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Standart treatment protocol approach in the treatment of multi drug resistant tuberculosis. Haluk Celalettin Çalışır, Aylin Öngel, Şule Bilgin, Korkmaz Oruç, Sinem Altunbey, Gülgün Çetintaş, Hülya Arda. SB Süreyyapaşa Chest Diseases and Chest Surgery Education and Training Hospital .
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Standart treatment protocol approach in the treatment of multi drug resistant tuberculosis Haluk Celalettin Çalışır, Aylin Öngel, Şule Bilgin, Korkmaz Oruç, Sinem Altunbey, Gülgün Çetintaş, Hülya Arda SB Süreyyapaşa Chest Diseases and Chest Surgery Education and Training Hospital 08-12 April 2008 Thorax Association 12. Annual Congress
AİM OF STUDY Evaluated results of the patients treated ‘Standard Treatment Protocol Approach’ for multi drug resistant tuberculosis management
Recommended treatment strategies for MDR-TB Standardized treatment Same treatment regime all patients Initially, standart treament According DST result regime swiched Standardized treatment followed by invidualized treatment Each regime is individually designed on the basis of patient history and then adjusted when DST results become available Empirical treatment followed by individualized treatment Guidelines for the programmatic management of drug-resistant tuberculosis WHO/HTM/TB 2006.361
Basic prensible for regimens design • Treatment is for a minimum duration of 18 months beyond conversion • Each dose is given as DOT throughout the treatment • DST, available and reliable lab, should be used to guide therapy. at least four drugs highly susceptible, based on DST and drug history • Pyrazinamid can be used for the entire treatment if it is judged to be effective. • History of drug taken • Drugs and regimes commonly used in the country and the prevalence of resistance to first-line and second-line drugs • Regimens should consist of at least four drugs with either certain or almost certain, effectiveness • At least six days a week • The drug dosages should be determined by body weight • An inject able agent (an amimoglycoside or capreomycin) is used for a minimum of 6 months Guidelines for the programmatic management of drug-resistant tuberculosis WHO/HTM/TB 2006.361
Kişileştirilmiş tdv Standart tdv Efficacy Maximum Moderate-High Cost High Moderate-High Risk of amplification Very low Low-Moderate Toxicity Moderate Moderate Technical capacity required High Moderrate Comparison of approaches to MDR-TB treatment A DOTS-Plus Handbook Guide to the Community-Based Treatment of MDR-TB Partner in Health Harward Medical School 2004
Advantages of Standartized treatment stratagies • Simpler operational aspects of implementation • Simpler drug ordering • Easier training • Less likelihood of mismanagement • Less dependence on highly technical laboratories Guidelines for the programmatic management of drug-resistant tuberculosis WHO/HTM/TB 2006.361
Previously treatment history (+) Cathegory I Cathegory II Cathegory IV CURED CURED
MATERIAL-METOD Of 1442 patiens, treated in 2004_2007 in our clinic 21 patients MDR-TB established through clinical, laboratory findigs were administered standart therapy
1 patient Moksifloksasin Thiosetazon Augmentin Sicloserin Klofozamin Capreomisin 20 patients standardized treatment protocol Amicasin ( in the first 4-6 months) Quinolon PAS Cycloserin Prothionamid Amicasin MATERIAL-METHOD No alteration in the treetment regimen excluted adverse effect.
Treatment outcome definitions for Category IV treatment • Cured: A Category IV patient who has completed treatment according to the programme’s protocol and has at least five consecutive negative cultures from samples collected at least 30 days apart in the 12 months of treatment. • Treatment completed A Category IV patient who has completed treatment according to the programme’s protocol but does not meet the definition for cure because of lack of bacteriological results. • Failed: Treatment will be considered to have failed if two or more cultures recorded in the final 12 months of therapy are positive, or if any one of the final three cultures is positive • Defaulted: A Category IV patient whose treatment was interrupted for two or more consecutive months for any reason. Guidelines for the programmatic management of drug-resistant tuberculosis WHO/HTM/TB 2006.361 Speaking the same language: treatment outcome definitions for MDR-TB Laserson KF et al. Int J Tuberc Lung Dis 2005
AVARAGE MİN-MAX AGE 37.38 ± 13.76 22 - 60 PREVIOUSLY TREATED HISTORY 3,6 ±1,28 2 - 7 RESISTANCE RATE 3.19 ± 0.98 2 - 4 RESULTS Total patient:1442 MDR-TB Patient: 21 (1.4%)
ADVERSE SIDE EFFECT Adverse side effect : 6 (28.5%) 1 Patient exculded protionamid 1 Patient exculeded sicloserin 1 Patient exculeded Amicasin
During analayses in 2008 Of 21 patients in 19 (90.4%) satisfactory results vere achieved. RESULTS
MDR-TB Standartized Treatment Outcomes Caminero JA. Int J Tuberc Lung Dis 2006, 10: 829-837 Suarez P G The Lancet 359 :1980-1989 Van Deun A Int J Tuberc Lung Dis 2004 8(5):560-567 Park S.K. Int J Tuberc Lung Dis 2006; 8: 361-368 Masjedi M.R. Int J Tuberc Lung Dis; 12(7):750-755
MDR-TB Indivudialized treatment outcomesStandardized treatment followed by individualized treatment Caminero JA. Int J Tuberc Lung Dis 2006, 10: 829-837 Palmero D.J. Int J Tuberc Lung Dis 2004 8(6):778-784 Geerling W.A. Int J Tuberc Lung Dis 2000 4(8):758-764 Narita M Chest 2001;120:343-348 Shean K.P Int J Tuberc Lung Dis 2000 12 (10) 1182-1189 Ward H.A. Int J Tuberc Lung Dis 2005 9(2): 164-169
MDR-TB Indivudialized treatment outcomesEmpirical treatment followed by individualized treatment Caminero JA. Int J Tuberc Lung Dis 2006, 10: 829-837 Mitmick S. D NEJM 2003;348:119-28 Park S.K Int J Tuberc Lung Dis 1998: 2 (11) :877-884 Thaoğlu K NEJM 2001;345:170-174 Chan E D AJRCCM 2004:169: 1103-1109 Saravia J. C. Int J Tuberc Lung Dis 2005: 9(4): 421-429
CURED/TREATMENT COMPLETED RATER IN THREE APROACH MDR-TB TREATMENT MENAGEMENT Standartized Treatment 44.1%-82% Standardized treatment followed by individualized treatment 45%-86% Empirical treatment followed by individualized treatment 44%-79%
SECOND-LINE TUBERCULOSIS DRUG RESISTANCE AT PATIENTWHO HAD PREVIOUSLY TREATMENT HISTORY Haluk C. Çalışır, Aylin Öngel, Nadi Bakırcı*,Hülya Arda,Kaya Köksalan**, Şule Kızıltaş, Sinem Ağca,Gülgün Çetintaş,Korkmaz Oruç TORAKS 2008
RESULTS Treatment of MDRTB by means of “standard treatment protocol” our clinic achieved the success rate of 90.4% in patients. Because of our hospital is one of the four MDR-TB treated referral centre, Standardized treatment approach which is simple and cause high cure rate, may use in all country.