BACKGROUND

Cough may be a manifestation of gastro-oesophageal reflux disease (GERD). The utility of acid suppression in GERD-related cough is uncertain.

AIM

To assess the impact of high-dose acid suppression with proton pump inhibitors (PPI) on chronic cough in subjects with rare or no heartburn.

METHODS

Subjects were nonsmokers without history of asthma, with chronic cough for >8 weeks. All subjects underwent a baseline 24-h pH/impedance study, methacholine challenge test and laryngoscopy. Subjects were randomised to either 40 mg of esomeprazole twice daily or placebo for 12 weeks. The primary outcome measure was the Cough-Specific Quality of Life Questionnaire (CQLQ). Secondary outcomes were response on Fisman Cough Severity/Frequency scores and change in laryngeal findings.

RESULTS

Forty subjects were randomised (22 PPI, 18 placebo) and completed the study. There was no difference between PPI and placebo in CQLQ (mean improvement 9.8 vs. 5.9 respectively, P = 0.3), or Fisman Cough Severity/Frequency scores. Proportion of patients who improved by >1 s.d. on the CQLQ was 27.8% (five of 18) and 31.8% (seven of 22) in the placebo and PPI groups respectively.

CONCLUSION

In subjects with chronic cough and rare or no heartburn, high-dose proton pump inhibitor does not improve cough-related quality of life or symptoms.

摘要

背景

咳嗽可能是胃食管反流病（GERD）的一种表现。酸抑制在 GERD 相关咳嗽中的作用尚不确定。

目的

评估质子泵抑制剂（PPI）高剂量抑酸对罕见或无烧心的 GERD 相关慢性咳嗽的影响。

方法

研究对象为无吸烟史、慢性咳嗽>8 周的非哮喘患者。所有患者均接受基线 24 小时 pH/阻抗研究、乙酰甲胆碱挑战试验和喉镜检查。患者随机分为每天两次 40mg 埃索美拉唑或安慰剂治疗 12 周。主要结局指标为咳嗽特异性生活质量问卷（CQLQ）。次要结局指标为 Fisman 咳嗽严重程度/频率评分的反应和喉发现的变化。

结果

40 例患者被随机分配（22 例 PPI，18 例安慰剂）并完成了研究。PPI 和安慰剂在 CQLQ 方面没有差异（平均改善分别为 9.8 和 5.9，P=0.3），或 Fisman 咳嗽严重程度/频率评分。CQLQ 改善>1 个标准差的患者比例分别为安慰剂组 27.8%（18 例中的 5 例）和 PPI 组 31.8%（22 例中的 7 例）。