Enzo Ierardi1, Antonio Giangaspero2, Giuseppe Losurdo2, Floriana Giorgio2, Annacinzia Amoruso2, Vincenzo De Francesco3, Alfredo Di Leo2, Mariabeatrice Principi2. 1. Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. ierardi. enzo@gmail.com. 2. Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. 3. Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari; Ospedali Riuniti, Gastroenterology Unit, Foggia, Italy.
Abstract
BACKGROUND AND AIMS: Antibiotic resistance is the main reason for failure of Helicobacter pylori (H. pylori) treatment. Currently, guidelines recommend a treatment guided by antimicrobial susceptibility testing after two failures. However, microbial culture is not feasible everywhere, and the limited number of effective antibiotics against the bacterium narrows the options; thus a rescue therapy combining antibiotics with a low resistance may be fitting. METHODS:Patients who have failed a first-line treatment (either prolonged triple or sequential regimens) and, successively, alevofloxacin-based triple therapy were considered for the study. Subjects underwent urea breath test (UBT), stool antigen test (ST) and endoscopy/histology to confirm the diagnosis. Cytopenia and impaired liver and kidney function were exclusion criteria. Fifty-four subjects were randomized 1:1 to two regimens: RMB Rabeprazole/Rifabutin/Minocycline/Bismuth sub-citrate or MTB Rabeprazole/Tinidazole/Minocycline/Bismuth sub-citrate both for 10 days. The results were checked 6 weeks after the end of therapy with ST/UBT plus endoscopy when indicated. RESULTS: RMB eradicated the bacterium in 21 patients. Two subjects dropped out. The eradication rate was 77.7% (CI 62.0-93.4%) at intention-to-treat and 84.0% (CI 69.6-98.4%) at per-protocol analysis. MTB was successful in 14 patients (51.9%, CI 33.1-70.7%). No patient withdrew from the treatment for adverse events. Drug-related side effects were reported only in 3 subjects, but in all cases the treatment was carried on. CONCLUSIONS: The association minocycline/rifabutin seems to have a synergic effect and a good therapeutic outcome in patients who have failed at least two previous regimens, although a trial on a large population is needed.
RCT Entities:
BACKGROUND AND AIMS: Antibiotic resistance is the main reason for failure of Helicobacter pylori (H. pylori) treatment. Currently, guidelines recommend a treatment guided by antimicrobial susceptibility testing after two failures. However, microbial culture is not feasible everywhere, and the limited number of effective antibiotics against the bacterium narrows the options; thus a rescue therapy combining antibiotics with a low resistance may be fitting. METHODS:Patients who have failed a first-line treatment (either prolonged triple or sequential regimens) and, successively, a levofloxacin-based triple therapy were considered for the study. Subjects underwent urea breath test (UBT), stool antigen test (ST) and endoscopy/histology to confirm the diagnosis. Cytopenia and impaired liver and kidney function were exclusion criteria. Fifty-four subjects were randomized 1:1 to two regimens: RMBRabeprazole/Rifabutin/Minocycline/Bismuth sub-citrate or MTB Rabeprazole/Tinidazole/Minocycline/Bismuth sub-citrate both for 10 days. The results were checked 6 weeks after the end of therapy with ST/UBT plus endoscopy when indicated. RESULTS:RMB eradicated the bacterium in 21 patients. Two subjects dropped out. The eradication rate was 77.7% (CI 62.0-93.4%) at intention-to-treat and 84.0% (CI 69.6-98.4%) at per-protocol analysis. MTB was successful in 14 patients (51.9%, CI 33.1-70.7%). No patient withdrew from the treatment for adverse events. Drug-related side effects were reported only in 3 subjects, but in all cases the treatment was carried on. CONCLUSIONS: The association minocycline/rifabutin seems to have a synergic effect and a good therapeutic outcome in patients who have failed at least two previous regimens, although a trial on a large population is needed.
Authors: Giuseppe Losurdo; Andrea Iannone; Floriana Giorgio; Mariabeatrice Principi; Alfredo Di Leo; Enzo Ierardi Journal: United European Gastroenterol J Date: 2015-12-15 Impact factor: 4.623