Liping Yan1, Xiaohong Kan2, Limei Zhu3, Kaijin Xu4, Jianjun Yin5, Li Jie6, Yong Li7, Ji Yue8, Wenyu Cui9, Juan Du10, Lihua Wang11, Shouyong Tan12, Xiangao Jiang13, Zhong Zeng14, Shenghui Xu15, Lin Wang16, Yu Chen17, Weiguo He18, Xusheng Gao19, Dapeng Bai20, Chengjie Zhao21, Xiaofeng Yan22, Yuyin Zhu23, Yumei Fan24, Lanpin Xie25, Aihua Deng26, Qing Zhang27, Heping Xiao28. 1. Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. 2. Department of Science and Education, Anhui Chest Hospital, Hefei, China. 3. Department of Tuberculosis, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. 4. Department of Infectious Diseases, The First Affiliated Hospital, Zhejiang University, Hangzhou, China. 5. Department of Outpatient, Center for Tuberculosis Control of Guangdong Province, Guangzhou, China. 6. Second Department of Tuberculosis, Chest Hospital of Xinjiang Uygur Autonomous Region of The PRC, Urumqi, China. 7. Department of Pulmonary Medicine, The Guangxi Zhuang Autonomous Region Longtan Hospital, Liuzhou, China. 8. Department of Tuberculosis, Public Health Clinical Center of Chengdu, Chengdu, China. 9. Department of Tuberculosis, Changchun Infectious Diseases Hospital, Changchun, China. 10. Department of Respiration, The Affiliated Hospital of Guizhou Medical University, Guiyang, China. 11. Department of Tuberculosis Medicine, Taiyuan Tuberculosis Hospital, Taiyuan, China. 12. Department of Tuberculosis Medicine, Guangzhou Chest Hospital, Guangzhou, China. 13. Department of Infectious Diseases, WenZhou Central Hospital, Wenzhou, China. 14. Department of Tuberculosis, The Fifth People's Hospital of Ganzhou, Chizhu, Shuixi Town, Ganzhou, China. 15. Fifth Department of Internal Medicine, Hunan Institute for Tuberculosis Control, Changsha, China. 16. Department of Pulmonary, 85th Hospital of peaple's Liberation Army, Shanghai, China. 17. Department of Tuberculosis, Henan Province Infectious Diseases Hospital, Zhengzhou, China. 18. Department of Tuberculosis, The Third People's Hospital of Hengyang, ErTang Village, Yumu Town, Hengyang, China. 19. Department of Tuberculosis, Shandong Provincial Chest Hospital, Jinan, China. 20. Department of Tuberculosis, Tianjin Haihe Hospital, Shuanggang town, Tianjin, China. 21. Department of Tuberculosis, Jinhua Guangfu Hospital of Zhejiang Province, Jinhua, China. 22. Department of Medical Affair, Chongqing Infectious Disease Medical Center, Xiaolongkan, Chongqing, China. 23. Second Department of Pulmonary, Ningbo No. 2 Hospital, Ningbo, China. 24. Tuberculosis Treatment Center, Hangzhou Red Cross Hospital, Hangzhou, China. 25. Department of Tuberculosis, Hebei Chest Hospital, Shijiazhuang, China. 26. Second Department of Internal Medicine, Jiangxi Chest Hospital, Nanchang, China. 27. Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: Zhangingbm123@163.com. 28. Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: xiaoheping_sars@163.com.
Abstract
PURPOSE: We designed a prospective, multicenter, randomized, controlled study to assess a 5-month regimen compared with the standard regimen on previously treated patients with pulmonary tuberculosis (TB). METHODS: We enrolled 917 sputum smear-positive patients undergoing additional treatment in 27 major tuberculosis hospitals in China. Patients were randomly assigned to a test group (n = 626)treated with a 5-month regimen of moxifloxacin, pasiniazid, rifabutin, ethambutol, and pyrazinamide or a reference group (n = 291) treated with an 8-month regimen of isoniazid, rifampicin, and streptomycin. All patients with a favorable response were followed up for 5 years after the end of treatment. FINDINGS: Of the study patients, 61 in the test group and 19 in the reference group had multidrug-resistant (MDR) TB. The treatment success rate in the study group was 74.12%, which was significantly higher than the 67.70% in the reference group (P = 0.04), whereas the treatment success rate of patients with MDR-TB was not significantly different between the test and reference groups (70.5% vs 63.1%, P =0.79). The adverse effects rates in the test and reference groups were 7.4% and 3.1%, respectively (P = .01). The difference in the TB recurrence rates between the group arm (9.6%) and the reference group (21.8%) was statistically significant (P < 0.001). IMPLICATIONS: The moxifloxacin, pasiniazid, rifabutin, ethambutol, and pyrazinamide test regimen yielded higher success and lower recurrence rates than the currently recommended isoniazid, rifampicin, and streptomycin regimen, but the rate of adverse effects was higher. ClinicalTrials.gov identifier: NCT02331823.
RCT Entities:
PURPOSE: We designed a prospective, multicenter, randomized, controlled study to assess a 5-month regimen compared with the standard regimen on previously treated patients with pulmonary tuberculosis (TB). METHODS: We enrolled 917 sputum smear-positive patients undergoing additional treatment in 27 major tuberculosis hospitals in China. Patients were randomly assigned to a test group (n = 626)treated with a 5-month regimen of moxifloxacin, pasiniazid, rifabutin, ethambutol, and pyrazinamide or a reference group (n = 291) treated with an 8-month regimen of isoniazid, rifampicin, and streptomycin. All patients with a favorable response were followed up for 5 years after the end of treatment. FINDINGS: Of the study patients, 61 in the test group and 19 in the reference group had multidrug-resistant (MDR) TB. The treatment success rate in the study group was 74.12%, which was significantly higher than the 67.70% in the reference group (P = 0.04), whereas the treatment success rate of patients with MDR-TB was not significantly different between the test and reference groups (70.5% vs 63.1%, P =0.79). The adverse effects rates in the test and reference groups were 7.4% and 3.1%, respectively (P = .01). The difference in the TB recurrence rates between the group arm (9.6%) and the reference group (21.8%) was statistically significant (P < 0.001). IMPLICATIONS: The moxifloxacin, pasiniazid, rifabutin, ethambutol, and pyrazinamide test regimen yielded higher success and lower recurrence rates than the currently recommended isoniazid, rifampicin, and streptomycin regimen, but the rate of adverse effects was higher. ClinicalTrials.gov identifier: NCT02331823.