Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study

Dela, Arif I; Tank, Nitish; Singh, A. P.; Piparva, Kiran G

doi:10.4103/0970-2113.217569

Cited by 49 publications

(65 citation statements)

References 8 publications

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“…Present findings confirm with those of Dela et al where 96% of total MDR cases were in the retreatment group as compared to 4% new cases. 1 In present study 9 cases (9.09%) had co morbidities like HIV and DM which was similar to the study by Dela et al in which 7.2% had these co morbidities. 1 In present study 90 cases (90.90%) had treatment adherence as compared to only 9 cases (9.09%) who had no good treatment adherence, thus showing a very efficiently functioning DOTs programme follow up, monitoring and supervision.…”

Section: Discussionsupporting

confidence: 91%

“…3 Due to all these factors MDR patients on treatment are more prone to various ADRs resulting in dropouts, insufficient treatment and thereby low success rates. 1 In present study the majority of patients (46.46%) were in the age group of 30-50 years with mean±standard deviation 36.82±14.47. Of the study subjects 59 males (59.59%) 1,3,12,13 In present study MDR TB was diagnosed in 92 retreatment cases (92.92%) that is, who had already received the first line anti tubercular drugs in the past and where cases of default, treatment failure or relapsed after treatment.…”

Section: Discussionmentioning

confidence: 48%

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Adverse drug reactions and treatment outcome analysis in multidrug resistant tuberculosis patients at a DOTS plus site

Velingker

Lawande

2020

Int J Basic Clin Pharmacol

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Background: Multidrug resistant tuberculosis (MDR TB) requires treatment with expensive, toxic, anti-tubercular drugs over a longer duration. Adverse drug reaction (ADR) to second line anti tubercular drugs affect compliance and hence treatment outcome. The primary objective of this study was to analyse ADRs and if these resulted in change or permanent suspension of drug. We also analysed treatment outcome, treatment adherence and co morbidities associated with MDR patients.Methods: A retrospective study was carried out at DOTS plus site in department of Pulmonary Medicine, Goa Medical College on registered MDR cases from November 2011 to October 2016. Socio demographic profile, diagnosis, treatment and ADRs were evaluated, ADRs were evaluated for frequency, causative drugs, management aspect and impact on treatment outcome.Results: Out of 201 MDR cases, 99 cases had 167 ADRs. Majority of patients having ADRs were in age group of 30-50 years with mean±standard deviation 36.82±14.47, 59 (59.59%) males and 40 (40.40%) females, 92 (92.92%) retreatment cases and 7 (7.07%) newly diagnosed. Majority of ADRs were vomiting 31(18.56%), joint pain 31 (18.56%), gastritis 21 (12.57%), hearing impairment 16 (9.58%), numbness in leg 14 (8.38%), depression 12 (7.18%). Treatment outcome of cases with ADR was cured 45 (45.45%), treatment completed16 (16.16%), progressed to XDR 6 (6.06%), transferred out 5 (5.05%), defaulter 14 (14.14%), death 13 (13.13%).Conclusions: It is very important to recognise at the earliest and treat the ADRs with least modification of the treatment regimen to have a good treatment outcome.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 48%

Adverse drug reactions and treatment outcome analysis in multidrug resistant tuberculosis patients at a DOTS plus site

Velingker

Lawande

2020

Int J Basic Clin Pharmacol

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“…Using hallas avoidability assessment scale, 51 ADRs were classified as 'not avoidable', 40 ADRs were 'possibly avoidable', 5 ADRs were 'not evaluable', and 2 were 'definitely avoidable' (Table 7). [4][5][6][7] Hepatotoxicity is defined as 1.5 times rise in pretreatment alanine transaminase (ALT) levels. Jaundice or hepatitis comprised of 8.16% of all ADR.…”

Section: Inclusion Criteriamentioning

confidence: 99%

An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India

Lakhani¹,

Singh²,

Barua³

et al. 2019

Int J Res Med Sci

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Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months at a tertiary care hospital. The patients with MDR tuberculosis on treatment with DOTS Plus regimen under RNTCP and who met the inclusion exclusion criteria were recruited after informed consent. ADRs were monitored daily till the patients remained admitted and thereafter monthly. Predisposing factors were recorded. Causality assessment was performed by Naranjo scale and WHO UMC scale, severity by Hartwig’s scale and avoidability by Halla’s scale.Results: There were 115 patients were recruited, 70 developed at least one ADR. 98 ADRs were reported. The commonest ADR reported were – gastrointestinal (38.76%), neurological (21.24%) and hepatobiliary (8.16%). Diabetes and HIV predisposed to development of ADRs. 58.18% ADRs were classified as possible and 37.5% as probable by Naranjo’s scale. 51.02% ADRs were classified as probable and 42.83% as possible by WHO-UMC. 56% were classified as mild, 36% moderate, and 6% severe via Hartwig’s scale. 51 ADRs were classified as avoidable and 40 ADRs were possibly avoidable.Conclusions: Monitoring and assessment of ADRs is necessary to promote awareness, curb resistance and maintain adherence.

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“…This is corroborated with the other studies like Sangeta V et al, 6 Rohan Hire et al, 7 Dela AI. 8 A large number of patients in the present study (67%) had complaint of arthralgia. This was in contrast to previous studies done by Nathanson et al, 9 Sangeta et al, 6 Hire et al 7 and Dela AI 8 where only few patients experienced minor joint pain.…”

Section: Discussionmentioning

confidence: 61%

A Study on Adverse Drug Reaction Profile of 2nd Line Drugs in Multi Drug Resistant (MDR) and Extensively Drug Resistant (XDR) Tuberculosis Cases Registered under DR-TB Centre in a Tertiary Care Hospital

Mahata¹,

A²,

Sen³

et al. 2020

jemds

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BACKGROUND The emergence of drug resistant mycobacterium has become a significant public health problem creating an obstacle to effective tuberculosis (TB) control. Freedom from TB is possible with timely, regular, complete treatment, with assurance, prevention and management of side effects of antitubercular drugs. Present study was conducted to evaluate common and rare adverse drug reactions (ADR) of CAT IV and CAT V to analyse demographic, radiological and bacteriological profile and treatment outcome in MDR & XDR patients. We wanted to evaluate the common and rare adverse drug reactions of intensive phase treatment of Multi Drug Resistant Tuberculosis (MDR) and Extensively Drug Resistant Tuberculosis (XDR) as per WHO-UMC Causality Assessment Scale. METHODS 76 patients of MDR and XDR Tuberculosis were admitted in DR-TB (Drug Resistant TB) centre, Burdwan Medical College and Hospital and the adverse drug reaction profile of 2 nd line drugs were analysed during the intensive phase from April 2016 to September 2017 after fulfilling the inclusion and exclusion criteria. Treatment was given as per the guidelines of Revised National TB Control Program PMDT (Programmatic Management of Drug-Resistant TB). RESULTS Adverse drug reactions on GI system were nausea 73 patients (96.10%), vomiting 70 (92.10%), acidity 41 (53.9%), and sulphurous belching and hepatitis 1 (1.31%) each. Peripheral neuropathy, hearing deficit, myopathy, skin rashes, hepatitis, nephrotoxicity, cardiac toxicity and convulsion were also observed. In psychosis, 3 (3.95%) had depression and made suicidal attempt. 1 each (1.31%) in hallucination and paranoia. 5 patients (6.58%) had blurring of vision, 2 patients (3.95%) had redness of eyes and one (1.31%) had eye irritation. Reactions were common in first 60 days of the regimen and in patients with BMI ≤18. CONCLUSIONS Vigilant monitoring is required for these patients during the initial period and sputum smear and culture conversion is very well correlated with clinical and radiological improvement.

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Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study

Cited by 49 publications

References 8 publications

Adverse drug reactions and treatment outcome analysis in multidrug resistant tuberculosis patients at a DOTS plus site

Adverse drug reactions and treatment outcome analysis in multidrug resistant tuberculosis patients at a DOTS plus site

An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India

A Study on Adverse Drug Reaction Profile of 2nd Line Drugs in Multi Drug Resistant (MDR) and Extensively Drug Resistant (XDR) Tuberculosis Cases Registered under DR-TB Centre in a Tertiary Care Hospital

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