1. filtvis tuberkulozis mkurnalobis efeqturobis da usafrTxoebis Sedareba
TB samkurnalo reJimSi
fiqsirebuldoziani kombinaciis da
arakombinirebuli preparatebis gamoyenebisas
randomizebuli kontrolirebadi klinikuri kvleva
Christian Lienhardt, MD, MSc, PhD; Sharlette V. Cook, MSc at all; 2011 American Medical Association. All rights reserved. JAMA, April 13, 2011—Vol 305, No. 14;
lali kupreiSvili,
“samSabaToba”,

2. kvlevis mizani: filtvis tuberkulozis mkurnalobaSi oTxkomponentiani fiqsirebuldoziani preparatis (FDC-4) gamoyenebis efeqturobisa da usafrTxoebis Sefaseba;

3. kvlevis meTodebi: kvlevis dizaini:
kvleva tardeboda wlebSi aziis, afrikisa da laTinuri amerikis 9 qveknis 11 bazaze;
kvleva Catarda paralelur jgufebSi; iyo Ria (arabrma), kontrolirebadi, randomizebuli;
SefasebisaTvis gamoyenebuli iyo non-inferiouty dizaini;

5. test (FDC) reJimi Sedgeboda sawyisi intensiuri fazis 8 kviris manZilze R, H, Z, E FDC – 4 saxiT miRebisagan, xolo momdevno 18 kvira gagrZelebis fazaSi HR FDC-2 formiT kviraSi 3-jer.
sakontrolo reJimi Sedgeboda igive wamlebisagan, mxolod gancalkevebuli saxiT. igi aseve iTvaliswinebda 8 kvirian yoveldRiur miRebas da momdevno 18 kviris manZilze HR-is miRebas kviraSi 3-jer FDC-2saxiT.

6. Efficacy and Safety of a 4-Drug Fixed-Dose Combination Regimen Compared With Separate Drugs for Treatment of Pulmonary Tuberculosis; JAMA. 2011;305(14):

7. CarTvis kriteriumebi:
CairTvebodnen -18 wlis asakis zemoT pacientebi, romelTac daudgindaT filtvis tuberkulozis axali SemTxveva, hqondaT naxvelis ori (+)nacxi mgb-ze pirdapiri mikroskopiiT. warsulSi 4 kviraze naklebi xniT hqondaT miRebuli tubsawinaaRmdego preparatebi. maTi misamarTebi iyo advilad misadgomi vizitorebis kontrolisTvis .
pacientebi ar CairTvebodnen-Tu I kviris manZilze saTuo iyo maT mier mkurnalobis CamTavreba; hqondaT meningiti, sxva filtvgareSe tb daavadebebi, insulindamokidebuli diabeti, RviZlis an Tirkmlis, sisxlis qronikuli daavadeba, periferiuli nevritebi. dadgenili iyo orsuloba an laqtacia, fsiqiuri aSliloba an alkoholizmi an raime winaaRmdegCveneba tubsawinaaRmdego preparatebis mimarT. pacientebi sawyisi uaryofiTi kulturiT an Rif-ze rezistentobiT.

8. Follow up
pacientebs afasebdnen mkurnalobis 2,3,5 da 6 Tvis bolos da Semdeg me-8, 10, 12, 15, 18, 24 da 30 Tveze;

9. mikrobiologia – naxvelis ori nimuSis Segroveba xdeboda yvela vizitis dros da mowmdeboda cil-nilsenis an fluoroscentuli mikroskopiis wesebiT mgb-s arsebobaze.
kulturis monacemTa Sedarebis saimedoobisTvis da sensitivobis da specifiurobis Sedegebis variaciaTa minimizaciisTvis gamoyenebuli iyo kulturis nimuSis damuSavebis modificirebuli versia yvela dadebiTi kultura (sadac iyo 5 koloniaze meti) iyo subkulturirebuli. 2 subkultura rCeboda nacionalur laboratoriaSi, xolo mesame igzavneboda supranacionalur laboratoriaSi antverpenSi (belgia), xarisxis kontrolis, Stamis identifikaciisa da mgrZnobelobis testirebisaTvis.
H, R, S -is mgrZnobelobis testireba xdeboda proporciuli meTodiT.
gamoiyeneboda agreTve sekvenireba,E spoligotipireba, MIRU-VNTR , Fingerprinting-i.

10. aranaklebi efeqturobis dasadastureblad 90%-iani sarwmunoebis moTxovnis gaTvaliswinebiT TiToeul jgufSi CarTuli unda yofiliyo 412 avadmyofi.
imis gaTvaliswinebiT (daSvebiT) ,rom
15% avadmyofebisa gamoeTiSebodnen kvlevas sawyis etapze negatiuri kulturis an R-rezistentobis gamo , rom 10% ar Caitarebda mkurnalobas, xolo 2% daikargeboda Semdgomi dakvirvebidan da Soreuli Sedegebidan, monawileTa sakmarisi raodenoba gansazRvruli iko 749 avadmyofiT TiToeul jgufSi.

11. usafrTxoebis analizi – yvela 1581 avadmyofi iyo Sefasebuli usafrTxoebis kuTxiT pirveli 2 Tvis manZilze; maTgan 67 (31 FDC jgufidan, 36 calkeulidan) warmoadgenda 1 Civils mainc, rac SesaZlo kavSirSi iyo tubsawinaaRmdego mkurnalobasTan.

12. M kvlevis Sedegebi:
protokoliT gansazRvruli analiziT dadebiTi Sedegi dafiqsirda:
fiqsirebuldoziani kombinaciiT namkurnaleb 555 (591-is 93.9%) pacientTan;
arakombinirebuli preparatebiT namkurnaleb 548 (579-is 94.6%) pacientTan (risk difference, −0.7% [90% confidence interval {CI}, −3.0% to 1.5%]).
ITT I modelSi dadebiTi Sedegi dafiqsirda:
fiqsirebuldoziani kombinaciiT namkurnaleb 570 (684-is 83.3%) pacientTan;
arakombinirebuli preparatebiT namkurnaleb 563 (664-is 84.8%) pacientTan (risk difference, −1.5% [90% CI,−4.7% to 1.8%]).
ITT II modelSi dadebiTi Sedegi dafiqsirda:
fiqsirebuldoziani kombinaciiT namkurnaleb 591 (658-is 89.8%) pacientTan;
arakombinirebuli preparatebiT namkurnaleb 589 (647-is 91.0%) pacientTan (risk difference, −1.2% [90% CI, −3.9% to 1.5%]).
gverdiTi movlenebis tipis da sixSiris mixedviT jgufebi mniSvnelovnad ar gansxvavdebodnen

14. daskvna:
4 komponentiani fiqsirebuldoziani sqemis Sedarebisas calkeul preparatebian reJimTan non-inferiority-s mkacri kriteriumebi daakmayofila analizis 3 saxeobidan 2-ma;
kvlevis Sedegebi ar axdenen FDC-4-is aranaklebi efeqturobis srul demonstrirebas arakombinirebul preparatebTan SedarebiT;
FDC-4-is gamoyenebis upiratesoba misi administrirebis met siioleSi mdgomareobs.

16. gmadlobT yuradRebisaTvis