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Outcome of patients subjected to short course chemotherapy (DOTS) under RNTCP at tertiary care institute

Sanjiv Zangde1*, Anjali Deshmukh2
1
Consutant Physician, Vighnharta Critical Care and Multispecialty Hospital, Borban, Nanded, Maharashtra, INDIA.

2Consutant Physician, Suryakant Consultant, Nanded, Maharashtra, INDIA.

Email: dr.dranju@rediffmail.com, drsanjivzangde98@gmail.com

Research Article

Abstract               Introduction: Tuberculosis is leading infectious cause of death worldwide being responsible for 3-million deaths annually, with 6% of all deaths worldwide attributable to tuberculosis. About 95% of tuberculosis cases and 98% of all deaths occur in poor developing countries. Present study was carried out to study outcome of newly diagnosed cases of Tuberculosis subjected to short course chemotherapy regimen under DOTS. Aims and Objectives: To study the outcome of patients subjected to short course chemotherapy (DOTS) under RNTCP at tertiary care institute. Material and Method: All the newly diagnosed cases of pulmonary and extra pulmonary tuberculosis attending OPD/IPD of Govt. Medical College Nanded and residing in area under coverage of RNTCP centre of GMC Nanded were included in this study. Name, age, sex, address, occupation, income, number of family members, presenting complaints in chronological order, past history, personal history, through general and systemic examinations, investigations were carried out and the findings were recorded. All the standard definitions defined by Central TB division of Directorate General of Health Services were used. All the patients were followed up regularly and outcome was recorded. Results: Out of 221 patients, 126 were of pulmonary tuberculosis and 95 were suffering from extra pulmonary tuberculosis. Out of all sputum positive cases 84.54% of patients were converted to sputum negative status after two months of Intensive phase. 66.66% patients were cured after DOTS. 19.04% cases of pulmonary tuberculosis and 90.52% of extra pulmonary tuberculosis had completed the treatment. Success Rate (Success Rate = cure + treatment completed) for pulmonary tuberculosis was found to be 85.70% and failure rate among smear positive was 2.08%. Success rate for extra pulmonary Tuberculosis was found to be 90.52%. Thus overall Success Rate for PTB and EPTB was found to be 87.78%. Conclusion: Overall success rate of DOTS amongst PTB and EPTB was found to be 87.78%. The treatment effectiveness of DOTS is evident from smear conversion rate at 2-3 months and success rate (cure rate >85%) both above satisfactory mark by RNTCP guidelines.

Keyword: tuberculosis, DOTS, success rate, outcome.

INTRODUCTION

Tuberculosis is the disease as old as mankind itself. Ancient Indians called it Rajyakshama the “king of diseases” in the Vedas1. History of tuberculosis can be traced to antiquity. The oldest existing medical document, fragments of Egyptian papyri have a mention of tuberculosis. The excavation of Egyptian mummies provided another proof of existence of tuberculosis of spine in some of the mummies2. Chinese writings of 2698 B.C. also have mention of conditions called “lung fever” and “lung cough” having symptoms similar to tuberculosis. Tuberculosis is leading infectious cause of death worldwide being responsible for 3-million deaths annually, with 6% of all deaths worldwide attributable to tuberculosis. About 95% of tuberculosis cases and 98% of all deaths occur in poor developing countries3. Most of the principles of supervised intermittent chemotherapy now called Directly Observed Treatment evolved from research primarily conducted in India, but it was Karel Styblo the ex-director of International Union Against Tuberculosis and Lung Diseases (IUATLD) who combined these principals into a comprehensive strategy called DOTS strategy. This strategy ensured monitoring, supervision and accountability for every patient started on treatment. He demonstrated through his research conducted in East Africa that this strategy could ensure a highly cost-effective treatment of tuberculosis in all the developing and poor nations4. Present study was carried out to study outcome of newly diagnosed cases of Tuberculosis subjected to short course chemotherapy regimen under DOTS attending GMC Nanded OPD and IPD and residing in area under coverage of RNTCP Centre in GMC Nanded.

 

AIMS AND OBJECTIVES

To study the outcome of patients subjected to short course chemotherapy (DOTS) under RNTCP at tertiary care institute.

 

MATERIAL AND METHOD

The present longitudinal study was conducted in the department of TB and chest of Govt. Medical College and Shri Guru Gobind Singhji Memorial hospital Nanded. The study was conducted during July 2006 to June 2008. All he newly diagnosed patients of tuberculosis were selected for the study. Following inclusion and exclusion criteria was used to select the study patients.

Inclusion Criteria

All newly diagnosed cases of pulmonary and extra pulmonary tuberculosis diagnosed microscopically, histopathologically and /or radiologically and attending OPD/IPD of Govt. Medical College Nanded and residing in area under coverage of RNTCP centre of GMC Nanded were included in this study.

Exclusion Criteria

  • Already diagnosed and on treatment patients of Anti tubercular drugs.
  • All cases of Defaulter, Failure and Relapse.
  • All cases below 15 years of age group.
  • All cases with deranged Liver function test and kidney function tests were excluded.

Data Collection was carried out on predesigned questionnaires. Name, age, sex, address, occupation, income, number of family members, presenting complaints in chronological order, past history, personal history, through general and systemic examinations, investigations were carried out and the findings were recorded. All the patients enrolled in the study were followed up regularly and outcome was recorded. All the standard definitions defined by Central TB division of Directorate General of Health Services were used. The success rate was calculated by adding cure rate and treatment completed rate.


 

Table 1: Distribution of new cases according to type of disease and category

Category

Pulmonary TB

EPTB (%)

Total (%)

Sputum +ve (%)

Sputum -ve (%)

I

96 (70.60)

10 (7.35)

30 (22.05)

136 (100)

III

N.A.

20 (23.52)

65 (76.48)

85 (100)

Total

96

30

95

221

 


There were total 221 patients enrolled in the study. Out of them 126 were of pulmonary tuberculosis and 95 were suffering from extra pulmonary tuberculosis. It was observed among the patients receiving category I treatment 70.60% were sputum positive at the time of study. The proportion of new smear positive to smear negative was found to be 3.2:1


 

Table 2: Sputum smear conversion in smear positive patients

Total sputum Positive patients n= 96

Time of sputum Examination

Result of Sputum

Death

Defaulter

Failure

Negative (%)

Positive (%)

96

At end of IP

81 (84.54)

05

02

08*

 

At end of

Extended IP

03 (60.00)

02

 

 

 

At end of 5 Months

00

02*

 

 

02*

*8 patients Defaulter, *2 patients failures, 2 patients died, *Subjected to Category II.

 


It was observed that out of all sputum positive cases 84.54% of patients were converted to sputum negative status after two months of Intensive phase. Sputum smear conversion among smear positive those received extended intensive phase was 60% (3/5). The sputum conversion Rate after extended Intensive phase was 87.50% (i.e. 84 out of 96). Defaulter rate in new smear positive patient was 8.33% (8 patients) and death rate in new smear positive patients was 2.08% (2 patients).


 

Table 3: Distribution of patients according to Treatment outcome

Treatment outcome

PTB (n = 126) (%)

EPTB (n=95) (%)

Total (n=221) (%)

Cured

84 (66.66)

N.A.

84 (38.00)

Treatment completed

24 (19.04)

86 (90.52)

110 (49.77)

Defaulter

14 (11.12)

07 (7.36)

21 (9.50)

Died

02 (1.59)

02 (2.12)

04 (1.80)

Failure

02 (1.59)

00

02 (0.93)

Total

126 (100)

95 (100)

221 (100)

 

Figure 1

 


Out of the total 126 pulmonary positive tuberculosis cases, 84 (66.66%) were cured after DOTS. 19.04% cases of pulmonary tuberculosis and 90.52% of extra pulmonary tuberculosis had completed the treatment. Overall defaulter rate was found to be9.50% whereas the death rate was 1.80%. Four patients were died in spite of initiation of treatment because of Adisonian crisis, Respiratory failure, massive haemoptysis and Septicaemia and Respiratory distress etc. Failure Rate was found to be 0.93% Success Rate (Success Rate = cure + treatment completed) for pulmonary tuberculosis was found to be 85.70% and failure rate among smear positive was 2.08%. Success rate for extra pulmonary Tuberculosis was found to be 90.52%. Thus overall Success Rate for PTB and EPTB was found to be 87.78%.

 

DISCUSSION

All newly diagnosed 121 patients of tuberculosis attending OPD and IPD of TB and chest department of Govt. Medical College and Shri Guru Gobind Singhji Memorial hospital Nanded. Out of total 221 patients, 126 were of pulmonary tuberculosis and 95 were suffering from extra pulmonary tuberculosis. It was observed among the patients receiving category I treatment 70.60% were sputum positive at the time of study. The proportion of new smear positive to smear negative was found to be 3.2:1 Sputum smear conversion rate after 2 months of intensive phase was 84.54%. Sputum smear conversion rate after 3 months in new smear positive cases was found to be 87.50%. Corresponding proportion of national level was observed to be 89%. Other studies in India like Chadha and Bhagi et al5 observed sputum conversion rate 92.6%, SK Srivasteva Ratan and R Prasad6 observed 92.9% and in abroad Becx. Bleumink Indonesia7 observed it to be 67.5% also A Mohan8 observed it to be 67%. Obtaining high sputum smear conversion is the precursor to high cure rate. As per RNTCP guidelines smear conversion rate among new smear positive cases should be more than 85%. Thus sputum smear conversion rate was satisfactory in the present study. Cure rate among new smear positive patients in present study was found to be 85.7%. According to RNTCP guidelines cure rate among new smear positive cases must be more than 85%. So this cure rate was satisfactory in this study. Similar observations were also reported by Chadha S.L. and R.P. Bhagi5 (cure rate was 91%). The overall defaulter rate was 9.50%. Defaulter rate in new smear positive cases was observed to be 8.33% in this study. As per RNTCP guidelines overall defaulter rate must not be more than 5% and action is warranted if it is more than 10% among new smear positive cases9. Chandrasekaran et al10 had observed 15% defaulter rate in new smear positive patients in their study. Dandona Rakhi11 observed that among new smear positive patientstreatment defaulters were 6.8%. Thus the findings in the present study suggested that overall defaulter rate was unsatisfactory and reflects under performance of DOTS providers in ensuring prompt and effective defaulter retrieval actions. There is urgent need to strengthen the mechanism for defaulter retrieval by increasing man power, training and adequate supervision. Overall death rate in the present study was 1.80% and death rate among new smear positive patients was 2.08%. According to RNTCP guidelines ‘No more than 4% of smear positive patients put on DOTS should die.’ Thus death rate was within excepted programme guidelines in the present study. Similarly a study in Tamil Nadu12 observed 4% death among smear positive 1651 patients. Success Rate of DOTS was calculated by adding cured and treatment completed rates. Success rate for new smear positive patients was 87.50% at end of treatment which was satisfactory according to RNTCP objectives of 85%. Similar findings were also reported by S.K. Srivastava et al6 (88.88%). SL Chadha and RP Bhagi et al5 observed success rate of 91.96%, failure rate of 1.2 and death rate of 0.93% in their study. Thus treatment effectiveness of DOTS was evident from smear conversion rate at 2-3 months and success rate (cure rate > 85%) both were above satisfactory mark by RNTCP guidelines.

 

CONCLUSION

Overall success rate of DOTS amongst PTB and EPTB was found to be 87.78%. The treatment effectiveness of DOTS is evident from smear conversion rate at 2-3 months and success rate (cure rate >85%) both above satisfactory mark by RNTCP guidelines.

 

REFERENCES

    1. A Mohan S.K. Sharma: Tuberculosis: History page - 5, First Edition, Jaypee Brothers medical publishers, New Delhi, 110002.
    2. Dr J.P. Baride and A.P. Kulkarni: Text book of community medicine 2nd edition 2002, page 346. Vora medical publications Mumbai.
    3. Zumla A, Grange J.: Science, Medicine and future of Tuberculosis, British Medical Journal Vol – 14. Oct – 1998, 763 – 765.
    4. Directly Observed Treatment Short course: Tuberculosis cure for all, ICMR Bulletin, March 2001, Vol – 31 No – 3, 37-43.
    5. Chadha S.L. and R.P. Bhagi: Treatment outcome in TB patients placed on Directly Observed Treatment Short course Chemotherapy: A Cohart study, Indian Journal of Tuberculosis 2000; 47, 155.
    6. S.K. Svivastava, R.K. Ratan, P. Srivastava and R. Prasad: Report on RNTCP urban pilot project in Lucknow Indian journal of Tuberculosis 2000, 47, 159.
    7. Becx Bleumink, Md. Jamaluddins, Lopragf Soldenhoff Rde, Wibow H, Aryono M: High cure rate in smear positive tuberculosis patients using ambulatory treatment with once weekly supervision during intesive phase in sulawesi, Republic of Indonesia. International Journal of Tuberculosis and Lung disease 3(12) 1999, 1066-1072.
    8. A Mohan, H. Nassir and A Niazi: Does Routine home visiting improve return rate and outcome of Dots patients who delay treatment? Eastern Mediterranean Health journal Vol-9 No=4, 2004.
    9. Managing RNTCP in your area atraining course module 5-10: central TB Division Directorate General of health Services Ministry of Health and family Welfare, Nirman Bhavan, New Delhi 1100-11.
    10. Chandrasekaran V. PG. Gopi. R. Subramani, A Thomas, K. Jaggarajamma and DR Narayan: Default during intensive phase of treatment under Dots programme. Indian journal of Tuberculosis; 2005, 52: 197-202.
    11. Dondona Rakhi: Gender differentials in RNTCP. Center for public health Research administrative staff college, hydrabad India January 2004.
    12. Subramani R, Santosh T, Frieden TR, Radhakrishna S, Gopi D.G, Selvakumar N, Sadacharam K, Narayan PR: Active community surveillance of the impact of different tuberculosis controle measure, Tiruvallur south India 1968-2001. International journal of TB epidemiology 10; 2006; 1093-1099.
 
 
 
 
 
 
     
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