8' Treatment and Followup Strategy

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8. Treatment and Follow-up
Strategy

• IRAN

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8.1 Use of standardized, empiric, or definitive
treatment regimens and rationale behind their
use

• Treatment regimen standardized
• Rationale
• Easy to administer,
• Cost effective,
• Less Misuse,
• Good outcome in 6 years experience.

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8.2 Treatment regimens and algorithms for their
design for both intensive and continuation
phases

• Previously treated with only FLDs
• Intensive phase
• FQ (Ofloxacin) Cs Pto Km /- PZA
• for 6 months with at least 4 months after culture
  conversion
•  
• Continuation phase
• FQ (Ofloxacin) Cs Pto
• For 18 months with at least 12 months negative
  culture

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8.2 Treatment regimens and algorithms for their
design for both intensive and continuation
phases

• Previously treated with only SLDs
• Intensive phase
• FQ (Levofloxacin) Cs Pto Cm PAS
• for 8 months with at least 4 months after culture
  conversion
• Continuation phase
• FQ (Levofloxacin) Cs Pto PAS
• For 18 months with at least 12 months negative
  culture

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8.3 Criteria to change the treatment regimen
from intensive to continuation phases and other
modifications in the regimen

•  
•  
•  
• Criteria for shift from initial phase to
  continuation phase
• Conversion of sputum culture to negative at least
  for 4 months.
•  
• Other modification
• Changes based on DST pattern to FLD
• Changes due to adverse effects that need drug
  discontinuation based on WHO guideline.

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8.4 Experience of the medical staff in using
second-line anti-TB drugs,

• MDR-TB management in this project will be carried
  on in a system with 6 years experience and the
  sub-national referral centers will be entered the
  project after training in national referral
  center.

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8.5 Transfer of patients and patient information
from inpatient to outpatient settings and in the
reverse direction, transfers between the prison
and the civilian sectors, between long-term care
or specialized housing facilities, sanatoria,
other regions, and other hospitals

•  
• NTP refers the suspected MDR-TB patients to
  National Referral Center (NRC) with special form.
• NRC will inform NTP about admission of the
  patients.
• 10 days before discharge, NRC will inform NTP
  about the date of discharge and summary of
  medical record(including treatment
  regimen)through special forms.
• NTP will inform district health center and ask
  for determination and introducing DOTS supervisor
  of the patients and then sending the required SLD
  for 3 months.
• There are monthly follow-up examination
  (including clinical and para-clinical ) which are
  done by district TB coordinator(physician) and
  results will be reflected to existent forms.

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8.5 Transfer of patients and patient information
from inpatient to outpatient settings and in the
reverse direction, transfers between the prison
and the civilian sectors, between long-term care
or specialized housing facilities, sanatoria,
other regions, and other hospitals

• Every six months the patients are referred to NRC
  and NTP is informed about this referral process.
  A copy of patient file will be accompanied.
• The result of this referral visit will be passed
  to district TB coordinator through NTP. If the
  regimen will be changed this information will go
  to periphery. And the combination and amount of
  SLDs will be modified and then sent to the
  district health center.
• The decision for discontinuation of the treatment
  course and determination of outcome result will
  be made by NRC (or RRC in the following years of
  project, if pilot goes well), and NTP will be
  informed about it formally.

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8.5 Transfer of patients and patient information
from inpatient to outpatient settings and in the
reverse direction, transfers between the prison
and the civilian sectors, between long-term care
or specialized housing facilities, sanatoria,
other regions, and other hospitals

• Transfer of patients and their information
  between prisons and civilian sector
• During the imprisonment
• Referring the suspected cases to NRC and
  returning to the prison after discharge and
  follow up examination will be similar.
• During and after releasing
• 10 days before release from prison (or
  transferring from prison to prison), NTP will be
  informed through District TB Coordinator. A
  letter will be sent to District Health Center
  located in area of residence of the patient for
  determination and introducing DOT supervisor and
  then required drugs for 3 months will be sent
  there.

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8.6 Monitoring for the effectiveness of
treatment with bacteriological and other tests

• Inpatient
• Monitoring of the patients is done in the
  hospital by obtaining frequent sputum smears and
  cultures monthly till the first negative culture
  turns out.
• Adverse drug reactions were monitored regarding
  clinical symptoms and signs. Besides, Blood Urea
  Nitrogen (BUN), Creatinine values and Liver
  Function Tests (LFT) are measured every 15 days.
• Outpatient
• Smears are taken monthly and cultures every 2
  months.
• Adverse drug reactions were monitored regarding
  clinical symptoms and signs. Besides, Blood Urea
  Nitrogen (BUN), Creatinine values and Liver
  Function Tests (LFT) are measured monthly.

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8.6 Monitoring for the effectiveness of
treatment with bacteriological and other tests

•  
• Otolaryngologic examinations and audiometery were
  performed for those who had been receiving
  amikacin in the case they developed hearing loss
  or tinitus. For patients who received
  Protionamide,
• Thyroid Function Tests (TFT) was conducted every
  2 months.

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8.7 Management of patients with associated
problems such alcohol or drug abuse,
homelessness, diabetes mellitus, and HIV
infection

•  
• Drug abuse
• For patients with drug abuse harm reduction
  service will be used (Methadone Therapy).
• Treatment management will be the same as others.
• DM
• Treatment management will be the same as others.
• Monitoring of side effect depends on situation of
  patient may be done with shorter interval.
• Close Monitoring of DM will be done. 

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8.7 Management of patients with associated
problems such alcohol or drug abuse,
homelessness, diabetes mellitus, and HIV
infection

•  
• HIV
• Treatment management will be the same as others.
• Monitoring of side effect depends on situation of
  patient may be done with shorter interval.
• ART will be initiated in patient with CD4 count
  less than 500cell/µl.
• Prophylaxis with co-trimoxazol will be initiated
  for all patients.
• Azithromycin will be initiated for patients with
  CD4 count less than 50cell/µl.
•  

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8.8 Availability and use of surgery for
diagnosis and treatment.

• NRC is located in a hospital which is referral
  center for thoracic surgery in I.R.IRAN.
• Management of complications such as empyema,
  pneumothorax, broncho-pleural fistula) will be
  done in NRC.
• Surgery for treatment of MDR-TB will be done only
  for patients who have all the following criteria
• At least 2 months receiving of effective Second
  Line Regimen ,
• Localized disease,
• Good vital capacity.