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Background - The introduction of fixed-dose combinations (FDCs) of TB treatment in Tunisia is recent (July 2009). WHO and the National Tuberculosis Programme recommend the use of fixed-dose combination (FDC) tablets for the treatment of tuberculosis (TB). The effectiveness of ADF has been demonstrated, however the risk of relapse and tolerance were controversial. Objective - Through a retrospective study, we evaluate, the contribution of FDCs compared with dissociated treatment (TD) (efficacy, tolerance and the occurrence of relapses). Patients and methods - This is a retrospective study conducted in the Department of Pneumology la Rabta. Are included patients with pulmonary tuberculosis (TB) first attack. Two groups were studied: Group I (TC) treated between July 2009 and June 2011 who received ADF. Group II (TD) treated between July 2008 and June 2009 who received TB dissociated treatment. Results - One hundred and seventy one patients were included: 122 in the TC group with an average age of 39.2 years and 49 patients in the TD group with an average age of 38.2 years. Male predominance was observed in the two groups (82/75.5%). The period of apyrexia was below 7 days at more than 80% of patients in the two groups. Sputum smears conversion were obtained between one and two months (median 52,8 vs 55,8 days) in both groups with no significant difference (p = 0.06). The rate of smears conversion at 2 months was 74% in TC group versus 65.3 % (p = 0.12). Eighty patients (65%) of the TC group and 29 patients (59%) of the TD group had one or more adverse effects to treatment without significant difference (p = 0.270). The most common adverse effects were those related to digestive system (17.2% vs 6.1%), liver toxicity (7.4% vs 4.1 %) and urticaria (9.8% vs 8.1%). The treatment successful rate was: 73.7 % in TC group and 77.5 % in TD group. There was no significant difference in treatment compliance, neither in relapse rate nor in the death rate. Conclusion - This study demonstrated non-inferiority of the effectiveness of ADF with a comparable safety. Its effects in the prevention of relapse and resistance BK remain unproven.
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