A study of adverse drug reactions in patients receiving treatment for multi-drug resistant tuberculosis

Shinde, Mayur P.; Halasawadekar, Nimish R.; Ramanand, Sunita J.; Pore, Shraddha M.; Ramanand, Jayprakash B.; Patil, Praveenkumar T.; Kumbhar, Arvind V.

doi:10.18203/2319-2003.ijbcp20170329

Cited by 3 publications

(4 citation statements)

References 3 publications

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“…In addition, ADRs were reported through real-time spontaneous reporting system by a physician in a study conducted by Shinde et al . [ 15 ] Whereas, in the present study, data of only patients hospitalized for a complaint of ADRs were gathered which could have resulted in underreporting of minor ADRs in some patients.…”

Section: Discussionmentioning

confidence: 91%

“…Same sets of ADRs were also reported in a study done by Kapadia et al ., Hoa et al ., Akshata et al ., and Shinde et al . [ 12 13 14 15 ]…”

Section: Discussionmentioning

confidence: 99%

“…Rest of the ADRs were classified as 82 ADRs (34.74%) as “Probable” ADRs and 125 ADRs (52.96%) as “Possible” ADRs which was conflicting to the study conducted by Shinde et al . [ 15 ] and Hire et al . [ 10 ]…”

Section: Discussionmentioning

confidence: 99%

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Ambispective study of adverse drug reactions in multi-drug resistant tuberculosis patients in Warangal, Telangana

Fatima¹,

Syeda²,

Adla³

et al. 2021

Lung India

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Background: Multidrug-resistant tuberculosis (MDR-TB) has become a global threat concerning to a risk of high mortality with the potential to cause adverse drug reactions (ADRs) which if not managed properly may affect patient compliance, resulting in below par treatment outcome. Aim: The aim of the study was to study, assess, and report the ADRs of patients diagnosed with MDR-TB. Subjects and Methods: An ambispective, observational study was conducted among confirmed cases of MDR-TB patients without any comorbidities during the period of January 2015–December 2018 in patients of age 15 years and above. Statistical Analysis: Data were analyzed descriptively using MS-Excel sheet 2013 and Chi-square test in GraphPad Prism 8.2.1. Results were expressed as either frequency, percentage, or mean ± standard deviation. ADRs were evaluated for causality, severity, and preventability attributes. Results: In the sample size of 400 patients, 236 (ADRs) were reported among 136 patients. The proportion of ADRs was higher in males ( P = 0.0001) and in the age group of 36–75 years ( P = 0.0211). Most commonly encountered ADRs include nausea and vomiting (35.31%) and arthralgia (14.04%), followed by peripheral neuropathy (8.93%) and giddiness (8.93%). Overall, 53% were of possible category and 60% of moderate level severity and 85% were unpreventable ADRs. Conclusion: Our study included 13 types of ADRs, of which most commonly reported were nausea and vomiting, arthralgia, and peripheral neuropathy and least common were psychosis, nephrotoxicity, and gynecomastia with a higher incidence in males. Majority of ADRs were moderate, unpreventable ADRs and had a possible relationship with the suspected drugs.

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Section: Discussionmentioning

confidence: 91%

“…Same sets of ADRs were also reported in a study done by Kapadia et al ., Hoa et al ., Akshata et al ., and Shinde et al . [ 12 13 14 15 ]…”

Section: Discussionmentioning

confidence: 99%

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Ambispective study of adverse drug reactions in multi-drug resistant tuberculosis patients in Warangal, Telangana

Fatima¹,

Syeda²,

Adla³

et al. 2021

Lung India

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“…[17][18][19][20][21][22] Penelitian di India oleh Sinde dkk dan Rathod dkk serta Sturdy dkk di Inggris juga mendapatkan hasil yang hampir sama. 19,20,23 Beberapa faktor yang diduga berpengaruh terhadap perbedaan prevalens TB pada laki-laki dan perempuan antara lain perbedaan faktor hormonal, variasi genetik dan karakteristik lain seperti kebiasaan merokok, konsumsi alkohol, penyalahgunaan obat dan pajanan polusi. 24 Gangguan imunitas pada subjek dengan status gizi kurang menyebabkan rentan terhadap infeksi TB.…”

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The Prevalens of Ototoxicity in Drug Resistance Tuberculosis Patients and The Associated Factors at Persahabatan General Central Hospital

et al. 2019

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Background: The treatment of drug resistance tuberculosis needs second line injection antituberculosis drug that associated with irreversible ototoxic. The aim of this study is to know the prevalence of ototoxicity in tuberculosis drug resistance patients and the contributing factors. Methods: This is a cross sectional study among drug resistance TB patients who receive kanamysin or capreomycin as a part of drug regimen during intensive phase in January to September 2017 at Persahabatan hospital. Ototoxic defined according to American Speech Language and Hearing Association (ASHA) 1994 criteria by comparing baseline audiometric examination before treatment with current result. Results: Seventy-two patients were included in this study. The prevalence of ototoxicity was found in 34 patients (47,2%). Ototoxic found in 5 subjects (14,7%) during the first month of treatment and 19 subjects (56%) without hearing disturbance complain. Ototoxic in kanamisin group (47,9%) is more frequent compared with capreomisin (36,8%). Ototoxicity was associated with age, the risk increases 5% every 1 year older p=0,029 aOR:1,050 IK95% (1,005-1,096). The prevalences of ototoxicity are higher in diabetes and increasing serum creatinin patients but statistically not significance. Sex, body mass index, the history of using injectable antiTB drug, HIV status and total dosis were not associated with ototoxicity. Conclusion: Ototoxicity is common in intensive phase of drug resistance tuberculosis treatment. Further study needed to determine the association of contributing factors. (J Respir Indo. 2019; 39(3):180-95)

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Adverse Drug Reactions Among Drug-Resistant Tuberculosis Treatment: An Observational Cohort Study

Babu¹,

Robin²,

Babu³

et al. 2021

Int J Pharm Pharm Sci

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Objective: Adverse drug reaction (ADR) is regarded as one of the major challenges in the treatment of drug-resistant tuberculosis (DR-TB). It can lead to non-compliance or interrupting treatment completion, which can contribute to avoidable morbidity, drug resistance, treatment failure, reduced quality of life, or mortality. Methods: A retrospective cohort study was conducted in the Ernakulam district of Kerala from 2016 to 2019. All DR-TB patients registered under the DR-TB center were enrolled in the study. Due to privacy and confidentiality HIV infected patients and patients below 12 y of age were excluded in this study and only the data with ADR reported by patients is collected from medical records. Results: Out of the total 146 patients, about 75 % of patients experienced at least one ADR during treatment, and a total of 208 ADRs were reported. Among all the ADRs, the most common ADR was gastritis (12.98%) followed by ototoxicity (10%) and vomiting (5.76%), etc. It was found that males (78.76%) within the age group 46-65 y exhibited more ADR than females. Some of the ADR requires drug withdrawal and replacement with other drugs and most of the patients also needed symptomatic treatment without modifying the treatment regimen. All ADR reported were collected and causality assessment was done via WHO and Naranjo scale. The majority of ADR belongs to the “probable” category in the WHO scale and Naranjo scale. The evaluation of the severity of ADR by using the Modified Hartwig and Siegel scale indicated that most of the ADR was of moderate level showing a 4b reaction. The study also assessed the preventability of ADR using the Schumock and Thornton preventability scale. Conclusion: Many of the ADRs were unidentified or not reported due to several reasons like milder ADR, patient lack of knowledge, Negligence of symptoms, unawareness of health providers, etc. Whereas the long-term treatment and diversities in age, gender, etc. were found as major contributors to ADR along with comorbidities. New drugs in combination with existing drugs created the potential for previously unnotified reactions. Pharmacovigilance should address the safety of therapy and identify ADRs, especially the serious ones with routine monitoring to prevent mortality, morbidity, and other negative outcomes.

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A study of adverse drug reactions in patients receiving treatment for multi-drug resistant tuberculosis

Cited by 3 publications

References 3 publications

Ambispective study of adverse drug reactions in multi-drug resistant tuberculosis patients in Warangal, Telangana

Ambispective study of adverse drug reactions in multi-drug resistant tuberculosis patients in Warangal, Telangana

The Prevalens of Ototoxicity in Drug Resistance Tuberculosis Patients and The Associated Factors at Persahabatan General Central Hospital

Adverse Drug Reactions Among Drug-Resistant Tuberculosis Treatment: An Observational Cohort Study

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