Three Times Weekly Anti-tuberculosis Treatment of Category 1 and Category 11 Patients of Pulmonary Tuberculosis Under Directly Observed Therapy (dots)

THREE TIMES WEEKLY ANTI-TUBERCULOSIS TREATMENT OF CATEGORY 1 AND CATEGORY 11 PATIENTS OF PULMONARY TUBERCULOSIS UNDER DIRECTLY OBSERVED THERAPY (DOTS) STRATEGY IN RURAL AREAS OF SINDH, PAKISTAN.

AUTHORS:

DR: BHURGRI GHULAM RASOOL

DR: SHAMIM-UR-REHMAN

DR: MOMINA TAKI MUHAMMAD

DR: SHAH MURAD MASTOEE.

DR: RAJ KUMAR CHOHAN.

DR: DAHRI GHULAM MUSTAFA.

DR: FAISAL KHAN.

DR: ATIF SHEIKH.

ABSTRACT:

OBJECTIVE:

The purpose of this study was to evaluate three times weekly anti-tuberculosis treatment (ATT) for both category 1 and category 11 patients of pulmonary tuberculosis under directly observed therapy to cut the cost and time required for ATT.

PLACE AND TIME:

This study was conducted at TB clinic, Muhammad Medical College Hospital Mirpurkhas, sindh, Pakistan, from July 2005 to June 2007

 Patients and Methods:

130 patients were enrolled for study. 70 patients of category 1 and 60 patients of category11 pulmonary TB who promised to come regularly for treatment three days a week for eight months. Patients were given antituberculosis drugs three days a week under strict observed therapy strategy for eight months according to World Health Organization guide lines for treatment of tuberculosis 2003.

Results:

At the end of eight months in category1, out of 70 patients 67 patients (96%) were cured, 3 patients (4%) who were sputum smear positive at the start of ATT remained sputum positive. In category 11 out of 60 patients, 53 patients (88%) were cured, 7 patients (12%) remained smear positive. Over all cure rates for both categories 1 and 11 was 92%.

CONCLUSION:

Three times a week ATT is as effective as daily regimen of ATT. It must be given under strict DOTS strategy. It saves 65-7-% of drug cost and time as compared to daily regimens.

Key words: Anti-tuberculosis treatment    ATT

          Directly Observed Therapy Short Course DOTS.

Address for correspondence:

(2) Dr:Ghulam Rasool Bhurgari

Assistant Professor

Department of Pharmacology and Therapeutics

Muhammad Medical College

Mirpurkhas, Pakistan

0333 2871918.

0345-3702876

E-mail drgr72@gmail.com

INTRODUCTION:

Nearly one third of the global population i.e. two billion people are infected with mycobacterium Tuberculosis and at risk of developing the disease. More than eight million people develop active tuberculosis (TB) every year and about million die (2).This problem is worse in Pakistan. There are no reliable data on the incidence and death caused by TB. It seems to be increasing every year. Although TB affects all classes of people, it is more prevalent in the poor especially of the productive ages of 22-55 years, causing great financial burden and misery to their families.

DOTS(Directly Observed Therapy Short course) was introduced in 1993 by World Health Organization(WHO) DECLARED TB A GLOBAL EMERGNCY IN RECOGNITION OF THE GROWING IMPORTANCE AS A PUBLIC HEALTH PROBLEM.(1)

A component of case management that helps to ensure that patients adhere to therapy is DOT.DOT means that a health care worker or another designated person watches the patient swallow each dose of TB medication. DOT ensures an accurate account of how much medication the patient really took. DOT should be considered for all patients because clinicians are often inaccurate in predicting which patient will adhere to medication regimens on their own. DOT has been shown to be effective when intermittent regimens are used. DOT can significantly reduce the frequency of development of drug resistant and of treatment failure or relapse after the end of treatment. Treatment for drug susceptible TB can be given intermittently if they are directly observed. Using intermittent regimens redress the total number of encounters with the Health worker, making these regimens more cost effective. (3)

Intermittent ATT given three times a week is as efficacious as daily therapy.Isoniazid; Rifampin, Pyrazinamide, and Streptomycin are all efficacious when given three times weekly as when given daily. This finding should not be surprising, because Mycobacterium tuberculosis doubles in 18-24 hours, compared with 12-20 minute for most bacteria(4).

DOTS has been employed with success UN many countries. We conducted this study under DOTS strategy to see the results of three days a week regimens to get better results with less cost.

PATIENTS AND METHODS:

Criteria for enrolling the patients for study:

1.  Patients who fulfilled the World Health Organization (WHO)diagnostic criteria for category 1(Patients who have never received treatment for TB) and category 11(Retreatment of ,relapse, treatment failure, smear positive who have taken ATT more than one month and defaulted)pulmonary tuberculosis (WHO) guidelines for national programmed treatment of tuberculosis 2003.

2.   Patients and their family promised to come regularly thrice a week for eight months.

130 patients were enrolled for study.70 patients of category 1 and 60 patients of category11.Out of 70 patients of category1, 40 patients (57%) were sputum smear positive and 30 patients (43%) were sputum smear negative.

In category 11 out of 60 patients, 10 patients (17%)were previously treated for 8 months,6 of these patients were sputum smear positive.50 patients had interrupted their treatment after more than one month. In category 11 36 patients (60%) was sputum smearing positive and 24 patients (40%) were sputum smear negative.

Out of the total 130 patients there were 70 male (54%) and 60 females (46%).Their ages ranged from 16-65 years. 80% of the patients were between 20 and 55 years of age.

MANAGMENT:

1.  COUNCILLING:

A. The patient and his family were informed about TB disease, its spread, progress and treatment. Regular treatment for 8 months will cure the patient. Irregular treatment or interruption of treatment before 8 months will make the disease resistant to treatment and chances of cure will diminish.

B. Diet: Advised to eat everything available. Diet should increase every day some patients are given drugs to stimulate appetite. Few patients needed short course of corticosteroids.

C. Emphasis was on regular visits and not to miss treatment at all.                    Patients and their family’s contact numbers and address were noted.

2. Drug Treatment: All the patients were given treatment 3 days a week under DOTS strategy. The drugs were given as separate drugs and doses were calculated according to weight of the patients as recommended by WHO guidelines for treatment of tuberculosis 2003 for 3 days week regimen.

In category 1 during initial phase months Rifamicin, Isoniazid, Pyrazinamide and Ethambutol were given and during continuation phase of six months Rifampcin, Isoniazid, and Ethambutol were given.

 In category 11 patients, during initial phase of two months Rifamicin,    Isoniazid, Pyrazinamide, Ethambutol and Streptomycin were given. In 3rd months initial phase Streptomycin was stopped and other four drugs were continued. During continuation phase of 5 months Ionized, Rifampin, and Ethambutol were continued

.

3. On every visit:

a. Patient was attended straight away on arrival with greetings and enquired about his health, family and job.

b. Temperature and weight recorded. Patients not gaining weight were advised to increase the diet. Some were given drugs to stimulate appetite and few given corticosteroids.

c. A glass of water and medicine given under supervision

d. Any co-existent illness was also treated.

e. On leaving, patient was reminded about the next visit. If he cannot come then medicine were given to his family member to give the patient under his supervision. The patient was made to feel that we care for him and want him to get better.

PROGRESS: X-RAY CHEST, ESR,Hb, and soutum smear for A.F.B were repeated at 2 months, 5 months and end of treatment at 8 months.

RESULT:

After completion of eight months of ATT, the following criteria were taken for cure.

                                                                                                                       Statistics

category type one patients of tuberculosis

categry two patients of tuberculosis

seventy patients in cat one

sixty patients in cat two

three patients missed

seven patients missed in cat two

N

Valid

70

60

70

60

3

7

 
Missing

2

12

2

12

69

65

Mean

1.0000

2.0000

3.0000

4.0000

5.0000

6.0000

Std. Error of Mean

.00000

.00000

.00000

.00000

.00000

.00000

Median

1.0000

2.0000

3.0000

4.0000

5.0000

6.0000

Std. Deviation

.00000

.00000

.00000

.00000

.00000

.00000

Frequency Table

                                      category type one patients of tuberculosis

Frequency

Percent

Valid Percent

Cumulative Percent

Valid

catone

70

97.2

100.0

100.0

Missing

System

2

2.8

Total

72

100.0

                                            categry two patients of tuberculosis

Frequency

Percent

Valid Percent

Cumulative Percent

Valid

cattwo

60

83.3

100.0

100.0

Missing

System

12

16.7

Total

72

100.0

                                                         three patients missed

Frequency

Percent

Valid Percent

Cumulative Percent

Valid

trees

3

4.2

100.0

100.0

Missing

System

69

95.8

Total

72

100.0

                                               seven patients missed in cat two

Frequency

Percent

Valid Percent

Cumulative Percent

Valid

svn

7

9.7

100.0

100.0

Missing

System

65

90.3

Total

72

100.0

FREQUENCIES

  VARIABLES=catone cattwo senty sixty tree svn

  /STATISTICS=STDDEV SEMEAN MEAN MEDIAN

  /PIECHART  FREQ

  /ORDER=  ANALYSIS .

Pie Chart

                

1. Sputum smear negative for AFB on three occasions.

2. Radiological opacities on x-ray chest had cleared or healed by fibrosis and calcification.

3.  Had gained weight.

4.  E.S.R had fallen to normal limits.

5.  Hb had risen.

6.  Patient was symptoms free and doing his job.

    In category 1 67 (96%) patients out of 70 cured.3 patients (4%) who were sputum positive at the start of ATT remained sputum smear positive. In category 11 53 patients (88%) out of 60 were cured.7 (12%) remained sputum positive as they were at the onset of ATT. Over all cure rate in both categories 1and 11 was 92%.

DISCUSSION:

The global target for successful treatment of new sputum smear patients is 85% or more (5) .Average treatment success among national DOTS programs is 82% close to the 85% global target. (6)We achieved the cure rate of 96% for category 1, 88% for category 11 pulmonary TB patients and overall cure rate in both categories 1 and 11 was 92%.

The result is better than the global target for national programs set by WHO. This may be because our total number of patients was small and few multi-drug- resistant (MDR) cases were enrolled.

We think our high cure rate is due to the fact that during this trail we did not let any patient miss even a single dose of medicine. Council ling on every visit was useful. We had to scare the patient that if, he misses even a single dose of medicine he will not be cured. He will die coughing up blood and no medicine will help.

Patient’s family was told that successful treatment of the patient is in their interest also otherwise they will catch the disease from the patient.

DIET ALSO PLAYED A BIG ROLE:

On every visit the patient was weighed and advised to increase his daily consumption of food. Some very anorexic patients were given tonics and steroids.

DOT’S strategy does not just mean giving medicines under peon’s supervision. Doctor and his team treating the patient should win the confidence of the patient by care, sympathy, concern and politeness so that patient can complete his ATT without interruption. This will increase the cure rate  and reduce development of MDR.

CONCLUSION:

3 days a week ATT for category 1 and category 11 pulmonary patients under a caring and strict DOTS strategy is more effective and less costly than half heartily supervised daily regimen.

If the total consumption of drugs for 8 months with 3 days a week regimen is compared with that of daily regimen for 8 months there is a saving of 65-70% in cost and time.

This means that with the amount allocated by Government for TB control, as many as three times more patients can be treated. It also means that only 40% sincere and dedicated personal can do better job than being done at present.

KEY MESSAGE:

a)                  All patients of category 1 and 11 pulmonary tuberculosis can be treated successfully with 3 days a week ATT regimen under DOTS strategy.

b)                  3 days a week ATT saves 65-70% money and time,

c)                  DOTS strategy can improve results if employed with sincerity and devotion.                                                  

REFERNCES:

1      Guideline for National tuberculosis programs on management of tuberculosis, World Health Organization 2003

2      Dye C etal. Global burden of tuberculosis:estimated incidence, prevelence and morbidity by country. JAMA 1999, 282(7):677-678

3      Core circulation on tuberculosis 4th edition 200 US Department of health and human services.

4    North RJ,Izzo AA,Mycobactrium Virulence J.EXP.Med 1993:177(6);1723-33.

5 An expanded DOTS framework for effective tuberculosis control WHO/CDS/TB/2002.297.Geneva:World Health Organization global tuberculosis programme; 2002.

6 Global tuberculosis control, planning,financing.WHOreport 2005. WHO/HTM/TB/2005.49.Geneva(Switzerland);World Heath Org.