To explore the clinical effect and safety of Qijia Lifei Capsule（芪甲利肺胶囊）combined with entecavir in the treatment of primary positive pulmonary tuberculosis complicated with hepatitis B.

A total of 102 patients with newly treated bacteriopositive pulmonary tuberculosis combined with hepatitis B（admitted from January 2022 to November 2022）were included in this study. According to the random number table method，they were divided into observation group and control group，with 51 patients in each group，including 1 patient felling out in the control group and 2 patients felling out in the observation group. The control group（50 cases）were given entecavir treatment. The observation group（49 cases）were treated with entecavir combined with Qijia Lifei Capsule，and the data of each group［efficacy，changes of TCM symptom scores（afternoon tidal fever，shortness of breath and low voice，night sweats and spontaneous sweating，phlegm，cough，etc.），changes of inflammatory response indexes and immune indexes，liver function indexes and incidence of liver function damage and improvement rate of quality of life］was observed.

Compared with that in the observation group，the total effective rate of the control group was lower（P<0.05）. Before treatment，TCM syndrome scores（afternoon tidal fever，shortness of breath and low voice，night sweats and spontaneous sweating，phlegm，cough，etc.），the levels of tumor necrosis factor-α（TNF-α），C-reactive protein（CRP），white blood cell count（WBC），immunoglobulin A/G/M（IgA/IgG/IgM），serum total bilirubin（TBiL），aspartate aminotransferase（AST），glutamyl transpeptidase（GGT），alkaline phosphatase（ALP），alanine aminotransferase（ALT）and other liver function indexeswere not significant（P>0.05）. After treatment，TCM syndrome scores（afternoon tidal fever，shortness of breath and low voice，nightsweats and spontaneous sweating，phlegm，cough，etc.），the levels of TNF-α，CRP，WBC，IgA/IgG/IgM，TBiL，AST，GGT，ALP，ALT and other indexes in observation group were better than those in the control group（P<0.05）. Compared with that in the controlgroup，the incidence of liver function impairmentwas lower in the observation group after treatment，and the improvement rate of life quality was higher（P<0.05）.

Qijia Lifei Capsule combined with entecavir has significant clinical effect in the treatment of primary bacteriopositive pulmonary tuberculosis complicated with hepatitis B，which can better improve the condition，immune function and quality of life of the patients to a certain extent and reduce the liver damage，and the treatment is safe and reliable.