RT Journal Article
SR Electronic
T1 Antituberculosis fixed multi-dose combination and single drug therapy in active tuberculosis: What is the benefit?
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP p4409
VO 38
IS Suppl 55
A1 Amina Kotti
A1 Hafaoua Daghfous
A1 Wafa Bouhawel
A1 Olfa Kahloul
A1 Fatma Tritar
A1 Fatma Tritar
YR 2011
UL http://erj.ersjournals.com/content/38/Suppl_55/p4409.abstract
AB Background: Fixed dose combinations (FDCs) in tuberculosis (TB) therapy reduce the number of tablets to be consumed, simplify the medication regimen and potentially improve compliance.Aim of study: Compare the efficacy and acceptability of anti-TB FDCs as single tablets (ST) in patients with active TB.Patients and methods: A total of consecutive 94 patients (57 men and 37 women; mean age 38,1±3,3 years) were randomly distributed into 2 groups: trial group (n= 41) patients treated daily with anti-TB FDCs and control group (n= 53) treated with standardized regimen (single tablets).Results: Stratified analyses showed a similar pattern for all the group dermographic, clinical and radiologic finding. The dosage of isoniazid, pyrazinamid and ethambutol was adequate in all patients. For rifampicin, dosage was statistically too low in trial group (p= 0,04). Serious adverse events were noted in 39% cases of trial group vs 11,5% cases in control group. According of cutaneous reactions (7,3% vs 5,7%) and toxic hepatitis (7,3% vs 3,7%) there was no statistically difference in 2 groups. Hematologic effects (21% vs 0%) were stastically higher in trial group (p= 0,018). All patients had a successful outcome. At 2 months of treatment, 50% of patients in trial group achieved sputum conversion vs 43% patients in control group without statistically significant difference. Radiologic sequellae was noted in 51% in trial group vs 36% in control group.Conclusion: The efficacy of the anti-TB FDCs regimen was non-inferior to that of the standardized regimens. But, hematologic effects were significantly higher in the group of patients treated with anti-TB FDCs.