Abstract:

Objective To observe the effectiveness and safety of bedaquiline in the treatment of multidrug-resistant/extensively drug-resistant tuberculosis (MDR/XDR-PTB) patients with sputum culture negative conversion. Methods From September 1,2018 to March 31, 2020, 67 culture-confirmed pulmonary TB cases who had gotten sputum culture conversion with anti-tuberculosis treatment in Wuhan Pulmonary Hospital were enrolled, including 2 MDR-PTB cases, 58 pre-XDR-PTB cases and 7 XDR-PTB cases. All patients were treated with bedaquiline-containing regimens. Adverse reactions and outcomes of treatment were analyzed. Results Fifty-nine patients completed the whole course of treatment with a cure rate of 82.1% (55/67) and a treatment success rate of 88.1% (59/67). Adverse outcomes (death, lost to follow-up) accounted for 11.9% (8/67) of all patients. At the end of the 12th week, the proportion of patients with obvious absorption or absorption of lesions was 74.6% (50/67), and 96.5% (55/57) at the end of treatment. At 12 weeks, the percentage of patients with cavity shrinking or closing reached 75.0% (15/20), this proportion then stabilized at 94.1% (16/17) from the end of the 36th week till the end of the whole treatment. A total of 182 adverse events occurred among 53 cases (79.1%,53/67) during the whole course of treatment, including 45 (24.7%) over grade Ⅲ events, and 4 (2.2%) serious adverse events. Adverse events mainly were impaired liver function (66 cases, 36.3%) and prolonged QTc (21 cases, 11.5%). Conclusion Bedaquilin-containing treatment for MDR/XDR-PTB patients with sputum culture conversion can promote lesion absorption at early stage, and can bring high treatment success rate with a low incidence of adverse events over Ⅲ grade.

Key words: Tuberculosis,pulmonary, Extensively drug-resistant tuberculosis, Tuberculosis,multidrug resistance, Bedaquiline, Clinical protocols