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Published on: April 5, 2017
New All-Oral Short-term Regimen for Multidrug-Resistant Tuberculosis: A Semi-randomized Controlled Trial Conducted in
Wei Jing1, Qingfeng Wang1, Jun Wang1
1Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People's Republic of China.
Background:
This study aimed to evaluate the efficacy and safety of an all-oral short-term regimen for treating multidrug-resistant tuberculosis (MDR-TB).
Methods:
In this semirandomized, controlled, multicenter clinical study, patients with MDR-TB who were sensitive to fluoroquinolones were assigned to treatment groups at enrollment. Patients were assigned to group C (4-6 months: bedaquiline + linezolid + clofazimine + moxifloxacin + cycloserine; 5 months: clofazimine + moxifloxacin + cycloserine) unless this protocol was unsuitable or unacceptable, in which case they were randomly assigned to group A (4-6 months: isoniazid + ethambutol + pyrazinamide + protionamide + amikacin + clofazimine + moxifloxacin; 5 months: ethambutol + pyrazinamide + clofazimine + moxifloxacin) or group B (4-6 months: isoniazid + ethambutol + pyrazinamide + protionamide + linezolid + clofazimine + moxifloxacin; 5 months: ethambutol + pyrazinamide + clofazimine + moxifloxacin). The primary outcome was the proportion of patients achieving successful outcomes.
Results:
From September 2020 to June 2023, 397 patients with MDR-TB were screened and 360 were enrolled. Among them, 90.3% of group C achieved good treatment outcomes, as compared with 57.1% in group A (control) and 75.0% in group B. Group C demonstrated higher sputum culture conversion and pulmonary cavity closure rates than group B, with group A showing the lowest rates. The most common adverse events were skin blackening (29.3%) and hyperuricemia (20.6%). Prolonged QT intervals were observed in 39 participants, predominantly in group C (24.3%).
Conclusions:
The all-oral 9- to 11-month short-term regimen shows promise as a new treatment option for MDR-TB. Incorporating bedaquiline into an orally administered regimen may improve treatment outcomes and reduce relapse rates. Despite certain limitations, these findings provide valuable insights for developing improved treatments for MDR-TB in China.
