Efficacy and Safety of Sitafloxacin-Containing Regimen for Improved Treatment of Nontuberculous Mycobacterial Lung Disease: A Multi-Center Retrospective Study

ABSTRACT Objectives To evaluate the efficacy and safety of sitafloxacin-containing regimens versus non-sitafloxacin therapy in patients with nontuberculous mycobacterial (NTM) pulmonary disease, focusing on sputum/BALF conversion rate, time of sputum/BALF culture conversion and radiographic improvement. Methods This retrospective cohort study analyzed 149 adults (76 control group vs. 73 sitafloxacin group) with NTM pulmonary disease treated between 2021 to 2024. Inclusion criteria: (1) Sitafloxacin group: ≥ 3 months of sitafloxacin-based therapy; (2) Both groups: Confirmed diagnosis of NTM pulmonary disease and age ≥ 18 years old. Exclusion criteria: extrapulmonary/disseminated NTM, HIV, active tuberculosis, or incomplete clinical data. Primary endpoint: culture conversion rate and time to culture conversion. Secondary endpoints: radiographic improvement and adverse events (AEs). Results The sitafloxacin group demonstrated significantly higher conversion rate (53.8% vs. 22.1%, P ˂ 0.001) and faster culture conversion than the control group without sitafloxacin (median 195 vs. 292 days, P ˂ 0.001). Radiographic improvement was more frequent with the sitafloxacin group (54.5% vs. 36.1%, P = 0.046). Compared to the control group, the sitafloxacin group exhibited no significant adverse events. Conclusions Sitafloxacin-based regimens accelerate microbiological clearance and promote radiographic healing in NTM pulmonary disease with good safety, positioning it as a viable drug for improved treatment of NTM infections.