Abstract
IntroductionThe prescription of an effective and well-tolerated antituberculosis (TB) treatment regimen is an important step in the management of TB.ObjectiveThe aim of the present study was comparison between fixed-dose combination (FDC) anti-TB drugs and separate drug formula (SDF) not only in pulmonary tuberculosis (PTB) but also in extrapulmonary tuberculosis (EPTB).Patients and methodsA total of 240 patients with TB were included in the present study: 122 patients had PTB and 118 had EPTB. Both patients with PTB and those with EPTB were divided into two groups according to receiving FDC or SDF. All patients had baseline clinical and laboratory data, including blood picture, liver function tests, renal function tests, erythrocyte sedimentation rate, uric acid, and chest radiography. Follow-up clinical, laboratory, and radiology assessments were done during the course of treatment. Patients who received FDC and those who received SDF were compared for clinical, laboratory, radiological improvement, and sputum conversion in PTB during the course of treatment; moreover, they were compared for drug tolerance, compliance with treatment, and development of adverse effects.ResultsBoth FDC and SDF in PTB and EPTB had comparable effect with respect to clinical improvement, and also sputum conversion in PTB; significant change in liver function was observed in PTB among those who received FDC, but better radiological clearance was detected with SDF. Both regimens were comparable with respect to compliance and adverse effects, except for more gastric disturbance with FDC.ConclusionSDF is recommended in patients with borderline liver function, gastrointestinal troubles, and presence of extensive radiological infiltrate.
Highlights
The prescription of an effective and welltolerated antituberculosis (TB) treatment regimen is an important step in the management of TB
Both fixed-dose combination (FDC) and separate drug formula (SDF) in pulmonary tuberculosis (PTB) and extrapulmonary tuberculosis (EPTB) had comparable effect with respect to clinical improvement, and sputum conversion in PTB; significant change in liver function was observed in PTB among those who received FDC, but better radiological clearance was detected with SDF
For patients with EPTB, no significant differences were detected with respect to clinical variables for patients who received FDC and those who received SDF (Table 2)
Summary
The prescription of an effective and welltolerated antituberculosis (TB) treatment regimen is an important step in the management of TB. The WHO documented that the incidence of TB worldwide in 2015 was 10.4 million cases, with 5.9 million cases were in men and one million cases in children [1]. Some studies have evaluated FDC versus SDF in the management of PTB [6,7], but to the best of our knowledge, no study has previously evaluated FDC regimen versus SDF in EPTB in our locality, so this study was performed aiming at evaluating efficacy, safety, compliance, and adverse effects of FDC versus SDF in both PTB and EPTB
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