A Single-Center Real-World Study of Anti-Fibrotic Therapy for Fibrotic Interstitial Lung Disease
Objective:To analyze the efficacy and safety of anti-fibrosis therapy in patients with fibrotic interstitial lung disease(FILD)in the real world and the risk factors of disease progression.Methods:Patients who were first diagnosed with FILD and started oral pirfenidone or nintedanib anti-fibrosis treatment were included.The patients were followed up for 2 years.The clinical data of the patients were collected and the baseline characteristics were analyzed,including gender,age,smoking history,basic lung function[forced vital capacity(FVC),diffusing capacity of the lungs for carbon monoxide(DLCO)],complications and shared drugs.Lung function was recorded at the beginning of anti-fibrosis,12 months and 24 months after anti-fibrosis treatment,and the annual decline rates of FVC and DLCO were analyzed.Drug-related adverse reactions and tolerance were collected.Logistic regression model was established to analyze the relationship between clinical variables and disease progression.Results:After 12 months of anti-fibrosis treatment,there was no significant difference in FVC and DLCO between 167 patients with FILD and before treatment(P>0.05).The FVC and DLCO of 67 patients with FILD decreased after 24 months of anti-fibrosis treatment,but there was no statistical difference(P>0.05).A total of 98 adverse events occurred in 110 patients treated with pirfenidone,and 70 adverse events occurred in 57 patients treated with nintedanib.Only some adverse events led to drug withdrawal.The most common side effect of both anti-fibrosis drugs was diarrhea.Compared with pirfenidone,the discontinuation rate of nintedanib due to adverse events was significantly higher(P<0.05).Logistic regression analysis showed that the risk factors of disease progression within 12 months after anti-fibrosis treatment were smoking and patients with idiopathic pulmonary fibrosis(IPF),while DLCO was a protective factor for disease progression.Conclusion:In the real world,anti-fibrosis therapy can maintain the stability of FVC and DLCO in FILD patients,and the adverse reactions related to anti-fibrosis drugs can be tolerated with high safety.Smoking and IPF patients are more prone to disease progression,and higher DLCO is a protective factor for disease progression in FILD patients.