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Comparison of 10 and 14 days of antofloxacin-based versus 14 days of clarithromycin-based bismuth quadruple therapy for Helicobacter pylori eradication: A randomized trial - 07/01/23

Doi : 10.1016/j.clinre.2022.102052 
Xiao-Jian He a, b, 1, Xiao-Ling Wang a, b, 1, Xiao-Yan Huang a, e, 1, Da-Zhou Li a, b, 1, Gang Liu a, b, , Wen Wang a, b, d, , Dong-Liang Li a, c,
a Fuzong Clinical Medical College of Fujian Medical University, Fuzhou, China, 
b Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China 
c Department of Hepatobiliary Disease, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China 
d Clinical Medical College of Xiamen University, Xiamen, China 
e Department of Oncology, 900TH Hospital of Joint Logistics Support Force, Fuzhou, China 

Corresponding author.

Highlights

Previous study has revealed that 14-days antofloxacin-based bismuth quadruple therapy was safe and effective for H. pylori eradication.
We further confirmed that the H. pylori eradication rate with ANT14 therapy was higher than with ANT10 and CLA14 therapy without significantly increasing the rates of adverse event in the study.
Meanwhile, longer durations have significantly higher eradication rates in patients with antibiotic-resistant strains or antibiotic-susceptible strains.
14 days of antofloxacin-based bismuth quadruple therapy may be a more effective way as the first-line treatment for H. pylori infection.

El texto completo de este artículo está disponible en PDF.

Abstract

Objective

Our team previously reported the use of antofloxacin-based bismuth quadruple therapy for the eradication of Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of 10 and 14 days of antofloxacin-based versus 14 days of clarithromycin-based bismuth quadruple therapy in the first-line treatment for H. pylori infection.

Methods

1174 patients with H. pylori infection were randomized into three groups: 10-days and 14-days antofloxacin (ANT10 and ANT14) groups who received 10 and 14 days of antofloxacin-based bismuth quadruple therapy (colloidal bismuth pectin 200 mg t.i.d., esomeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and antofloxacin 200 mg q.d.), 14-days clarithromycin (CLA14) group who received 14 days of clarithromycin-based bismuth quadruple therapy (colloidal bismuth pectin 200 mg t.i.d., esomeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b.i.d.). Eradication rate, antibiotic resistance and adverse events were analyzed.

Results

The intention-to-treat (ITT) and per-protocol (PP) analyses have showed statistically different eradication rates between ANT14 group and ANT10 group (ITT p = 0.001; PP p < 0.001), but no statistical difference between ANT10 group and CLA14 group (ITT p = 0.340; PP p = 0.092). Treatment regimen, drug resistance and therapy duration were important clinical factors related to H. pylori eradication rates in multivariate logistic analysis. Longer durations had significantly higher eradication rates in patients with antibiotic-resistant strains or antibiotic-susceptible strains. The incidences of nausea and bitter taste were significantly higher in CLA group compared with ANT group (p = 0.002 for nausea; p = 0.002 for bitter taste). The ANT10 and ANT14 group had similar adverse event rates of gastrointestinal reactions.

Conclusion

The study showed that the H. pylori eradication rate with ANT14 therapy was higher than that with ANT10 and CLA14 therapy without significantly increasing the rates of adverse event. 14 days of antofloxacin-based bismuth quadruple therapy may be a more effective way as the first-line treatment for H. pylori infection.

El texto completo de este artículo está disponible en PDF.

Keywords : Antofloxacin, Clarithromycin, H. pylori, Quadruple therapy

Abbreviations : H. pylori, ANT, CLA, AMO, PPI, 13C-UBT, ITT, PP, GI disease, CG, PU


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Vol 47 - N° 1

Artículo 102052- janvier 2023 Regresar al número
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