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吡非尼酮治疗特发性肺纤维化的疗效和安全性:一项荟萃分析和系统评价。

The effects and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis: a meta-analysis and systematic review.

机构信息

Department of Respiratory and Critical Care Medicine, Qingdao Hospital of Traditional Chinese Medicine(Qingdao Hiser Hospital), No.4 Renmin Road, Shibei District, Qingdao, 266000, Shandong Province, China.

Department of General Practice, Qingdao Hospital of Traditional Chinese Medicine(Qingdao Hiser hospital), Qingdao, China.

出版信息

Eur J Med Res. 2021 Oct 30;26(1):129. doi: 10.1186/s40001-021-00601-y.

Abstract

BACKGROUND

It is necessary to systematically evaluate the efficacy and adverse reactions of pirfenidone in the treatment of patients with idiopathic pulmonary fibrosis (IPF).

METHODS

Pubmed et al. databases were searched up to March 15, 2021 for randomized controlled trials (RCT) of pirfenidone in the treatment of IPF. Two authors collected and compared the indicators including progression-free survival (PFS), vital capacity (VC), forced vital capacity (FVC), and adverse reactions. RevMan 5.3 software and Stata 15.0 software were used for meta-analysis.

RESULTS

A total of 8 reports with 9 RCTs involving 1824 IPF patients were included. Meta-analysis results showed that compared with the control group, pirfenidone could prolong the PFS phase of IPF patients (HR = 0.65, 95% CI 0.55 ~ 0.76, P < 0.001), slow down the VC of IPF patients (SMD = 0.43, 95% CI 0.21 ~ 0.66, P < 0.001), and decrease FVC (SMD = 0.31, 95% CI 0.14 ~ 0.48, P < 0.001). The main adverse reactions of pirfenidone were gastrointestinal reactions, photosensitivity and skin rashes.

CONCLUSION

Pirfenidone is beneficial to prolong the PFS of IPF patients, improve lung function, and it is safe for clinical use. However, more high-quality RCTs are still needed to provide reliable evidence for the treatment of IPF.

摘要

背景

系统评价吡非尼酮治疗特发性肺纤维化(IPF)的疗效和不良反应十分必要。

方法

检索 Pubmed 等数据库,截至 2021 年 3 月 15 日,纳入吡非尼酮治疗 IPF 的随机对照试验(RCT)。由 2 位作者提取并比较无进展生存期(PFS)、肺活量(VC)、用力肺活量(FVC)及不良反应等指标。采用 RevMan 5.3 软件和 Stata 15.0 软件进行 Meta 分析。

结果

共纳入 8 篇文献,9 项 RCT,共纳入 1824 例 IPF 患者。Meta 分析结果显示,与对照组相比,吡非尼酮可延长 IPF 患者的 PFS 期(HR=0.65,95%CI 0.550.76,P<0.001),减缓 IPF 患者的 VC(SMD=0.43,95%CI 0.210.66,P<0.001),降低 FVC(SMD=0.31,95%CI 0.14~0.48,P<0.001)。吡非尼酮的主要不良反应为胃肠道反应、光敏性和皮疹。

结论

吡非尼酮有利于延长 IPF 患者的 PFS,改善肺功能,临床使用安全。但仍需要更多高质量 RCT 提供可靠证据,以指导 IPF 的治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f173/8557612/0d0020f3c537/40001_2021_601_Fig1_HTML.jpg

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