Оцінка співвідношення користь–ризик антибіотиків у фармаконагляді: систематичний аналіз міжнародних баз даних

Анотація

Introduction. To conduct a systematic analysis of benefit-risk profiles of commonly used antibiotics based on international pharmacovigilance databases for the period 2021–2026. Materials and methods. Data were analyzed from VigiBase, FDA Adverse Event Reporting System (FAERS), EudraVigilance, and the National Register of Adverse Drug Reactions of Ukraine. The benefit-risk assessment included frequency and severity of adverse events, clinical efficacy from randomized controlled trials, and population characteristics. Statistical analysis used proportional reporting ratios and relative risk calculations. Results and discussion. Analysis of over 20 million adverse event reports showed that antibiotic-related adverse events increased from 2.8 million cases in 2021 to 3.4 million in 2025 (21.4% increase). Gastrointestinal disorders (28.3%), allergic reactions (19.5%), and hepatotoxicity (12.4%) were most frequently reported. Penicillins demonstrated the best benefit-risk ratio (8.5:1), followed by third-generation cephalosporins (6.2–6.8:1). Macrolides and fluoroquinolones showed moderate ratios (2.8–3.5:1), while aminoglycosides had the poorest ratios (1.8–2.0:1). In Ukraine, 2,456 antibiotic-related adverse events were reported (18.3% of all adverse drug reactions), with medication dosing errors in 34.2% of antibiotic-treated patients. Conclusions. Penicillins and third-generation cephalosporins are first-line antibiotics with superior benefit-risk profiles suitable for most clinical situations. Macrolides and fluoroquinolones require cautious use with monitoring. Aminoglycosides should be reserved for limited situations, with mandatory monitoring of renal and hearing function. Ukraine requires improvements in adverse event reporting systems and enhanced physician awareness regarding antibiotic safety.