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Bangladesh National Guidelines and
Operational Manual for Tuberculosis Control
NTP, 2014
Dr Shahjada Selim
Registrar
Department of Medicine
Shaheed Suhrawardy Medical College & Hospital, Dhaka
Background
• Tuberculosis (TB) is a major public health problem
in Bangladesh since long. Estimates suggest that
daily about 880 new TB cases and 176 TB deaths
occur in the country.
• Nearly one-third of the global population, i.e. two
billion people, is infected with Mycobacterium
tuberculosis and thus at risk of developing the
disease. More than nine million people develop
active TB every year and about two million die.
• More than 90% of global TB cases and deaths
occur in the developing world, where 75% of
cases are in the most economically productive
age group (15-54 years).
Bangladesh national guidelines and operational manual for tuberculosis dr shahjadaselim
Vision Statement of the National TB
Control Programme
• To eliminate tuberculosis as a public
health problem in Bangladesh.
Goal of Tuberculosis Control for
Bangladesh
• The overall goal of TB control is to reduce
morbidity, mortality and transmission of TB
until it is no longer a public health problem.
Definition of tuberculosis
• Tuberculosis is an infectious disease, caused
by the bacillus called
Mycobacterium tuberculosis.
• The bacilli usually enter the body by inhalation
through the lungs and spread to other parts of
the body via the blood stream, the lymphatic
system, or through direct extension to other
organs.
• Tuberculosis of the lungs or pulmonary
tuberculosis is the most common form of TB
and occurs in about 80% of cases. Extra-
pulmonary tuberculosis can affect any part of
the body other than lungs.
Difference between TB infection
and TB disease
TB infection
• TB spreads through droplet infection. TB
bacilli stay suspended in the air as droplets.
Healthy people become infected with TB
through inhalation of the droplets containing
TB bacilli. Around 90% of the infected people
do not progress to TB disease because of their
immunity. Around 10% of the infected people
develop TB disease in their lifetime.
TB disease
• Around 10% of the people infected with TB bacilli
may progress to TB disease in their lifetime. TB
bacilli multiply in their lungs or other organs and
produce the symptoms and signs. Around 5% of
the infected people develop TB disease within
months or years and the remaining in their old
age that is known as reactivation of the
disease. TB disease means TB infection plus
presence of signs and symptoms of TB.
Spread of tuberculosis bacilli
• Patients with pulmonary tuberculosis who
cough up TB bacilli through coughing,
sneezing and spitting are the main source of
TB infection. Presence of TB bacilli in the
sputum can be identified on microscopic
examination of sputum specimens. Such
patients whose sputum contains TB bacilli are
known as smear- positive cases.
• If the bacilli cannot be identified on
microscopy examination of sputum specimens
of pulmonary cases, the patients are known as
smear-negative cases.
Extra-pulmonary cases are almost never
infectious, unless they have pulmonary
tuberculosis as well.
Development of tuberculosis
• If the body immune mechanism is not
seriously compromised, approximately 90% of
the infected cases will not develop
tuberculosis disease; in this case the bacilli
usually remain dormant within the body. The
remaining 10% of infected individuals will
subsequently develop disease, half of them
shortly after infection, the other half later in
their life
Signs and symptoms of TB
• Pulmonary TB should be suspected in a person
who presents with persistent cough for three
weeks or more, with or without production of
sputum despite the administration of a non-
specific antibiotic.
• Respiratory symptoms: shortness of breath,
chest pain, coughing up of blood.
• General symptoms: loss of weight, loss
of appetite, fever, night sweats.
Signs and symptoms of
extra-pulmonary TB
• TB lymph adenitis: swelling of lymph nodes
• Pleural effusion: fever, chest pain, shortness
of breath
• TB arthritis: pain and swelling of joints
• TB of the spine: radiological findings with or
without loss of function
• Meningitis: headache, fever, stiffness of neck
and subsequent mental confusion
Diagnosis
• The most cost-effective tool for screening
pulmonary TB suspects is microscopy
examination of their sputum by the Ziehl-
Neelsen method.
• Radiological (X-ray) examination of the lungs.
• Tuberculin skin test (Mantoux Test).
• Culture of TB bacilli.
• FNAC and Biopsy (LN or other affected
organs).
Case definitions by site &
bacteriological status in adults
Case definitions by previous
treatment history
Flow chart for diagnosis and follow up of pulmonary TB
Diagnose the case as EPTB using the following diagnostic tools
TREATMENT OF TUBERCULOSIS
Aims of treatment
• To cure the patient of TB
• To prevent death from active TB or its late
effects
• To prevent relapse of TB
• To decrease transmission of TB to others
• To prevent the development of acquired drug
resistance
Basic Principles of TB treatment
• Right combination of drugs to kill
different bacterial populations.
• Drugs are given for the right duration (several
months) to kill the bacilli.
• Drugs are given in the right dosage to achieve
therapeutic but not toxic effect
Bangladesh national guidelines and operational manual for tuberculosis dr shahjadaselim
Dosages of FDC tablet
• 4FDC- isoniazid 75 mg + rifampicin 150 mg +
pyrazinamide 400 mg + ethambutol275 mg
• 2FDC- isoniazid 75 mg + rifampicin 150 mg
• 3FDC- isoniazid 75mg+ rifampicin 150mg+
ethambutol 275mg
Bangladesh national guidelines and operational manual for tuberculosis dr shahjadaselim
Bangladesh national guidelines and operational manual for tuberculosis dr shahjadaselim
Bangladesh national guidelines and operational manual for tuberculosis dr shahjadaselim
Bangladesh national guidelines and operational manual for tuberculosis dr shahjadaselim
Bangladesh national guidelines and operational manual for tuberculosis dr shahjadaselim
Treatment of tuberculosis in special
situation
• Drug-induced hepatitis
• Most anti-TB drugs can damage the liver. Isoniazid,
pyrazinamide and rifampicin are most commonly
responsible, ethambutol rarely. When a patient
develops hepatitis duringTB treatment, the hepatitis
may be due to the anti-TB drugs but may also have
another cause. It is important to rule out other
possible causes before deciding that the hepatitis is
drug induced. If the diagnosis of drug-induced
hepatitis is made, the anti-TB drugs should be
stopped.
The drugs must be withheld until the jaundice or hepatic
symptoms have resolved and liver function tests have
returned to normal. If liver function tests cannot be
done, then it is advisable to wait two weeks after the
jaundice has disappeared before recommencing anti-TB
treatment. In most cases the patient can restart the
same anti-TB drugs without return of hepatitis.
• This can be done either gradually (one by one) or all at
once (if the hepatitis was mild). However if the
hepatitis produced severe jaundice, it is advisable to
avoid pyrazinamide. A suggested regimen in such
patient is 2SHE/10HE. A severely ill TB patient with
drug-induced hepatitis may die without anti-TB drugs.
In this case the patient should be treated with two of
the least hepatotoxic dugs, streptomycin and
ethambutol. After the hepatitis has resolved, usual TB
treatment should be restarted. Incase of extensive TB,
ofloxacin can be considered in conjunction with
streptomycin and ethambutol as an interim non-
hepatotoxic regimen.
• Acute viral hepatitis
• TB treatment should be deferred until the acute
hepatitis has resolved. When it is necessary to
treat during acute hepatitis, the combination of
streptomycin and ethambutol for three months is
the safest option. If the hepatitis has resolved,
the patient can receive a continuation phase of
six months isoniazid and rifampicin. If the
hepatitis has not fully resolved, streptomycin and
ethambutol should be continued for a total of 12
months
• Chronic liver disease
• Patients with liver disease should not receive
pyrazinamide. Isoniazid plus rifampicin plus
one or two non-hepatotoxic drugs such as
streptomycin and ethambutol can be used for
total treatment duration of 8 months
(2SHRE/6HR)
• Renal failure
• Isoniazid, rifampicin and pyrazinamide are
either eliminated almost entirely by billiary
excretion or metabolized into non-toxic
compounds. These drugs can therefore be
given in normal doses to patients with renal
failure. Patients with severe renal failure
should receive pyridoxine with isoniazid in
order to prevent peripheral neuropathy.
• Pregnancy
Most anti TB drugs are safe for use in pregnancy
with the exception of streptomycin which is
ototoxic to the fetus.
• Breast-feeding women
• A woman with TB who is breast-feeding should receive
a full course of anti-TB drugs.Regular and full course
chemotherapy is the best way to prevent transmission
of tubercle bacilli to her baby. The mother and baby
should stay together and breast-feeding should be
continued. Prophylactic treatment with isoniazid
should be given for at least three months ahead of the
time the mother is considered non-infectious. BCG
vaccination of the newborn should be postponed until
the end of the isoniazid prophylax.
• Women taking oral contraceptive pills
• Rifampicin reduces the efficacy of estrogen
thus increases the risk of pregnancy. A higher
dose of estrogen (50 µ) can be used with
rifampicin or another form of contraception .
may be used.
• Diabetes mellitus
• During the course of anti-TB treatment a
diabetes mellitus patient may require
treatment with insulin.
DRUG-RESISTANT TUBERCULOSIS
• Depending on the number of resistant drugs,
we distinguish the following categories of
resistance:
• Mono-resistance: resistance to one type of
drugs (e.g. isoniazid).
• Poly-resistance: resistance to more than one
type of drug (e.g. streptomycin,isoniazid and
ethambutol).
MDR-TB: this is a subcategory of poly-
resistance. TB resistant to at least
isoniazid and rifampicin.
Extensive drug-resistant tuberculosis
(XDR-TB): this is a subcategory of MDR-
TB.XDR-TB is defined as MDR-TB plus
resistance to a quinolone and an
injectable second-line drug (kanamycin,
capreomycin etc.)
• The Standard MDR TB Regimen
• 8{Km-Z-Lfx(Ofx)-Eto-Cs}/12{Lfx(Ofx)-Eto-Cs-Z}
Length of treatment for the standard
MDR TB regimen
Date of first sustained
conversion
Length of injectable agent Length of total treatment
for standard MDR TB
regimen
Between month 0 and 4 8 month total 20-22 months
Between months 5 and 8 Add 4 months from
conversion date
Add 18 months from
conversion date
• The Standard XDR TB Regimen
• 12(Cm-Z-Mfx-PAS-Cs-Amx/Clv-Lzd-Cfz)/12(Z-
Mfx-PAS-Cs-Amx/Clv-Lzd-Cfz)
Length of treatment for standard XDR
TB regimen
Date of first sustained
conversion
Length of injectable agent Length of total treatment
for standard MDR TB
regimen
Between month 0 and 2 12 month total 24 months
Between months 3 and 6 Add 10 months from
conversion date
Add 22 months from
conversion date
Thank you

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Bangladesh national guidelines and operational manual for tuberculosis dr shahjadaselim

  • 1. Bangladesh National Guidelines and Operational Manual for Tuberculosis Control NTP, 2014 Dr Shahjada Selim Registrar Department of Medicine Shaheed Suhrawardy Medical College & Hospital, Dhaka
  • 2. Background • Tuberculosis (TB) is a major public health problem in Bangladesh since long. Estimates suggest that daily about 880 new TB cases and 176 TB deaths occur in the country. • Nearly one-third of the global population, i.e. two billion people, is infected with Mycobacterium tuberculosis and thus at risk of developing the disease. More than nine million people develop active TB every year and about two million die.
  • 3. • More than 90% of global TB cases and deaths occur in the developing world, where 75% of cases are in the most economically productive age group (15-54 years).
  • 5. Vision Statement of the National TB Control Programme • To eliminate tuberculosis as a public health problem in Bangladesh.
  • 6. Goal of Tuberculosis Control for Bangladesh • The overall goal of TB control is to reduce morbidity, mortality and transmission of TB until it is no longer a public health problem.
  • 7. Definition of tuberculosis • Tuberculosis is an infectious disease, caused by the bacillus called Mycobacterium tuberculosis. • The bacilli usually enter the body by inhalation through the lungs and spread to other parts of the body via the blood stream, the lymphatic system, or through direct extension to other organs.
  • 8. • Tuberculosis of the lungs or pulmonary tuberculosis is the most common form of TB and occurs in about 80% of cases. Extra- pulmonary tuberculosis can affect any part of the body other than lungs.
  • 9. Difference between TB infection and TB disease
  • 10. TB infection • TB spreads through droplet infection. TB bacilli stay suspended in the air as droplets. Healthy people become infected with TB through inhalation of the droplets containing TB bacilli. Around 90% of the infected people do not progress to TB disease because of their immunity. Around 10% of the infected people develop TB disease in their lifetime.
  • 11. TB disease • Around 10% of the people infected with TB bacilli may progress to TB disease in their lifetime. TB bacilli multiply in their lungs or other organs and produce the symptoms and signs. Around 5% of the infected people develop TB disease within months or years and the remaining in their old age that is known as reactivation of the disease. TB disease means TB infection plus presence of signs and symptoms of TB.
  • 12. Spread of tuberculosis bacilli • Patients with pulmonary tuberculosis who cough up TB bacilli through coughing, sneezing and spitting are the main source of TB infection. Presence of TB bacilli in the sputum can be identified on microscopic examination of sputum specimens. Such patients whose sputum contains TB bacilli are known as smear- positive cases.
  • 13. • If the bacilli cannot be identified on microscopy examination of sputum specimens of pulmonary cases, the patients are known as smear-negative cases. Extra-pulmonary cases are almost never infectious, unless they have pulmonary tuberculosis as well.
  • 14. Development of tuberculosis • If the body immune mechanism is not seriously compromised, approximately 90% of the infected cases will not develop tuberculosis disease; in this case the bacilli usually remain dormant within the body. The remaining 10% of infected individuals will subsequently develop disease, half of them shortly after infection, the other half later in their life
  • 15. Signs and symptoms of TB • Pulmonary TB should be suspected in a person who presents with persistent cough for three weeks or more, with or without production of sputum despite the administration of a non- specific antibiotic. • Respiratory symptoms: shortness of breath, chest pain, coughing up of blood. • General symptoms: loss of weight, loss of appetite, fever, night sweats.
  • 16. Signs and symptoms of extra-pulmonary TB • TB lymph adenitis: swelling of lymph nodes • Pleural effusion: fever, chest pain, shortness of breath • TB arthritis: pain and swelling of joints • TB of the spine: radiological findings with or without loss of function • Meningitis: headache, fever, stiffness of neck and subsequent mental confusion
  • 17. Diagnosis • The most cost-effective tool for screening pulmonary TB suspects is microscopy examination of their sputum by the Ziehl- Neelsen method. • Radiological (X-ray) examination of the lungs. • Tuberculin skin test (Mantoux Test). • Culture of TB bacilli. • FNAC and Biopsy (LN or other affected organs).
  • 18. Case definitions by site & bacteriological status in adults
  • 19. Case definitions by previous treatment history
  • 20. Flow chart for diagnosis and follow up of pulmonary TB
  • 21. Diagnose the case as EPTB using the following diagnostic tools
  • 23. Aims of treatment • To cure the patient of TB • To prevent death from active TB or its late effects • To prevent relapse of TB • To decrease transmission of TB to others • To prevent the development of acquired drug resistance
  • 24. Basic Principles of TB treatment • Right combination of drugs to kill different bacterial populations. • Drugs are given for the right duration (several months) to kill the bacilli. • Drugs are given in the right dosage to achieve therapeutic but not toxic effect
  • 26. Dosages of FDC tablet • 4FDC- isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol275 mg • 2FDC- isoniazid 75 mg + rifampicin 150 mg • 3FDC- isoniazid 75mg+ rifampicin 150mg+ ethambutol 275mg
  • 32. Treatment of tuberculosis in special situation • Drug-induced hepatitis • Most anti-TB drugs can damage the liver. Isoniazid, pyrazinamide and rifampicin are most commonly responsible, ethambutol rarely. When a patient develops hepatitis duringTB treatment, the hepatitis may be due to the anti-TB drugs but may also have another cause. It is important to rule out other possible causes before deciding that the hepatitis is drug induced. If the diagnosis of drug-induced hepatitis is made, the anti-TB drugs should be stopped.
  • 33. The drugs must be withheld until the jaundice or hepatic symptoms have resolved and liver function tests have returned to normal. If liver function tests cannot be done, then it is advisable to wait two weeks after the jaundice has disappeared before recommencing anti-TB treatment. In most cases the patient can restart the same anti-TB drugs without return of hepatitis.
  • 34. • This can be done either gradually (one by one) or all at once (if the hepatitis was mild). However if the hepatitis produced severe jaundice, it is advisable to avoid pyrazinamide. A suggested regimen in such patient is 2SHE/10HE. A severely ill TB patient with drug-induced hepatitis may die without anti-TB drugs. In this case the patient should be treated with two of the least hepatotoxic dugs, streptomycin and ethambutol. After the hepatitis has resolved, usual TB treatment should be restarted. Incase of extensive TB, ofloxacin can be considered in conjunction with streptomycin and ethambutol as an interim non- hepatotoxic regimen.
  • 35. • Acute viral hepatitis • TB treatment should be deferred until the acute hepatitis has resolved. When it is necessary to treat during acute hepatitis, the combination of streptomycin and ethambutol for three months is the safest option. If the hepatitis has resolved, the patient can receive a continuation phase of six months isoniazid and rifampicin. If the hepatitis has not fully resolved, streptomycin and ethambutol should be continued for a total of 12 months
  • 36. • Chronic liver disease • Patients with liver disease should not receive pyrazinamide. Isoniazid plus rifampicin plus one or two non-hepatotoxic drugs such as streptomycin and ethambutol can be used for total treatment duration of 8 months (2SHRE/6HR)
  • 37. • Renal failure • Isoniazid, rifampicin and pyrazinamide are either eliminated almost entirely by billiary excretion or metabolized into non-toxic compounds. These drugs can therefore be given in normal doses to patients with renal failure. Patients with severe renal failure should receive pyridoxine with isoniazid in order to prevent peripheral neuropathy.
  • 38. • Pregnancy Most anti TB drugs are safe for use in pregnancy with the exception of streptomycin which is ototoxic to the fetus.
  • 39. • Breast-feeding women • A woman with TB who is breast-feeding should receive a full course of anti-TB drugs.Regular and full course chemotherapy is the best way to prevent transmission of tubercle bacilli to her baby. The mother and baby should stay together and breast-feeding should be continued. Prophylactic treatment with isoniazid should be given for at least three months ahead of the time the mother is considered non-infectious. BCG vaccination of the newborn should be postponed until the end of the isoniazid prophylax.
  • 40. • Women taking oral contraceptive pills • Rifampicin reduces the efficacy of estrogen thus increases the risk of pregnancy. A higher dose of estrogen (50 µ) can be used with rifampicin or another form of contraception . may be used.
  • 41. • Diabetes mellitus • During the course of anti-TB treatment a diabetes mellitus patient may require treatment with insulin.
  • 42. DRUG-RESISTANT TUBERCULOSIS • Depending on the number of resistant drugs, we distinguish the following categories of resistance: • Mono-resistance: resistance to one type of drugs (e.g. isoniazid). • Poly-resistance: resistance to more than one type of drug (e.g. streptomycin,isoniazid and ethambutol).
  • 43. MDR-TB: this is a subcategory of poly- resistance. TB resistant to at least isoniazid and rifampicin. Extensive drug-resistant tuberculosis (XDR-TB): this is a subcategory of MDR- TB.XDR-TB is defined as MDR-TB plus resistance to a quinolone and an injectable second-line drug (kanamycin, capreomycin etc.)
  • 44. • The Standard MDR TB Regimen • 8{Km-Z-Lfx(Ofx)-Eto-Cs}/12{Lfx(Ofx)-Eto-Cs-Z}
  • 45. Length of treatment for the standard MDR TB regimen Date of first sustained conversion Length of injectable agent Length of total treatment for standard MDR TB regimen Between month 0 and 4 8 month total 20-22 months Between months 5 and 8 Add 4 months from conversion date Add 18 months from conversion date
  • 46. • The Standard XDR TB Regimen • 12(Cm-Z-Mfx-PAS-Cs-Amx/Clv-Lzd-Cfz)/12(Z- Mfx-PAS-Cs-Amx/Clv-Lzd-Cfz)
  • 47. Length of treatment for standard XDR TB regimen Date of first sustained conversion Length of injectable agent Length of total treatment for standard MDR TB regimen Between month 0 and 2 12 month total 24 months Between months 3 and 6 Add 10 months from conversion date Add 22 months from conversion date