|Year : 2019 | Volume
| Issue : 1 | Page : 1-4
Study of outcome of management of MDR-TB cases under programmatic condition in India
Ajay Agarwalla1, Somnath Bhattacharya2, Atin Dey2, Saurav Kar2, Arunabha Datta Chaudhuri2
1 Department of Microbiology, Malda Medical College, Malda, West Bengal, India
2 Department of Pulmonary Medicine, R.G. Kar Medical College and Hospital, Kolkata, West Bengal, India
|Date of Submission||21-Feb-2019|
|Date of Acceptance||26-Mar-2019|
|Date of Web Publication||26-Apr-2019|
Dr. Somnath Bhattacharya
3/1 B.M. Banerjee Road (Bye Lane), Belgharia, Kolkata - 700 056, West Bengal
Source of Support: None, Conflict of Interest: None
Background: Multi-drug resistant tuberculosis is a grave challenge for tuberculosis control program in India. These patients are treated with standardized 2nd line antitubercular drugs for a period of at least 24 months and are followed up by serial sputum cultures under RNTCP.
Aims: This study aims to analyze various outcomes of treatment of MDR-TB patients under DOTS-Plus program and impact of different parameters over the outcome.
Materials and Methods: In this retrospective study treatment outcome all the MDR-TB patients who have initiated treatment from concerned DRTB centre over a period of six months, have been taken for analysis, after 30–36 months of starting the therapy. Outcomes are categorized as cured, treatment completed, treatment default, treatment failure, and death as per program guideline. Outcome of different group of patients are compared also.
Results: Out of total 71 patients 54 resides in rural area and 52 have low BMI (<18.5). Total 27 (38%) patients are successfully treated. Treatment failure observed in 11 (16%). 20 (28%) patients defaulted. Rural patients have lower success rate (33%) and high default rate (30%). Low BMI patients have poor success (29%).
Conclusion: The present study finds a low success rate in comparison to WHO reports from India. Default rate is also found to be high. Majority of patients are from rural area and they have higher default rate compared to urban patients. Patients with low BMI have lower success rate and these patients constitutes about three-fourth of total patients. But as the total number of patients is very small, the significance of this observation cannot be ascertained.
Keywords: Multi drug resistant tuberculosis, standardized regimen, treatment outcome
|How to cite this article:|
Agarwalla A, Bhattacharya S, Dey A, Kar S, Chaudhuri AD. Study of outcome of management of MDR-TB cases under programmatic condition in India. J NTR Univ Health Sci 2019;8:1-4
|How to cite this URL:|
Agarwalla A, Bhattacharya S, Dey A, Kar S, Chaudhuri AD. Study of outcome of management of MDR-TB cases under programmatic condition in India. J NTR Univ Health Sci [serial online] 2019 [cited 2020 Apr 6];8:1-4. Available from: http://www.jdrntruhs.org/text.asp?2019/8/1/1/257164
| Introduction|| |
Tuberculosis (TB) is a major public health problem in India as India accounts for one-fourth of global TB burden. For proper management of tuberculosis patients, The Revised National Tuberculosis control programme (RNTCP) accepted Directly Observed Treatment Short-course (DOTS) strategy which covered the entire nation in March 2006. But multi-drug resistant TB i.e. resistant to Rifampicin and Isoniazid has posed a challenge with an estimated 71000 MDR-TB cases emerge annually from the notified pulmonary TB cases in India and now India has become the country with highest MDR-TB burden of. With this background, Programmatic Management of Drug Resistant TB (PMDT) services has started in 2007. Under this program, drug resistance is detected by either phenotypic drug susceptibility testing or by genotypic testing. The patients having resistance to both Rifampicin and Isoniazid or having resistance to only Rifampicin are considered as MDR-TB (Due to high incidence of INH resistance in India) and scheduled for initiating standardized 2nd line chemotherapy comprising of six drugs (kanamycin, levofloxacin, ethionamide, ethambutol, cycloserine, pyrazinamide). For the pretreatment evaluation and subsequent initiation of treatment, DR-TB Centres are established where patients are admitted for a brief period initially. The follow up is done by monthly sputum culture. Treatment period is at least 24 months which may extends depending on follow-up culture report. Success of treatment depends on several factors like severity of illness, regimen used for treatment, presence of comorbid illness, and general health condition of patients. Another important factor is patient compliance considering the prolonged treatment period. For this reason treatment outcome of Drug-resistant Tuberculosis is extremely variable as reported from different countries with success rate from 37% to 60%.,,, The Indian studies have also reported variable success rates, though WHO has reported 46% overall success rate in India. This present study aims to analyze the various outcomes of management of MDR-TB patients treated by standardized 2nd line chemotherapy. It also tries to assess the impact of different demographic profiles and clinical conditions on the outcome.
| Materials and Methods|| |
This is a retrospective study approved by the Institutional Ethics Committee of the tertiary care hospital to which the DRTB centre is attached with concurrence of the program administrators. All MDR-TB patients who have initiated treatment from DRTB center over a period of 6 months, have been taken for outcome analysis after 30–36 months of initiation of treatment. The patients who are transferred out, whose outcome data are not available at the time of data analysis are excluded from the study. The baseline demographic data, clinical features and relevant comorbid conditions are recorded from the individual case record form. Treatment outcome is analyzed according to guideline prevailing during the course of treatment and is categorized as cured, treatment completed, treatment default, treatment failure, and death. A patient is declared cured after completion of treatment for at least 24 months with last 5 consecutive negative sputum culture results and if one follow-up culture is positive then it should be followed by at least 3 consecutive negative cultures. Those patients who have completed treatment and are clinico-radiologically improved but do not meet the definition of cure or treatment failure due to lack of bacteriological results are declared treatment completed. Cured and treatment completed, these together define treatment success. Patients having two or more positive cultures of the last five cultures or any positive cultures of the final three cultures are considered as treatment failure. If treatment is interrupted for two or more consecutive months for any reasons then it is considered as treatment default. A patient who dies for any reason during the treatment course is termed as death in outcome. Outcome data of all patients are recorded. Patients are subdivided according to demographic and clinical conditions and outcome data of each group are separately recorded. We have analyzed the results by using IBM SPSS Statistics Version 20 software and have taken proportions wherever implicated and have performed “Z test” for proportion with P value < 0.05 as significant.
| Results|| |
Outcome data of total 71 patients were available for the study. The baseline demographic and clinical profiles have been depicted in [Table 1]. Outcome of these 71 patients are shown in [Table 2]. Out of 71, 22 (31%) were declared cured and 05 (7%) completed treatment. So, the treatment success was achieved in 27 (38%) cases. Comparison of demographic and clinical profiles among drug- resistant TB patients are shown in [Table 3]. The success rate was lower in patients having BMI less than 18.5 kg/m2 in comparison to patients having BMI greater than 18.5 kg/m2 (29% vs. 64%; P value 0.008). The success rate was higher in urban patients than rural ones, (53% vs. 33%; P value 0.147). Patients having resistance to only Rifampicin have higher success rate than those with combined Rifampicin and Isoniazid resistance (53% vs. 33%; P value 0.147). The impact of low BMI over the treatment outcome was statistically significant (P < 0.05) value. However, none of these differences i.e. treatment success rate in urban/rural and Rifampicin/Rifampicin + Isoniazid resistance patients was statistically significant as P values in both scenarios were more than 0.05. Impact of HIV and diabetes mellitus over the outcomes of treatment could not be compared as these co-morbidities were present in very few cases.
| Discussion|| |
Treatment of Drug-resistant Tuberculosis with 2nd line drugs is very complex and outcome is worse than treatment of Drug-sensitive Tuberculosis. A meta-analysis of several studies from 23 countries by Ahuja et al. showed that success rate was variable with overall success rate 54% and default rate 23%. A more recent meta-analysis by Kibret et al. found successful outcome in 63.5% cases but success rate was low among patients treated with standardized 2nd line regimen compared to those treated with individualized regimen. In the present study all the patients are treated with standardized 2nd line drugs as per PMDT guideline. The notable thing is that this study is performed with patients being enrolled for treatment under DOTS-Plus program in the first 6 months after starting the program in that particular district—so it underscores the initial performance of the program along with its weakness. This study shows a low success rate (38%) and high default rate (28%) which may be seen in initial months of the program initiation. At the beginning of DOTS—Plus program under RNTCP, in 2007 one study showed success rate of 38% with high default rate of 24%. But more recent studies with patients treated under programmatic condition with standardized regimen show better success rate ranging from 54 to 63% and a lower default rate ranging from 9.2% to 23%.,, Majority of the patients (73%) in this study are of low BMI (<18.5 kg/m2) and their success rate is significantly less compared to patients having BMI more than 18.5 kg/m2 (29% vs. 64%; P value 0.008). Another Indian study also found that average BMI of patients with successful treatment was significantly more than that of patients with unfavorable outcome. We also observe that in comparison to urban patients, rural patients have both low success rate (53% vs. 33%) and high default rate (23% vs. 30%). The rural patients account for almost 3/4th of our study population—this factor also reduces the overall success rate. But as the total number of patients under study is low, further comments cannot be made from this observation.
The strength of our study lies in the fact that it has proved various impact factors like poor nutritional status, rural residency and combined rifampicin and isoniazid resistance adversely affect the outcome. The study may help to find out various implementional defects present at the beginning of DRTB centers where significant improvement may enhance the functional effectivity of the program. However, there are several weaknesses in the study like low study population and its inability to show impact of co-morbidities like DM, HIV on outcomes as number of patients suffering from those co-illness were very few.
| Conclusion|| |
The present study which is done at the commencement of DOTS-Plus program in the particular district shows a below average success rate with high default rate. Majority of patients of this study belong to low BMI category who have shown poor success. It is also found that rural patients have a high default rate. So, improvement of nutritional status of patients as well as strengthening of the program network in the rural areas, both are necessary for better outcome though these facts should be further validated in future by studies with large number of patients.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]