Introduction
The prescription of effective and well-tolerated antituberculosis (TB) treatment regimen is an important step in the management of TB.
Objective
To compare the outcome of fixed-dose combination (FDC) therapy versus standard treatment (ST) in treatment of pulmonary tuberculosis (PTB) and extrapulmonary TB in Assiut Governorate.
Patients and methods
In this prospective cross-sectional analytic study, 120 patients were included. Overall, 60 had PTB based on sputum-positive acid-fast bacilli, and 60 had extrapulmonary TB based on biopsy or culture from the affected sites. Patients were classified into two groups: 80 patients received FDC in the form of four-drug combinations in the intensive phase and the two-drug combination therapy in the continuation phase (group 1) and 40 patients received ST in the form of four separate drugs in the intensive phase and the two separate drugs in the continuation phase (group 2). Follow-up of clinical data, laboratory markers, sputum conversion in PTB during the course of treatment, drug tolerance, compliance, and developing of adverse effect was done in both groups.
Results
There is no statistically significant difference between both groups regarding improvement of the fever and anorexia and weight loss (P > 0.05 for each). Moreover, there are no statistically significant changes in the sputum conversion between both groups after 2, 4, and 6 months, respectively. There is a statistically significant increase in the percentage of the patients, with increase of alanine aminotransferase, aspartate aminotransferase, and bilirubin level along the course of the treatments in patients receiving FDC and ST (P < 001) but still within normal limits, and there is no need to stop or change the therapy. No significant difference between the two groups regarding the adverse effects such as nausea, vomiting, anorexia, blurred vision, peripheral neuropathy, arthralgia, and skin rash is recorded.
Conclusion
Both FDC and ST have comparable results, with no superiority of either one over the other.