关键词: 结核,肺, 利福平, 药物耐受性, 临床方案, 治疗结果

Abstract:

Objective: To evaluate the efficacy and safety of a 6-month short-course B-Pa-L/M (bedaquiline-pretomanid-linezolid-moxifloxacin) regimen in Chinese patients with rifampicin-resistant pulmonary tuberculosis (RR-PTB). Methods: This nationwide, multicenter, prospective, single-arm clinical trial was conducted at 18 designated tuberculosis hospitals across China from March to November 2025. Inclusion criteria: age 14-65 years, rifampicin-resistant confirmed by phenotypic drug susceptibility testing or molecular biological assay, sputum smear ≥1 time 2+ or ≥2 times 1+, and chest imaging consistent with pulmonary tuberculosis. Exclusion criteria: severe extrapulmonary tuberculosis, severe hepatic or renal dysfunction, QTc prolongation, HIV infection, malignancy, and severe psychiatric/neurological disorders. A total of 35 patients were screened; 1 was excluded due to negative baseline culture, and 35 were enrolled (B-Pa-L 10 cases, B-Pa-L-M 25 cases). Patients received the B-Pa-L/M regimen for 6 months. Treatment outcomes, sputum culture conversion, radiological improvement, and adverse events were assessed. Results: In the B-Pa-L subgroup (10 cases), 8 were cured, 1 lost to follow-up and 1 withdrew; in the B-Pa-L/M subgroup (25 cases), 22 were cured, 2 lost to follow-up and 1 was excluded due to negative baseline culture. The overall cure rate was 85.7% (30/35), and 5 (14.3%) had unfavorable outcomes. Of 32 patients with evaluable imaging, 28 (87.5%) showed marked radiological improvement, and 4 (12.5%) showed partial improvement, yielding a total radiological improvement rate of 100.0%. Adverse events were reported in 14 patients (40.0%), with 3 (8.6%) requiring discontinuation or dose reduction. The most common adverse events were peripheral neuropathy in 7 patients (20.0%), gastrointestinal reactions in 3 (8.6%), and hepatic dysfunction in 2 (5.7%). Severe adverse events included acute pancreatitis (1 case), severe nausea/vomiting (1 case), visual impairment (1 case), and bilateral lower extremity numbness/pain (1 case); all resolved after drug interruption or symptomatic treatment. No treatment-related deaths occurred. Conclusion: The B-Pa-L/M regimen demonstrated a high cure rate and favorable radiological improvement in Chinese patients with RR-PTB, with a manageable safety profile. These findings provide important clinical evidence for short-course treatment of drug-resistant tuberculosis in China.

Key words: Tuberculosis, pulmonary, Rifampin, Drug tolerance, Clinical protocols, Treatment outcome