1. Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study.
- Author
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Fu, Liang, Zhang, Xilin, Xiong, Juan, Sun, Feng, Weng, Taoping, Li, Yang, Zhang, Peize, Li, Hui, Yang, Qianting, Cai, Yi, Liang, Hancheng, Chen, Qiuqi, Wang, Zhaoqing, Liu, Lei, Chen, Xinchun, Zhang, Wenhong, and Deng, Guofang
- Subjects
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MULTIDRUG-resistant tuberculosis , *TUBERCULOSIS , *COHORT analysis , *LONGITUDINAL method , *TUBERCULOSIS patients - Abstract
• Three new multidrug-resistant tuberculosis (MDR-TB)/ pre-extensive drug-resistant tuberculosis (pre-XDR-TB) regimens, five drugs for 9 months. • The first cohort of short-course regimens for MDR-TB in China. • Of 99 assessable participants, 92.9% had a favorable outcome. • Culture conversion was 82.5% at month 2 and 97.9% at month 6. • Majority of adverse effects were manageable and reversible. Long, ineffective, and toxic regimens hinder the treatment of patients with multidrug-resistant tuberculosis (MDR-TB) and pre-extensive drug-resistant tuberculosis (pre-XDR-TB). We conducted a multicenter cohort study to prospectively evaluate the safety and efficacy of three 9-month, all-oral, 5-drug regimens. Regimen A (bedaquiline [Bdq]+linezolid [Lzd]+moxifloxacin [Mfx]+cycloserine [Cs]+pyrazinamide [Pza]) and Regimen B (Lzd+Mfx+Cs+clofazimine [Cfz]+Pza) were used to treat MDR-TB patients (Groups A and B, respectively, assigned according to the patient's treatment preference), while Regimen C (Bdq+Lzd+Cs+Cfz+Pza) was used to treat pre-XDR-TB patients (Group C). The primary endpoint was the occurrence of an unfavorable outcome within 12 months of treatment completion, regardless of regimen. A total of 104 patients (34 in Group A, 46 in Group B, and 24 in Group C), with a median age of 35.5 (29.0-54.0) years, were included in the analysis population. At 12 months after treatment completion, five patients were deemed non-assessable. Of the remaining 99 participants, seven (7.1%) had an unfavorable outcome (including two deaths from any cause, four with treatment failure, and one loss to follow-up) and 92 (92.9%) had a favorable outcome. Culture conversion was achieved in 82.5% (80/97) of participants at month 2 and in 97.9% (94/97) of participants at month 6. Adverse events (AEs) resulting in drug adjustment occurred in 69.2% (72/104) of participants, mainly due to Lzd and Pza use. A QT interval prolongation of ≥ 500 ms occurred in 5.8% (6/104) of participants. The primary outcome of the three tailored, 9-month, all-oral, 5-drug regimens was satisfactory in the vast majority of MDR-TB and pre-XDR-TB patients, with manageable and reversible AEs. [Display omitted] [ABSTRACT FROM AUTHOR]
- Published
- 2023
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