Treatment and recurrence on re-treatment tuberculosis patients: a randomized clinical trial and 7-year perspective cohort study in China.

Previously treated TB patients still pose a serious threat to global control of TB, yet new re-treatment therapies were little studied. This study aimed to examine the therapeutic effects of new re-treatment regimens, and explore risk factors associated with recurrence after successful treatment. We conducted a cohort study in nine regions of China and enrolled previously treated TB patients from October, 2008 to December, 2010. Patients were randomly divided into four treatment regimen groups including standard, high-dose, long-course, and individualized treatment. After treatment, those with successful treatment outcomes were followed up to 7 years. The effects of different regimens and the information of recurrence were recorded. Risk factors to poor treatment outcomes were calculated using logistic regression model, while risk factors to recurrence or death were calculated using Cox model. Four hundred ninety-two participants were enrolled during the study time and 419 patients were included in our analysis of treatment effects. Overall, the treatment success rate is 75.9%, and the recurrence and death rate is 6.9% and 3.8%, respectively. Reduced risks of poor outcomes were observed in patients who were treated with high-dose and individualized regimen compared with standard regimen, and the adjusted ORs were 0.3 (0.1-0.6), 0.2 (0.1-0.5), respectively. In our analysis of factors associated with recurrence, all documented variables were not significant. Revised re-treatment regimen has better therapeutic effects compared to standard regimen, but it was not associated with lower risk of TB recurrence. Further studies are warranted to evaluate the role of other revised re-treatment regimens in recurrence risk. Trial registration: chictr.org Identifier: ChiCTR1800017441.

RCT Entities:   Population Interventions Outcomes