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Clinical and genetic analysis of amiodarone induced hepatotoxicity of cardiac inpatients

dc.contributor.advisorMilovanović, Dragan
dc.contributor.otherMiloradović, Vladimir
dc.contributor.otherĐorđević, Nataša
dc.contributor.otherRadovanović Dinić, Biljana
dc.creatorJovanović, Jovan
dc.date.accessioned2020-02-26T15:44:49Z
dc.date.available2020-02-26T15:44:49Z
dc.date.available2020-07-03T15:16:47Z
dc.date.issued2019-07-04
dc.identifier.urihttp://nardus.mpn.gov.rs/handle/123456789/12009
dc.identifier.urihttp://eteze.kg.ac.rs/application/showtheses?thesesId=7182
dc.identifier.urihttps://fedorakg.kg.ac.rs/fedora/get/o:1217/bdef:Content/download
dc.description.abstractSAŽETAK: Akutna hepatotoksičnost je jedan od najvećih problema farmakovigilance. Dijagnoza ovog neželjenog dejstva bi trebalo da se zasniva na kliničkim kriterijumima ali i na detekciji specifičnih biomarkera hepatocelularnog i/ili holestatskog oštećenja. Nekoliko studija je dokazalo povezanost toksičnih efekata amjodarona i aktivnosti superoksid dizmutaze (SOD). Istraživanje je sprovedeno u dva dela. Jedan je bio prospektivna kontrolisana studija, dizajnirana prema kohorti bolesnika koji imaju hepatotoksičnost i primaju amjodaron i drugi, koji je obuhvatio retrospektivno prikupljanje podataka i posledičnu analizu sa dva opservaciona dizajna, studije tipa „slučaj-kontrola“ (pojava hepatotoksičnosti) i kohortne studije (izloženost faktoru rizika-amjodaronu). Istraživanje je bilo sprovedeno u Klinici za kardiologiju, prema etičkim principima naučno-istraživačkog rada. Retrospektivnu populaciju su činili pacijenti koji su lečeni u klinici u proteklih deset godina. Podaci su bili prikupljani uvidom u istorije bolesti. Za prospektivnu, kontrolisanu studiju koristitili su se uzorci krvi bolesnika koji se leče na klinici, određivani su biomarkeri hepatotoksičnog oštećenja i genetski polimorfizam SOD2. Tokom prospektivne, kontrolisane studije korišćeni su detaljni podaci neinvazivne kliničke dijagnostike koja je od značaja za varijable istraživanja. Statistička analiza prikupljenih podataka je obuhvatila proračun veličine uzorka i statističku obradu. Primarne nezavisne varijable su bile: prisustvo Val16Ala polimorfizma (rs4880) SOD2, u prospektivnoj studiji i uzimanje amjodarona, u retrospektivnoj kohorti. Primarna zavisna varijabla je bilo prisustvo hepatotoksičnosti. S obzirom da su podaci u dostupnoj literaturi za datu populaciju oskudni i kontroverzni, rezultati predstavljaju originalni doprinos u oblasti rasvetljavanja mehanizma i značaja hepatotoksičnosti udružene sa upotrebom amjodarona kod hospitalizovanih bolesnika.sr
dc.description.abstractABSTRACT: Acute hepatotoxicity represents nowadays one of the greatest problems in pharmacovigilance. The diagnosis of this adverse reaction should be based on clinical criteria as well as on the detection of specific biomarkers of hepatocellular and / or cholestatic damage. Several studies have demonstrated the correlation of toxic effects of amiodarone and the activity of superoxide dizmutase (SOD). The research consisted of two parts. One was a prospective controlled study, designed according to the cohort of patients with hepatotoxicity and receiving amiodarone and the other, which included retrospective data collection and consequent analysis with two observational designs, case-control study (hepatotoxicity) and cohort study (exposure to risk factor-amiodarone). The research was conducted at the Clinic for Cardiology, according to the ethical principles of scientific research. The retrospective population consisted of patients who have been treated in the Clinic for the past ten years. The data were collected by screening the medical records of the patients. For a prospective, controlled study, blood samples of patients who are being hospitalized at the clinic were used for determination of hepatotoxic lesion biomarkers and genetic polymorphism of SOD2. During the prospective, controlled study were used detailed noninvasive clinical diagnostic data, which were important for the research variables. Statistical analysis of the collected data included a sample size calculation and statistical processing. Primary independent variables were: presence of Val16Ala polymorphism (rs4880) SOD2 in prospective study and amiodarone administration in a retrospective cohort. The primary dependent variable was the presence of hepatotoxicity. Considering the fact the data in available literature for the given population are scarce and controversial, the results will be an original contribution to the field of clarification of the mechanism and significance of hepatotoxicity associated with the use of amiodarone in hospitalized patients.en
dc.formatapplication/pdf
dc.languagesr
dc.publisherУниверзитет у Крагујевцу, Факултет медицинских наукаsr
dc.relationinfo:eu-repo/grantAgreement/MESTD/Basic Research (BR or ON)/175007/RS//
dc.rightsopenAccessen
dc.sourceУниверзитет у Крагујевцуsr
dc.subjecthepatotoksičnostsr
dc.subjecthepatotoxicityen
dc.subjectamiodaroneen
dc.subjectbiomarkersen
dc.subjectsuperoxide dismutaseen
dc.subjectrisk factorsen
dc.subjectprognostic significance.en
dc.subjectamjodaronsr
dc.subjectbiološki markerisr
dc.subjectsuperoksid dizmutazasr
dc.subjectfaktori rizikasr
dc.subjectprognostički značajsr
dc.titleKlinička i genetska analiza hepatotoksičnosti uzrokovane amjodaronom kod hospitalizovanih pacijenatasr
dc.title.alternativeClinical and genetic analysis of amiodarone induced hepatotoxicity of cardiac inpatientsen
dc.typedoctoralThesisen
dc.rights.licenseBY
dc.identifier.fulltexthttp://nardus.mpn.gov.rs/bitstream/id/49064/Jovan_Jovanovic_Medicinski.pdf
dc.identifier.fulltexthttp://nardus.mpn.gov.rs/bitstream/id/49063/Disertacija.pdf


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