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Adverse drug reaction profile of daily regimen antituberculosis treatment
OBJECTIVES: The objective was to estimate the proportion of adverse drug reactions (ADRs) to daily regimen antituberculosis treatment (ATT) among the ADRs received in the ADR monitoring center (AMC) of the institution and to describe its pattern. MATERIALS AND METHODS: This was a descriptive study c...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer - Medknow
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635344/ https://www.ncbi.nlm.nih.gov/pubmed/36337372 http://dx.doi.org/10.4103/picr.PICR_279_20 |
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author | Sankar, K. N. Hari Roch, Kevin Jom, Doyce Palappallil, Dhanya S. Panattil, Prabitha Sankaranarayanan, Rajani K. |
author_facet | Sankar, K. N. Hari Roch, Kevin Jom, Doyce Palappallil, Dhanya S. Panattil, Prabitha Sankaranarayanan, Rajani K. |
author_sort | Sankar, K. N. Hari |
collection | PubMed |
description | OBJECTIVES: The objective was to estimate the proportion of adverse drug reactions (ADRs) to daily regimen antituberculosis treatment (ATT) among the ADRs received in the ADR monitoring center (AMC) of the institution and to describe its pattern. MATERIALS AND METHODS: This was a descriptive study conducted in the Department of Pharmacology of a Government Medical College in Central Kerala and the period under study was October 2017–June 2020. The data on ADR were entered into a structured pro forma and data were analyzed using SPSS for Windows Version 16.0 (SPSS Inc., Chicago, USA). RESULTS: Of the 643 ADRs, 98 (15.24%) were suspected to be due to the daily regimen of ATT. The most common organ system affected was hepatobiliary 46 (46.9%) namely hepatitis in 35 and asymptomatic elevated liver enzymes in 11 followed by eye with 26 reports of decreased vision. In 96 (97.95%), the suspected ADR had probable causality and in 2 (2.04%) it was possible. Seventy-seven (78.6%) ADR reports were serious as well as moderate-level 4b in severity and 57 (58.16%) were probably preventable. The mean days of onset of ADR after starting the ATT regimen were 56.40 ± 58.29 days (range 1–180). Decrease in vision with a mean duration of 125.23 ± 55.46 days had the longest latency in onset among all the ADRs. CONCLUSIONS: Of all the ADRs reported to AMC 15.24% were due to the daily regimen of ATT. Hepatitis was the most common ADR encountered followed by decrease in vision. The majority of the ADRs were probable in causality, serious, moderate-level 4b in severity, and probably preventable. |
format | Online Article Text |
id | pubmed-9635344 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Wolters Kluwer - Medknow |
record_format | MEDLINE/PubMed |
spelling | pubmed-96353442022-11-05 Adverse drug reaction profile of daily regimen antituberculosis treatment Sankar, K. N. Hari Roch, Kevin Jom, Doyce Palappallil, Dhanya S. Panattil, Prabitha Sankaranarayanan, Rajani K. Perspect Clin Res Original Article OBJECTIVES: The objective was to estimate the proportion of adverse drug reactions (ADRs) to daily regimen antituberculosis treatment (ATT) among the ADRs received in the ADR monitoring center (AMC) of the institution and to describe its pattern. MATERIALS AND METHODS: This was a descriptive study conducted in the Department of Pharmacology of a Government Medical College in Central Kerala and the period under study was October 2017–June 2020. The data on ADR were entered into a structured pro forma and data were analyzed using SPSS for Windows Version 16.0 (SPSS Inc., Chicago, USA). RESULTS: Of the 643 ADRs, 98 (15.24%) were suspected to be due to the daily regimen of ATT. The most common organ system affected was hepatobiliary 46 (46.9%) namely hepatitis in 35 and asymptomatic elevated liver enzymes in 11 followed by eye with 26 reports of decreased vision. In 96 (97.95%), the suspected ADR had probable causality and in 2 (2.04%) it was possible. Seventy-seven (78.6%) ADR reports were serious as well as moderate-level 4b in severity and 57 (58.16%) were probably preventable. The mean days of onset of ADR after starting the ATT regimen were 56.40 ± 58.29 days (range 1–180). Decrease in vision with a mean duration of 125.23 ± 55.46 days had the longest latency in onset among all the ADRs. CONCLUSIONS: Of all the ADRs reported to AMC 15.24% were due to the daily regimen of ATT. Hepatitis was the most common ADR encountered followed by decrease in vision. The majority of the ADRs were probable in causality, serious, moderate-level 4b in severity, and probably preventable. Wolters Kluwer - Medknow 2022 2021-07-12 /pmc/articles/PMC9635344/ /pubmed/36337372 http://dx.doi.org/10.4103/picr.PICR_279_20 Text en Copyright: © 2021 Perspectives in Clinical Research https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. |
spellingShingle | Original Article Sankar, K. N. Hari Roch, Kevin Jom, Doyce Palappallil, Dhanya S. Panattil, Prabitha Sankaranarayanan, Rajani K. Adverse drug reaction profile of daily regimen antituberculosis treatment |
title | Adverse drug reaction profile of daily regimen antituberculosis treatment |
title_full | Adverse drug reaction profile of daily regimen antituberculosis treatment |
title_fullStr | Adverse drug reaction profile of daily regimen antituberculosis treatment |
title_full_unstemmed | Adverse drug reaction profile of daily regimen antituberculosis treatment |
title_short | Adverse drug reaction profile of daily regimen antituberculosis treatment |
title_sort | adverse drug reaction profile of daily regimen antituberculosis treatment |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635344/ https://www.ncbi.nlm.nih.gov/pubmed/36337372 http://dx.doi.org/10.4103/picr.PICR_279_20 |
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