Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- esomeprazole plus amoxicillin
- Conditions
- H. Pylori Infection
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- eradication rate
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.
Detailed Description
Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies. H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole.
Exclusion Criteria
- •Age \< 18 years old.
- •The time frame was less than 6 months from the previous eradication therapy.
- •The previous eradication therapy included furazolidone.
- •Allergic to the medication.
- •Pregnant or lactating women.
- •Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy.
- •Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.
Arms & Interventions
High-dose dual therapy group
esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group
Intervention: esomeprazole plus amoxicillin
Furazolidone-based quadruple therapy
furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy
Intervention: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole
Outcomes
Primary Outcomes
eradication rate
Time Frame: 42 days
eradication rate of H pylori, presenting with negative results on the 13C-UBT test
Secondary Outcomes
- frequency of the adverse events(42 days)
- compliance rate of the drugs(42 days)