Efficacy of pirfenidone for the treatment of pulmonary fibrosis An updated systematic review protocol of randomized controlled trial

Abstract

Background: This study will systematically assess the efficacy and safety of pirfenidone for the treatment of patients with pulmonary fibrosis (PF). Methods: We will search potential records from following literature sources from their inceptions to the present without language, and publication status limitations: Cochrane Library, EMBASE, PUBMED, the Cumulative Index to Nursing and Allied Health Literature, the Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. In addition, we also search grey literature sources, such as dissertations, conference proceedings, as well as the reference lists of included studies. All randomized controlled trials related to the pirfenidone for treating PF will be included. All the process of study selection, data extraction, and methodological evaluation will be carried out by 2 authors independently. The primary outcome comprises of all-cause-mortality, and lung function status, as measured by forced vital capacity. The secondary outcomes consist of 6-minute walk distance, progression-free survival, dyspnea, acute exacerbation, quality of life, and adverse events. Whenever possible, all results data will be pooled and meta-analysis will be performed. Results: This study will systematically assess the efficacy and safety of pirfenidone for the treatment of patients with PF. Conclusion: The findings of the present study will summarize most recent evidence of pirfenidone for PF. Ethics and dissemination: No individual data will be analyzed in this study, thus, no research ethics approval is required in this study. The findings of this study are expected to be disseminated in a peer-reviewed journal or conference presentations. PROSPERO registration number: PROSPERO CRD42019126958. Abbreviations: CIs = confidence intervals, PF = pulmonary fibrosis.