Abstract：Objective：To observe the clinical effects of Youfuning Capsules combined with 2HRZE/4HR regimen on newly active pulmonary tuberculosis. Methods： A total of 140 cases with newly active pulmonary tuberculosis were divided into the control group and the treatment group according to the random number table method， with 70 cases in each group. The control group was given 2HRZE/4HR regimen，and the treatment group was additionally given Youfuning Capsules orally based on the treatment of the control group， and the two groups were treated continuously for six months. The negative conversion rate of sputum and the absorption improvement rate of lung lesions were compared between the two groups. The levels of forced vital capacity (FVC)， maximum peak expiratory flow (PEF)， forced expiratory volume in one second (FEV1)，interferon-γ (IFN-γ)，interleukin (IL)-4，IL-17 and IL-10 before and after treatment were compared between the two groups. The levels of regulatory T cells (Treg)，helper T cells 1 (Th1)，helper T cells 2 (Th2)，helper T cells 17 (Th17) and Th1/Th2 and Th17/Treg in the two groups were compared， and the clinical effects and the incidence of adverse reactions in the two groups were evaluated. Results： After treatment， the total effective rate， negative conversion rate of sputum and absorption improvement rate of lung lesions in the treatment group were 85.71%， 85.71% and 81.43%， respectively， while the total effective rate， negative conversion rate of sputum and absorption improvement rate of lung lesions in the control group were 67.14%， 67.14% and 57.14%， respectively； the difference was statistically significant (P＜0.05). After treatment，the levels of FEV1，FVC，PEF，IFN-γ， IL-17， Th1， Th17 and Th1/Th2 and Th17/Treg in the two groups were enhanced when compared with those before treatment (P＜0.05)， and the above levels in the treatment group were higher than those in the control group (P＜0.05). The levels of IL-10 and Treg in both groups were decreased when compared with those before treatment (P＜0.05)，and the levels of IL-10 and Treg in the treatment group were lower than those in the control group (P＜0.05). There was no significant difference in the comparison of IL-4， Th2 levels and incidence of adverse reactions between the two groups before and after treatment (P＞0.05). Conclusion：Youfuning Capsules combined with 2HRZE/4HR regimen has a significant clinical effect on the treatment of newly active pulmonary tuberculosis，which can improve lung function，promote lung lesion absorption， reduce inflammatory responses， and regulate Th1/Th2 and Th17/Treg immune imbalance， with great safety.