Culture-based susceptibility-guided tailored versus empirical concomitant therapy as first-line Helicobacter pylori treatment: A randomized clinical trial.

Autor: Lee JH; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Min BH; Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Gong EJ; Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea., Kim JY; Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea., Na HK; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Ahn JY; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Kim DH; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Choi KD; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Min YW; Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Lee H; Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Lee JH; Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Jung HY; Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Kim JJ; Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jazyk: angličtina
Zdroj: United European gastroenterology journal [United European Gastroenterol J] 2024 Sep; Vol. 12 (7), pp. 941-950. Date of Electronic Publication: 2024 Jun 17.
DOI: 10.1002/ueg2.12609
Abstrakt: Background: With the increasing resistance to antimicrobial agents, susceptibility-guided tailored therapy has been emerging as an ideal strategy for Helicobacter pylori treatment. However, susceptibility-guided tailored therapy requires additional cost, time consumption, and invasive procedure (endoscopy) and its superiority over empirical quadruple therapy as the first-line H. pylori treatment remains unclear.
Aims: To compare the efficacy of culture-based susceptibility-guided tailored versus empirical concomitant therapy as the first-line Helicobacter pylori treatment.
Methods: This open-label, randomized trial was performed in four Korean institutions. A total of 312 Patients with H. pylori-positive culture test and naïve to treatment were randomly assigned in a 3:1 ratio to either culture-based susceptibility-guided tailored therapy (clarithromycin-based or metronidazole-based triple therapy for susceptible strains or bismuth quadruple therapy for dual-resistant strains, n = 234) or empirical concomitant therapy (n = 78) for 10 days. Eradication success was evaluated by 13 C-urea breath test at least 4 weeks after treatment.
Results: Prevalence of dual resistance to both clarithromycin and metronidazole was 8%. H. pylori eradication rates for tailored and concomitant groups were 84.2% and 83.3% by intention-to-treat analysis (p = 0.859), respectively, and 92.9% and 91.5% by per-protocol analysis, respectively (p = 0.702), which were comparable between the two groups. However, eradication rates for dual-resistant strains were significantly higher in the tailored group than in the concomitant group. All adverse events were grade 1 or 2 based on the Common Terminology Criteria for Adverse Events and the incidence was significantly lower in the tailored group. The proportion of patients discontinuing treatment for adverse events was comparable between the two groups (2.1% vs. 2.6%).
Conclusions: The culture-based susceptibility-guided tailored therapy failed to show superiority over the empirical concomitant therapy in terms of eradication rate. Based on these findings, the treatment choice in clinical practice would depend on the background rate of antimicrobial resistance, availability of resources and costs associated with culture and susceptibility testing.
(© 2024 The Author(s). United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)
Databáze: MEDLINE
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