Abstract
BackgroundTo verify the efficacy and safety of an inexpensive regimen for specific multidrug-resistant tuberculosis (MDR-TB) based on Minimum Inhibitory Concentration (MIC) Drug sensitivity test(DST), a prospective cohort study was conducted in China.MethodsMDR-TB cases were prospectively enrolled through a clinical access programmes with strict inclusion and exclusion criteria, given the regimen and followed up, observed the treatment outcome and adverse effects (AEs) .ResultsA total of 114 patients were enrolled into the study. The overall treatment favorable 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,respectively. 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) and no one was caused by Pa༈0%,0/114).ConclusionsThe regimen was proved to be effective, safe and inexpensive. It is suitable for specific drug resistant population in China, especially for newly-treated patients, which could be expected to be developed into a short-course therapy.Clinical Trials Registration: China Clinical Trial Registry ChiCTR- OPC-16009380
Efficacy of an Inexpensive Regimen Containing Pasiniazine for Multidrug-Resistant Tuberculosis with Low-concentration resistance to Isoniazid: a prospective cohort study in a high Tuberculosis burden area