Low-dose Pirfenidone Combined With Glucocorticoid For Interstitial Lung Disease-The Real World

Objective:To investigate the efficacy and safety of low-dose Pirfenidone combined with glucocorticoid in the treatment of interstitial lung disease.Methods:This study was a retrospective,multicenter clinical research.The clinical data of patients with interstitial lung disease(ILD)diagnosed in two general hospitals,Qilu Hospital of Shandong University and Affiliated Hospital of Shandong University of traditional Chinese medicine,from October 2017 to October 2019 were collected.The patients were treated with low-dose Pirfenidone and glucocorticoid for 12 months and were followed up for 12 months.To evaluate the effect of treatment by analyzing the change of symptom scores during 6 months.The relationships between sex,age,smoking history,FVC%,DLco%,disease type and disease progression were also analyzed.Adverse drug reactions(ADRS)and drug tolerance were collected in all patientsResults:271 patients were included in this study,including 134 patients with IPF,57 patients with CTD-ILD,46 patients with IPAF,and 34 patients with unclassified HP.During the follow-up period,24 patients(8.86%)died.250 patients completed 3 months follow-up,214 patients completed 6 months follow-up,and 152 patients completed 12 months follow-up.mMRC,cough scores were significantly decreased 3 months and 6 months after treatment(P<0.05).The daytime cough score in the sixth month was significantly lower than that in the third month(P<0.001).There was no significant difference in mMRC score and night cough score between the sixth month and the third month after treatment(P>0.05).In the third month after treatment,250 patients completed the follow-up.Disease progression was assessed in 20%of patients and disease stability in 80%patients.In the sixth month after therapy,214 patients were followed up,17.76%were progressive and 82.24%were stable.152 patients were followed up in the twelfth month,21.71%were progressive and 78.29%were stable.The risk of disease progression in IPF is 2.98 times than that of non-IPF patients after 3 months of treatment.The risk of disease progression in smokers is 2.50 times than that in non-smokers.Each 1%increase in DLco accounted for a 5%reduction in the risk of disease progression.124 patients developed adverse reactions related to Pirfenidone,the most common of which were digestive symptoms(36.53%)and skin rash(12.18%).Glucocorticoid-related adverse reactions occurred in 111 patients and hormone face were most common(38.01%).The incidence of glucose and lipid metabolic disorders and infection were 8.49%and 8.12%,respectively.Drug interruption occured in 24 cases(8.86%),the dosage was adjusted in 56 patients(20.66%),and the drug discontinuation occured in 53 cases(19.56%).17 patients(6.27%)stopped taking glucocorticoid and 36 patients(13.28%)stopped taking pirfenidone due to drug related adverse reactions.Conclusions:Low-dose Pirfenidone combined with glucocorticoid can relieve cough and dyspnea in patients with interstitial lung disease.Adverse reactions related to Pirfenidone and Glucocorticoid were well tolerated in most patients.The treatment is worthy of clinical application.