To evaluate the clinical efficacy and safety of stepwise integrated traditional Chinese and Western medicine therapy versus conventional Western medicine alone in patients with severe pulmonary tuberculosis complicated with respiratory failure.

A prospective randomized controlled trial was conducted in 80 patients with severe pulmonary tuberculosis complicated by respiratory failure admitted to Shaanxi Provincial Tuberculosis Prevention and Treatment Hospital from August 2022 to August 2024, including 46 males and 34 females, aged 31-78 years [(56.35±9.58) years]. Patients were randomly assigned by a random number table method to either the control group or the observation group, with 40 patients in each group. The control group received conventional Western medicine treatment, while the observation group received stepwise integrated traditional Chinese and Western medicine treatment on the basis of the same Western medicine regimen. The study compared the clinical efficacy, time to resolution of clinical symptoms, pulmonary function parameters [forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF)], inflammatory cytokines [interferon-gamma (IFN-γ), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α)], and the incidence of adverse drug reactions between the two groups.

The total clinical effective rate in the observation group was significantly higher than that in the control group (P<0.05). The time to resolution of clinical symptoms (including fever, cough, dyspnea, etc.) in the observation group was significantly shorter than that in the control group (P<0.05). After treatment, FEV1, FVC and PEF were significantly increased in both groups compared with baseline values, and the increases in the observation group were significantly greater than those in the control group (P<0.05), the serum levels of IFN-γ, IL-6 and TNF-α were significantly decreased in both groups, and the decreases in the observation group were significantly greater than those in the control group (P<0.05). There was no statistically significant difference in the incidence of adverse drug reactions between the two groups (P>0.05), and no severe adverse reactions were observed in either group.

Stepwise integrated traditional Chinese and Western medicine therapy can significantly reduce systemic inflammatory response, effectively relieve clinical symptoms, and improve pulmonary function in patients with severe pulmonary tuberculosis complicated with respiratory failure, with no increase in adverse drug reactions, suggesting a favorable efficacy and safety profile.