Adverse drug reactions and treatment outcome analysis in multidrug resistant tuberculosis patients at a DOTS plus site
Keywords:Adverse drug reaction, ADR management, DOTS plus, MDR TB, RNTCP
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.
Dela AI, Tank ND, Singh AP, Piparva KG. Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study. Lung India. 2017;34(6):522-6.
Akshata JS, Chakraborty A, Swapna R, Buggy S, Somashekar M. Adverse drug reactions in management of multi drug resistant tuberculosis, in tertiary chest institute. J Tuber Res. 2015;3:27-33.
Patel SV, Bhikhubhai NK, Shringarpure KS, Mehta KG, Shukla LK. Adverse drug reactions in patients put on multi drug resistant tuberculosis (MDR-TB) treatment in seven districts of Central Gujarat. J Young Phar. 2015;7:425-31.
World Health Organization, Global Tuberculosis Report, Geneva; 2012.
World Health Organization, Multidrug and extensively drug resistant tuberculosis; 2010 global report on surveillance and response, Geneva: WHO; 2010.
Iseman MD. Treatment of multi drug resistant tuberculosis. N Engl J Med. 1993;329:784-91.
Drobniewski FA, Balabanova YM. The diagnosis and management of multi drug resistant tuberculosis at the beginning of the new millennium. Int J Infect Dis. 2002;6(1):521-31.
Central TB Division DGHS, Ministry of Health and Family Welfare. DOTS plus guidelines. New Delhi; 2010.
Holtz TH. XDR TB in South Africa; Revised definition. PloS Med. 2007;4(4):161.
Bhatt GS, Vyas S. Epidemiological study of multi drug resistant cases registered under revised national tuberculosis programme of Ahmedabad city. Ahmedabad, Gujarat university; 2010.
Datta BS, Hassan G, Kadri SM, Qureshi W, Kamili MA, Singh H. Multidrug resistant and extensively drug resistant tuberculosis in Kashmir, India. J Infect Dev Countries. 2010;4(1):19-23.
Cavanaugh JS, Kazennyy BY, Nguyen ML, Kiryanova EV, Vitek E, Khorosheva TM. Outcome and follow up of patients treated for multi-drug resistant tuberculosis in Orel, Russia. Int J Tubercul Lung Dis. 2012,16(8):1069-74.
Chiang CY, Enarson DA, Yu MC, Bai KJ, Huang RM, Hsu CJ, et al. Outcome of pulmonary multi drug resistant tuberculosis, A 6 year follow up study. Eur Respir J. 2006;28(5):980-5.
Nathanson E, Gupta R, Huamani P, Leimane V, Pasechnikov AD, Tupasi TE. Adverse events in the treatment of multidrug resistant tuberculosis, results from the DOTS plus initiative. Int J Tubercul Lung Dis. 2004;8(11):1382-4.
Pauline J, Desai VB, Mohan NS, Fedrick JS, Ramchandran R, Raman B. Outcome of standardized treatment for patients with MDR TB from Tamil Nadu, India. Indian J Med Res. 2011;133(5):529-34.
Arora VK, Sarin R, Singla R, Khalid UK, Mathuria K, Singla N, et al. DOTS plus for with multi drug resistant tuberculosis in India. Early results after three years. Indian J Chest Dis Allied Sci. 2007;49(20):75-9.
Lewis WC, Calden G, Thurston JR, Gilson WE. Psychiatric and neurological reactions to cycloserine in the treatment of tuberculosis. Dis Chest. 1957;32:172-82.
Snavely SR, Hodges GR. The neurotoxicity of antibacterial agents. Ann Intern Med. 1984;101:92-104.