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Index TB guideline- EPTBDr.Akhilesh. KAsst Professor
Pulmonary MedicineAIMS,KOCHI
India accounts for 20% of all TB incidence cases in the world
Non-HBCs20%
Pakistan3%
Ethiopia3%
Philippines3%
South Africa5%
Bangladesh4%
Nigeria5%
Indonesia6%
China14%
India20%
Other 13 HBCs16%
Source: WHO Global Report 2009
Evolution of TB Control in India• 1950s-60s Important TB research at TRC
and NTI
• 1962 National TB Program (NTP)
• 1992 Program Review•only 30% of patients diagnosed; •of these, only 30% treated
successfully
• 1993 RNTCP pilot began
• 1998 RNTCP scale-up
• 2001 450 million population covered
• 2004 >80% of country covered
• 2006 Entire country covered by RNTCP
Impact - RNTCP
oNearly 22 million deaths have been saved since 1995.
o 45% decrease in death due to TB since 1990
o Global target of 85% cure rate and 70% of case detection rate consistently achieved 2003 onward
o Case fatality reduced from 29% to 4% in NSP cases
SMCSI MC 22 - 03 - 2016 5
Current views leading to change in regime to daily regime
• High rates of “relapse” in RNTCP ~ 12 - 15%
• Increasing INH Resistance remain high( 20-40%)
Magnitude of The problem
• 15%-20% of all TB cases in India in HIV negative Immunocompetent
• >50%( 45-56%) – HIV Positive
• Usually Paucibacillary
• 75% have lymph node or pleural TB
• Occur in all age groups but incidence is higher in children / young
• HIV Negative • HIV Positive
EPTB
AlIMS &
Principles
• Patient Centred approach• Promote early diagnosis• Access to tissue based diagnosis• Addressing Drug resistance• Avoiding unnecessary , invasive and costly tests.• Access to HIV Testing• Identify patients with concurrent active Pulmonary TB• Ensuring effective treatment with appropriate regimen• Promoting adherence• Record keeping and public health promotion
Major questions raised by providers• Use of tuberculin skin testing
• Role of the Xpert MTB/RIF test in diagnosing EPTB• • Role of other polymerase chain reaction (PCR)-based tests in diagnosing EPTB
• Empirical treatment
• Corticosteroids in EPTB
• Duration of anti-tuberculosis treatment (ATT) in EPTB
• Definition of treatment failure in terms of clinical parameters prompting extended treatment, revised diagnosis, or consideration of drug resistance.
DEFINITIONS
Genexpert In EPTB
LYMPHNODE TB Additional test to conventional smear microscopy, culture and
cytology in FNAC specimens.(Strong)Quick diagnosis,Reduced stigma from overdiagnosis,R Resistnace
TB MENINGITITISAdjunctive test for tuberculous meningitis (TBM). A negative Xpert result does not rule out TBM. Decision to give ATT should be based on clinical features and CSF
profile.( Conditional)
PLEURAL TB Should not be routinely used to diagnose pleural TB (Strong)
Steroids in EPTB
TB MENINGITIS ( HIV Negative)
TBM in HIV-negative -RECOMMENDEDDuration of steroid treatment should be for at least 4 weeks, with
tapering as appropriate.(Strong)
TBM(HIV Positive)- May be used where other life-threatening opportunistic infections are absent.
( Conditional)
• TB Pericarditis(HIV Negative)- Recommended for HIV-negative patients with TB pericarditis with pericardial effusion.(Conditional)
• TB Pericarditis(HIV Positive)- Recommended for HIV-positive patients with TB pericarditis with pericardial effusion.(Conditional)
• Pleural TB(Irrespective of HIV Status)
- Not routinely recommended in pleural TB.( Conditional)
Duration Of Treatment
• Peripheral LN TB - 6 months ATT standard first-line regimen (2RHZE/4RHE) is recommended for peripheral lymph node
TB.(Strong)
• Abdominal TB- 6 months ATT standard first-line regimen is recommended for abdominal TB( Strong)
• TB Meningitis- TB meningitis should be treated with standard first-line ATT for at least 9 months.(Conditional)
CNS TB
EPIDEMOLOGY
• Estimated 1% all cases of TB In India
• High case fatality rate• Long Term sequelae
Who should be investigated?
Diagnostic Method
Selected patients Comments
Lumbar puncture
All LymphocyticPleocytosis with Low Serum/CSF Glucose ratio
HIV testing All Integrated Counselling For Seropositive
Chest Xray All Active /past TB
CT Brain All R/O hydrocephalus
MRI Brain Selected cases Diagnostic uncertainty
CSF SAMPLING
• Minimum 6 ml needed for adults ;3 ml for children
CSF Gram stain ,AFB Smear,TC
CSF / Serum Glucose Ratio
Mycobacterial culture ,Species identification& DST
Rule out other causes- Viral/ Cryptococcal/ Bacterial/Fungal
Genexpert-Adjunctive test. Negative Doesnot rule out TBM .1 ml optimal for Xpert( High False Neg)
Sensitivity-80.5% Specifcity -97.8%)
IGRA Not recommended
ADA is not useful
Diagnostic accuracy of Other PCR test highly variable
2 HRZE+7 HRE Referral – As early as possible
Follow up till 2 years at regular interval
DR suspect- Poor response to ATT/or
MDR contact
Steroids indicatedDexa ( 0.4 mg/kg/24 hr in divided doses)
and taper
Alternate Regimen( Tech.Advisory Sub comitee)
Streptomycin in IP Phase instead of Ethambutol in visual impairment or cannot be assessed
Pyrazinamide instead of Ethambutol in CP Phase
Total Duration can be extended upto 12 months
Stopping Treatment- Clinical resolutionResidual neurological deficit should not be used as a sign of activity
Surgery-V/P Shunt
CNS TUBERCULOMA
Presumptive Tuberculoma
• Any patient presenting with seizures, headache, fever or focal neurological deficits with neuroimaging features consistent with a mass lesion of inflammatory nature.
DiagnosisPrevious history and contact with TB case
CXR and CT for looking alt sites
HIV
MRI – Confirmatory
CSF- May be Normal / finding of TBM
Culture – sensitivity low
PCR test validity doubtful.
Stereotactic/ open biopsy- Invasive
9-12 months Repeat MRI after 3 ,9 &12 months
Failure- If lack of reduction in size /increase in size after 3-6 months of
Tt
Paradoxical Reaction-if increase in size / number
after 3 months-Steroid/ ATT
Before putting second line in suspected MDR assess Risk/Benefit ratio.Tissue diagnosis- Sent H/P, AFB Culture,
SPINAL TB
Clinical Features
• Localised back pain>6 weeks with tenderness in spinous process with or without fever, Wt loss with or without spinal cord compression.
• Patient with advanced disease may have spinal deformity, paraspinal muscle wasting
• In children failure to thrive, night cry, inability to walk/cautious gait
Test Patient Comment
Chest X ray All Rule out PTB
HIV All Integrated Counselling and test
Xray Spine Limited Lesion will be delayed presentation in CXR( 3-6 months)Follow up and monitoring
MRI Spine All ConfirmationExtend of DiseaseEarly Identification
CT Spine Selected cases Limited use in spinal cord involvement
Biopsy All P/C or Open Send Specimen For A)Routine and AFB CultureB)Microscopy and AFB SmearC)Histopathology and Cytology
Genexpert/PCR test Not Insufficient evidence
TREATMENT
• Start ATT if Clinico radiological evidence even if Biopsy is not possible after assessing risk of procedure
• 2 HRZE+10 HRE ( Maximum upto 18 months of Tt)
• Surgery For Diagnosis, Spinal deformity, Neurological Deficit
Follow up
• If any new signs of Neurological deficit report immediately
• Patient with Neurological Deficit weekly monitoring with neural chart
• X ray spine every 3 months
• MRI at 6,9,12,18 following Tt Initiation
• Follow up every 6 months for 2 years after stopping treatment
• Report to physician if any new signs after Stopping RX
Bone & Joint TB
• MC in Immuno suppressed and Old TB
• In the early course, aspiration of synovial fluid/ pus usually not diagnostic but should send for Microscopy and Culture
• Biopsy of the affected structure/ sinus tract curettage / Edge biopsy can be done and to be send for microscopy and culture and H/P
• CBNAAT limited role
• Treatment Regimen 2 HRZE+ 10-16 HRE
Pleural TB
Test Patients CommentsChest Xray All -Confirmation/PTB
-Monitoring
HIV Test All Integrated Counselling& test
CT Scan Selected Cases -Alternate diagnosis(CA)-Disseminated Disease
USG Chest Selected cases Alt. To CXRThoracocentesis All Diagnostic only.Send for
TC,DC,Cytology,AFB smear,Culture,protein,sugar,LDH(S.LDH also)
Sputum AFB Selected cases CBNAAT/AFB Smear/AFB culture
Pleural Biopsy Selected cases High yield H/P ,AFB Culture& Microscopy
Thoracoscopy Selected cases -More yield than Closed Pleural Bx.-Uncertain Diagnosis
PLEURAL FLUID CRITERIA
ExudativeHigh ADA
Genexpert Not Recommended
Sensitivity-46.4%Specificity-99.1%)
>70U/L- High
40-70 U/L- indeterminate
<40 U/L- Less likely
2 HRZE+4 HRE Steroids not recommended
Follow up CXR after 8 weeks
General Improvement 2 weeks
Significant Improvement 6-8 weeks
Worsening initially – Paradoxical Reaction
Lymph node Tuberculosis
Type Symptoms
Presumptive Peripheral LN TB LNE >1 cm in axilla, neck, groin+ Constitutional features
Mediastinal TB Constitutional featuresCough,feverHilar enlargement in CXR and/orMediastinal widening in CT Chest in the absence of evidence of active PTB
Abdominal LN TB Dull, colicky abdominal pain, distensionConstitutional features Abdominal LNE on USG ,CT or MR
DIAGNOSIS
TEST PATIENT COMMENTCXR All Cases Active/Old PTB
HIV All cases Integrated counselling & tests
USG/CT chest&/or abdomen
Selected cases Uncertain diagnosis
FNAC All Gene Xpert/AFB Smear/AFB Culture& DST/Cytology
Excision Biopsy Selected •If FNAC inconclusive•Alternate diagnosis
Gene Xpert/AFB smear/AFB Culture & DST,Histopath
• Specimen should be taken before starting ATT
• Non dependant Aspiration by Z technique for superficial LNE
• Image guided Aspiration for Deep LNE
• Abdominal LNE- CT Guided/USG Guided FNAC or Biopsy
• Mediastinal LNE- EBUS guided FNAC if facility available
Genexpert should be used as an additional test to cytology( Strong)Sensitivity -83.1% Specificity -93.1%
PERPIPHERAL LNE2 HRZE+4 HRE
Follow up after 4 Months
Worsening in 1St 3 months- paradoxical reaction
If Residual LNE ( largest LN)< 1 cm at the end of Tt- No active TB
If largest LN>1 cm- Partial responders
Expert Group suggest additional 3 months of ATT - Biopsy / AFB Culture if failed to respond to that
Some group suggest further ATT not needed ( insufficient data)
Follow up – 4 Months If CXR s/o no improvement------------- CT Chest
WHEN TO STOP ATT?
if no improvement after 4 months of Tt documented clinicoradiologically ( Difference of opinion)
Mediastinal LNE2HRZE+ 4 HRE
Abdominal TB
Most common site -Abdomen distal to duodenum( Jejunum,ileum,colon,peritoneum)
Test Patient Comments
CXR/HIV All Rule out PTBIntegrated counselling
Ascitic fluid All Cytology,ADA,Albumin and protein,AFB Smear,AFB culture,Routine C& S
USG abdomen All Ascites,Omental thickening, Mesentric adenopathy
USG Guided FNAC/Core biopsy from Mesentric or RPLN ,omentum,peritoneum
Selected Microscopy &Culture of FNAC/Biopsy specimen than fluid aloneSend for H/P,M/C copy, Culture
CT/MRI Abdomen Selected Diagnostic UncertaintyLaproscopy Selected( Cost, Invasive) Tubercles in thickened
peritoneum,omentum and Liver Fibro-adhesive peritonitisTargeted Diagnostic sample increase yield
SAAG<1.1High protein (>2.5 g/DL)
ADA >39 IU/L
Sensitivity in Smear AFB and AFB Culture Low
PCR – Variable accuracy( No Recommendation)
Test Patients Comments
Ileocolonoscopy ( Retrograde ileoscopy)
All casesRule Out IBD
Sent for H/p,AFB Culture
CT/MR enterography /enteroclysis
Selected •Short Segment stricture•Necrotic Nodes•Ileocaecal wall thickening
UGIE Selected
Barium study Selected UGIE Contraindicated orSmall Bowel stricture
PCR BASED -NOT RECOMMENDED – HIGHLY VARIABLE ACCURACY
TREATMENT
2 HRZE+4 HREExtension as per Physician’s
discretion
All Presumptive GI TB should be referred to GI
Follow Up after 3 & 6 Months
SurgeryStricture-Endoscopic
Dilatation/Resection of strictureP/c or Endoscopic biliary stenting,Drainge of Liver
abscess
UROGENITAL TB
SYMPTOMS
• Lower urinary symptoms ( frequency, urgency, nocturia) with dysuria and/or
hematuria for 2 weeks which has not responded with 5 day course of antibiotics
• ( Avoid FQ if suspecting TB)
• Generalised symptoms
CXR/HIV/RFT All cases
Urine M/c and aerobic culture( Non mycobactrial
Sterile pyuria( s/oTB)Asso.TBBacterial infection
Early Morning Urine sample 3 -5sample needed for smear AFB and AFB Culture. Low sensitivity ; but culture confirmative
USG KUB All cases ( Normal in early disease; if pick up hydronephrosis s/o TB)
IV urography ( plain Xray) Selected cases( widely available; Low sensitivity)
Contrast enhanced CT urography Selected cases( More Sensitivity)
MR urography without contrast Selected( Expensive; but no need of contrast, more sensitive
FNAC/Biopsy AFB Smear/ Culture & DST/H/P
Urethroscopy with or without bladder biopsy
Selected cases
Biopsy Most of the cases( AFB smear , Culture/HP), DST)
Diagnosis
CXR/HIV Test All CasesUSG or CT abdomen or Chest Selected casesFNAC All( AFB Smear, Culture with
DST, Cytology, Xpert)Excision Biopsy Selected ( If FNAC
inconclusive or alt .diagnosis)AFB Smear,Culture& DST,Xpert, Histopath
Genexpert Sensitivity -87-100% Specificity-92-98%
Cardiac Tuberculosis
Test Patients CommentsChest Xray All Water Bottle SignHIV AllECG All Low Voltge ,T wave
flatteningECHO All Pericardial EffusionCT and Cardiac MRI
Selected
• Microbiological Diagnosis Poor yield• Xpert – Not Recommended• ADA- Contributory• 2 HRZE+4 HRE• FUP after 4 Months• Steroids indicated
TAKE HOME MESSAGE
• Treatment of EPTB is to be individualised
• Clinician is having discretion in deciding duration of
treatment ,methods of obtaining tissue for sampling etc
• Sensitivity of Newer techniques in EPTB low so that
diagnostic utility will vary depends on site of involvement
• Further study needed in certain areas – Researches should
be encouraged