title: Clofazimine for the treatment of multidrug-resistant tuberculosis: prospective, multicenter, randomized controlled study in China.
abstract: BACKGROUND
  Clofazimine (Cfz) has shown activity against Mycobacterium tuberculosis, including multidrug-resistant (MDR) strains in vitro and in animal studies. Here we evaluate the clinical efficacy and tolerability of using Cfz to treat MDR tuberculosis in China.
  
  
  METHODS
  We enrolled 105 patients who had sputum culture-positive MDR tuberculosis in 6 major tuberculosis specialty hospitals in China. Patients were randomly assigned to either the Cfz therapy group (n = 53) or control group (n = 52). Patients in the 2 groups were given 21 months of individual-based chemotherapy regimens based on medication history and drug susceptibility test results. The Cfz therapy group regimens incorporated 100 mg of Cfz once daily for 21 months.
  
  
  RESULTS
  Three patients in each group discontinued therapy because of side effects or other reasons. Sputum culture conversion to negative was earlier in patients who received Cfz compared with controls (P = .042 by log-rank test). Chest computed tomography showed cavitary changes in 46 patients in the Cfz therapy group and 45 in the control group. Cavity closure was earlier in patient who received Cfz compared with controls (P = .047 by log-rank test). The treatment success rate in the Cfz group was 73.6%, higher than that in control group (53.8%; P = .035). Side effects in skin only occurred in the Cfz group. The rates of skin discoloration and ichthyosis were 94.3% and 47.2%, respectively.
  
  
  CONCLUSIONS
  Using Cfz to treat MDR tuberculosis promotes cavity closure, accelerates sputum culture conversion, and improves treatment success rates.
authors.affiliation: Tuberculosis Multi-Disciplinary Diagnosis and Treatment Centre, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute.
authors.forename: Shenjie
authors.initials: S
authors.lastname: Tang
authors.affiliation: Tuberculosis Center for Diagnosis and Treatment, Shanghai Pulmonary Hospital, Tongji University School of Medicine.
authors.forename: Lan
authors.initials: L
authors.lastname: Yao
authors.affiliation: Tuberculosis Center for Diagnosis and Treatment, Shanghai Pulmonary Hospital, Tongji University School of Medicine.
authors.forename: Xiaohui
authors.initials: X
authors.lastname: Hao
authors.affiliation: Tuberculosis Center for Diagnosis and Treatment, Shanghai Pulmonary Hospital, Tongji University School of Medicine.
authors.forename: Yidian
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Tuberculosis Center for Diagnosis and Treatment, Shanghai Pulmonary Hospital, Tongji University School of Medicine.
authors.forename: Linhai
authors.initials: L
authors.lastname: Zeng
authors.affiliation: Anhui Chest Hospital.
authors.forename: Gang
authors.initials: G
authors.lastname: Liu
authors.affiliation: Kunming Third People's Hospital.
authors.forename: Mingwu
authors.initials: M
authors.lastname: Li
authors.affiliation: Hangzhou Red Cross Hospital.
authors.forename: Fujian
authors.initials: F
authors.lastname: Li
authors.affiliation: Souzhou Fifth People's Hospital.
authors.forename: Meiying
authors.initials: M
authors.lastname: Wu
authors.affiliation: Anhui Tongling Second People's Hospital.
authors.forename: Yousheng
authors.initials: Y
authors.lastname: Zhu
authors.affiliation: Shanghai Minhang Center for Disease Control and Prevention, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Sun
authors.affiliation: Tuberculosis Center for Diagnosis and Treatment, Shanghai Pulmonary Hospital, Tongji University School of Medicine.
authors.forename: Jin
authors.initials: J
authors.lastname: Gu
authors.affiliation: Souzhou Fifth People's Hospital.
authors.forename: Xiafang
authors.initials: X
authors.lastname: Wang
authors.affiliation: Tuberculosis Center for Diagnosis and Treatment, Shanghai Pulmonary Hospital, Tongji University School of Medicine.
authors.forename: Zhanjun
authors.initials: Z
authors.lastname: Zhang
mesh_terms: D000293:Adolescent; D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D002681:China; D002991:Clofazimine / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000302:isolation & purification; D013183:Sputum / Q000382:microbiology; D016896:Treatment Outcome; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy*; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy* / Q000382:microbiology; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D002991:Clofazimine
keywords: clofazimine; efficacy; multidrug-resistant tuberculosis; tolerability