General Manual Text (26 55)Pages

8/3/2019 General Manual Text (26 55)Pages

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Flow chart II

Treatment and follow up of Re-treatment cases (CAT 2)(Send sputum for pre-treatment culture and ABST)

2 HRZES

1 HRZE

Examine sputum (end of the 3rd

month)

Positive Negative

Continue 1 HRZE Start continuation phase5 HRE

Examine sputum

(end of the 4th

month) Examine sputum

end of the 5th

month and

end of treatment)

Positive Negative

Further treatment

determined by result Start continuation phase

of pre-treatment 5 HRE Positive Negative

culture & ABST

Examine sputum

(end of the 5th month and end of treatment) Do a CXR**

and stop ATT

(Cured)

Positive Negative

Do a CXR** and stop ATT

(Cured)

Chronic Case

Refer to a Chest Physician

**Optional

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Flow chart III

Treatment and follow up of smear-negative PTB cases

Smear-negative PTB

(Send sputum for pre-treatment culture)

2 HRZE(S)

CXR after 1 month

Examine sputum (end of the 2nd

month).

Negative Positive

Start Continuation Phase Treatment Failure

4 HR

Examine sputum Stop ATT

* Do a CXR Re-registerStop ATT Start CAT 2

(Completed Rx)

* If no improvement in the abnormality found in the original CXR, refer the patient to a

Chest Physician.

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Directly Observed Treatment

Directly Observed Treatment (DOT) is one of the important elements of the

internationally recommended strategy for TB control. Directly Observed Treatment

means that an observer watches the patient swallow their tablets. This ensures that a TB

patient takes the right anti-tuberculosis drugs, in the right doses at the right intervals

without interruption and ensures that the patient completes the full course of treatment.

Why is Directly Observed Treatment necessary?

Patient compliance is a key factor in treatment success. Many patients who receive self-

administered treatment often take drugs irregularly and a significant proportion of

patients stop treatment before completion due to various reasons. It is impossible to

predict who will or will not comply. Therefore directly observed treatment is required to

ensure treatment adherence and it also helps to motivate the patient to continue treatment.

It is recommended in the intensive phase of treatment at least for all sputum positive

cases. A patient who misses one attendance for DOT can be traced immediately,

counseled and returned to treatment.

Patient compliance should be promoted through a patient centered approach by:

- Facilitating easy access to treatment, by organizing directly observed

treatment as close to patients home (or the work place) as possible

- Providing anti-tuberculosis drugs free of charge- Providing polite and rapid attention.

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National policy for the implementation of Directly Observed

Treatment (DOT)

Patients who will be given DOT

New Pulmonary TB (sputum positive and negative) casesIntensive phase:

All new Pulmonary TB (sputum positive and negative) patients should be given

directly observed treatment daily during the intensive phase. This should be

arranged as far as possible community based, or hospital based wherever

necessary as in the case of very ill patients or those patients who are unable to

come daily for supervised treatment

Continuation phase:

Since the continuation phase also contains Rifampicin, every effort should be

made to give each dose under observation. Wherever this is not possible patients

will be advised to attend the chest clinic once a week, and the first dose will be

given under direct observation and the remaining six doses will be supplied for

self-administration at home. DTCO will make arrangements for supervisory visits

to check drug intake (including pill counts).

Extra pulmonary TBIntensive Phase:

Drugs will be given under direct observation

Continuation phase:

Since the continuation phase also contains Rifampicin, every effort should be

made to give each dose under observation. Wherever this is not possible patients

will be advised to attend the chest clinic once a week and the first dose will begiven under direct observation and the remaining six doses will be supplied for

self-administration at home. The DTCO will make arrangements for supervisory

visits to check drug intake (including pill counts).

All Re-treatment casesDirectly Observed treatment should be given throughout the entire period of

treatment daily, both in the intensive and continuation phase of treatment.

Admission to hospital is recommended whenever possible.

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DOT Providers

The following categories will provide Direct Observation of Treatment.

Health workers at state health care facilities Field health care workers General practitioners Trained volunteers Community leaders

Trained community volunteers or community leaders need regular support, motivation

and supervision by the NTP staff to ensure that quality is maintained.

Provision of drugs for the DOT Centres -

Drugs for each patient will be delivered to the DOT centres from the District Chest Clinic

by the PHI or any other staff assigned by the DTCO.

Interruption of treatment (default)

Directly Observed Treatment adapted to the needs of the patient is the best method of

avoiding treatment interruption. However, even with directly observed treatment and

during the continuation phase of treatment, which may be self-administered, there may be

treatment interruption.

Measures to minimize treatment interruption

At the time of registration of a TB patient, the staff must educate the patient and the

family regarding the duration of treatment and the importance of adherence to treatment.

It is vital to record the patients address and other relevant addresses e.g. parents or workplace etc. in order to help locate the patients who interrupt treatment. As far as possible,

the address should be verified at the beginning of treatment.

Management of patients who interrupt treatment

It is important to take action on defaulters immediately. Patients should be contacted the

day after missing a dose during the intensive phase and as soon as possible during the

continuation phase. It is important to find out the reason for the patients absence in order

to take appropriate action and continue treatment.

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Table 3 Actions in interruption of TB treatment

Interruption for less than 1 month

Trace patient Solve the cause of interruption Continue treatment and prolong it to compensate for missed dosesInterruption for 1-2 months

Action 1 Action 2

Continue treatment and prolong it to

compensate for missed doses

Treatment Continue treatment and

received: prolong it to compensate

for

< 5 months missed doses

Trace the patientSolve the cause of

interruption

Do 3 sputum smears.Continue treatment

while waiting

If smears negative

or EPTB

If one or more

smears positive

do culture &

ABST

> 5 months Category 1: Start Cat 2

Category 2: refer for advice

(may evolve to Chronic)

Interruption for 2 months or more (defaulter)

Action 1 Action 2

Do 3 sputum smearsSolve the cause of

interruption, if possible

No treatment while

waiting for results

Send culture & ABST

Negative smears

or EPTB

One or more

smears positive

Clinical decision on individual basis

whether to restart or continue treatment,

or no further treatment

If on Category 1 Start Category 2

If on Category2 Refer for advice (may

evolve to Chronic)

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ESSENTIAL (FIRST LINE) ANTI-TB DRUGS5Isoniazid (INAH)

Isoniazid is highly bactericidal against replicating tubercle bacilli. It is rapidly absorbed

and diffuses readily into all fluids and tissues. The plasma half-life, which is genetically

determined, varies from less than one hour in fast acetylators to more than three hours in

slow acetylators. It is largely excreted in the urine within 24 hours, mostly as inactive

metabolites.

Uses

Isoniazid is a component of all TB chemotherapeutic regimens currentlyrecommended by WHO.

Isoniazid alone is occasionally used in chemoprophylaxisAdministration

Isoniazid is normally given orally.

Dosages

For treatment-

Adults and children: 5mg/kg (4-6mg/kg) daily, maximum 300mg.

10 mg/kg 3 times weekly

Preventive therapy:

Adults: 300mg daily for at least 6 months

Children: 5mg/kg daily (maximum 300mg) for at least 6 months

Side-effects

Isoniazid is generally well tolerated at recommended doses.

Systemic or cutaneous hypersensitivity reactions occasionally occur during the firstweeks of treatment.

Peripheral neuropathy may occur in persons with malnutrition, chronic alcoholics, andpregnant women or in diabetics. This can be prevented or minimized by giving,

supplementary pyridoxine 10 mg daily to those at risk.

Other less common forms of neurological disturbances including optic neuritis, toxicpsychosis, and generalized convulsions can develop in susceptible individuals,

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particularly in the later stages of treatment, which occasionally may necessitate

withdrawal of Isoniazid.

Hepatitis is an uncommon but potentially serious reaction that can usually be avertedby prompt withdrawal of the treatment. Monitoring of hepatic transaminases should

be done in patients with pre-existing chronic liver disease.

Isoniazid tends to raise plasma concentrations of phenytoin and carbamazapine byinhibiting their metabolism in the liver. Therefore it may be necessary to reduce the

dosages of these drugs during treatment with Isoniazid.

Patients on treatment with Isoniazid should be cautioned against eating Red fishsuch as skipjack and tuna, which contain high concentrations of histamine. Isoniazid

is an inhibitor of histaminase, which is normally present in the tissues and is

responsible for the inactivation of ingested histamine. As a result, the histamine level

in the tissues of the patient tends to rise shortly after a meal containing these varieties

of fish, and the patient may experience symptoms of histamine intoxication like

erythema, severe headache, red eyes, palpitation, diarrohoea, vomiting and wheezing.

Isoniazid is not teratogenic and can be used during pregnancy.

Rifampicin

Rifampicin has a potent bactericidal and sterilizing effect against tubercle bacilli in both

cellular and extra-cellular locations. Following oral administration, it is rapidly absorbed

and distributed throughout the cellular tissues and body fluids.

Since resistance develops rapidly, Rifampicin must always be administered in

combination with other effective anti-mycobacterial agents.

Uses

It is a component of all 6 months and 8 months TB chemotherapeutic regimens currently

recommended by WHO.

Administration and dosage:

Rifampicin is administered orally and should preferably be given at least 30 minutes

before meals, since absorption is reduced when it is taken with food.

This however may not be clinically significant and food can reduce intolerance to the

drugs.

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Adults and children: 10 mg/kg (8-12 mg/kg) daily, maximum 600mg daily.

10mg/kg 3 times weekly

Side-effects

Rifampicin is well tolerated by most patients at currently recommended doses

Side-effects include:

Gastro-intestinal - nausea, anorexia, vomiting and abdominal pain Hepatitis is a major side effect although it is rare. Alcoholics and pre existing liver

disease may increase the risk and it may be advisable to monitor the liver function

tests in these high-risk groups.

The following reactions are more likely to occur with intermittent therapy:

Flu syndrome - consisting of attacks of fever, chills, malaise headache, bonepain

Cutaneous reaction consisting of flushing, and pruritus with or without a rash *Thrombocytopenia and purpura *Heamolytic aneamia and acute renal failure may occur *Respiratory shock syndrome consisting of shortness of breath and rarely

associated with collapse and shock. may occur

* If these reactions occur Rifampicin must be stopped immediately and admitted to

hospital for management. It should not be given again.

Drug interactions

Rifampicin induces hepatic enzymes and may accelerate clearance of drugs metabolized

by the liver, and patients may need higher dosages of these drugs. These include

corticosteroids, oral contraceptives, oral hypoglyceamic agents, oral anticoagualants,

anticonvulsants, and cimetidine, cyclosporin and digitalis glycosides.

Since Rifampicin reduces the effectiveness of oral contraceptives, women should be

advised to use an alternative method of contraception.

Rifampicin is excreted in urine, tears, sweat and other body fluids and may colour them

red or orange. Patients should be warned of discoloration of urine and other body fluids.

Rifampicin may be used safely in pregnancy. Vitamin K should be administered at birth

to an infant of a mother taking Rifampicin because of the risk of postnatal haemorrhage.

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Pyrazinamide

Pyrazinamide is bactericidal and particularly effective against bacilli in an acid

environment inside macrophages. It is highly effective during the first two months of

treatment by destroying the intracellular bacilli and reduces the risk of relapse.Uses:

It is a component of all 6 month and 8 month TB chemotherapeutic regimens currently

recommended by WHO.


It is administered orally and is rapidly absorbed from the gastro-intestinal tract and

rapidly distributed throughout all tissues and fluids.

Adults and children: (for the first 2 or 3 months)

25mg/kg daily (20-30 mg/kg)

35 mg/kg (30-40mg/kg) 3 times weekly

Side-effects

Gastro intestinal symptoms- nausea, anorexia Hypersensitivity reactions are rare, but some patients may complain of flushing of

the skin

Hepatitis is the most important adverse effect, though it is rare. Hyperuriceamia may occur due to diminished excretion of uric acid in urine, but

this is often asymptomatic. Arthralgia may occur and treatment with simple

analgesics is often sufficient. Attacks of acute gout are uncommon.

Ethambutol

Ethambutol has a bacteriostatic effect. It is used in combination with other ant-TB drugs

to prevent the emergence of drug resistant strains.

It is given orally and absorbed readily from the gastro intestinal tract.


Ethambutol is given orally

Adults: 15mg/kg (15-20 mg/kg) daily

30mg/kg (25-35mg/kg) 3 times weekly.

Children: Maximum 15mg/kg daily

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Ethambutol is not recommended in children who are too young for assessment of visual

acuity and red- green colour discrimination (generally under 6 years of age).

Side-effects

Dose dependant optic neuritis is the most important side effect and can result in

impairment of visual acuity and colour vision. Early changes are usually reversible, but

blindness can occur if treatment is not discontinued promptly. Therefore patients should

be advised to report immediately to a clinician if their vision deteriorates.

Streptomycin

Streptomycin is bactericidal in action. It is not absorbed from the gastrointestinal tract and

must be given by intra-muscular injection

Streptomycin is excreted entirely through the kidneys and therefore drug should be used

in reduced dosage and with extreme caution in patients with renal insufficiency and in the

elderly.


Streptomycin must be administered by deep intra-muscular injection. Syringes and

needles should be sterilized properly. Whenever possible use disposable syringes andneedles.

Adults and children: 15mg/kg (12-18mg/kg) daily or 3 times weekly.

Patients over the age of 60 years may not be able to tolerate more than 500mg daily.

Side-effects

Hypersensitivity reactions are rare.If they do occur (usually during the first fewweeks of treatment), streptomycin should be withdrawn immediately. Once fever

and skin rash have resolved, desensitization may be attempted.

Auditory nerve damage can occur resulting in deafness and is more common inelderly and in patients with renal impairment.

Vestibular damage is uncommon, with the recommended doses, but if headache,vomiting, vertigo, dizziness and nystagmus occur, doses should be reduced.

Nephrotoxicity can occur

Streptomycin should not be used in pregnancy. It crosses the placenta and can causeauditory nerve impairment and nephrotoxicity in the foetus.

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Fixed Dose Combination (FDC) tablets

Tablets containing a combination of four drugs (RHZE), three drugs (RHE) and two

drugs (RH) will be used in identified districts in Sri- Lanka from 2005.

Table 4 Number of tablets of FDC used in CAT 1 and CAT 2

Weight (Kg)

Category

70

CATEGORY 1

Duration of

treatment

Intensive phase-daily

RHZE (tab)

150+75+400+275mg

2 3 4 52 months

Continuation phase-daily

RH (tab)

150+75

2 3 4 54 months

CATEGORY 2

Intensive phase-daily

RHZE (tab)

150+75+400+275mg

&

Streptomycin

2

0.5g

3

0.75g

4

1g

5

1g

2 months

RHZE (tab)

150+75+400+275mg

2 3 4 5

1 month

Continuation phase-daily

RHE (tab)

150+75+275mg

2 3 4 55 months

*Patients over 60 years, the dose of streptomycin 0.5g, irrespective of the weight

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Management of Side-effects of First-line Anti-TB drugs

Side-effects of anti-tuberculosis drugs are of two types.

Major side-effects are those, which causes serious health hazards. In this case, the anti-

tuberculosis drugs should be stopped and the patient referred to hospital for management.

Minor side-effects cause only relatively little discomfort. They often respond to

symptomatic treatment. In general, a patient who develops minor side-effects should

continue the anti-TB treatment.

Table 5 Adverse effects of first-line anti-TB drugs

Drug Common side-effects Rare side-effects

Isoniazid Peripheral neuropathy Hepatitis Histamine Reaction after

ingestion of red fish e.g., bala,

kelawalla

Convulsions, pellagra.

Joint pains,

Agranulocytosis, lupoid

reaction, skin rash

Rifampicin Gastro-intestinal-nausea,anorexia, abdominal pain

Hepatitis Reduced effect of oral

contraceptives, antiepileptic

drugs, oral hypoglyceamic

drugs and theophyllines

Acute renal failure, shock,

thrombocytopenia, skin rash,Flu syndrome (with

intermittent doses) pseudo

membranous colitis, pseudo

adrenal crisis.

Pyrazinamide Joint pains Hepatitis Gastrointestinal symptoms, skinrashes, sideroblastic aneamia.

Streptomycin Auditory and vestibulardamage (also to the foetus)

Renal damageSkin rash

Ethambutol Optic neuritis Skin rash, joint pains,peripheral neuropathy.

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Table 6 Symptom based management of side-effects of Anti-TB drugs

Side-effects Drug(s) responsible Management

MINOR CONTINUE DRUGS

1.Anorexia, nausea,

abdominal pain

2.Joint pain

3.Burning sensation in feet

4.Orange/red urine

5.Histamine reaction

Rifampicin or bulk of

the drugs

Pyrazinamide

Isoniazid

Rifampicin

Isoniazid

Give drugs with small

meals or last thing at night

Give Asprin/NSAIDs

Pyridoxine 100 mg daily

Reassurance

Advice not to eat Red fish

MAJOR STOP DRUGS RESPONSIBLE

REFER FOR EVALUATION

1. Itching of skin, skin rash

2. Deafness

3. Dizziness, vertigo,nystagmus

4. Jaundice (other causes

excluded)

5. Vomiting and confusion

6. Visual impairment

7. Shock, purpura, acute renal

failure, haemolytic anaemia

Streptomycin

Streptomycin

Streptomycin

Most anti-TB drugs

especially INAH,

Rifampicin and

Pyrazinamide

Most anti-TB drugs

Ethambutol

Rifampicin

Stop anti-TB drugs

(See page 40)

Stop Streptomycin

Stop Streptomycin

Stop anti-TB drugs

(see page 39)

Stop anti-TB drugs

Stop Ethambutol

Stop Rifampicin

(Never give again)

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Management of severe drug reactions

Hepatitis

Most anti-TB drugs can damage the liver. Isoniazid, pyrazinamide and rifampicinare the drugs most commonly responsible and ethambutol rarely.

When a patient develops hepatitis during anti-TB treatment, it is important to ruleout other possible causes of hepatitis before deciding that the hepatitis is drug-

induced.

Mild transient increases in serum transaminases may occur during the initialtreatment. This rise is not more than 2-3 folds of the normal. This subsequently

falls to normal despite continuation of anti-TB drugs. This is not an indication to

stop anti-TB drugs provided serum bilirubin level remains normal.

Ideally, pre-treatment base-line Liver Function Tests (LFTs) should be done in allpatients. Since this may not be practical, it should be done at least on those who

are at a higher risk of developing drug-induced hepatitis e.g. known chronic

alcoholics, pre-existing liver disease, pregnant mothers and the elderly.

Liver function tests should be performed when patient is having symptoms &signs suggestive of hepatitis. i.e. nausea, vomiting with or without icterus or

hepatomegaly.

If drug-induced hepatitis is diagnosed, all anti-TB drugs should be stopped andpatient may need admission to hospital.

Repeat the Liver Function Tests after 1-2 weeks. Sometimes tuberculous disease is so severe that all anti TB drugs cannot be

withdrawn. In such situations, patient should be treated with two of the least

hepatotoxic drugs streptomycin and ethambutol (provided the patient is not

allergic to the latter two drugs) until the LFTs come back to normal.

Once LFTs return to normal, challenge doses of original drugs can bereintroduced sequentially in the order of isoniazid, rifampicin and pyrazinamide

with daily monitoring of the patients clinical condition and at least weekly

monitoring of LFTs. If symptoms recur early, LFTs should be repeated before one

week. Isoniazid should be introduced initially at 50 mg/day increasing

sequentially to 300 mg/day after 2-3 days if no reaction occurs, and then

continued. After a further 2-3 days without reaction, rifampicin should be added at

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a dose of 75 mg/day increasing sequentially to full dose after 2-3 days and then

continued. The final drug to add is pyrazinamide starting with a dose of

250mg/day increasing to the full dose after 2-3 days.

If there is no further reaction, standard chemotherapy can be continued, and anyalternative drugs introduced temporarily can then be withdrawn.

During this procedure if the patient complains of a recurrence of symptomssuggestive of hepatitis, LFTs should be repeated, and if found abnormal the drug

added last should be withdrawn and attempts should not be made to reintroduce it.

A suitable alternative drug regimen should be used on the advice of and under the

supervision of a chest physician e.g. 2 SHE / 10 HE,

2 HRE / 7 HR,

2 H3R3Z3E3/ 4 H3R3.

Generally, all previously used first-line anti TB drugs can be recommenced onmost patients who develop anti-TB drug induced hepatitis, without a recurrence of

the liver impairment.

N.B. Ideally it is better to get advice from a chest physician for the management

of drug induced hepatitis

Table 7 Re introduction of anti- TB drugs following drug induced hepatitis after

LFTs return to normal

Isoniazid 50mg, increase to full dose over 2-3 days and continue at full dose for

another 2-3 days

No symptoms

LFTs normal

Rifampicin 75mg, increase to full dose over 2-3 days and continue at full dose for

another 2-3 days

No symptoms

LFTs normal

Pyrazinamide 250mg, increase to full dose over 2-3 days and continue at full dose for

another 2-3 days

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Severe cutaneous reactions

If the reaction is only pruritus and no rash, (and there is no obvious cause e.g.scabies) give symptomatic treatment with anti-histamines, reassure and continue

anti-TB treatment and observe the patient closely.

However, if a skin rash develops, stop all anti-TB drugs. Wait till the rash resolves. Sometimes the patient may need steroids. Once the reaction has resolved, the anti-TB drugs should be re-introduced. The

drug, which was responsible for the reaction, should be identified.

The idea of drug challenging is to identify the drug responsible for the reaction.Drug challenge starts with the anti-TB drug least likely to be responsible for the

reaction (i.e. isoniazid). The idea of starting with a small challenge dose (e.g. 50mg of isoniazid) is that if a reaction occurs to a small challenge dose, it will be

less severe than the reaction to a full dose. The dose is gradually increased to the

full dose over a period of three days. The procedure is repeated, adding in one

drug at a time. A reaction after adding in a particular drug identifies that drug as

the one responsible for the reaction. There is no evidence that this challenge

process gives rise to drug resistance.

If the drug responsible for the reaction is pyrazinamide, ethambutol orstreptomycin, anti-TB treatment should be resumed without the offending drug. If

possible, the offending drug should be replaced with another drug. It may be

necessary to extend the duration of the treatment regimen. This prolongs the total

time of TB treatment, but decreases the risk of relapse.

Rarely, the patients develop hypersensitivity reactions to the two most powerfulanti-TB drugs- isoniazid and rifampicin. These drugs form the cornerstone of

Short Course Chemotherapy.

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Table 8 Re introduction of anti-TB drugs following sever cutaneous drug

reaction

Likelihood of

causing a reaction

Challenge doses

Drug Day 1 Day 2 Day 3

Isoniazid 50 mg 300 mg 300mg

Rifampicin 75 mg 300 mg Full dose

Pyrazinamide 250 mg 1 gm Full dose

Ethambutol 100 mg 500 mg Full dose

Streptomycin

Least Likely

Most Likely 125 mg 500 mg Full dose

Adverse reactions to FDCs

Adverse reactions to drugs are not more common if FDCs are used. Nevertheless,

whenever side-effects to one or more components in a FDC are suspected, there will be a

need to switch to single-drug formulations. Reactions to FDCs which warrant withdrawal

of drugs generally occur in only 3-6% of patients on TB treatment.

Role of steroids

Indications for treatment with steroids:

TB meningitis with altered level of consciousness and focal neurological signs TB pericarditis TB pleural effusion- when large and with severe symptoms and not responding

satisfactorily with anti-TB drugs alone.

TB peritonitis

Hypo-adrenalism TB laryngitis (with life threatening airway obstruction) Severe hypersensitivity reactions to anti-TB drugs Renal tract TB (to prevent ureteric scarring) Massive lymph gland enlargement with pressure effects Spinal TB with neurological involvement (e.g. paraplegia).

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MONITORING OF TREATMENT

Monitoring of treatment

There are two ways to monitor tuberculosis patients on treatment.

6

Bacteriological monitoring is done for sputum smear positive pulmonary TB casesby examination of sputum smears at regular intervals during treatment.

Monitoring the drug intake during intensive phase and drug collectionduring the continuation phase by reviewing the treatment cards.

Monitoring of sputum smear-positive pulmonary TB patients

Response to treatment should be monitored by sputum smear examination. Generally two

sputum samples should be collected for smear examination at each follow up sputum

check.

Sputum smear examinations should be performed at the end of the intensive phase of

treatment, during the fifth month and at the end of treatment. Negative sputum smears

indicate good treatment progress.

The best way to monitor the sputum smear-positive patients is to check for sputum

conversion from smear positive to negative. Conversion from smear positive to negative

is the best indicator that the intensive phase of chemotherapy has been regular and is

effective.

After two months of chemotherapy, more than 80% of new smear positive PTB cases

should be smear negative and after 3 months, the rate should be more than 90%.

Pulmonary smear positive relapse cases should have approximately the same rates of

sputum conversion as new pulmonary smear positive cases. Other smear positive re-treatment cases such as treatment failures may have sputum conversion rates of more than

75% after three months of receiving the re-treatment regimen

Sputum smears are again checked at the end of the 5th

month and at the end of treatment.

In a new smear-positive PTB case if the sputum smear is positive at the end of 5 months

or later, these cases are considered as treatment failures, re-registered and given CAT 2

regimen

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Sputum smear-negative PTB patients

Sputum smear negative patients should be monitored clinically. It is important to check

the sputum smear at the end of two months. If the sputum is positive, there are two

possibilities:

- An error at the time of initial diagnosis- i.e., a true smear positive patientincorrectly diagnosed as smear negative at the beginning of treatment

- Progress of the disease due to non- adherence to treatment

In such a situation the intensive phase with all four drugs should be continued for a

further one month under direct observation.

Extrapulmonary TB patients

These patients are monitored by assessing the clinical response to treatment.

Table 9 Schedule for follow up sputum examination

Category of patients When to do sputum smear

CAT 1 (smear-positive PTB) End of the 2nd month(End of the3

rdmonth if smear- positive

at the end of the 2nd

month)

End of the 5th month End of treatment

CAT 1 (smear-negative PTB) End of the 2nd month End of treatment

CAT 2

Relapse

Treatment after failure

Treatment after default

(smear-positive)

End of the 3rd month(End of the 4

thmonth if smear-positive

at the end of the 3rd

month)

End of the 5th month End of treatment

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Treatment Outcome

At the end of treatment course for each patient, the treatment outcome is recorded in the

District Tuberculosis Register.

There are six possible treatment outcomes.

1. CuredA patient who was initially sputum smear-positive and has completed treatment

and is sputum smear-negative in the last month of treatment and on at least one

previous occasion.

2.

Treatment completedA smear-positive patient who has completed treatment, but who does not meet the

criteria to be classified as cure or failure (e.g. follow up sputum examination not

done or results not available).

OR

A smear-negative PTB or Extrapulmonary TB Patient who has completed

treatment.

3. Treatment FailureA patient who is sputum smear-positive at 5 months or later during treatment

4. DiedA patient who dies for any reason during the course of treatment.

5. DefaultPatient whose treatment was interrupted for two consecutive months or more

before the completion of treatment.

6. Transfer outPatient who has been transferred to another district for continuation of treatment

and whose treatment outcome is not known at the initial treatment unit

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TUBERCULOSIS AND HIV

The Human Immunodeficiency Virus (HIV) destroys the immune system of an individual

and increases his susceptibility to many infections including TB.

HIV is the most potent factor known to increase the risk of progression of latent

tuberculous infection to tuberculous disease. In a HIV negative patient who is infected

withM. tuberculosis, the lifetime risk of developing tuberculosis is only 10%, whereas in

person dually infected with TB and HIV, it is 50%

Tuberculosis is the most important life threatening opportunistic infection associated with

HIV infection. It is the leading cause of death among people who are HIV positive and

accounts for more than one third of AIDS deaths worldwide.

Features of HIV related TB

TB usually occurs earlier in the course of HIV infection than other opportunistic

infections seen in HIV, but it may occur at any stage of HIV infection as a result of rapid

progression of a recently acquired new or re-infection. As a result of TB infection in a

HIV infected person there is a transient drop in CD4 count and progression of the HIV

infection.

As HIV infection progresses the CD4 lymphocyte count declines and the immune system

is less efficient in preventing the growth and spread of M. tuberculosis, As a result,

disseminated and extrapulmonary disease is more common in HIV positive patients than

in HIV negative patients. Nevertheless, pulmonary TB is still the most common form of

TB seen, in HIV infected patients, with or without concomitant extrapulmonary TB.

Pulmonary TB

The presentation of pulmonary TB in HIV infected individuals depends on the stage of

the degree of immunosuppression. The clinical picture, sputum result, and chest X-ray

appearance often differ in early and late HIV infection. (Table 9)

Diagnosis

The diagnosis of TB in HIV infected patients is often difficult because:

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- The sputum smear examinations tend to be more frequently negative,particularly in the late stages of HIV infection

- X-ray abnormalities are often atypical- The Tuberculin skin test is often negative due to immunosuppression.

Table 10 How PTB differs in early and late HIV infection

Features of PTB Stages of HIV infection

Early Late

Clinical picture Often resembles post primary

PTB

Often resembles primary

TB

Sputum smear result Often positive Often negative

Chest X-ray - Often cavities

- Lymphadenopathy usually

absent

- Pleural effusions rare

- Often infiltrates,

- No cavities

- Lymphadenopathy and

pleural effusions often

present

Treatment of HIV associated TB

Generally anti-TB treatment in HIV positive patients is the same as for HIVnegative TB patients.

It is important that these patients should receive Directly Observed Treatment.(DOT). Effective treatment using DOTS can cure TB, prevent the spread of the

disease and prolong the life of HIV patients.

Adverse reactions to anti-TB drugs are more common in HIV positive patients. The rate of recurrence of TB after completion of treatment is higher in HIV

positive patients than in HIV negative TB patients. For patients known to have

HIV co-infection, secondary prophylaxis with isoniazid 300mg daily may be

given for 9 months after cessation of anti-TB treatment.

The Case Fatality Rate is higher in HIV +ve TB patients than in HIV ve TBpatients. The excess deaths in TB/HIV patients are partly due to the tuberculosis

itself and partly due to other HIV related problems.

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Primary prophylaxis

HIV positive patients with a positive Mantoux test above 5 mm should be screened for

active TB. If there is no active disease they should be given INAH prophylaxis for 9

months.

Screening of TB patients for HIV

TB patients in the high-risk group (IV drug users, commercial sex workers, homosexuals,

people having multiple sexual partners, institutionalized individuals) need Voluntary

Counseling and Testing (VCT). Patients with atypical presentations and disseminated TB

also need VCT.

TB treatment and anti-retroviral therapy

Rifampicin stimulates the activity of cytochrome P450 that metabolizes protease

inhibitors (PIs e.g. saquinavir, ritonavir, indinavir, nelfinavir, amprenavir) and

nonnucleoside reverse transcriptase inhibitors (NNRTIs, e.g. nevirapine, delavirdine). PIs

and NNRTIs also enhance or inhibit the same enzyme system and this may result in

decreased blood levels of rifampicin and the anti-retrovirals resulting in ineffectiveness of

both.

In patients with HIV and TB, the priority is to treat TB, especially the smear positive TB

patients.

Possible options for antiretroviral therapy in TB patients include:

Defer antiretroviral therapy until TB treatment is completed Defer antiretrovirals until the end of intensive phase and use ethambutol and

isoniazid for 6 months in the continuation phase

Treat TB with a rifampicin containing regimen and use efavirenz + 2 nucleosidereverse transriptase inhibitors (NRTIs).

Treat TB with rifampicin containing regimen and use 2 NRTIs; then change tomaximally suppressive highly active antiretroviral therapy (HAART) regimen on

completion of TB treatment.

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PREGNANCY AND TUBERCULOSIS

Diagnosis

In pregnancy, chest X-rays should be avoided as far as possible, especially during the first

trimester, because of the adverse effects of x-rays on the foetus.

Therefore, diagnosis will depend more on sputum examination when a pregnant mother

presents with symptoms suggestive of tuberculosis. However, if an X-ray is absolutely

necessary, this may be done with the abdomen covered with a lead apron.

Treatment during Pregnancy

Anti-TB treatment should be started as soon as the diagnosis is made, and the full course

of treatment given.

The basic principles of treatment are the same in pregnancy. Most anti-TB drugs are safe

for use during pregnancy except streptomycin.

Streptomycin should not be given because it can cause oto-toxicity in the foetus.

Pregnant mothers should be given pyridoxine 10mg daily along with INAH.

Vitamin K should be administered at birth to the infant of a mother taking rifampicin

because of the risk of post-natal haemorrhage.

Treatment during breast-feeding

A patient who has TB and is breast-feeding should receive the full course of anti-TB

treatment. Properly taken treatment is the best way of preventing transmission of TB to

her baby. All anti-TB drugs are compatible with breast-feeding. A patient taking anti-TB

treatment can continue to breastfeed her baby in the normal way.

Breastfeeding should be avoided only in cases where the mother has dual TB/HIV

infection.

Management of a newborn child of a mother with active TB

8

Do not separate the child from the mother unless she is acutely ill. If the mother is sputum smear negative, and if the infant has no evidence of

congenital TB, BCG is given to the infant.

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If the mother is sputum smear-positive at the time of delivery, infant should becarefully examined for evidence of active disease.

- If the infant is ill at birth and congenital TB is suspected, a full course ofanti-TB treatment should be given.

- If the child is well, give prophylactic treatment with INAH 5mg/ kg bodyweight, daily for three months. BCG is withheld.

The Mantoux skin test is done after three months.- If the Mantoux test is negative and the child is well, prophylactic treatment

with INAH is stopped and child is given BCG.

- If the Mantoux test is positive, careful examination of the child for activeTB is done including a chest X-ray.

- If active disease is diagnosed, a full course of anti-TB treatment should becommenced.

- If the physical examination and the chest X-ray are normal, INAHchemoprophylaxis is continued up to six months and BCG is given.

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ROLE OF BCG VACCINATION

BCG (Bacillus Calmette Guerin) is a live attenuated vaccine derived fromM. bovis. It is a

freeze-dried vaccine. It can be stored at room temperature up to one month and in a

refrigerator at 4C up to one year.

It is easily killed by direct sunlight. Once reconstituted, it should be used within four

hours and any remaining solution should be discarded.

Dose- 0.05 ml of vaccine is administered to newborn infants aged less than one year

and 0.1 ml for children aged over one year. It should be administered intradermally to

the upper lateral aspect of the left arm.

The National Policy of Sri Lanka is to give BCG vaccination to all newborn babies

immediately after birth. BCG vaccination is carried out under the Expanded Programme

of Immunisation (EPI)

BCG protects the young children against serious disseminated forms of TB, like TB

meningitis and military TB.

It does not decrease the spread of TB in the community

Complications of BCG vaccination

Complications after BCG vaccination are uncommon. It includes the following:

9

Subcutaneous abscess at the site of injection due to secondary infection Ulceration at the site of injection Swelling with or without abscess formation of the regional lymph glands(BCG

adenitis)

Disseminated TB (which is extremely rare and occurs only in severelyimmunosuppressed patients).

Some of the complications are due to faulty immunization technique.

Most complications resolve on their own. In the case of suppurative lymphadenitis or

progressive adenitis surgical removal of affected nodes may be required. INAH may be

given for 3- 6-months for non healing ulcers or sinuses.

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Contraindications for BCG vaccination

Contraindications for vaccination are extremely uncommon. The only two known

conditions where children should not be vaccinated are:

Congenital or acquired immunodeficiency

Children with clinical signs of AIDSBCG should be withheld in the presence of skin sepsis, and systemic infections until these

conditions resolve.

If the mother is sputum smear positive at the time of delivery, the baby is commenced on

chemoprophylaxis and BCG administered at the end of the period of chemoprophylaxis.

(Refer page 49- 50).

BCG in HIV positive infants

The WHO recommended policy is to give BCG vaccination to HIV positive babies who

do not have any evidence of HIV disease. But it should not be given to children with

symptoms of HIV/AIDS.

Absent BCG scar

This is a common occurrence. If the mother is certain that there was no reaction to BCG

vaccination, or if there is no BCG scar, revaccination may be done. In children under 5

years revaccination may be done without Mantoux test.

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PREVENTION OF TUBERCULOSIS

From the public health point of view, the best way to prevent TB is to identify the

infectious cases as early as possible and provide effective treatment to cure them. This

interrupts the chain of transmission.

BCG vaccination

This protects young children against serious disseminated forms of TB, but does not have

an impact on the spread of the disease in the community, and does not protect the child

from developing post-primary tuberculosis in later life.

Contact screening

Household contacts of infectious TB patients (adults and children >5 years) should be

screened for symptoms of TB. Those who have symptoms suggestive of TB should be

investigated with sputum smears irrespective of the duration of the symptoms.

Children under the age of 5 years should be screened with chest X-ray and Mantoux test.

Preventive treatment

The aim of preventive treatment is to prevent progression ofM. tuberculosis infection to

disease.

Primary chemoprophylaxis

When a person is exposed to TB bacilli, but not yet infected eg. newborn breastfed baby

of a sputum smear-positive mother

Secondary chemoprophylaxisA person who is infected, but not yet developed clinical disease e.g. tuberculin positive

close contacts of sputum smear-positive patients.

In Sri Lanka, chemoprophylaxis is given for the following groups:

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Breast fed infants of sputum smear-positive mothers. Household contacts below 5 years of age of sputum smear-positive patients, who

do not have evidence of active disease.

Prophylactic treatment in Sri Lanka is INAH 5mg/ kg body weight for 6 months.

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Health Education

Health education is a critical component of tuberculosis control. The target groups, which

need to be addressed, are the patients and their families, health personnel, and the

community.The health staff should educate the patients and their families regarding the disease, how

it is spread, and the duration of treatment. It must be emphasized that TB is curable if the

treatment is taken fully and to stress the importance of directly observed treatment.

Patients should be made aware of the risks of irregular and incomplete treatment. Health

workers should also teach them simple ways of decreasing the risk of transmitting the

disease, like covering the mouth with the hand when coughing and to use a sputum pot

with a lid and disposing of the sputum by burning.

The general public should be educated regarding the disease and the symptoms and the

importance of seeking medical advice early if they have any symptoms suggestive of TB.

They should be made aware of the locations and the facilities available for the

management of TB. Also, education should be aimed at removing the social stigma

attached to TB, so that symptomatic patients will seek treatment early.

Health personnel should also be made aware of the importance of identifying TB suspects

early and referring them for investigation.

General Manual Text (26 55)Pages

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