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抗酸治疗与特发性肺纤维化的疾病进展:三项随机对照试验数据分析。

Anti-acid treatment and disease progression in idiopathic pulmonary fibrosis: an analysis of data from three randomised controlled trials.

机构信息

Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Duke Clinical Research Institute, Durham, NC, USA.

出版信息

Lancet Respir Med. 2013 Jul;1(5):369-76. doi: 10.1016/S2213-2600(13)70105-X. Epub 2013 Jun 14.

Abstract

BACKGROUND

Abnormal acid gastro-oesophageal reflux is common in patients with idiopathic pulmonary fibrosis (IPF) and is considered a risk factor for development of IPF. Retrospective studies have shown improved outcomes in patients given anti-acid treatment. The aim of this study was to investigate the association between anti-acid treatment and disease progression in IPF.

METHODS

In an analysis of data from three randomised controlled trials, we identified patients with IPF assigned to receive placebo. Case report forms had been designed to prospectively obtain data about diagnosis and treatment of abnormal acid gastro-oesophageal reflux in each trial. The primary outcome was estimated change in forced vital capacity (FVC) at 30 weeks (mean follow-up) in patients who were and were not using a proton-pump inhibitor or histamine-receptor-2 (H2) blocker.

FINDINGS

Of the 242 patients randomly assigned to the placebo groups of the three trials, 124 (51%) were taking a proton-pump inhibitor or H2 blocker at enrolment. After adjustment for sex, baseline FVC as a percentage of predicted, and baseline diffusing capacity of the lung for carbon monoxide as a percentage of predicted, patients taking anti-acid treatment at baseline had a smaller decrease in FVC at 30 weeks (-0·06 L, 95% CI -0·11 to -0·01) than did those not taking anti-acid treatment (-0·12 L, -0·17 to -0·08; difference 0·07 L, 95% CI 0-0·14; p=0·05).

INTERPRETATION

Anti-acid treatment could be beneficial in patients with IPF, and abnormal acid gastro-oesophageal reflux seems to contribute to disease progression. Controlled clinical trials of anti-acid treatments are now needed.

FUNDING

National Institutes of Health.

摘要

背景

特发性肺纤维化(IPF)患者常出现胃酸胃食管反流异常,且被认为是 IPF 发病的一个危险因素。回顾性研究显示,给予抗酸治疗可改善患者预后。本研究旨在探究抗酸治疗与 IPF 疾病进展的相关性。

方法

我们对三项随机对照试验的数据进行分析,纳入了接受安慰剂治疗的 IPF 患者。病例报告表设计用于前瞻性获取每个试验中异常胃酸胃食管反流的诊断和治疗数据。主要结局为接受或未接受质子泵抑制剂或组胺受体 2(H2)阻滞剂治疗的患者在 30 周(平均随访时间)时用力肺活量(FVC)的估计变化。

结果

在三项试验的安慰剂组中,242 例患者随机分组,其中 124 例(51%)入组时正在服用质子泵抑制剂或 H2 阻滞剂。在校正了性别、基线 FVC 占预计值的百分比以及基线一氧化碳弥散量占预计值的百分比后,基线时接受抗酸治疗的患者 FVC 在 30 周时的下降幅度小于未接受抗酸治疗的患者(-0.06 L,95%CI -0.11 至 -0.01;差值 0.07 L,95%CI 0.01~0.14;p=0.05)。

结论

抗酸治疗可能对 IPF 患者有益,异常胃酸胃食管反流似乎与疾病进展有关。目前需要开展抗酸治疗的对照临床试验。

资助

美国国立卫生研究院。

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