Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for XXXX treatment.

@entity1 @entity378 @entity648 @entity1907
OBJECTIVES: Fixed-dose combination formulations, which simplify the administration of drugs and prevent the development of drug resistance, have been recommended as a standard anti- @entity378 treatment regimen. However, the composition and dosage recommendations for fixed-dose combination formulations differ from those for separate formulations. Thus, questions about the effectiveness and side effects of combination formulations remain. The aim of this study was to compare the safety and efficacy of these two types of anti- @entity378 regimens for @entity1907 treatment. METHOD: A prospective, randomized controlled study was conducted using the directly observed treatment short-course strategy. @entity1 were randomly allocated to one of two short-course regimens. One year after completing the treatment, these @entity1 ' outcomes were analyzed. ClinicalTrials.gov: NCT00979290. RESULTS: A total of 161 @entity1 were enrolled, 142 of whom were evaluable for safety assessment. The two regimens had a similar incidence of adverse effects. In the per-protocol population, serum @entity648 concentrations at the peak level, at week 4, and at week 8 were significantly higher for the fixed-dose combination formulation than for the separate formulations. All @entity1 had negative sputum cultures at the end of the treatment, and no relapse occurred after one year of follow-up. CONCLUSIONS: In this randomized study, transient higher serum @entity648 levels were noted for the fixed-dose combination regimen compared with the separate formulations during treatment. However, no significant difference in safety or efficacy was found between the groups when the directly observed treatment short-course strategy was used.
