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Clin Infect Dis. 2015 May 1;60(9):1361-7. doi: 10.1093/cid/civ027. Epub 2015 Jan 20.

Clofazimine for the treatment of multidrug-resistant tuberculosis: prospective, multicenter, randomized controlled study in China.

Author information

1
Tuberculosis Multi-Disciplinary Diagnosis and Treatment Centre, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute.
2
Tuberculosis Center for Diagnosis and Treatment, Shanghai Pulmonary Hospital, Tongji University School of Medicine.
3
Anhui Chest Hospital.
4
Kunming Third People's Hospital.
5
Hangzhou Red Cross Hospital.
6
Souzhou Fifth People's Hospital.
7
Anhui Tongling Second People's Hospital.
8
Shanghai Minhang Center for Disease Control and Prevention, 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.

KEYWORDS:

clofazimine; efficacy; multidrug-resistant tuberculosis; tolerability

PMID:
25605283
DOI:
10.1093/cid/civ027
[Indexed for MEDLINE]

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