Abstract:

Objective To analyze the treatment efficacy and safety of optimized regimen for re-treated patients with drug-susceptibility pulmonary tuberculosis. Methods This was a multi-center, randomized, open, parallel, controlled prospective cohort study for retreated drug-susceptible pulmonary tuberculosis. All of 381 subjects with either positive smear and positive culture, or with negative smear but culture positive were enrolled in the study. Two hundred and forty-four cases were randomly enrolled in the optimized regimen group and 137 cases in the standard regimen. SPSS 19.0 software was used for data statistics, and chi square test was used for data analysis. When the theoretical frequency is less than 1, Fisher exact probability test was used. The difference is statistically significant (P<0.05). Treatment outcome and side effect during treatment were compared between the two groups. Results At the end of treatment, the success rate was 84.0% (205/244, 175 cases cured and 30 cases completed treatment) in the optimized regimen group and 74.5% (102/137, 92 cases cured and 10 cases completed treatment) in the standard treatment group. The treatment success rate of optimized regimen group was significantly higher than that of the standard regimen group (χ²=5.128, P=0.024). There was no significant difference between the two groups in the incidence of both side effects (25.8% (63/244) in optimized regimen group and 21.2% (29/137) in standard regimen group respectively; χ ²=1.037,P=0.309);and severe side effects (2.5% (6/244) vs. 4.4% (6/137); χ²=0.525, P=0.469). Conclusion The optimized regimen can increase treatment success patients with re-treated drug-susceptible pulmonary TB without increasing the side effects.

Key words: Tuberculosis, pulmonary, Antitubercular agents, Retreatment, Clinical protocols