Is there an increased risk of TB relapse in patients treated with fixed-dose combination drugs in Indonesia?
Int J Tuberc Lung Dis
; 12(2): 174-9, 2008 Feb.
Article
em En
| MEDLINE
| ID: mdl-18230250
ABSTRACT
SETTING:
South Sulawesi Province, Republic of Indonesia.OBJECTIVE:
To compare relapse rates among tuberculosis (TB) patients treated with fixed-dose combination drugs (FDCs) and patients treated with the same regimen using loose drugs.METHODOLOGY:
Between 1999 and 2001, new smear-positive TB patients were randomly allocated to treatment with four-drug FDCs or loose drugs to study differences in treatment outcomes. Although it was not in the original study design, in 2004-2005 we performed a follow-up study by home visit of cured patients. We conducted an interview and tried to collect a sputum sample from each patient. If the patient was absent or had died, a proxy interview was conducted. The sputum samples were examined by microscopy and culture.RESULTS:
The overall relapse rate was 7.0% in patients who were able to produce a sputum sample. Relapse appeared to be more frequent in the FDC group compared to the loose drug group (10.1% vs. 2.7%, P = 0.074).CONCLUSION:
This is the first documented long-term follow-up study of patients treated with four-drug FDCs. There is an indication that treatment of new sputum smear-positive TB patients with FDCs provides an increased risk of relapse compared to treatment with loose drugs. The long-term results of treatment with FDCs should be carefully evaluated in other settings.
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Bases de dados:
MEDLINE
Assunto principal:
Tuberculose Pulmonar
/
Antituberculosos
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
/
Female
/
Humans
/
Male
País/Região como assunto:
Asia
Idioma:
En
Revista:
Int J Tuberc Lung Dis
Ano de publicação:
2008
Tipo de documento:
Article
País de afiliação:
Indonésia