Abstract:Objective To evaluate the efficacy and safety of bedaquiline (BDQ-containing) regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB)/extensively drug-resistant tuberculosis (XDR-TB), and provide clinical data for the use of BDQ in drug-resistant TB patients in China. Methods Clinical data of tuberculosis patients receiving BDQ-containing regimen in a hospital from March 2018 to September 2019 were collected, efficacy and adverse reactions during treatment were analyzed. Results Sixty-nine patients were enrolled, 10 (14.5%) of whom had XDR-TB, 63 cases (91.3%) completed 24 weeks of BDQ-containing treatment, two patients died of cardiac arrest and respiratory failure during treatment, three were transferred, one was lost to follow-up, 39 patients (56.5%) reported 108 times of adverse events, most adverse events were classified as grade 1 or grade 2 (75 times, 69.4%), and the most common grade 3 and above adverse events were QT interval prolongation. 29 cases (46.0%) were positive in sputum culture at baseline, the negative conversion rates of sputum culture at week 8, 12 and 24 were 93.1% (27 cases), 100.0% (29 cases) and 93.1% (27 cases) respectively, sputum culture of 2 patients returned to positive at week 24; the median time of negative conversion of sputum culture was 24 days (interquartile interval: 14-61 days). Among 52 patients with pulmonary cavity, 48 (92.3%) completed 24 weeks of BDQ-containing treatment, the cavity closure rates at week 12 and 24 were 37.5% and 64.6% respectively. Conclusion Compared with the traditional treatment regimen, BDQ-containing treatment regimen for 24 weeks can improve the negative conversion rate of sputum culture and cavity closure rate in patients with MDR/XDR-TB, but attention should be paid to the monitoring and management of QT interval.