A highly effective and inexpensive standardized treatment of multidrug- resistant tuberculosis: A muticenter prospective study in china

Abstract BackgroundTo verify the efficacy and safety of an inexpensive standardized treatment for multidrug-resistant tuberculosis (MDR-TB) based on minimum inhibitory concentration (MIC) drug sensitivity test(DST), a multicenter prospective study was conducted in eastern China.MethodsPatients diagnosed as MDR-TB with isoniazid resistance at low concentration and rifampicin resistance, second-line/injectable agents sensitive) were prospectively enrolled, given the regimen of Ak Mfx(Lfx)CsPtoPaZ for six months followed by 12 months of Mfx(Lfx)CsPtoPaZ and followed up for treatment outcomes and adverse events (AEs).ResultsA total of 114 patients were enrolled into the study. The overall rate of favorable treatment rate was 79.8% (91/114), among 91 cases with favorable treatment, 86(75.4%)cured and 5 (4.4%) completed treatment. 23 cases got unfavorable outcome including 10 8.8% (10/114) failures, 8.8% (10/114) losing follow up ,0.9%(1/114) withdrawing treatment due to intolerance to drugs and 1.8%(2/114 ) died. Treatment favorable rate was significantly higher in newly treated MDR-TB (91.7%, 33/36) than that in retreated MDR-TB (74.4%, 58/78, p = 0.03). The investigators recorded 42 AEs occurrences in 30 of 114 patients༈26.3%). Clinicians rated most AEs as mild or moderate (95.24%, 40/42) .ConclusionsThe regimen was proved to be effective, safe and inexpensive. It is suitable for specific drug resistant population, especially for newly-treated patients, which could be expected to be developed into a short-course regimen.Clinical Trials RegistrationChina Clinical Trial Registry ChiCTR- OPC-16009380