The influence of adverse drug reactions and adverse events, associated with the use of valproic acid, carbamazepine or lamotrigine in the pediatric population, on parental beliefs about treatment

Ciljevi istraživanja u okviru doktorske disertacije obuhvatili su ispitivanje vrste i učestalost ispoljenih uobičajenih neželjenih reakcija na valproinsku kiselinu, karbamazepin i lamotrigin u pedijatrijskoj populaciji. Takođe, istraživanje je imalo za cilj da se ispita kakav je uticaj monoterapije valproinskom kiselinom na metabolizam tireoidne žlezde kod dece sa epilepsijom, kao i da se identifikuju potencijalni faktori rizika za razvoj subkliničkog hipotireoidizma kod ove grupe. Treće, nadovezujući se na rezultate ovih istraživanja, cilj istraživanja je bio da se ispita kako prisustvo neželjenih reakcija na navedene lekove utiče na stavove i odluke roditelja u pogledu terapije. U istraživanje su bili uključeni pedijatrijski pacijenti kojima je dijagnostikovana epilepsija ili febrilne konvulzije, a koji su lečeni uz pomoć valproinske kiseline, lamotrigina ili karbamazepina, u periodu od najmanje šest meseci. Kod njih je rađen test tireoidne funkcije i merene su serumske koncentracije valproinske kiseline. Za ispitivanje stavova roditelja korišćen je upitnik - Liverpulski profil neželjenih događaja (LAEP), dok je u cilju ispitivanja stavova roditelja prema terapiji deteta i terapiji uopšte, korišćen upitnik o stavovima prema terapiji (BMQ). Statistička analiza je izvršena upotrebom programa PASW 18, a razlike između eksperimentalne i kontrolne grupe testirane su pomoću Hi-kvadrat i Mann-Whitney U testa. Bivarijantna Pearson-ova korelacija je korišćena za utvrđivanje veze između BMQ i LAEP rezultata. Nakon toga, prosta regresiona analiza je upotrebljena kako bi se utvrdio uticaj godina, pola, tipa napada, leka, dužine trajanja terapije, obrazovnog profila roditelja na BMQ i LAEP rezultate. Prosečna dužina trajanja terapije valproinskom kiselinom u okviru ovog istraživanja bila je 2,80±1,96 godina. Pacijenti koji su primenjivali valproinsku kiselinu imali su veću koncentraciju tireostimulirajućeg hormona (p<0,001) i slobodnog trijodotironina (p<0,05) u poređenju sa kontrolnom grupom. Trajanje monoterapije valproinskom kiselinom <4 godine je bio faktor rizika za povišene koncentracije tireostimulirajućeg hormona...The goals of the research were to investigate the types and frequencies of common adverse reactions of valproic acid, carbamazepine and lamotrigine in the pediatric population. Moreover, the research aimed to examine the impact of valproic acid monotherapy on thyroid gland metabolism in children with epilepsy, and to identify potential risk factors for the development of subclinical hypothyroidism in this group. Furthermore, based on the results of these studies, the dissertation aimed to examine how the presence of adverse reactions to antiepileptic drugs affects the attitudes and decisions of the parents in terms of therapy. The study included pediatric patients diagnosed with epilepsy or febrile convulsions who were treated with valproic acid, lamotrigine or carbamazepine for a period of at least six months. Testing of thyroid function and measurement of serum concentration of valproic acid was performed. To examine the attitudes of the parents, the Liverpool profile of adverse events (LAEP) questionnaire was used, while the questionnaire on attitudes towards therapy (BMQ) was used in order to examine the attitudes of the parents towards the therapy of the child and the therapy in general. Statistical analysis was performed using the PASW 18 program, and the differences between the experimental and the control group were tested with Hi-squared and Mann-Whitney U test. The Pearson correlation was used to determine the relationship between BMQ and LAEP results. Subsequently, a simple regression analysis was used to determine the effect of years, sex, type of attack, drug, duration of therapy, parent education profile on BMQ and LAEP results. The average duration of valproic acid therapy in this study was 2.80±1.96 years. Patients who were on valproic acid had a higher concentration of the thyrostimulating hormone (p<0.001) and free triiodothyronine (p<0.05) compared with the control group. The duration of valproic acid treatment