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吡非尼酮治疗特发性肺纤维化患者的疗效和安全性:系统评价和随机对照试验的荟萃分析。

Efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis patients: a systematic review and meta-analysis of randomised controlled trials.

机构信息

Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.

Department of Geriatrics, Henan Provincial People's Hospital, Zhengzhou, China.

出版信息

BMJ Open. 2021 Dec 31;11(12):e050004. doi: 10.1136/bmjopen-2021-050004.

DOI:10.1136/bmjopen-2021-050004
PMID:34972762
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8720994/
Abstract

OBJECTIVES

Idiopathic pulmonary fibrosis (IPF) has been defined as a distinctive type of chronic fibrotic disease, characterised by a progressive decline in lung function and a common histological pattern of interstitial pneumonia. To analyse the efficacy and safety of pirfenidone in the treatment of IPF, a systematic review and meta-analysis was performed.

DESIGN

This is a meta-analysis study.

PARTICIPANTS

Patients were diagnosed as IPF.

INTERVENTIONS

Use of pirfenidone.

PRIMARY AND SECONDARY OUTCOME

Progression-free survival (PFS), acute exacerbation and worsening of IPF and Impact on adverse events.

MEASURES

The inverse variance method for the random-effects model was used to summarise the dichotomous outcomes, risk ratios and 95% CIs.

RESULTS

A total of 9 randomised controlled trials with 1011 participants receiving pirfenidone and 912 controls receiving placebo were summarised. The pooled result suggested a statistically significant difference inall-cause mortality after pirfenidone use, with a summarised relative ratio of 0.51 (p<0.01). Longer PFS was observed in patients receiving pirfenidone compared with those who were given placebo (p<0.01). The IPF groups presented a high incidence of adverse events with a pooled relative ratio of 3.89 (p<0.01).

CONCLUSIONS

Pirfenidone can provide survival benefit for patients with IPF. Pirfenidone treatment was also associated with a longer PFS, a lower incidence of acute exacerbation and worsening of IPF.

摘要

目的

特发性肺纤维化(IPF)已被定义为一种独特的慢性纤维化疾病,其特征是肺功能进行性下降和间质性肺炎的常见组织学模式。为了分析吡非尼酮治疗特发性肺纤维化的疗效和安全性,进行了系统评价和荟萃分析。

设计

这是一项荟萃分析研究。

参与者

患者被诊断为特发性肺纤维化。

干预措施

使用吡非尼酮。

主要和次要结果

无进展生存期(PFS)、急性加重和特发性肺纤维化恶化以及对不良事件的影响。

测量

采用随机效应模型的逆方差法对二分类结局进行汇总,计算风险比和 95%置信区间。

结果

共纳入 9 项随机对照试验,1011 例患者接受吡非尼酮治疗,912 例患者接受安慰剂治疗。汇总结果表明,使用吡非尼酮后全因死亡率存在统计学差异,汇总相对比为 0.51(p<0.01)。与安慰剂组相比,接受吡非尼酮治疗的患者 PFS 更长(p<0.01)。特发性肺纤维化组不良事件发生率较高,汇总相对比为 3.89(p<0.01)。

结论

吡非尼酮可为特发性肺纤维化患者提供生存获益。吡非尼酮治疗还与更长的 PFS、更低的急性加重和特发性肺纤维化恶化发生率相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/c7da686ee45e/bmjopen-2021-050004f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/885686aaf572/bmjopen-2021-050004f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/70c09337f70c/bmjopen-2021-050004f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/e12a6b89d735/bmjopen-2021-050004f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/c7da686ee45e/bmjopen-2021-050004f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/885686aaf572/bmjopen-2021-050004f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/70c09337f70c/bmjopen-2021-050004f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/e12a6b89d735/bmjopen-2021-050004f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/91d6/8720994/c7da686ee45e/bmjopen-2021-050004f04.jpg

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