Yadong Du1, Chao Qiu2, Xiaohong Chen3, Jing Wang1, Wei Jing1, Hongqiu Pan4, Wei Chen5, Yufeng Liu6, Chunxiang Li7, Xiu'e Xi8, Hongyun Yin9, Jianfeng Zeng10, Xia Zhang11, Tao Xu12, Qingfeng Wang1, Ru Guo1, Jun Wang1, Yu Pang13, Naihui Chu1. 1. Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China. 2. Department of Drug-Resistant Tuberculosis, Jiamusi Tuberculosis Control Hospital, Jiamusi, People's Republic of China. 3. Department of Tuberculosis, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, People's Republic of China. 4. Department of Pulmonary,The Third People's Hospital of Zhenjiang, Zhenjiang, People's Republic of China. 5. Department of Tuberculosis, Shenyang Chest Hospital, Liaoning Province Shenyang, People's Republic of China. 6. Department of Chest, Qingdao Chest Hospital, Qingdao, People's Republic of China. 7. Department of Tuberculosis, Changsha Central Hospital, Changsha, People's Republic of China. 8. Department of Tuberculosis, Xinxiang Medical College Affiliated Hospital, Xinxiang, People's Republic of China. 9. Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai Pulmonary Hospital of Tongji University, Shanghai, People's Republic of China. 10. Department of Pulmonary, The Third People's Hospital of Shenzhen, Shenzhen, People's Republic of China. 11. Department of Tuberculosis, Nanjing Chest Hospital, Nanjing, People's Republic of China. 12. Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College, Beijing, People's Republic of China. 13. National Clinical Laboratory on Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.
Abstract
BACKGROUND: The emergence of multidrug-resistant tuberculosis (MDR-TB) poses a serious obstacle to global TB control programs. METHODS: We carried out a prospective, randomized, multicenter study in China that was focused on the potential of a shorter regimen containing clofazimine (CFZ) for the treatment of MDR-TB. There were 135 MDR-TB cases that met eligibility requirements and were randomly stratified into either the control group or experimental group. Patients in the control group received an 18-month treatment regimen, whereas patients in the experimental group received a 12-month treatment regimen containing CFZ. RESULTS: At the completion of the treatment period, the difference in sputum-culture conversion rates between the experimental group and the control group was not significant. Notably, by the end of 3 months of treatment, 68.7% patients receiving the experimental regimen had sputum-culture conversion, as compared with 55.9% of those receiving the control regimen; this was a significant difference, suggesting an early sputum conversion (P = .04). There were 67 adverse events reported in 56 patients in this study, including 32 in the control group and 35 in the experimental group. No significant difference in the overall incidences of adverse events was observed between the 2 groups. CONCLUSIONS: The MDR-TB patients treated with the shorter regimen containing CFZ had a comparable successful outcome rate when compared to those with the standard regimen. The patients assigned to the experimental group achieved more rapid sputum-culture conversion, reflecting superior antimicrobial activity against MDR-TB. CLINICAL TRIALS REGISTRATION: Chinese Clinical Trial Registry ChiCTR 1800020391.
RCT Entities:
BACKGROUND: The emergence of multidrug-resistant tuberculosis (MDR-TB) poses a serious obstacle to global TB control programs. METHODS: We carried out a prospective, randomized, multicenter study in China that was focused on the potential of a shorter regimen containing clofazimine (CFZ) for the treatment of MDR-TB. There were 135 MDR-TB cases that met eligibility requirements and were randomly stratified into either the control group or experimental group. Patients in the control group received an 18-month treatment regimen, whereas patients in the experimental group received a 12-month treatment regimen containing CFZ. RESULTS: At the completion of the treatment period, the difference in sputum-culture conversion rates between the experimental group and the control group was not significant. Notably, by the end of 3 months of treatment, 68.7% patients receiving the experimental regimen had sputum-culture conversion, as compared with 55.9% of those receiving the control regimen; this was a significant difference, suggesting an early sputum conversion (P = .04). There were 67 adverse events reported in 56 patients in this study, including 32 in the control group and 35 in the experimental group. No significant difference in the overall incidences of adverse events was observed between the 2 groups. CONCLUSIONS: The MDR-TBpatients treated with the shorter regimen containing CFZ had a comparable successful outcome rate when compared to those with the standard regimen. The patients assigned to the experimental group achieved more rapid sputum-culture conversion, reflecting superior antimicrobial activity against MDR-TB. CLINICAL TRIALS REGISTRATION: Chinese Clinical Trial Registry ChiCTR 1800020391.
Authors: Juan Espinosa-Pereiro; Adrian Sánchez-Montalvá; Maria Luisa Aznar; Maria Espiau Journal: Medicina (Kaunas) Date: 2022-01-26 Impact factor: 2.430
Authors: Abdul Wahid; Abdul Ghafoor; Abdul Wali Khan; Yaser Mohammed Al-Worafi; Abdullah Latif; Nisar Ahmed Shahwani; Muhammad Atif; Fahad Saleem; Nafees Ahmad Journal: Front Pharmacol Date: 2022-09-06 Impact factor: 5.988