OBJECTIVE To explore the treatment effect of Bailing tablet on patients with connective tissue disease associated interstitial lung disease(CTD-ILD) and its effects on cytokines and T-lymphocyte subsets of patients, and explore its possible mechanism.

METHODS Eighty cases of CTD-ILD patients were randomly divided into control and treatment group. Patients in control group(n=40) were treated with regular treatment, and on the basis of the control group, patients in treatment group(n=40) were treated with Bailing tablets for 3 months. The main outcome measures were the traditional Chinese medicine(TCM) syndrome score, asthma control questionnaire(ACQ) score, overall efficacy, 6-minute walking distance(6MWD), T-lymphocyte subsets(CD4⁺%, CD8⁺%, CD4⁺/CD8⁺T cell ratio), and cytokines(IL-4, IL-10, IFN-γ, TNF-α) levels.

RESULTS After treatment, the ACQ and TCM score in treatment group were lower than those in control group(P<0.05), the overall efficacy and 6MWD in treatment group were higher than those in control group(P<0.05). CD4⁺%, CD8⁺%, IL-4 and TNF-α in treatment group were lower than those in control group(P<0.05). The ratio of CD4⁺/CD8⁺ and the levels of IFN-γ and IL-10 in the treatment group were significant higher than those before treatment, and the increase was more than those in the control group(P<0.05). There were no significant abnormalities in safety indexes and no adverse events in the 2 groups before and after treatment.

CONCLUSION Bailing tablet is effective in the adjuvant treatment of CTD-ILD patients, which can significantly improve clinical symptoms, contribute to the recovery of patients’ cardiopulmonary function, regulate T-lymphocyte subpopulation and related cytokines, reduce inflammatory response, and inhibit the progression of pulmonary fibrosis.