Abstract
BACKGROUND: Use of fixed-dose combinations(FDCs) of tablets against tuberculosis(TB)is now being recommended by WHO .However,the composition and dosage recommendations for FDCs differ from those for separate formulations.
OBJECTIVE: Compare drug hypersensitivity reactions of anti-TB FDCs as single tablets(ST)in patients with active TB.
METHODS: Retrospective study including 560 patients,divided into: Group1(G1 n=250) treated daily with FDCs (rifampicin,isoniazid , ethambutol, pyrazinamid)during 2months and FDCs(rifampicin, isoniazid)during 4months and Control group(G2 n= 290) treated with standardized regimen(2HRZE/4HR).
RESULTS: The mean age was 38,1years and active pulmonary TB was predominant in 2groups.Drug hypersensitivity reaction was noted in respectively 13,2%(G1) and 14,8 %(G2). Urticarial reactions was the most adverse effect noted in 28,2%(12,4%vs15,8%).According of the adverse effects there was no statistically difference except hematologic effects:Thrombopenia and leucopenia were stastically higher in patients treated with FDCs (p=0,018).Pyrazinamide was implicated in most cases(55.8%vs 47%, p<0,05),followed by isoniazid (G1:27.9%vs23% p< 0,05).Comparing the dose of Isoniazid, Rifampicin,Pyrazinamid and Ethambutol in the 2 groups, there was a significant difference in doses of Isoniazid and Rifampicin.For rifampicin,dosage was statistically low for patients treated with FDCs (p=0,04).
CONCLUSION: Adverse drug reaction anti-TB drugs whatever form is not an uncommon. Hematologic effects significantly higher in patients treated with FDCs and Significant difference in doses of Isoniazid and Rifampicin can be the reason of these.
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