|Year : 2014 | Volume
| Issue : 2 | Page : 63-67
The profile and treatment outcomes of sputum smear positive pulmonary tuberculosis re-treatment cases, in a district medical college of West Bengal, India
Abinash Agarwala1, Kaushik Saha2, Shelley Shamim3, Partha Pratim Roy1
1 Department of Pulmonary Medicine, Mednipore Medical College, Medinipur, India
2 Departments of Pulmonary Medicine, Burdwan Medical College and Hospital, Kolkata, West Bengal, India
3 Departments of Pulmonary Medicine, Calcutta National Medical College, Kolkata, West Bengal, India
|Date of Web Publication||23-Jun-2014|
Akra Dutta Bagan, Kolkata 700 018, West Bengal
Source of Support: None, Conflict of Interest: None
Background: In a high tuberculosis (TB) burden county like India with different regional demography, knowledge about patient profile has a pivotal role in determining and identifying the factors associated with poor treatment outcomes among TB re-treatment cases. Aim: The aim was to describe the demography and clinical characteristics of TB re-treatment cases and to evaluate the factors associated with poor treatment outcomes among those patients. Settings and Design: A prospective longitudinal cohort study was carried out at chest medicine outdoor from February, 2011 to 2014 in a district medical college of West Bengal, India. Materials and Methods: Sputum smear positive re-treatment pulmonary TB patients attending our chest medicine outdoor during the 3 years study period were evaluated for demographic and clinical characteristics on the basis of previous treatment history and records at the beginning of the study. Patients were followed-up during the 8 months treatment period (Category II treatment regimen under Revised National TB Control Program). At the end of the study period, treatment outcomes were analyzed and factors associated with poor treatment outcomes were identified. Statistical Analysis: All variables were described by proportions, and differences between independent groups were compared using the Chi-square test and Fisher's exact test, as applicable. Results: Among 74 patients, re-treatment was successful in 75.7% of relapse case, 66.7% of loss to follow-up cases and 53.8% of failure cases. Re-treatment failure was higher (38.5%) in treatment failure cases compare to relapse cases (10.8%) and initial loss to follow-up cases (16.7%). Young age, male, unmarried, employed who work outside appears to be the risk factors for loss to follow-up. Low body mass index, treatment from the private sector, history of alcoholism, radiological cavitory lesion, larger duration of previous treatment, lesser gap from previous treatment has unfavorable outcome. Conclusion: Patients relapses after a single course of anti-TB treatment are likely to be cured with the Category II re-treatment regimen and failure cases have a high risk of re-treatment failure. Loss to follow-up patients should be educated, and extra care must be taken to prevent further loss to follow-up during re-treatment.
Keywords: Failure, loss to follow-up, outcome, relapse, risk factor, treatment, tuberculosis
|How to cite this article:|
Agarwala A, Saha K, Shamim S, Roy PP. The profile and treatment outcomes of sputum smear positive pulmonary tuberculosis re-treatment cases, in a district medical college of West Bengal, India. J Assoc Chest Physicians 2014;2:63-7
|How to cite this URL:|
Agarwala A, Saha K, Shamim S, Roy PP. The profile and treatment outcomes of sputum smear positive pulmonary tuberculosis re-treatment cases, in a district medical college of West Bengal, India. J Assoc Chest Physicians [serial online] 2014 [cited 2022 Aug 18];2:63-7. Available from: https://www.jacpjournal.org/text.asp?2014/2/2/63/135113
| Introduction|| |
According to the World Health Organization (WHO), tuberculosis (TB) cases are broadly classified into "new" or "re-treatment" (previously taken anti-TB drugs for ≥ 1 month) TB cases. "Re-treatment" patients are further classified as "relapse," "treatment after failure" and "treatment after the loss to follow-up." 
Each year, 10-20% of TB patients in low and middle-income countries present with previously treated TB and are started on therapy empirically with a standardized five drug re-treatment regimen as recommended by the WHO and also Revised National TB Control Program (RNTCP) of India. India is the highest TB burden country with WHO statistics for 2011 giving an estimated incidence figure of 2.2 million cases of TB for India out of global incidence of 8.7 million cases and in 2011 304,431 people needed TB re-treatment in India.  It is estimated that annually more than 1 million people in over 90 countries are treated with the 8 months regimen (2 months of streptomycin [S], isoniazid [H], ethambutol [E], rifampicin [R], and pyrazinamide [Z]; 1 month of R, H, E and Z; and 5 months of R, H and E after failing, interrupting, or relapsing from prior treatment). , Unlike treatment regimens for new TB patients, the currently recommended re-treatment regimen has never been evaluated for efficacy in randomized clinical trials or prospective cohort studies.  The WHO formulated there commendation to add streptomycin to the four first-line drugs used for initial therapy for empiric TB re-treatment from expert opinion in an era prior to the emergence of widespread drug-resistant TB (DRTB) and prevalent human immunodeficiency virus (HIV) infection.  Recently, updated WHO guidelines recommend drug-susceptibility testing (DST) in all cases of re-treatment TB patients, and treatment of confirmed treatment failures and suspected multidrug-resistant TB cases with region-specific standardized regimens. , However, access to DST and to the second line TB drugs remains poor in high-burden countries like India, despite the findings that inadequate regimens amplify drug-resistance and the standardized re-treatment regimen is still generally the mainstay of national programs in resource limited settings. ,,, Identification of the cause of loss to follow-up and poor treatment outcome may help in planning the country-specific prevention strategies to reduce the need for the re-treatment, resulting in cost savings and diminished morbidity and transmission. The purpose of this study was to address the often-posed query regarding the effectiveness of Category II regimen for re-treatment of sputum smear positive pulmonary TB (PTB) cases and to analyze the associated patient related factors implicated in poor treatment outcome of patients.
| Materials and methods|| |
0Study settings and design
The study was carried out in Chest Medicine Department of a district medical college with attached Directly Observed Treatment, Short-course (DOTS) center. This was an observational, prospective longitudinal cohort study and done from February, 2011 to January, 2014.
During the first 2 years of the study period, all re-treatment TB cases, attended chest medicine outdoor clinic, were screened. About 105 re-treatment TB cases were screened and tested initially for positivity of sputum smear for acid fast bacilli. A total of 74 sputum smear positive PTB case were included during the first 2 years of the study period.
Re-treatment TB cases were defined according to WHO criteria [Table 1]. All re-treatment PTB cases were treated by the 8 months regimen of anti-TB drugs under RNTCP guideline of TB treatment. Treatment outcomes were defined as per WHO criteria [Table 1].
|Table 1: Case definitions of re-treatment TB groups and treatment outcomes of those patients |
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A detailed history of the patients regarding demography, educational and economic status, contact of TB, and previous TB treatment were taken. During treatment under DOTS, patients were followed-up regularly and required laboratory investigations, chest X-ray, and sputum smear examination were performed. At the end of the study, treatment outcomes of the re-treatment PTB cases were noted and the associated risk factors or the reasons for poor outcomes were analyzed.
All variables were described by proportions, and differences between independent groups were compared using the Chi-square test and Fisher's exact test, as applicable. Treatment outcomes were grouped as successful (cured and completed) and adverse (failed, died, lost to follow-up, not evaluated), and patients in each of these groups were compared in terms of their demographic and disease characteristics. P <0.05 was considered as statistically significant.
The study was ethically approved by the Institutional Ethical Committee.
| Results|| |
Among 74 the re-treatment sputum positive PTB patients 64.5% were male and 35.5% were female with a male:female of 1.8:1. Most common presenting complaints were cough (92.1%) and fever (84.2%), followed by weight loss, anorexia, and hemoptysis. Most of the patients have a body mass index (BMI) in the range of 14-19.5 (73.4%) with a median value of 18.5. Only 14 (9.2%) patients were diabetic, and only 4 (2.6%) were HIV positive. Alcoholism is fairly common (30.2%).
Cure rate is highest among relapse cases (75.7%) followed by treatment after lost to follow-up (66.6%) and treatment after failure (53.8%) patients [Table 2]. Fisher exact test failed to demonstrate any statistically significant difference (P = 0.21) between re-treatment groups due to low number of cases.
Demographic and clinical factors showed an association with poor treatment outcome of patients [Table 3]. Cure rate is higher among patients with normal BMI (>18.5). Recent history of contact with TB was most of the time absent in adult PTB (12 out of 76 have contact history). Patients with contact history of TB had slightly higher failure rate. Patients received previous treatment under non-DOTS had lower cure rate (54.5%) than others and slightly higher death rate. Alcoholism only slightly decreases the chance of cure, but it significantly increases the chance of lost to follow-up (17.4% vs. 3.9%, with Chi-square test, P < 0.05).
|Table 2: Treatment outcomes of different types of re-treatment sputum smear positive pulmonary TB patients |
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|Table 3: Association of treatment outcomes with demographic and clinical characteristics of re-treatment sputum smear positive pulmonary TB patients |
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Treatment outcomes had been affected by the severity of the PTB (assessed from radiological extension and severity of the lesions) [Table 4]. Patients with cavitory PTB had more severe form of disease than noncavitary ones. Cavitary PTB cases had higher failure rate (22.2%) than noncavitary ones (10.3%). All the three patients died had cavitary lesions. Noncavitary PTB cases had higher loss to follow-up rate (10.3%) than cavitary ones (6.7%). Treatment success achieved better in patients with ≤2 radiological zones involvement (84.4%). Treatment failure rate was significantly higher among patients with a <6 months interval from previous treatment (43.7%).
|Table 4: Patient factors associated with poor treatment outcome of re-treatment TB patients |
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Most common side-effect during anti-TB therapy was nausea and vomiting (32.9%) followed by vertigo, giddiness, neuropathy, and skin rash. Most of these side-effects occurred during 1 st month of therapy.
| Discussion|| |
Recent studies have queried the utility of using the standard Category II regimen in re-treatment TB patients, especially in patients failed a Category I regimen. , In our study, treatment success differed considerably among three re-treatment groups, with the highest success rate in relapse cases (75.7%) and lowest success rate in failure cases (53.8%), similar to previous studies. , Loss to follow-up was frequent in patients with a prior history of loss to follow-up during previous treatment, and similarly failure rate was also highest in patients with previous treatment failure. Although treatment regimen is same in all re-treatment groups,  but findings of our study address the need for different management strategies for different re-treatment groups. , For example, treatment failure is commonly due to drug-resistance, while recurrence may be due to poor economic or health condition. Loss to follow-up patients may require intensified case management and education rather than more intensive treatment. TB is poorly managed or handled by the private sector in India, as evidenced by different studies. ,,, Successful TB control requires the commitment of the private health care sector toward patients and notification of the disease. RNTCP had developed and implemented guidelines for the involvement of nongovernmental organizations (2001) and private practitioners (2002), and created a task force mechanism to involve medical colleges in the RNTCP. , Our study noted that failure and death rate was higher in patients on non-DOTS anti-TB treatment. Hence, private sector must be further sensitized, trained and extensively involved in the program in order to reduce the development of re-treatment cases. Risk factors for treatment failure or relapse are low body weight, cavitation on chest X-ray, high bacterial burden, short treatment duration, and drug-resistance, as supported by findings of our study. ,, Young age, male, unmarried, employed who work outside appears to be the risk factors for loss to follow-up. Low BMI, treatment from the private sector, history of alcoholism, radiological cavitory lesion, larger duration of previous treatment, and lesser gap from previous treatment has unfavorable outcome. Hence, identifying local patient characteristics that confer a higher risk of relapse, failure, or loss to follow-up from primary TB treatment may help to plan and implement country-specific prevention strategies aiming to reduce the need for the re-treatment, resulting in cost savings and diminished morbidity and transmission.
| Conclusion|| |
Patient's relapses after a single course of anti-TB treatment are likely to be cured with the Category II re-treatment regimen and failure cases have a high risk of re-treatment failure. Loss to follow-up patients should be educated and extra care must be taken to prevent further loss to follow-up during re-treatment. Re-treatment cases represent a serious threat to TB control in many settings, and could significantly undermine the overall success of the DOTS strategy.
| References|| |
|1.||World Health Organization. Treatment of Tuberculosis Guidelines. 4 th ed. World Health Organization; 2010. Available from: http://www.whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf. [Last accessed on 2014 May 17]. |
|2.||World Health Organization. Fact Sheet No. 104: Tuberculosis. Geneva: WHO; 2010. Available from: http://www.who.int/mediacentre/factsheets/fs104/en/print.html. [Last accessed on 2014 May 16]. |
|3.||Mak A, Thomas A, Del Granado M, Zaleskis R, Mouzafarova N, Menzies D. Influence of multidrug resistance on tuberculosis treatment outcomes with standardized regimens. Am J Respir Crit Care Med 2008;178:306-12. |
|4.||Menzies D, Benedetti A, Paydar A, Royce S, Madhukar P, Burman W, et al. Standardized treatment of active tuberculosis in patients with previous treatment and/or with mono-resistance to isoniazid: Asystematic review and meta-analysis. PLoS Med 2009;6:e1000150. |
|5.||Rouillon A. The Mutual Assistance Programme of the IUATLD. Development, contribution and significance. Bull Int Union Tuberc Lung Dis 1991;66:159-72. |
|6.||World Health Organization (WHO). Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis. Geneva, Switzerland: World Health Organization (WHO); 2010. |
|7.||Espinal MA. Time to abandon the standard retreatment regimen with first-line drugs for failures of standard treatment. Int J Tuberc Lung Dis 2003;7:607-8. |
|8.||Matthys F, Rigouts L, Sizaire V, Vezhnina N, Lecoq M, Golubeva V, et al. Outcomes after chemotherapy with WHO category II regimen in a population with high prevalence of drug resistant tuberculosis. PLoS One 2009;4:e7954. |
|9.||Quy HT, Lan NT, Borgdorff MW, Grosset J, Linh PD, Tung LB, et al. Drug resistance among failure and relapse cases of tuberculosis: Is the standard re-treatment regimen adequate? Int J Tuberc Lung Dis 2003;7:631-6. |
|10.||Ottmani SE, Zignol M, Bencheikh N, Laâsri L, Chaouki N, Mahjour J. Results of cohort analysis by category of tuberculosis retreatment cases in Morocco from 1996 to 2003. Int J Tuberc Lung Dis 2006;10:1367-72. |
|11.||World Health Organization. Treatment of Tuberculosis: Guidelines for National Programmes. WHO/CDS/TB/2003.313. 3 rd ed. Geneva, Switzerland: WHO; 2003. |
|12.||Zignol M, Wright A, Jaramillo E, Nunn P, Raviglione MC. Patients with previously treated tuberculosis no longer neglected. Clin Infect Dis 2007;44:61-4. |
|13.||Uplekar M. Involving private health care providers in delivery of TB care: Global strategy. Tuberculosis (Edinb) 2003;83:156-64. |
|14.||Prasad R, Nautiyal RG, Mukherji PK, Jain A, Singh K, Ahuja RC. Treatment of new pulmonary tuberculosis patients: What do allopathic doctors do in India? Int J Tuberc Lung Dis 2002;6:895-902. |
|15.||Uplekar M, Juvekar S, Morankar S, Rangan S, Nunn P. Tuberculosis patients and practitioners in private clinics in India. Int J Tuberc Lung Dis 1998;2:324-9. |
|16.||World Health Organization. The Behaviour and Interaction of TB Patients and Private for-Profit Health Care Providers in India: A Review. WHO/TB/97.223. Geneva, Switzerland: WHO; 1997. |
|17.||Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Involvement of Non-Governmental Organizations in the Revised National Tuberculosis Programme. New Delhi, India: CTD; 2001. |
|18.||Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Involvement of Private Practitioners in the Revised National Tuberculosis Programme. New Delhi, India: CTD; 2002. |
|19.||Thomas A, Gopi PG, Santha T, Chandrasekaran V, Subramani R, Selvakumar N, et al. Predictors of relapse among pulmonary tuberculosis patients treated in a DOTS programme in South India. Int J Tuberc Lung Dis 2005;9:556-61. |
|20.||Pulido F, Peña JM, Rubio R, Moreno S, González J, Guijarro C, et al. Relapse of tuberculosis after treatment in human immunodeficiency virus-infected patients. Arch Intern Med 1997;157:227-32. |
|21.||Panjabi R, Comstock GW, Golub JE. Recurrent tuberculosis and its risk factors: Adequately treated patients are still at high risk. Int J Tuberc Lung Dis 2007;11:828-37. |
[Table 1], [Table 2], [Table 3], [Table 4]