Efficacy Of Pirfenidone Combined With Hormones In Progressive Pulmonary Fibrosis

Objective:To study the efficacy and safety of pirfenidone combined with hormone in patients with progressive pulmonary fibrosis(PPF),and to provide the basis for better treatment of patients with progressive pulmonary fibrosis.Methods:The study was a retrospective clinical study.Clinical data of patients clinically diagnosed with interstitial pulmonary disease in Jining First People’s Hospital from June 2019 to June 2022 were collected,and patients meeting the diagnostic criteria for PPF treated with hormones and hormones combined with pifenidone were selected according to the clinical diagnosis and treatment guidelines for PPF formulated.Clinical data of patients were collected,including:gender,age,first symptoms,complications,drug sharing,smoking history,occupational exposure history,Pa O2,lung function,chest CT signs,etc.The differences in clinical characteristics between the control group receiving hormone therapy alone and the experimental group receiving pirfenidone combined with hormone therapy were analyzed,and the difference in efficacy between the two groups after 3 months and6 months of treatment was observed.The main efficacy observation indexes included:FVC accounted for the predicted value%,D_Lco accounted for the predicted value%.Secondary outcome measures:changes of cough symptom score and m MRC score.In addition,the study also collected the drug-related adverse reactions and drug tolerance of all patients during drug treatment.Results:1.A total of 151 patients with clinically diagnosed progressive pulmonary fibrosis were selected according to the inclusion and exclusion criteria.The disease types included 83 cases(54.9%)of unclassified IIP,41 cases(27.2%)of CD-ILD and 27 cases(17.9%)of IPAF.The disease types of CD-ILD included UCTD16 cases,RA 15 cases,DM/PM 8 cases,SS 1 case and SLE1 case.2.During the study,16 cases(10.6%)were lost to follow-up and 17cases(11.3%)died.The causes of death included pulmonary infection in 6cases,respiratory failure in 2 cases,heart failure in 2 cases,and other causes in 7 cases.The study eventually included 118 patients.3.Among the 118 patients,70 patients with progressive interstitial lung disease received hormone therapy(control group),and 48 patients received pirfenidone combined hormone therapy(experimental group).There were no significant differences in the clinical data collected between the two groups,including gender,age,first symptom,comorbidities,common drug,smoking history,occupational exposure history and Pa O2,imaging features(all P>0.05).4.There was no significant difference between the two groups in FVC and D_Lco before treatment(P=0.5,P=0.31).After treatment,the percentage of FVC in the control group was significantly different in 3months and 6 months compared with that before treatment(P<0.05),showing a decreasing trend.There was no statistical difference in FVC%in March compared with before treatment(P=0.107),but there was statistical difference in 6 months compared with before treatment(P<0.05),showing a downward trend.The difference of FVC in%of predicted value before and after treatment between 2 groups was statistically significant in 3 months and 6 months(P<0.05);After treatment,the percentage of D_Lco in the control group was significantly lower than that before treatment in 3 months and 6 months(P<0.05).Compared with before treatment,the proportion of D_Lco(%)in 3months and 6 months of experimental group was statistically different(P<0.05),and decreased.The difference of D_Lco in%of predicted value before and after treatment between 2 groups was statistically significant in 3 months and 6 months(P<0.05).The decrease trend of D_Lco%of predicted value in experimental group is slightly gentle.5.There were no significant differences in the distribution of secondary efficacy observation indexes daytime cough score,nighttime cough score and m MRC score between the two groups before treatment(P=0.372,P=0.290,P=0.645);After treatment,there were no statistical differences in the distribution of daytime cough score and nighttime cough score in the control group compared with before treatment(P=0.683,P=0.480).After treatment,there were statistical differences in the distribution of daytime cough score and nighttime cough score in the test group compared with before treatment(P<0.05).There were statistical differences in the distribution of daytime and nighttime cough scores between the two groups after treatment(P<0.05).There was no statistical difference in m MRC score distribution between the two groups before and after treatment(P=0.206,P=0.695),and no statistical difference in m MRC score distribution between the two groups after treatment(P=0.297).6.Among 48 patients in the hormone combined with pirfenidone group(experimental group),32 cases(66.7%)had adverse events,all of which were mild or moderate.In the control group,41(58.6%)of 70patients had adverse events,all of which were hormone-related adverse reactions.No patients in experimental group and control group were interrupted due to serious adverse reactions.Conclusion:Pirfenidone combined with hormone can delay the decline of lung function in patients with progressive pulmonary fibrosis and improve respiratory symptoms and quality of life in patients to a certain extent.Pirfenidone combined with hormone-related adverse drug reactions is controllable and safe.