Adverse Drug Reactions and Outcome Analysis of MDR Tb Patients on Dots Plus Regimen

Authors

  • Vishakha K Kapadia AMCMET Medical College, Ahmedabad
  • Sanjay B Tripathi AMCMET Medical College, Ahmedabad

Keywords:

MDR TB, DOTS Plus, ADR, Cat IV

Abstract

Introduction: The emergence of drug resistant mycobacteria has become a significant public health problem world over creating an obstacle to effective TB control. Present study was conducted to evaluate pattern and frequency of adverse drug reactions (ADR) of CAT IV, to analyze demographic, radiological and bacteriological profile and treatment outcome in MDR TB patients.

Method: Total 102 MDR TB patients (with in vitro resistance to Isoniazid and Rifampicin) were analyzed retrospectively who had completed treatment from august 2007 to June 2014. Analysis was made for extent of lung lesion, correlation of sputum smear and culture conversion with clinical and radiological improvement, risk factors for adverse outcome and adverse drug reactions.

Result: Forty six patients (45.09%) were cured/treatment completed, nine patients (8.82%) failed, 21 patients (20.05%) defaulted and 26 patients (25.49%) died of total 102 patients. Mean time for sputum smear and culture conversion were 4.2±2.0 and 4.19±2.3 months, respectively. Advanced lung lesion, cavitations, poor adherence to treatment and BMI less than 18 are variables associated with poor outcome. Fifty (52.94%) patients experienced adverse drug reactions and 42 of them required drug modifications.

Conclusion: The ADRs were more common in the first 60 days of the regimen & in patient with BMI<18. Hence vigilant monitoring is required for these types of patients during the initial period. Sputum smear and culture conversion are very well correlated with clinical and radiological improvement.

References

Mohan A, Sharma SK. Epidemiology. In: Sharma SK, Mohan A, editors. Tuberculosis. New Delhi: Jaypee Brothers Medical Publishers; 2001 p. 14-29.

WHO MDR TB Factsheet (PDF) http://www.who.int/tb/challenges/mdr/mdr_tb_factsheet.pdf. Retrieved 9 May 2015.

Farmer, Paul (2001). "The Major Infectious Diseases in the World — to Treat or Not to Treat?". New England Journal of Medicine 345 (3): 208–10.

Ling DI, Zwerling AA, Pai M. GenoType MTBDR assays for the diagnosis of multi-drug resistant tuberculosis. Eur Respir J 2008; 32 : 1165-74.

Goble M, Iseman MD, Madsen LA, et al. Treatment of 171 patients with pulmonary tuberculosis resistant to isoniazid and rifampin. N Engl J Med 1993; 328:527 –532

Park MM, Davis AL, Schluger NW, et al. Outcome of MDR-TB patients, 1983–1993: prolonged survival with appropriate therapy. Am J Respir Crit Care Med. 1996; 153: 317–324

Park SK, Kim CT, Song SD. Outcome of chemotherapy in 107 patients with pulmonary tuberculosis resistant to isoniazid and rifampin. Int J Tuberc Lung Dis 1998; 2:877–884

Kritski AL, Rodrigues de Jesus LS, Andrade MK, et al. Retreatment tuberculosis cases: factors associated with drug resistance and adverse outcomes. Chest. 1997; 111:1162–1167

Fujiwara PI, Sherman LF. Multidrug-resistant tubercu-losis: many paths, same truth. Int J Tuberc Lung Dis .1997; 1:297–298

Singla R, et al. Seven-year DOTS-Plus pilot experience in India: results, constraints and issues. Int J Tuberc Lung Dis. 2009 Aug;13(8):976-81.

Johnston JC, Shahidi NC, Sadatsafavi M, Fitzgerald JM. Treatment outcomes of multidrug-resistant stu-berculosis: a systematic review and meta-analysis. PLoS One. 2009;4(9):e6914.

Malla P, Kanitz EE, Akhtar M, Falzon D, Feldmann K,8. Gunneberg C et al. Ambulatory-based standard-ized therapy for multidrug resistant tuberculosis: ex-perience from Nepal, 2005 -2006. PLoS One 2009; 4:08313

Törün T, Güngör G, Ozmen I, Bölükbaşi Y, Maden E, Biçakçi B, Ataç G, Sevim T, Tahaoğlu K. Side effects associated with the treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2005;9(12):1373-7.

Thomas A, Ramchandra R, Rehaman F, Jaggarajamma K, Santha T, Selvakumar N, et al. Management of mul-ti-drug resistant tuberculosis in the field- Tuberculosis Research Centre experience. Indian J Tuberc 2007: 54: 117-124

Wai yew W., Kuen Chan C, Hung Chau C, Cheuk Ming Tam C et al. Outcomes of Patients With Multidrug-Resistant Pulmonary Tuberculosis Treated With Of-loxacin/ Levofloxacin-Containing Regimens. Chest. 2000;117;744-751

Palmero DJ, Ambroggi M, Brea A et al. Treatment and follow up of HIV negative multi-drug resistant tuber-culosis patients in an infectious diseases referral hospi-tal, Buenos Aires, Argentina. Int J Tuberc Lung Dis. 2004; 8:779-784.

Suaraz PG, Floyd K, Portocarrero J et al. Feasibility and cost effectiveness of standardised second line drug treatment for chronic tuberculosis patients: A national cohort study in Peru . Lancet 2002; 359: 1980-1989

VK Arora, R Sarin, R Singla et al. DOTS-Plus for pa-tients with multi-drug resistant tuberculosis in India: Early results after three years. Indian J Chest Dis Allied Sci. 2007; 49: 75-79

International organization for migration tuberculosis working group. Outcome of second line tuberculosis treatment in migrants from Vietnam. Trop Med Int Health. 1998;3:975-980.

Geerligs WA, Van Altina R, De Lange WCM, Van Soolingen D, Vander Der werf TS. Multi-drug resistant tuberculosis: Long term treatment outcome in the Netherlands. Int J Tuberc Lung Dis. 2000; 4:758-764..

Tahaoglu K, Torun T, Sevim T et al. The treatment of multidrug resistant tuberculosis in Turkey. New Eng-land J Med. 2001; 345: 170-174.

D Falzon, E Jaramillo, HJ Schünemann et al. WHO guidelines for the programmatic management of drug-resistant tuberculosis: 2011 update. Eur Respir J. 2011;38:516–528

WHO Global tuberculosis report 2012World Health Organization, Geneva, Switzerland (2012)

SD Ahuja, D Ashkin, M Avendano et al. Multidrug resistant pulmonary tuberculosis treatment regimens and patient outcomes: an individual patient data me-ta-analysis of 9,153 patients PLoS Med. 2012;9:e1001300

D Falzon, N Gandhi, GB Migliori et al. Resistance to fluoroquinolones and second-line injectable drugs: im-pact on MDR-TB outcomes Eur Respir. 2012.

S Olson, RA English, RS Guenther, AB Claiborne Facing the reality of drug-resistant tuberculosis in India: chal-lenges and potential solutions. Summary of a joint workshop by the Institute of Medicine, the Indian Na-tional Science Academy, and the Indian Council of Medical Research National Academies Press (US), Washington DC (2012)

Downloads

Published

2016-01-31

How to Cite

1.
Kapadia VK, Tripathi SB. Adverse Drug Reactions and Outcome Analysis of MDR Tb Patients on Dots Plus Regimen. Natl J Community Med [Internet]. 2016 Jan. 31 [cited 2024 Apr. 29];7(01):5-9. Available from: https://www.njcmindia.com/index.php/file/article/view/843

Issue

Section

Original Research Articles