| Abstract | Akne su upalno kožno oboljenje koje najviše pogađa osobe u adolescentskoj i pubertetskoj dobi, s mogućnošću nastavka bolesti u odrasloj dobi. Akne nastaju uslijed promjena u pilosebacealnoj jedinici. Iako su potrebna dodatna istraživanja o nastanku akni, mnogi ih znanstvenici dovode u vezu s genetičkom podlogom, prehranom, stresom, hormonskom neravnotežom te tipom kože pojedinca. Medicinsko liječenje akni ovisi o tipu akni. Ovaj rad donosi pregled svih nuspojava lijekova za liječenje akni (ATK D10) koje je Hrvatska agencija za lijekove i medicinske proizvode (HALMED) zaprimila u razdoblju od 1. siječnja 2018. do 31. prosinca 2018. godine. Analizirana je 141 prijava sumnji na nuspojave lijekova skupine D10, a rezultati su analizirani prema dobi i spolu pacijenta, prijavitelju, ozbiljnosti, ishodu, pripadnosti nuspojava prema klasifikaciji organskih sustava Medicinskog rječnika za regulatorne poslove (MedDRA) te djelatnoj tvari. Udio broja prijava nuspojava lijekova skupine D10 u ukupnom broju prijava nuspojava lijekova bio je 3,1%. Ukupno je analizirano 369 nuspojava lijekova od kojih se najveći broj odnosio na pacijente ženskog spola (64,5%) i dobnu skupinu od 18 do 44 godine (39,7%). Najviše nuspojava prijavljeno je od strane ljekarnika (43,3%) i nisu bile ozbiljne. Najčešće nuspojave lijekova skupine ATK D10 prijavljene su za azitromicin (23,1%), metilprednizolon (21,4%), klindamicin (13,3%), deksametazon (9,8%) te doksiciklin (8,7%), a najveći broj nuspojava rezultirao je oporavkom bez posljedica na pacijenta (35,2%). Podaci su uspoređeni s europskom i svjetskom bazom nuspojava lijekova te je vidljiva podudarnost u većini podataka. |
| Abstract (english) | Acne is an inflammatory skin disease that mostly affects people in adolescence and puberty, with possibility of continuing the disease into adulthood. Acne is caused by changes in the pilosebaceal unit. Although more researches are needed on the onset of acne, many scientists have linked it to the genetic background, diet, stress, hormonal imbalance and skin type of an individual. The medical treatment for acne depends on the type of acne. This paper provides an overview of all side effects of medicinal product belonging to ATC: D10 group reported to the Croatian Agency for Medicinal Products and Medical Devices (HALMED) from January 1, 2018 to January 31, 2018. In total, 141 suspected adverse drug reactions from ATC:D10 group were analyzed and the results are divided by patient's age and gender, reporter qualification, seriousness criteria, outcome, affiliation of adverse reactions according to the Medical Dictionary of Regulatory Affairs (MedDRA) organic system classification and active substance. The proportion of reports of adverse drug reactions of D10 group in the total number of reports of adverse drug reactions was 3.1%. In total, 369 adverse drug reactions were analyzed and most of them are related to female patients (64.5%) and the 18-44 patient age group (39.7%). Most adverse reactions were reported by pharmacists (43.3%) and were not serious. The most common side effects for drugs from ATK: D10 group were reported for azithromycin (23.1%), methylprednisolone (21.4%), clindamycin (13.3%), dexamethasone (9.8%), and doxycycline (8.7%), and the highest number of side effects resulted in patient-free recovery (35.2%). The data are compared with the European and world-wide database of side effects of medicines, and there is a clear coincidence in most of the data. |
