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1、Effective Diagnosis, Treatment, and Control of TuberculosisWorld Health Organization Regional Office for South-East AsiaNew DelhiSouth-East Asia accounts for nearly40% of all tuberculosis cases2TB is the leading single infectious cause of death in South-East AsiaNumber of deaths (1000s)Deaths from i
2、nfectiousagents in South-East Asia3TB is a Leading Killer of WomenDeaths among women4Tuberculosis A Global EmergencylTB kills 5,000 people a day 2-3 million each yearlOne third of the worlds population is infected with TBlTB kills more young women than any other diseaselMore than 100,000 children wi
3、ll die needlessly from TB this yearlHundreds of thousands of children will become TB orphans this year5TB and AIDSLifetime Risk of TB6TB Control:The 5 components of DOTSTB RegisterlPolitical commitmentlDiagnosis by microscopylAdequate supply of SCC drugslDirectly observed treatmentlAccountability7Di
4、agnosis of pulmonary tuberculosis lPatients with TB feel ill and seek care promptlylActive case finding is unnecessary and unproductive lMicroscopy is appropriate technology, indicating infectiousness, risk of death, and priority for treatment lX-ray is non-specific for TB diagnosis lSerological and
5、 amplification technologies (PCR, etc.) currently of no proven value in TB control8Diagnosis of Pulmonary TuberculosisThree specimens optimallSpot specimen on first visit; sputum container given to patientlEarly morning collection by patient on next daylSpot specimen during second visit9Three sputum
6、 smears are optimal10Reporting on AFB MicroscopyNumber of bacilli seenResult reportedNone per 100 oil immersion fieldsNegative1-9 per 100 oil immersion fieldsScanty, reportexact number10-99 per 100 oil immersion fields1+1-10 per oil immersion field2+ 10 per oil immersion field3+11Diagnosis of Pulmon
7、ary TBCough 3 weeksAFB X 3Broad-spectrum antibiotic 10-14 daysIf symptoms persist, repeat AFB smears, X-rayIf consistent with TBAnti-TB TreatmentIf 1 positive, X-ray and evaluation If 2/3 positive: Anti-TB RxIf negative:12Microscopy is more objective and reliable than X-rayInter-observeragreement13M
8、icroscopy is a more specific test than X-ray for TB diagnosisSpecificity14X-ray-based evaluation causes over-diagnosis of TBNTI, Ind J Tuberc, 1974Over-diagnosis15Role of Chest X-raylNo chest X-ray pattern is absolutely typical of TBl10-15% of culture-positive TB patients not diagnosed by X-rayl40%
9、of patients diagnosed as having TB on the basis of x-ray alone do not have active TBToman K. Tuberculosis case finding and chemotherapy. WHO, 1979X-ray is unreliable for diagnosing and monitoring treatment of tuberculosis16Proportion of patients with pulmonaryTB who have positive AFB smears 01020304
10、0506070HIV NegativeEarly HIVLate HIVAFB positivity in TB patients17X-ray findings in TB patients with HIV infectionEarly HIVLate HIV(severe immuno-compromise)18DOTS more than doubles accuracy of diagnosis of TB in SEARExpected range19Prompt treatment of infectious cases reduces spread of tuberculosi
11、slSmear-positive patients usually seek carelSmear-positive patients are 4-20 times more infectiouslUntreated, a smear-positive patient may infect 10-15 persons/yearlSmear-positive patients are much more likely to die if untreatedRouillon A. Tubercle 1976;57:275-9920Treatment CategoriesTB treatmentca
12、tegoryTB PatientsIlNew smear-positive pulmonary TBlNew smear-negative pulmonary TB with extensiveparenchymal involvementlNew cases of severe forms of extra-pulmonary TBIIlSputum smear-positive relapseslSputum smear-positive treatment failure caseslSputum smear-positive cases requiring treatmentafter
13、 interruptionIIIlNew smear-negative pulmonary TBlNew less severe forms of extra-pulmonary TB21Severe and less severe forms of extra-pulmonary TBSevereMeningitisLess SevereLymph nodesMiliaryPericarditisBone (excluding spine)Bilateral or extensivepleural effusionSpinalIntestinalTB/HIV, A Clinical Manu
14、al, World Health Organization 1996Pleural effusion (unilateral)Peripheral joint224 H RI2 HRZE(2 HRZS)2 H3R3Z3E3 (2 H3R3Z3S3)6 HE4 HR33Recommended treatment regimensDirect observation is recommended for all patients and is particularly essential when intermittent regimens are usedContinuation PhaseAl
15、ternative treatment regimens(if smear + at end of initial phase of Cat I or Cat II,one more month of initial phase is given)TBtreatmentcategoryInitial phaseIII2 HRZ2 H3R3Z36 HE4 HRR4 H33333(2 S H R Z E /1 H R Z E5 H R EII2 SHRZE/1 HRZE333333333)5 HRE23Doses of first-line anti-TB drugsPyrazinamide (Z
16、)25 (20-30)35 (30-40)Ethambutol (E)15 (15-20)30 (25-35)All these anti-TB drugs should be given as a single daily dose. Direct observation is recommended for all patients and is particularly essential when intermittent regimens are used.Thiacetazone is not effective when given intermittently and is n
17、ot recommended for use in high HIV prevalence areas.Isoniazid (H)5(4-6)10 (8-12)Recommended Dose (mg/kg)Anti-TB Drug(Abbreviation)DailyIntermittent3x/wkRifampicin (R)10 (8-12)10 (8-12)Streptomycin (S)15 (12-18)15 (12-18)Thiacetazone (T)2.5Not applicable24Role of IsoniazidlMainstay of anti-TB treatme
18、ntlLife saving in TB meningitis lBactericidal for rapidly dividing organismslPrevents emergence of resistance to other drugslIntermittent treatment more effective than daily treatment in animal model and equally effective in clinical trialslSafe and effective for preventive treatment25Role of Rifamp
19、icinlNecessary for short-course treatmentlEssential for at least first 2 months of regimens of 6-9 month durationlBactericidal for rapidly dividing and slow-growing organismslPrevents emergence of resistance to other drugslIntermittent treatment more effective than daily treatment in animal model an
20、d equally effective in clinical trials26Role of PyrazinamidelEssential for 6- and 8-month regimenslNo benefit if given for more than 2 monthslRelatively ineffective at preventing emergence of resistance to other drugs27Pyrazinamide is essential for the first two months of 6/8-month treatmentAm Rev R
21、espir Dis 1987;136:1339-42Relapses28Pyrazinamide does not give any additional benefit if given beyond two months in short-course treatmentAm Rev Respir Dis 1991;143:700-6Cure Rate (%)29Role of Ethambutol/ StreptomycinlPrevent emergence of resistance to other drugs givenlHasten sputum conversionlBact
22、eriostatic or weakly bactericidal against rapidly dividing organisms30Role of ThiacetazonelPrevent emergence of resistance to other drugs givenlBacteriostaticlShould not be given to HIV+ patients because of risk of fatal skin reactions31Relapse rates are low with directly observed intermittent treat
23、ment in both HIV-positive and HIV-negative patientsAm J Respir Crit Care Med 1996:154:1034-38Relapse ratesRelapse (%)32Adverse reactions to anti-TB drugsIsoniazidl Peripheral neuropathyl HepatitisDrugsAdverse reactionsPyrazinamidel Joint painsl HepatitisRifampicinl Gastroentestinal (anorexia, nausea
24、,vomiting, abdominal pain)l Hepatitisl Reduced effectiveness of oralcontraceptive pillEthambutoll Optic neuritisStreptomycinl Auditory & vestibular nerve damage(also to foetus)l Renal damage33Management of LogisticsManagementof StocksCHOICEUSEPURCHASEDISTRIBUTIONSTORAGEQuantificationFinancingTender
25、bidsOrderQuality ControlRe-packagingTransportationInformationfor user & for consumerAdequate buffer stocks must be maintained at national, state/regional, and local levels34Drug requirements are determined based on:lNumber of cases in different treatment categories treated in previous yearlStandardi
26、zed regimens usedlExisting stockslEnsuring reserve (buffer) stocks at each level35Keys for effective distribution and storage of anti-TB drugslStorage conditions (temperature and humidity)lManagement inside the stores:uappropriate spaceuimplementation of FEFO principle (First-Expired, First-Out)ures
27、erve stockslConditions of handling and transportation to the peripheral levellImplementation of drug accounting system at all levels where drugs are stored or administered36Directly Observed TreatmentlTreatment observer must be accessible and acceptable to the patient and accountable to the health s
28、ystemlObservation is a service to patients and providerslMany patients do not take medicines regularly, even if excellent health education is providedlImpossible to predict which patient will take medicine37Directly Observed Treatment(DOT) vs DOTSlDirectly observed treatment (DOT) is one element of
29、the DOTS strategylAn observer watches and helps the patient swallow the tabletslDirect observation ensures treatment for the entire course uwith the right drugsuin the right dosesuat the right intervals38DOT is necessary even whendrug supply ensured Chaulk CP. JAMA 1998;279:943-8Treatment SuccessDOT
30、No DOT39Directly Observed Treatment is the Standard of Care“DOT has emerged as the standard of care”(Bayer, Lancet, 1995)“Every patient with TB in this country should receive DOT” (Iseman, NEJM, 1993)“DOT seems imperative where the disease has become epidemic” (Chaulk, JAMA, 1996)40Why is it necessa
31、ry to directly observe treatment?lAt least one third of patients receiving self-administered treatment do not adhere to treatmentlImpossible to predict which patients will take medicineslDOT necessary at least in the initial phase of treatment to ensure adherence and achieve sputum smear conversionl
32、A TB patient missing one attendance can be traced immediately and counseled41Modes of ObservationlHealth care workerslNon-governmental organizationslCommunity volunteerslReligious leaderslChild survival workers, lay midwives, etc.DOT is feasible in each community by identifying and involving the str
33、engths of the community.42DOT prolongs survival ofHIV-infected TB patients SCC with DOTSCC without DOT43Systematic Monitoringand AccountabilitylGood record-keeping is the cornerstone of successlThe DOTS recording system enablesuMonitoring of patient outcomesuEvaluation of programme performanceuAnaly
34、sis of epidemiologic datauOperational researchlEvery level of health system accountable for patient diagnosis and cure44Treatment outcomes in sputum smear-positive patientsCurePatient who is smear negative at (orone month prior to) completion oftreatment and on at least oneprevious occasionTreatment
35、completedCompleted treatment but follow-up smearresults are not availableTreatment failureRemains or becomes again smearpositive 5 months or more after startingtreatmentDiedPatient who dies for any reason duringtreatmentTransferred outPatient who has been transferred toanother treatment centre and w
36、hosetreatment results are not knownDefaulted (treatment interrupted)Patient whose treatment has beeninterrupted for more than 2 consecutive months before the end of treatment45SupervisionlEffective supervision at all levels is key to successlSupervision is the process of helping staff improve their
37、performancelKey areas: 4laboratory work 4patient categorization4direct observation4drug storage and stock4record keeping4reporting46DOTS can reduce the burden of TBAnnual percentage decline in incidence/prevalence47DOTS can reduce drug resistanceDecline (percent)48Results of DOTS in 112,842 patients
38、 with smear-positive pulmonary TB in ChinaLancet 1996;347:358-62Cure rateCure rate (%) New Patients 2 H3R3Z3S3 / 4 H3R3 Previously treated patients2 H3R3Z3S3E3 / 6 H3R3E349Treatment outcomes, DOTS areas, South East Asia, New Smear+ Patients 1997 25,871 308 7,708 19,492 94 9,014 2,303 3,506 1,87350DO
39、TS triples treatment success in South East Asia51DOTS is succeeding in South East AsialMore than 500,000 TB patients treated with DOTS in South-East AsialMore than 50,000 lives savedlMore than 2 million TB infections preventedlMore than 200,000 TB cases preventedlMore than US$150 million saved52DOTS
40、 in the context of HIVlDOTS can:uProlong life and improve its qualityuStop the spread of TBuPrevent emergence of MDRTBuReverse the trend of MDRTBFailure to use DOTS in the face of HIV can lead to explosive spread of TB, with cases tripling and drug resistance increasing rapidly53Economic benefits of
41、 DOTS: IndonesiaSawert, WHO, 19980123456789 10 11 12 13 14 15 16 17 18 19 20Years of implementation020406080Return on each dollar invested in DOTS$55 saved for every $1 invested54DOTS is Expandingin South East Asia 0300501001502001994199519961997199819990100200400500600(Thousands)Cases treated Pop.
42、Covered (million) Population covered Total Cases treated New SS+ 55The Sooner DOTS is Implemented, the FasterTB Will be Controlled in South-East Asia0199520002005201020150202YearGTB/WHO500100015002000250030003500400056Deaths from TB (thousands)Deaths from TB with and without rapidDOTS expansion, SE Asia, 2000-202057DOTS is accelerating in South-East Asia, but needs to become more extensive and intensive Target Zone750,000 more new ss+ patients need to be treated yearly58
