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慢性咳嗽与埃索美拉唑:一项双盲安慰剂对照平行研究。

Chronic cough and esomeprazole: a double-blind placebo-controlled parallel study.

机构信息

Division of Cardiovascular and Respiratory Studies, Hull York Medical School, University of Hull, Castle Hill Hospital, Cottingham, UK.

出版信息

Respirology. 2011 Oct;16(7):1150-6. doi: 10.1111/j.1440-1843.2011.02014.x.

Abstract

BACKGROUND AND OBJECTIVE

Gastro-oesophageal reflux has been implicated in the pathogenesis of chronic cough. Guidelines on management suggest a therapeutic trial of anti-reflux medication. Esomeprazole is a proton pump inhibitor licensed for the long-term treatment of acid reflux in adults and we compared the effects of esomeprazole and placebo on patients with chronic cough.

METHODS

This was a prospective, single-centre, randomized, double-blind, placebo-controlled, parallel group study conducted over 8weeks. Fifty adult non-smokers with chronic cough and normal spirometry were randomized. Patients completed cough-related quality-of-life and symptom questionnaires and subjective scores of cough frequency and severity at the beginning and end of the study. They also kept a daily diary of symptom scores. Citric acid cough challenge and laryngoscopic examination were performed at baseline and the end of the study. The primary outcome was improvement in cough score.

RESULTS

There were no differences in cough scores in the placebo and treatment arms of the study although some significant improvements were noted when compared to baseline. In the cough diary scores there was a trend towards greater improvement in the treatment arm in patients with dyspepsia.

CONCLUSIONS

Esomeprazole did not have a clinically important effect greater than placebo in patients with cough. It suggests a marked placebo effect in the treatment of cough.

摘要

背景和目的

胃食管反流与慢性咳嗽的发病机制有关。管理指南建议进行抗反流药物治疗试验。埃索美拉唑是一种质子泵抑制剂,获准用于成人胃酸反流的长期治疗,我们比较了埃索美拉唑和安慰剂对慢性咳嗽患者的影响。

方法

这是一项为期 8 周的前瞻性、单中心、随机、双盲、安慰剂对照、平行组研究。将 50 名非吸烟的慢性咳嗽且肺功能正常的成年患者随机分组。患者在研究开始和结束时完成与咳嗽相关的生活质量和症状问卷以及咳嗽频率和严重程度的主观评分,并记录每日症状评分日记。在基线和研究结束时进行柠檬酸咳嗽激发试验和喉镜检查。主要结局是咳嗽评分的改善。

结果

尽管与基线相比,研究中安慰剂和治疗组的咳嗽评分均无差异,但有一些显著改善。在咳嗽日记评分中,消化不良患者治疗组的改善趋势更大。

结论

埃索美拉唑在咳嗽患者中的疗效并不优于安慰剂。这表明在咳嗽治疗中存在明显的安慰剂效应。

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