Evaluation of optimal regimens for treatment of rifampicin resistant-tuberculosis: Multicenter, randomized controlled study in China

Background: Rifampicin resistant-tuberculosis (RR-TB) is meant by resistance to rifampicin detected using phenotypic or genotypic methods, with or without resistance to other anti-TB drugs , including R mono- or polydrug Resistance (RMR/RPR-TB) in addition to MDR/XDR-TB. RMR/RPR-TB is increasing recently, however its optimal treatment regimens are not known. Methods: We enrolled 145 patients who had sputum-culture-positive RMR/RPR-TB in nine major tuberculosis specialized hospital in China.Patients were randomly assigned to 12-month regimen group (n=73) and 18-month regimen group (n=72). All patients had positive sputum-smear microscopy results at the time of RMR/RPR-TB diagnosis. Results: 4 patients in each group discontinued therapy because of side effects or other reasons. The sputum culture conversion rates in 12-month regimen group and 18-month regimen group were respectively 68.5% (50/73) and 70.8% (51/72) (P>0.05) at the end of treatment. Of 12-month regimen group, 45 had cavitary changes noted on initial chest computed tomography, and of 18-month regimen group, 47 had cavitary changes. The cavity closure rates of in 12-month regimen group and 18-month regimen group were respectively 60% (27/45) and 63.8% (30/47) (P>0.05). During the next 12-month follow-up, 4 (8 %) of 50 in 12-month regimen group and 3 (5.9 %) of 51 in 18-month regimen group respectively, had TB recurrence (P>0.05). Side-effects including liver injury and gastrointestinal adverse events etc. are similar in two groups. Conclusions: 12-month regimen for treatment of Rifampicin resistant-tuberculosis was not inferior to 18-month regimen.