New All-Oral Short-term Regimen for Multidrug-Resistant Tuberculosis: A Semi-randomized Controlled Trial Conducted in China
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 39 participants or records.
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