Abstract:

Objective To investigate the early efficacy and safety of the regimen containing bedaquiline in the treatment of multidrug-resistant pulmonary tuberculosis (MDR-PTB). Methods According to the inclusion criteria, 79 MDR-PTB patients diagnosed in Shandong chest hospital from September 2018 to December 2020 were prospectively studied, all of them completed 24-week anti-tuberculosis treatment containing bedaquiline. Basic characteristics (gender, age, residence, body mass index (BMI)) and clinical information (mycobacterium sputum smear and culture results, electrocardiogram, blood routine, liver and kidney function, chest CT, adverse drug reactions), etc.) were collected. To monitor the time of negative conversion of sputum culture, the occurrence of adverse drug reactions, and the treatment outcome during the treatment containing bedaquiline were monitored, and the factors affecting the treatment outcome were analyzed. Results Of the 79 cases, 72 (91.1%) had good outcomes and 7 (8.9%) had adverse outcomes after completing 24-week treatment. Multivariate logistic regression analysis showed that BMI <18.5 (20.8% (5/24)) and aged ≥45 years (27.8% (5/18)) were the risk factors for adverse outcomes (OR (95%CI) were 9.393 (1.443-61.125) and 7.769 (1.289-46.835), respectively. The median (quartile) of sputum culture negative conversion time was 4 (2, 8) weeks. The cumulative sputum culture negative conversion rate gradually increased with the extension of treatment time. The sputum culture negative conversion rates at 2, 4, 8, 12, 16, 20 and 24 weeks were 30.4% (24/79), 51.9% (41/79), 70.9% (56/79), 83.5% (66/79), 87.3% (69/79), 88.6% (70/79) and 91.1% (72/79), respectively. Fifty-three patients (67.1%) had adverse drug-resistant, of which one had serious gastrointestinal reactions, 30 (38.0%) had prolonged Q-Tc interval, and Q-Tc interval ≥500 ms was found in 15 (19.0%); the Q-Tc interval increased first and then decreased with the increase in usage time of bedaquiline, and the peak was at the 12th week ((436.10±27.97) ms). Conclusion The treatment containing bedaquiline showed good outcome for MDR-PTB, with a higher rate of negative conversion of sputum culture in the early stage; adverse outcomes were more likely to happen in malnutrition, middle-aged and elderly patients. The Q-Tc interval of patients during treatment should be monitored.

Key words: Tuberculosis,multidrug resistance, Bedaquiline, Efficacy, Safety