Clofazimine for Treatment of Pulmonary Extensively Drug-Resistant Tuberculosis in China [PublishAheadOfPrint]

We performed a multicenter, prospective and randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary end-point was the time to sputum-culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of "cure" and 1 (4.5%) "complete treatment," for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were "cure" and 6 (22.2%) "complete treatment" by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between CLO and control groups. The average sputum-culture conversion time was 19.7 months for the experimental group, which was statistically no different than that of the control group (20.3 months, P=0.57). Of the 22 patients in the CLO group, 12 (54.5%) had adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% (7/22) of patients exhibiting this adverse effect in the CLO group versus 11.1% (3/27) for the control group. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment.

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