Adverse Drug Reactions and Associated Socio-demographic Factors amongst Drug-resistant Tuberculosis Patients: A Retrospective Review
Background: Drug-resistant tuberculosis (DR-TB) needed prolonged treatment using the majority of second-line drugs (SLDs). Most of SLDs are reported to be associated with a higher rate of adverse drug reactions (ADRs), which may be a deterrent to treatment compliance. Hence, timely and intensive mon...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2025-01-01
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| Series: | Journal of Medical Evidence |
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| Online Access: | https://journals.lww.com/10.4103/JME.JME_118_22 |
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| author | Rajesh Tiwari Aditi Bharti Akanksha Tomar |
| author_facet | Rajesh Tiwari Aditi Bharti Akanksha Tomar |
| author_sort | Rajesh Tiwari |
| collection | DOAJ |
| description | Background:
Drug-resistant tuberculosis (DR-TB) needed prolonged treatment using the majority of second-line drugs (SLDs). Most of SLDs are reported to be associated with a higher rate of adverse drug reactions (ADRs), which may be a deterrent to treatment compliance. Hence, timely and intensive monitoring and management of ADR are essential components of the programmatic management of DR-TB (PMDT) to enhance treatment outcomes.
Aim:
This study aimed to evaluate the occurrence, management and risk factors for ADRs in DR-TB patients, and its association with treatment outcomes at a designated DR-TB Centre.
Patients and Method:
A record-based review was conducted at the district DR-TB Centre, Jabalpur, Madhya Pradesh. Study participants included patients enrolled under PMDT guidelines from January 2018 to December 2019. Conventional multidrug-resistant TB patients and transferred-out cases were excluded. Data collection and review were done through the NIKSHAY portal, PMDT treatment cards, ward DR-TB registers and case sheets traced by NIKSHAY ID. The severity of ADR was assessed using the Modified Scale of Hartwig and Siegel into mild, moderate and severe. Data were analysed using IBM SPSS software version 20. Chi-square test and t-test were applied, with a 95% confidence interval considering P ≤ 0.05 to be significant.
Results:
Out of 221 DR-TB patients, 42 patients reported at least one ADR (19%). Amongst these, a total of 78 episodes were reported during their course of treatment. Most frequent ADRs were related to the gastrointestinal system (47.5%), followed by weakness (17.9%) and jaundice or body aches (7.7% each). Most (73.1%) of the ADRs were mild to moderate while only 26.9% were severe on Hartwig and Siegel scale. Successful treatment outcome (cured and treatment completed) is reported to be 61.1% overall while only 35.7% amongst those reporting ADR. Moreover, treatment outcomes and low socio-economic status were statistically significant with ADRs.
Conclusion:
In this study, ADR is found to be reported by one-fifth of the patients. All were successfully managed without requiring any change of regime. However, reporting an ADR is significantly associated with unsuccessful treatment outcomes of DR-TB. |
| format | Article |
| id | doaj-art-6a63ef5f23274b6d92afb8c4a8ccab9b |
| institution | DOAJ |
| issn | 2667-0720 2667-0739 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Medical Evidence |
| spelling | doaj-art-6a63ef5f23274b6d92afb8c4a8ccab9b2025-08-20T03:09:12ZengWolters Kluwer Medknow PublicationsJournal of Medical Evidence2667-07202667-07392025-01-01614910.4103/JME.JME_118_22Adverse Drug Reactions and Associated Socio-demographic Factors amongst Drug-resistant Tuberculosis Patients: A Retrospective ReviewRajesh TiwariAditi BhartiAkanksha TomarBackground: Drug-resistant tuberculosis (DR-TB) needed prolonged treatment using the majority of second-line drugs (SLDs). Most of SLDs are reported to be associated with a higher rate of adverse drug reactions (ADRs), which may be a deterrent to treatment compliance. Hence, timely and intensive monitoring and management of ADR are essential components of the programmatic management of DR-TB (PMDT) to enhance treatment outcomes. Aim: This study aimed to evaluate the occurrence, management and risk factors for ADRs in DR-TB patients, and its association with treatment outcomes at a designated DR-TB Centre. Patients and Method: A record-based review was conducted at the district DR-TB Centre, Jabalpur, Madhya Pradesh. Study participants included patients enrolled under PMDT guidelines from January 2018 to December 2019. Conventional multidrug-resistant TB patients and transferred-out cases were excluded. Data collection and review were done through the NIKSHAY portal, PMDT treatment cards, ward DR-TB registers and case sheets traced by NIKSHAY ID. The severity of ADR was assessed using the Modified Scale of Hartwig and Siegel into mild, moderate and severe. Data were analysed using IBM SPSS software version 20. Chi-square test and t-test were applied, with a 95% confidence interval considering P ≤ 0.05 to be significant. Results: Out of 221 DR-TB patients, 42 patients reported at least one ADR (19%). Amongst these, a total of 78 episodes were reported during their course of treatment. Most frequent ADRs were related to the gastrointestinal system (47.5%), followed by weakness (17.9%) and jaundice or body aches (7.7% each). Most (73.1%) of the ADRs were mild to moderate while only 26.9% were severe on Hartwig and Siegel scale. Successful treatment outcome (cured and treatment completed) is reported to be 61.1% overall while only 35.7% amongst those reporting ADR. Moreover, treatment outcomes and low socio-economic status were statistically significant with ADRs. Conclusion: In this study, ADR is found to be reported by one-fifth of the patients. All were successfully managed without requiring any change of regime. However, reporting an ADR is significantly associated with unsuccessful treatment outcomes of DR-TB.https://journals.lww.com/10.4103/JME.JME_118_22adverse drug reactionsdrug-resistant tuberculosisoutcometreatment |
| spellingShingle | Rajesh Tiwari Aditi Bharti Akanksha Tomar Adverse Drug Reactions and Associated Socio-demographic Factors amongst Drug-resistant Tuberculosis Patients: A Retrospective Review Journal of Medical Evidence adverse drug reactions drug-resistant tuberculosis outcome treatment |
| title | Adverse Drug Reactions and Associated Socio-demographic Factors amongst Drug-resistant Tuberculosis Patients: A Retrospective Review |
| title_full | Adverse Drug Reactions and Associated Socio-demographic Factors amongst Drug-resistant Tuberculosis Patients: A Retrospective Review |
| title_fullStr | Adverse Drug Reactions and Associated Socio-demographic Factors amongst Drug-resistant Tuberculosis Patients: A Retrospective Review |
| title_full_unstemmed | Adverse Drug Reactions and Associated Socio-demographic Factors amongst Drug-resistant Tuberculosis Patients: A Retrospective Review |
| title_short | Adverse Drug Reactions and Associated Socio-demographic Factors amongst Drug-resistant Tuberculosis Patients: A Retrospective Review |
| title_sort | adverse drug reactions and associated socio demographic factors amongst drug resistant tuberculosis patients a retrospective review |
| topic | adverse drug reactions drug-resistant tuberculosis outcome treatment |
| url | https://journals.lww.com/10.4103/JME.JME_118_22 |
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