PT - JOURNAL ARTICLE AU - Zhang, Yiru AU - Fu, Hongxin AU - Zhang, Chenxia AU - Xu, Bihan AU - Bi, Kefan AU - Yang, Meifang AU - Yu, Haiying AU - Li, Yongtao AU - Guo, Jing AU - Wu, Wei AU - Xu, Kaijin AU - Zhang, Ying TI - Efficacy and Safety of Sitafloxacin-Containing Regimen for Improved Treatment of Nontuberculous Mycobacterial Lung Disease: A Multi-Center Retrospective Study AID - 10.64898/2026.01.13.26343918 DP - 2026 Jan 01 TA - medRxiv PG - 2026.01.13.26343918 4099 - http://medrxiv.org/content/early/2026/01/16/2026.01.13.26343918.short 4100 - http://medrxiv.org/content/early/2026/01/16/2026.01.13.26343918.full AB - 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.Competing Interest StatementThe authors have declared no competing interest.Funding StatementNational Infectious Disease Medical Center(B2022011-1);Jinan Microecological Biomedicine Shandong Laboratory project (JNL-2022050B);Pioneer and Leading Goose R&D Program of Zhejiang (2025C04013)Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:Ethics committee of the First Affiliated Hospital, Zhejiang University School of Medicine gave ethical approval for this work (Approval number: 2025B-IIT Ethics Approval No. 0666).I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.YesAll data produced in the present work are contained in the manuscript