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评估特发性肺纤维化多项试验中的治疗效果。

Assessing the treatment effect from multiple trials in idiopathic pulmonary fibrosis.

机构信息

Centre for Rare Lung Disease, Policlinico University Hospital, Modena, Italy.

出版信息

Eur Respir Rev. 2012 Jun 1;21(124):147-51. doi: 10.1183/09059180.00000912.

Abstract

The magnitude of treatment effect can be assessed by a number of methods. One method of collectively analysing data is that used by the Cochrane Collaboration. Their systematic reviews identify, analyse and present research-based evidence in an accessible format. These reviews may contain meta-analyses combining data from multiple studies to provide robust evaluations of overall treatment effects. In 2003, Cochrane reviews of data for treatment with corticosteroids in idiopathic pulmonary fibrosis (IPF) found no evidence supporting their use; similarly, reviews of immunomodulatory agents found very little evidence to support their use. A recent update of these Cochrane reviews failed to identify any evidence supporting the use of corticosteroids in IPF; however, a review of non-steroid agents in the treatment of IPF identified 15 clinical trials suitable for analysis. Two trials of interferon-γ-1b were combined, and no treatment effect was observed in terms of survival. Two Japanese trials of treatment with pirfenidone were combined, and a positive effect of pirfenidone on pulmonary function decline was observed. Meta-analysis of three phase III studies suggested that pirfenidone significantly increased progression-free survival by 30%. The findings of this systematic review, although not presenting new original data, together with an acceptable safety profile, suggest that pirfenidone may have a role in IPF treatment.

摘要

治疗效果的大小可以通过多种方法来评估。一种集体分析数据的方法是由 Cochrane 协作组织使用的方法。他们的系统评价以易于理解的格式确定、分析和呈现基于研究的证据。这些综述可能包含对来自多个研究的数据进行的荟萃分析,以对整体治疗效果进行稳健的评估。2003 年,Cochrane 对特发性肺纤维化 (IPF) 皮质类固醇治疗数据的综述发现,没有证据支持其使用;同样,对免疫调节剂的综述发现,很少有证据支持其使用。最近对这些 Cochrane 综述的更新没有发现任何支持在 IPF 中使用皮质类固醇的证据;然而,一项关于非甾体药物治疗 IPF 的综述确定了 15 项适合分析的临床试验。两项干扰素-γ-1b 的试验被合并,在生存方面没有观察到治疗效果。两项日本的吡非尼酮治疗试验被合并,吡非尼酮对肺功能下降有积极影响。三项 III 期研究的荟萃分析表明,吡非尼酮显著增加无进展生存期 30%。这项系统评价的结果,尽管没有提出新的原始数据,并且具有可接受的安全性特征,表明吡非尼酮可能在 IPF 治疗中具有作用。

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