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Chinese Journal of Antituberculosis ›› 2026, Vol. 48 ›› Issue (10): 1480-1486.doi: 10.19982/j.issn.1000-6621.20260378

• Original Articles • Previous Articles     Next Articles

A 6-month short-course regimen for rifampicin-resistant pulmonary tuberculosis in China: a nationwide multicenter single-arm clinical trial

Nie Wenjuan1, Zhang Mingyue1, Zhang Yungui2, Rukeyamu·Abudushalamu 3, Xu Bing4, Jin Long5, Liang Ruixia6, Wang Furong7, Xiong Yu8, Cui Junwei9, Yi Hengzhong10, Zhang Fan11, Li Hongzhi12, Cao Xuegang13, Qiu Lei14, Bao Zhijian15, Wang Guangming16, Zhang Fan17, Song Yanan18, Zhang Haiqin19, Chu Naihui1(), Cheng Shiming20()   

  1. 1 Beijing Chest Hospital, Capital Medical University, Beijing 101149, China
    2 Yunnan Provincial Infectious Diseases Hospital, Kunming 650301, China
    3 Infectious Disease Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830013, China
    4 Shenyang Tenth People’s Hospital, Shenyang 110044, China
    5 Infectious Disease Hospital of Heilongjiang Province, Harbin 150500, China
    6 Henan Provincial Chest Hospital, Zhengzhou 450008, China
    7 The Fourth Hospital of Inner Mongolia Autonomous Region, Hohhot 010070, China
    8 Shandong Public Health Clinical Center, Jinan 250100, China
    9 The First Affiliated Hospital of Henan Medical University, Xinxiang 453000, China
    10 Hunan Chest Hospital, Changsha 410013, China
    11 Fuzhou Pulmonary Hospital of Fujian Province, Fuzhou 350008, China
    12 Henan Provincial Infectious Diseases Hospital, Zhengzhou 450015, China
    13 Jilin Provincial Tuberculosis Hospital, Changchun 130500, China
    14 The Fourth People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan 750021, China
    15 Hangzhou Red Cross Hospital, Hangzhou 310003, China
    16 The First Affiliated Hospital of Ningbo University, Ningbo 315020, China
    17 Hulunbuir Infectious Disease Hospital of Inner Mongolia Autonomous Region, Hulunbuir 162650, China
    18 The Fourth Hospital of Ulanqab, Inner Mongolia Autonomous Region, Ulanqab 012000, China
    19 The Third Hospital of Baotou, Inner Mongolia Autonomous Region, Baotou 014040, China
    20 Chinese Antituberculosis Association, Beijing 100101, China
  • Received:2026-06-29 Online:2026-10-10 Published:2026-09-30
  • Contact: Chu Naihui, Email: dongchu1994@sina.com;Cheng Shiming, Email: smcheng@163.com
  • Supported by:
    Beijing Research Center for Major Respiratory Infectious Diseases(BJRID2025-013);Beijing Municipal Health Commission Excellent Clinical Research Program for Research-Oriented Wards(BRWEP2024W042160100);Beijing Municipal Health Commission Dengfeng Program(G202511062)

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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

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