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Table of Content - Volume 3 Issue 3- September 2016


A study of treatment outcomes of sputum smear positive pulmonary tuberculosis re-treatment cases at tertiary health care center

 

Deepak Onkar Patil1, Sanjay Dattu Mahajan2*

 

1Professor, 2Associate Professor, Department of Respiratory Medicine, Dr. Ulhas Patil Medical College and Hospital, Jalgaon, Maharashtra, INDIA.

Email: drdopatil@gmail.com

 

Abstract              Background: National Tuberculosis Control Programme (RNTCP) of India, based on the DOTS strategy, patients are treated with an intermittent short-course regimen with drugs administered thrice weekly on alternate days. Aims and Objectives: To study treatment outcomes of sputum smear positive pulmonary tuberculosis re-treatment cases at tertiary health care center. Methodology: After approval from institutional ethical committee this cross -sectional study was carried out in the department of the pulmonary medicine (TB Chest) at tertiary health care center during the year January 2016 to January 2017 in all retreatment TB case. So, during one year period total 97 patients included into study after written explained consent. All the necessary information like age, sex etc. was noted. The statistical analysis done of Z-test (Standard error of difference between two proportions ) Result : In our study we have found that the majority of the patients were in the age group of 50-60 were 29.90%, followed by 40-50, 24.74%, >60 were 18.56%,30-40 were 17.53%, and 20-30 -9.28%. The majority of the patients were Male i.e. 58.76% followed by Female -41.24%.Treatment Success were 69.07 %, Treatment not successful were 30.93%. Relapse - 46.39%, Treatment after loss to follow up- 32.98%, Treatment after failure-20.61.Factors associated Treatment not successful were Low SES (Z=2.3792. P< 0.02), Old age (Z= 2.92, P<0.05), Alcohol intake (Z= 2.56, P<0.05), Tobacco use (Z=3.2, P<0.01), Diabetes (Z=4.1, P<0.001). Immunocompromised (Z=5.12, P<0.0001). Conclusion: It can be concluded from our study that Factors associated Treatment not successful were Low SES, Old age, Alcohol intake, Tobacco use, Diabetes, Immunocompromised status etc.

Key Words: Sputum smear positive pulmonary tuberculosis re-treatment cases, National Tuberculosis Control Programme (RNTCP), Directly Observed Treatment Short course (DOTS).

 

INTRODUCTION

National Tuberculosis Control Programme (RNTCP) of India, based on the DOTS strategy, patients are treated with an intermittent short-course regimen with drugs administered thrice weekly on alternate days.1 The treatment consists of an initial 2-month intensive phase of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E), followed by a 4-month continuation phase of RH.1 Under controlled clinical trial conditions, similar short course treatment regimens have been found to be highly successful, with reported end-of-treatment cure rates of 95–100% and relapse rates of 3–8% over a 2-year follow-up period.2 The RNTCP has been remarkably successful and has achieved high cure rates of 80–85% nationally.3 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.”4 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.5

 

MATERIAL AND METHODS

After approval from institutional ethical committee this cross -sectional study was carried out in the department of the pulmonary medicine (TB Chest) at tertiary health care center during the year January 2016 to January 2017 in all retreatment TB case. So, during one year period total 97 patients included into study after written explained consent. All the necessary information like age, sex etc. was noted. The operative definition were used like- Re-treatmentpatient groups, Relapse patients- They have previously been treated for TB, were declared cured or treatment completed at the end of their most recent course of treatment and are now diagnosed with a recurrent episode of TB (either a true relapse or a new episode of TB caused by reinfection). Treatment after failure, patients- They are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment, Treatment after loss to follow-up, patients- They have previously been treated for TB and were declared lost to follow-up at the end of their most recent course of treatment (these were previously known as treatment after default patients). Other, previously, treated, patients- they are those who have previously been treated, for TB but whose outcome after their most recent, course of treatment is unknown or undocumented. Outcome Cured-A pulmonary TB patient with bacteriologically confirmed TB at the beginning of treatment, who was smear or culture-negative in the last, month of treatment and on at least one previous, occasion. Treatment completed- A TB patient who completed treatment without evidence of failure but with no record to show, that sputum smear or culture results in the last, month of treatment and on at least one previous occasion were negative, either because tests, were not done or because results are unavailable. Treatment, failed- A TB patient whose sputum smear or culture is positive at month 5 or later during treatment, Died A TB patient who dies for any reason before starting or during the course of treatment. Lost to follow-up- A TB patient who did not start treatment or whose, treatment was interrupted for two consecutive, months or more. Treatment success- The sum of cured and treatment completed as described by Abinash Agarwala13. The statistical analysis done of Z-test (Standard error of difference between two proportions)

 

RESULT

 

Table 1: Distribution of the patients as per the age

Age

No.

Percentage (%)

20-30

9

9.28

30-40

17

17.53

40-50

24

24.74

50-60

29

29.90

>60

18

18.56

Total

97

100.00

The majority of the patients were in the age group of 50-60 were 29.90%, followed by 40-50 24.74%, >60 were 18.56%, 30-40 were 17.53%, and 20-30 -9.28%.

 

Table 2: Distribution of the patients as per the sex

Sex

No.

Percentage (%)

Male

57

58.76

Female

40

41.24

Total

97

100.00

The majority of the patients were Male i.e. 58.76% followed by Female -41.24%.


 

Table 3: Distribution of the patients as per the treatment outcome

Re-treatment TB patients

Treatment Success (%)

Treatment not successful (%)

Cured

Completed

Total

Died (%)

Failure (%)

Lost to follow up (%)

Relapse (n= 45)

32

( 71.11)

7

(15.55)

39

(86.67)

3 ( 6.67)

1 (2.22)

2 (4.44)

Treatment after loss to follow up (n=32)

15 (46.88)

0

(0.00)

15 (46.88)

2 (6.25)

13 (40.63)

2 (6.25)

Treatment after failure (n= 20)

13 (40.63)

0

13 (40.63)

3 (9.38)

3 (9.38)

1 (3.13)

Total (n=97 )

60 (61.86)

7 (7.22)

67 (69.07)

8 (8.25)

17 (17.53)

5 (5.15)

 


(Figures in bracket indicates the horizontal percentages) From above table it is clear that Treatment Success were69.07 %, Treatment not successful were 30.93%. Relapse - 46.39%, Treatment after loss to follow up- 32.98%, Treatment after failure-20.61.

 

 

Table 4: Factors associated with the Treatment not successful

Factors

Treatment Success (%)

(n=67)

Treatment not successful (%) (n=30)

P-value

Low SES

25

19

Z=2.3792. P< 0.02.

Old age

21

17

Z= 2.92, P<0.05.

Alcohol intake

19

15

Z= 2.56, P<0.05.

Tobacco use

17

13

Z=3.2, P<0.01.

Diabetes

12

9

Z=4.1, P<0.001.

Immunocompromised

1

8

Z=5.12, P<0.0001

Factors associated Treatment not successful were Low SES (Z=2.3792. P< 0.02), Old age (Z= 2.92, P<0.05), Alcohol intake (Z= 2.56, P<0.05), Tobacco use (Z=3.2, P<0.01), Diabetes (Z=4.1, P<0.001). Immunocompromised (Z=5.12, P<0.0001).

 

DISCUSSION

The factors associated with deaths in the patents were Lower baseline body weight, delay in care seeking, multidrug resistance and a history of previous treatment were associated with increased risk of death. Previously reported risk factors for mortality among tuberculosis patients include advanced age,6,7 low literacy,8 alcoholism, 6 human immunodeficiency virus (HIV) infection,8,9 multidrug resistance,9-12 In our study we have found that the majority of the patients were in the age group of 50-60 were 29.90%, followed by 40-50, 24.74%, >60 were 18.56%,30-40 were 17.53%, and 20-30 -9.28%. The majority of the patients were Male i.e. 58.76% followed by Female -41.24%.Treatment Success were 69.07 %, Treatment not successful were 30.93%. Relapse - 46.39%, Treatment after loss to follow up- 32.98%, Treatment after failure-20.61.Factors associated Treatment not successful were Low SES (Z=2.3792. P< 0.02), Old age (Z= 2.92, P<0.05), Alcohol intake (Z= 2.56, P<0.05), Tobacco use (Z=3.2, P<0.01), Diabetes (Z=4.1, P<0.001). Immunocompromised (Z=5.12, P<0.0001). These findings are similar to Abinash Agarwala et al 13 they found Among 74 patients, retreatment was successful in 75.7% of relapse case, 66.7% of loss to follow-up cases and 53.8% of failure cases. Retreatment 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 hasunfavorable outcome

 

CONCLUSION

It can be concluded from our study that Factors associated Treatment not successful were Low SES, Old age, Alcohol intake, Tobacco use, Diabetes, Immunocompromised status etc.

 

REFERENCES

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