Оцінка безпеки застосування левофлоксацину при лікуванні хворих на туберкульоз органів дихання
pdf (Українська)

Keywords

levofloxacin
adverse reactions
pharmacovigilance
report cards
respiratory tuberculosis
safety use

Abstract

The aim of the study – to assess safety of levofloxacin use in the treatment of patients with respiratory tuberculosis in the Kharkiv region for 2025. The safety assessment of pharmacotherapy by levofloxacin was carried out using the method ofspontaneous reports, which is widely used in pharmacovigilance. There were analyzed the report ca on adverse reactions received from phthisiatric healthcare institutions of the Kharkiv region in 2025. During the conducted pharmacovigilance study, it was found that in the Kharkiv region in 2025, 32 cards-reports on adverse reactions were registered when using levofloxacin (tablets, 500 mg) for the treatment of respiratory tuberculosis. Adverse reactions developed in young and middle-aged men. 53 adverse reactions were registered in the report cards, among which the majority of patients' complaints were related to the gastrointestinal tract – 28.3% of cases; musculoskeletal system and skin – 20.8% of cases each; nervous system – 17.0% of cases; immune system – 11.3% of cases. All registered adverse reactions are non-serious and predictable. Thus, safety assessment showed that the treatment of respiratory tuberculosis with levofloxacin is relatively safe, as no serious and unpredictable adverse reactions were registered.

https://doi.org/10.33250/20.02.204
pdf (Українська)

References

1. Treatment of drug-resistant tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline. P. Nahid, S. R. Mase, G. B. Migliori et al. Am. J. Respir. Crit. Care Med. 2019. V. 200 (10). P. e93–e142. https://doi.org/10.1164/rccm.201909-1874ST.
2. Зведені настанови ВООЗ з туберкульозу. Модуль 4: лікування. Лікування лікарсько-стійкого туберкульозу (2020 р.). URL: https://phc.org.ua/sites/default/files/users/user90/WHO%20consolidated%20guidelines%20on%20tuberculosis%20Module%204%20Treatment%20Drug-resistant%20tuberculosis%20treatment_UKR.pdf.
3. FDA Drug Safety. Communication FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes. 2018. URL: https://www.fda.gov/media/114192/download.
4. Антибіотик левофлоксацин – ефективний засіб проти лікарсько-стійкого туберкульозу 2025. URL: https://helpme.com.ua/antibiotik-levofloksacin-efektivnij-zasib-proti-likarsko-stijkogo-tuberkulozu/.
5. Березняков І. Г. Високодозові короткі курси левофлоксацину для лікування хворих на позалікарняні пневмонії: аналіз аргументів «за» і «проти». Ліки України. 2019. № 2 (228). С. 1–7.
6. Henriksen D. P., Brabrand M. Fluoroquinolone administration and outcomes in patients hospitalized for community acquired pneumonia: a case of confounding by indication? Clin. Infect. Dis. 2016. V. 63, No. 5. P. 706.
7. Хиць А. Р. Мультирезистентний туберкульоз: оновлені рекомендації ATS. 2019. URL: https://www.umj.com.ua/en/news-166779-multirezistentnij-tuberkuloz-onovleni-rekomendatsiyi-ats-2019.
8. Державний експертний центр МОЗ України. Карти повідомлення про побічні реакції та/або відсутність ефективності лікарських засобів при їх медичному застосуванні. URL: https://dec.gov.ua/materials/karti-povidomlen-pro-pobichni-reakczi-ta-abo-vidsutnist-efektivnosti-likarskih-zasobiv-pri-h-medichnomu-zastosuvanni/.