Clinical efficacy study of Fuzheng Huayu Formula combined with pirfenidone in treating idiopathic pulmonary fibrosis
Objective:To explore the clinical efficacy of Fuzheng Huayu Formula in the treatment of idiopathic pulmonary fibrosis(IPF)with type of blood stasis due to qi deficiency.Methods:A total of 80 IPF patients with type of blood stasis due to qi deficiency were randoinly divided into control group and treatment group,with 40 cases in each group.The treatment group was treated with pirfenidone combined with Fuzheng Huayu Formula,and the control group was treated with pirfenidone combined with placebo.The two groups were treated for 3 months,and the differences of traditional Chinese medicine(TCM)syndrome symptom scores,dyspnea indexes(Borg score),chest imaging changes,lung function changes,inflammation and immune function related indicators,and expression levels of pulmonary fibrosis related cytokines before and after treatment were compared between the two groups.Results:①The total effective rate of the control group and the treatment group was 77.5%and 90%,and the difference between the two groups was statistically significant(P<0.05).②Compared with the control group,CD4+/CD8+T lymphocytes ratio and interleukin(IL)-10 level in the treatment group were significantly increased after treatment(P<0.05),and the levels of IL-4,IL-6,IL-17,matrix metalloproteinase-2(MMP-2),tissue metalloproteinase-1(TIMP-1),connective tissue growth factor(CTGF),platelet-derived growth factor(PDGF)transforming growth factor(TGF)-β1 in the treatment group were significantly decreased(P<0.05).And there was no significant difference in tumor necrosis factor-α(TNF-α),interferon-γ(INF-γ)and IL-2 levels between the two groups after treatment(P>0.05).Conclusion:Fuzheng Huayu Formula has synergistic effect with pirfenidone in the treatment of IPF.The combination of both drugs was more effective than pirfenidone alone.The mechanism may be related to inhibition of inflammatory factors and fibrosis-related cytokines,and regulation of the differentiation direction of CD4+T lymphocyte subset,in which TGF-β/Smads signaling pathway may play a key role.