Abstract

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

Highlights

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

  • Search strategy Two investigators conducted computer search of Cochrane Library, PubMed, EMBase, China national knowledge infrastructure (CNKI), Chinese Biomedical Literature Database and Wanfang Database for randomized controlled trials (RCT) on the applications of pirfenidone in the treatment of IPF, the search time limit was from the establishment of each database to March 15, 2021

  • Inclusion and exclusion criteria The inclusion criteria for RCTs in this meta-analysis were: 1 RCT design on the pirfenidone use in the treatment of patients with IPF; 2 all patients met the diagnostic criteria for IPF, and the experimental group was treated with pirfenidone and other clinical treatments were the same as the control group, the control group adopted conventional treatment methods using placebo or blank control, and the treatment duration was at least 3 months; 3 evaluation indicators were reported such as disease progression-free survival (PFS), vital capacity (VC), forced vital capacity (FVC), adverse reactions, etc

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Summary

Introduction

It is necessary to systematically evaluate the efficacy and adverse reactions of pirfenidone in the treatment of patients with idiopathic pulmonary fibrosis (IPF). It has been reported that the annual incidence of IPF in Taiwan from 2000 to 2007 was 2.8 per 100,000 to 6.4 per 100,000, with the highest incidence in. The previous treatment of IPF often included hormones and immunosuppressive agents, with the goal of reducing inflammation as much as possible and delaying the progression of inflammation to fibrosis [7, 8]. In view of the current limited clinical application report data of pirfenidone and the inconsistent results of related studies for technical limitations of randomized controlled trials (RCTs), this present meta-analysis aimed to systematically evaluate the efficacy and safety of pirfenidone in the treatment of IPF, to provide evidence to the IPF treatment and clinical drug use

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