Randomized clinical trial: comparison of personalized and quadruple concomitant therapy in the treatment of Helicobacter pylori infection
| Autor: | Perković, Nikola |
|---|---|
| Přispěvatelé: | Tonkić, Ante, Bevanda, Milenko, Bratanić, Andre, Marušić, Ana |
| Jazyk: | chorvatština |
| Rok vydání: | 2023 |
| Předmět: |
BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Interna medicina
Helicobacter pylori Pathology. Clinical medicine Randomized clinical trial BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Internal Medicine Helicobacter infekcije Patologija. Klinička medicina udc:616(043.3) Randomizirano kliničko ispitivanje Helicobacter Infections |
| Popis: | Primarni cilj ovog istraživanja bio je usporediti konkomitantnu četverostruku terapiju s ciljanom personaliziranom terapijom kao eradikacijskim liječenjem prve linije infekcije H. pylori u Splitskodalmatinskoj regiji Hrvatske u kojoj postoji visoka rezistencija na klaritromicin (>20%). Sekundarni cilj bio je usporediti usklađenost i stopu štetnih događaja između ova dva terapijska režima. MATERIJALI I METODE U otvorenom, randomiziranom kliničkom ispitivanju, provedenom između siječnja 2019. i siječnja 2020. 80 pacijenata s infekcijom H. pylori nasumično je dobilo ili četverostruku konkomitantnu terapiju (esomeprazol 40 mg, amoksicilin 1 gr, metronidazol 500 mg, klaritromicin 500 mg dva puta dnevno tijekom 14 dana) ili personaliziranu terapiju u skladu s rezultatima ispitivanja osjetljivosti na antimikrobne lijekove. Status eradikacije procijenjen je 4 tjedna nakon liječenja. REZULTATI Stope eradikacije bile su značajno veće u ciljanoj skupini nego u konkomitantnoj skupini, kako u ITT analizi (70 prema 92,5%, p The primary objective of this study was to compare concomitant quadruple with the tailored, personalized therapy as first-line eradication treatment of H. pylori infection in Split-Dalmatia region of Croatia in which there is a high clarithromycin resistance (>20%). The secondary objective was to compare the compliance and adverse events rate between these two therapeutic regimes. MATERIALS AND METHODS In an open-label,randomised clinical trial, conducted between January 2019 and January 2020, 80 patients with H.pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 gr, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or tailored therapy in accordance with the results of the antimicrobial susceptibility testing. Eradication status was assessed 4 weeks after treatment. RESULTS Eradication rates were significantly higher in tailored group than in concomitant group both in intention-to-treat (70 vs. 92.5%, p |
| Databáze: | OpenAIRE |
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