Title Sumnje na nuspojave lijekova koji inhibiraju Brutonovu tirozin kinazu
Title (english) Suspected side effects of drugs that inhibit Bruton's tyrosine kinase
Author Josipa Milardović
Mentor Siniša Tomić (mentor)
Committee member Jelena Ban (predsjednik povjerenstva)
Committee member Karlo Wittine (član povjerenstva)
Committee member Siniša Tomić (član povjerenstva)
Granter University of Rijeka (Faculty of Biotechnology and Drug Development) Rijeka
Defense date and country 2022-09-16, Croatia
Scientific / art field, discipline and subdiscipline BIOTECHNICAL SCIENCES Biotechnology
Abstract Za liječenje različitih vrsta limfoma B limfocita otkriveni su lijekovi koji inhibiraju Brutonovu tirozin kinazu (BTK) odnosno enzim koji potiče malignu proliferaciju B limfocita. Njenom inhibicijom blokiraju se signalni putevi koji su bitni u nastajanju malignih promjena. U ovu skupinu lijekova ubrajaju se ibrutinib, akalabrutinib i zanubrutinib. Ovaj diplomski rad donosi analizu svih prijava sumnji na nuspojave lijekova koji inhibiraju BTK, koje su Agenciji za lijekove i medicinske proizvode (HALMED) prijavljene u razdoblju od 1. siječnja 2015. godine do 31. prosinca 2021. godine. Prijave su analizirane s obzirom na: spol, dob, struku prijavitelja, ozbiljnost, kriterij ozbiljnosti, klasifikaciju organskih sustava Medicinskog rječnika za regulatorne poslove (MedDRA), učestalost prijave i lijekove u istodobnoj primjeni. U promatranom razdoblju zaprimljene su 123 prijave sa ukupno 220 nuspojava. Najveći broj prijava zabilježen je za muški spol (65,9%) i za dobnu skupinu od 65 do 74 godina (28,5%). Najveći broj nuspojava prijavili su liječnici, a veliki broj nuspojava ocijenjen je ozbiljnima (69,9%). Od ukupno 220 nuspojava najveći broj njih prema klasifikaciji organskih sustava pripada u SOC infekcije i infestacije (17,7%), SOC poremećaji kože i potkožnog tkiva (10%) te SOC srčani poremećaji (8,2%), a najčešće su prijavljivane fibrilacija atrija, sepsa i pneumonija. Navedeni podaci o nuspojavama lijekova koji inhibiraju BTK u skladu su s podacima na europskoj i svjetskoj razini. Broj prijava sumnji na nuspojave, kako lijekova koji inhibiraju BTK tako i ostalih lijekova, raste svake godine. To je rezultat kvalitetnog rada HALMEDA i drugih svjetskih agencija na promicanju svjesnosti o važnosti prijavljivanja sumnji na nuspojave lijekova. Potrebni su daljnji napori u unaprjeđenju sigurnosti lijekova koji inhibiraju BTK kako bi se osiguralo sigurno i učinkovito liječenje pacijenata sa što manje štetnih nuspojava.
Abstract (english) Drugs that inhibit Bruton's tyrosine kinase (BTK), which is an enzyme that promotes malignant proliferation of B lymphocytes, have been discovered for the treatment of different types of B lymphocyte lymphoma. Inhibition of this enzyme blocks the signaling pathways that are important in the development of malignant changes. This group of drugs includes ibrutinib, acalabrutinib and zanubrutinib. This thesis provides an analysis of all suspected reports of adverse reactions to drugs that inhibit BTK, which were reported to the Agency for Medicinal Products and Medical Devices (HALMED) in the period from January 1, 2015 to December 31, 2021. Reports were analyzed considering: gender, age, reporter qualification, seriousness, seriousness criteria, Medical Dictionary of Regulatory Affairs (MedDRA) organ system classification, the most common adverse reactions and concomitant medications. In the observed period, 123 reports were received with a total of 220 adverse reactions. The highest number of reports was recorded for males (65.9%) and for the age group 65 to 74 years (28.5%). The highest number of adverse reactions was reported by doctors, and a large number of them were assessed as serious (69.9%). Out of a total of 220 adverse reactions, the highest number of them according to the classification of organ systems belongs to SOC infections and infestations (17.7%), SOC disorders of the skin and subcutaneous tissue (10%) and SOC heart disorders (8.2%) and the most commonly reported were atrial fibrillation, sepsis and pneumonia. The data in this thesis are in accordance with the data at European and global level. The number of reports of suspected adverse reactions, both for drugs that inhibit BTK and for other drugs, is higher every year. This is the result of the quality work of HALMED and other world agencies, to raise awareness on the importance of reporting suspected adverse drug reactions. Further efforts are needed to improve the safety of BTK-inhibiting drugs to ensure safe and effective treatment of patients with as few adverse reactions as possible.
Keywords
lijekovi koji inhibiraju Brutonovu tirozin kinazu
nuspojave lijekova
farmakovigilancija
Keywords (english)
drugs that inhibit Bruton's tyrosine kinase
adverse drug reactions
pharmacovigilance
Language croatian
URN:NBN urn:nbn:hr:193:560968
Study programme Title: Biotechnology in medicine Study programme type: university Study level: graduate Academic / professional title: magistar/magistra biotehnologije u medicini (magistar/magistra biotehnologije u medicini)
Type of resource Text
File origin Born digital
Access conditions Access restricted to authenticated users
Terms of use
Created on 2022-09-15 20:31:59