Randomized Controlled Study in China

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 cul-ture 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