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1. REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME UPDATES 1 Presenter: Dr. JITHIN GEORGE 2. India is the highest tuberculosis burden country accounting for more than one-fifth of the global incidence 2 Indonesia 6% Nigeria 5% Other countries 20% Other 13 HBCs 16% China 14% South Africa 5% Bangladesh 4% Ethiopia 3% Pakistan 3% Phillipines 3% India 21% Source: WHO Geneva; WHO Report 2014: G Tuberculosis Control; Surveillance, Planning and Financing Global annual incidence = 9.6 million India annual incidence = 2.2 million India is 17th among 22 High Burden Countries (in terms of TB incidence rate) 3. What is the RNTCP? 3 4. RNTCP 4 5. RNTCP 5 6. Objectives of RNTCP 6 7. END TB STRATEGY VISION - A world free of TB – Zero Deaths , Disease and Suffering due to TB GOAL - END THE GLOBAL TB EPIDEMIC INDICATORS Reduction of TB Death Compared with 2015(%) Reduction in TB Incidence Rate Compared to 2015(%) TB Affected Family facing Catastrophic cost due to TB(%) MILESTONES TARGETS 2020 2035 SDG 2020 END TB 2035 35% 75% 90% 95% 20% (<85/100,000 ) 50% (<55/100,000 ) 80% (<20/100,000 ) 90% (<10/100,000 ) 0 0 0 0 8. The Components Of The New End TB Strategy Pursue High quality DOTS expansion and enhancement Address Tuberculosis/HIV, MDR-TB and other challenges Contribute to health system strengthening Engage all health care providers Empower people with Tuberculosis, and communities Enable and promote research 8 9. Unique Features of RNTCP District Tuberculosis Control Society • Modular training • Patient wise boxes • Sub-district level supervisory staff (STS, STLS) for treatment & microscopy • Robust reporting and recording system 9 10. Case Findings Most common symptom of TB Cough for 2 weeks or more 11. 11 Definitions of presumptive TB 12. •Presumptive DR TB- Refers to those patient who have failed treatment with first line drugs, patients who are contacts of DR- TB ,TB patients who are found positive on any follow-up sputum smear examination during treatment with first line drugs, previously treated TB cases, TB patients with HIV co-infection. 13. •Microbiologically confirmed TB Case- Refers to a presumptive TB Patient with biological specimen positive for acid fast bacilli, or positive for Mycobacteriuom tuberculosis on culture, or positive for tuberculosis through quality assured rapid diagnostic molecular test. Case definitions 14. •Clinically diagnosed TB Case- Refers to a presumptive TB Patient who is not microbiologically confirmed, but has been diagnosed by the clinician on the basis of X-ray abnormalities, histopathology or clinical signs with a decision to treat the patient with a full course of Anti-TB treatment. 15. • Pulmonary tuberculosis (PTB)- Refers to any microbiologically confirmed or clinically diagnosed case of TB involving the lung parenchyma or the tracheo-bronchial tree. • Extra Pulmonary tuberculosis(EPTB)- Refers to any microbiologically confirmed or clinically diagnosed case of TB involving organs other than the lungs such as pleura, lymph node, intestine, genitourinary tract, joints and bones, meninges of the brain etc. Miliary TB is classified as pulmonary TB because there are lesions in the lungs. A patient with both PTB and EPTB should be classified as a case of PTB. 16. New case – A TB patient who has never had treatment for TB or has taken ATD for <1 month. Previously treated patients have received one month or more ATD in the past. This may be: •Recurrent TB case – A TB patient previously declared as successfully treated (cured/treatment completed) and who is subsequently found to be microbiologically confirmed TB case is a recurrent TB case. (Previously called relapse.) •Treatment after failure – Patients are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment. 17. •Treatment after loss to follow-up – A TB patient previously treated for TB for one month or more and who was declared lost to follow- up in their most recent course of treatment and subsequently found microbiologically confirmed TB cases. •Other previously Treated Patients- Are those who have previously been treated for TB but whose outcome after their most recent course of treatment is unknown or undocumented. 18. Transferred in: A TB Patient who is received for treatment in a Tuberculosis Unit, after registered for treatment in another TB Unit . Mono resistance (MR) – A TB patient whose biological specimen is resistant to one first-line anti-TB drug only. Poly resistance (PDR) – A TB patient whose biological specimen is resistant to more than one first-line anti-TB drug, other than both INH and Rifampicin. Multi-drug resistance (MDR) – A TB patient whose biological specimen is resistant to both INH and Rifampicin with or without resistance other first-line ATD, based on results from a Quality Assured Laboratory. (No changes.) 19. Rifampicin resistance (RR) – Resistance to Rifampicin detected by phenotypic or genotypic methods with or without resistant to other ATD excluding INH. Patient with RR should be managed as if they are in MDR TB case. Extensive drug resistance (XDR) – MDR TB case whose biological specimen was resistant to a Fluroquinolone (FQ) and a second-line injectable ATD from a Quality Assured Laboratory. (No changes.) 20. Treatment outcomes Cured A microbiologically confirmed TB at the beginning of the treatment who was smear- or culture-negative at the end of complete treatment Treatment completed Treatment completed as recommended by the national policy without evidence of failure BUT no record that three or more consecutive cultures taken at least 30 days apart are negative after the intensive phase Treatment success TB patients either cured or treatment completed are accounted in the treatment success. (New addition). 21. Lost to follow-up A TB patient whose treatment was interrupted for one consecutive month or more. (New addition). Not evaluated A TB patient for whom no treatment outcome is assigned. (Former transfer out). Treatment regimen changed Previously, it was called as switched over to MDR treatment. A patient who has been diagnosed as having MDR-TB by an RNTCP accredited laboratory, prior to being declared as Failure, and is placed on the RNTCP MBR-TB treatment regimen. 22. Died Patient who died during the corse of treatment regardless of any cause. Failure A TB patient whose biological specimen is positive by smear or culture at the end of the treatment. (Changed). 23. Tools for microbiological confirmation of TB Sputum Smear Microscopy (for AFB): Zeihl- Neelson Staining and Fluorescence staining. Culture: Solid (Lowenstein Jensen) media or Agar-based 7H11/10 medium Automated Liquid culture systems. Drug Sensitivity Testing: Modified DST for MGIT (Mycobacteria growth indicator tube system) 960 system (for both first and second line drugs). 24. Rapid molecular diagnostic testing: Line Probe Assay for MTB complex and detection of RIF& INH resistance Nucleic Acid Amplification Test (NAAT) Xpert MTB/Rif testing using the GeneXpert system. Used in sputum and as well as extra- pulmonary specimen. Dx of DR-TB. Radiology, TST(tuberculin skin test) ,IGRA (interferon gamma release assay) are other tools for diagnosis of tuberculosis. 25. Two samples are collected within a day or two consecutive days. One sample is collected on the spot under supervision and other is collected early in the morning. Sputum should be at least 2 ml in quantity. Results of sputum tests should be reported within a day. 26. Diagnostic Algorithms for Pulmonary Tuberculosis 27 27. Sputum Specimen specimen “a” (first specimen) The spot sputum specimen, irrespective of whether it is collected prior or after the morning specimen specimen “b” second specimen The morning specimen “c” specimen The space for the “c” specimen should be left blank. 29 28. Sputum Smear Interpretation 30 If The Slide Has (NO. Of AFB) Result Grading No. Of Fields To Be Examined No AFB In 100 Oil Immersion Fields Neg 0 100 1-9/100 Oil Immersion Fields Pos Scanty* 100 10-99/100 Oil Immersion Fields Pos 1+ 100 1-10/Oil Immersion Field Pos 2+ 50 >10/Oil Immersion Field Pos 3+ 20 *Record Actual Number Of Bacilli Seen In 100 Fields – eg. “Scanty 4” Smear-positive results including those of scanty positives are always recorded in Red ink in the tuberculosis laboratory register 29. The most common symptom of pulmonary Tuberculosis is a persistent cough for two weeks or more Patients suspected to have pulmonary Tuberculosis should have two sputum smears examined Sputum samples should be examined as soon as possible and not later than 2 DAYS after it is collected 31 30. The strategies adopted in the treatment of TB are based on both scientific and operational research. 1. Domiciliary treatment 2. Short course chemotherapy 3. Intermittent regimen 4. Direct observation of treatment Domiciliary Treatment Domiciliary chemotherapy has been proved to be as effective as sanatoria treatment. Smear-positive TB patients treated on a domiciliary basis have achieved high cure rates as good as those when treated at sanatorium, besides having other social benefits of being at home. 31. Short Course Chemotherapy Short course chemotherapy regimens have made it possible to treat and cure TB patients in as short a period as six to eight months. Reduction in the duration of treatment regimens was possible because of the introduction of Rifampicin and Pyrazinamide. Thus contributed to improvement in the treatment adherence. 32. Isoniazid (H): Isoniazid is a potent drug, exerting early bactericidal activity, prevents emergence of drug resistant mutants to any companion drug and has low rates of adverse drug reactions. Rifampicin (R): Rifampicin is a potent bactericidal and sterilizing drug acting on semidormant bacilli which multiply intermittently, thereby causing relapse. Pyrazinamide (Z): Pyrazinamide is a bactericidal and sterilizing drug effective in eliminating the semi-dormant bacilli multiplying slowly in an acidic environment. Ethambutol (E): Ethambutol is an effective bacteriostatic drug helpful in preventing emergence of resistance to other companion drugs. Streptomycin (S): Streptomycin is a bactericidal drug known to reduce septicaemia and toxicity 33. Intermittent Treatment Intermittent regimens should only be used in a programme of directly observed treatment (DOT). The formulation of intermittent regimens in the treatment of TB is based on the principle of existence of lag period. “In vitro experiments demonstrated that, after a culture of M. tuberculosis is exposed to certain drugs for some time, it takes several days before new growth occurs”. Thus, there is no need to maintain blood levels of drugs for 24 hours in the treatment of tuberculosis Advantages of intermittent regimen are: 1. As effective as daily treatment 2. Facilitates DOT 3. Reduction in total quantity of drugs consumed 4. Fewer adverse reactions 34. Directly Observed Treatment Short-course Chemotherapy (DOTS) DOT is a supportive mechanism that ensures the best possible results in treatment of TB. Here, a DOT Provider helps the patient in taking the treatment, thereby ensuring adherence. Studies shown that there will be poor treatment outcome and high death rates in the absence of DOT, even when regular supply of drugs is ensured. Hence, by providing DOT, RNTCP ensures that patients receive the right drugs, in the right doses, at the right intervals and for the right duration. 35. The five key components of DOTS 1. Political commitment to control Tuberculosis 2. Case detection by sputum smear microscopy examination among symptomatic patients 3. Patients are given anti-Tuberculosis drugs under the direct observation of the health care provider/community DOT provider. 4. Regular, uninterrupted supply of anti- Tubeculosis drugs 5. Systematic recording and reporting system that allows assessment of treatment results of each and every patient and of whole Tuberculosis control programme 37 36. Treatment Groups Type of patient Regimen Intensive Phase (IP) Continuation Phase (CP) New •New includes former categories I and III •Red coloured Box •TOTAL -78 dose •Sputum smear- positive •Sputum smear- negative •Extra-pulmonary •Others 2H3R3Z3E3 4H3R3 Previously Treated •Smear-positive relapse •Smear-positive failure •Smear-positive treatment after default •Others 2H3R3Z3E3S3 / 1H3R3Z3E3 5H3R3E3 39 “NEW” •Red coloured Box •78 dose •Includes former categories I & III •TOTAL -78 dose 37. 40 38. Dosages For Anti-tuberculosis Drugs In mg/Kg Body Wt Drug Daily Dosage, mg/kg (range) Daily Treatment Treatment three times a week Isoniazid H 5 (4-6) 10 (8-12) Rifampicin R 10 (8-12) 10 (8-12) Streptomycin S 15 (12-18) 15 (12-18) Ethambutol E 15 (13-17) 30 (25-35) Pyrazinamide Z 25 (20-30) 35 (30-40) 39. New daily regimen 40. Weight band :- 41. Adverse Effects of ATD 42. Follow-up of treatment: Clinical follow-up – (new addition) Should be at least monthly – the patient may visit the clinical facility, or the medical officer may conduct the review when she/he visits the house of the patient to observe improvement of chest symptoms, weight gain, control the co-morbid conditions such as HIV and diabetes and to monitor any adverse reaction to ATD. Follow-up laboratory investigation For PTB cases – sputum smear examination at the end of IP and at the end of treatment. (In the previous guidelines, follow-up sputum smear to be done at 2, 4 and 6 months for new cases and 3, 5 and 8 months in previously treated cases.) 43. •In case of clinical deterioration, the Medical Office may consider repeat sputum smear even during CP. (New addition.) •At the completion of treatment, sputum smear and culture should be done for every patient •CXR – to be offered whenever required and available. Long-term follow-up After completion of treatment, the patient should be followed up at the end of 6, 12, 18 and 24 months. Any clinical symptoms and/or cough, sputum microscopy and/or culture should be considered. 44. TB Rx IN LIVER DISORDERS- 3 REGIMENS 45. EXTRAPULMONARY TB
