Cargando…

A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India

OBJECTIVE: 1) To assess the adverse drug reactions (ADRs) of second-line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR-TB) in central India on the basis of causality, severity and avoidability scales. 2) To investigate the relationship of MDR-TB (primary or secondary) an...

Descripción completa

Detalles Bibliográficos
Autores principales: Hire, Rohan, Kale, A. S., Dakhale, G. N., Gaikwad, Nilesh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Università Cattolica del Sacro Cuore 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4165500/
https://www.ncbi.nlm.nih.gov/pubmed/25237474
http://dx.doi.org/10.4084/MJHID.2014.061
_version_ 1782335112360230912
author Hire, Rohan
Kale, A. S.
Dakhale, G. N.
Gaikwad, Nilesh
author_facet Hire, Rohan
Kale, A. S.
Dakhale, G. N.
Gaikwad, Nilesh
author_sort Hire, Rohan
collection PubMed
description OBJECTIVE: 1) To assess the adverse drug reactions (ADRs) of second-line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR-TB) in central India on the basis of causality, severity and avoidability scales. 2) To investigate the relationship of MDR-TB (primary or secondary) and the presence of diabetes mellitus (DM) with mean smear conversion time. Material and Methods: A prospective, observational study was carried out on diagnosed multidrug-resistant tuberculosis patients enrolled for DOTS-Plus regimen at TB and Chest Disease Department from January 2012 to December 2012 with a follow-up of nine months. Encountered ADRs were noted along with the time of sputum conversion. RESULTS: Total 64 ADRs were reported in 55 patients out of total 110 patients (n=110). As per the Naranjo causality assessment of ADRs, seven patients had definite, 45 had probable, and 3 had possible causal relation with drugs of DOTS-Plus regimen. As per the Hartwig’s severity assessment scale, there were total 7 ADRs in Level 1, 6 in Level 2, 33 in Level 3 and 9 in Level 4. Hallas avoidability assessment scale divided the ADRs as 3 being definitely avoidable, 26 possibly avoidable, 23 not avoidable and three not evaluable. Mean sputum smear conversion time was significantly higher in patients with a secondary type than that of primary type of MDR TB and in patients with DM than those without DM. CONCLUSION: ADRs were common in patients of MDR-TB on DOTs-Plus drug regimen. It was due to lack of availability of safer and equally potent drugs in DOTs-Plus drug regimen compared to DOTS regimen in non-resistant TB. The frequency and severity of ADRs can be reduced by strict vigilance about known and unknown ADRs, monitoring their laboratory and clinical parameters and instituting appropriate measures.
format Online
Article
Text
id pubmed-4165500
institution National Center for Biotechnology Information
language English
publishDate 2014
publisher Università Cattolica del Sacro Cuore
record_format MEDLINE/PubMed
spelling pubmed-41655002014-09-18 A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India Hire, Rohan Kale, A. S. Dakhale, G. N. Gaikwad, Nilesh Mediterr J Hematol Infect Dis Original Article OBJECTIVE: 1) To assess the adverse drug reactions (ADRs) of second-line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR-TB) in central India on the basis of causality, severity and avoidability scales. 2) To investigate the relationship of MDR-TB (primary or secondary) and the presence of diabetes mellitus (DM) with mean smear conversion time. Material and Methods: A prospective, observational study was carried out on diagnosed multidrug-resistant tuberculosis patients enrolled for DOTS-Plus regimen at TB and Chest Disease Department from January 2012 to December 2012 with a follow-up of nine months. Encountered ADRs were noted along with the time of sputum conversion. RESULTS: Total 64 ADRs were reported in 55 patients out of total 110 patients (n=110). As per the Naranjo causality assessment of ADRs, seven patients had definite, 45 had probable, and 3 had possible causal relation with drugs of DOTS-Plus regimen. As per the Hartwig’s severity assessment scale, there were total 7 ADRs in Level 1, 6 in Level 2, 33 in Level 3 and 9 in Level 4. Hallas avoidability assessment scale divided the ADRs as 3 being definitely avoidable, 26 possibly avoidable, 23 not avoidable and three not evaluable. Mean sputum smear conversion time was significantly higher in patients with a secondary type than that of primary type of MDR TB and in patients with DM than those without DM. CONCLUSION: ADRs were common in patients of MDR-TB on DOTs-Plus drug regimen. It was due to lack of availability of safer and equally potent drugs in DOTs-Plus drug regimen compared to DOTS regimen in non-resistant TB. The frequency and severity of ADRs can be reduced by strict vigilance about known and unknown ADRs, monitoring their laboratory and clinical parameters and instituting appropriate measures. Università Cattolica del Sacro Cuore 2014-09-01 /pmc/articles/PMC4165500/ /pubmed/25237474 http://dx.doi.org/10.4084/MJHID.2014.061 Text en This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Hire, Rohan
Kale, A. S.
Dakhale, G. N.
Gaikwad, Nilesh
A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India
title A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India
title_full A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India
title_fullStr A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India
title_full_unstemmed A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India
title_short A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India
title_sort prospective, observational study of adverse reactions to drug regimen for multi-drug resistant pulmonary tuberculosis in central india
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4165500/
https://www.ncbi.nlm.nih.gov/pubmed/25237474
http://dx.doi.org/10.4084/MJHID.2014.061
work_keys_str_mv AT hirerohan aprospectiveobservationalstudyofadversereactionstodrugregimenformultidrugresistantpulmonarytuberculosisincentralindia
AT kaleas aprospectiveobservationalstudyofadversereactionstodrugregimenformultidrugresistantpulmonarytuberculosisincentralindia
AT dakhalegn aprospectiveobservationalstudyofadversereactionstodrugregimenformultidrugresistantpulmonarytuberculosisincentralindia
AT gaikwadnilesh aprospectiveobservationalstudyofadversereactionstodrugregimenformultidrugresistantpulmonarytuberculosisincentralindia
AT hirerohan prospectiveobservationalstudyofadversereactionstodrugregimenformultidrugresistantpulmonarytuberculosisincentralindia
AT kaleas prospectiveobservationalstudyofadversereactionstodrugregimenformultidrugresistantpulmonarytuberculosisincentralindia
AT dakhalegn prospectiveobservationalstudyofadversereactionstodrugregimenformultidrugresistantpulmonarytuberculosisincentralindia
AT gaikwadnilesh prospectiveobservationalstudyofadversereactionstodrugregimenformultidrugresistantpulmonarytuberculosisincentralindia