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: Shenjie Tang, Lan Yao, Xiaohui Hao, Yidian Liu, Linhai Zeng, Gang Liu, Mingwu Li, Fujian Li, Meiying Wu, Yousheng Zhu, Hua Sun, Jin Gu, Xiafang Wang, Zhanjun Zhang
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 60 Issue 9 Pg. 1361-7 (May 01 2015) ISSN: 1537-6591 [Electronic] United States
• PMID: 25605283 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: [email protected].

Chemical References

• Antitubercular Agents
• Clofazimine

Topics

• Adolescent
• Adult
• Antitubercular Agents (therapeutic use)
• China
• Clofazimine (administration & dosage, therapeutic use)
• Female
• Humans
• Male
• Microbial Sensitivity Tests
• Middle Aged
• Mycobacterium tuberculosis (drug effects, isolation & purification)
• Sputum (microbiology)
• Treatment Outcome
• Tuberculosis, Multidrug-Resistant (drug therapy)
• Tuberculosis, Pulmonary (drug therapy, microbiology)
• Young Adult