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Multicenter Study Clinical Trial
Third-line rescue therapy with bismuth-containing quadruple regimen after failure of two treatments (with clarithromycin and levofloxacin) for H. pylori infection.
- J P Gisbert, A Perez-Aisa, L Rodrigo, J Molina-Infante, I Modolell, F Bermejo, M Castro-Fernández, R Antón, B Sacristán, A Cosme, J Barrio, Y Harb, M Gonzalez-Barcenas, M Fernandez-Bermejo, A Algaba, A C Marín, A G McNicholl, and H. pylori Study Group of the Spanish Gastroenterology Association.
- Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IP), Playa de Mojácar 29. Urb. Bonanza., 28669, Boadilla del Monte, Madrid, Spain, gisbert@meditex.es.
- Dig. Dis. Sci. 2014 Feb 1; 59 (2): 383-9.
BackgroundHelicobacter pylori eradication therapy with a proton pump inhibitor (PPI), clarithromycin, and amoxicillin fails in >20 % of cases. A rescue therapy with PPI-amoxicillin-levofloxacin still fails in >20 % of patients.AimTo evaluate the efficacy and tolerability of a bismuth-containing quadruple regimen in patients with two consecutive eradication failures.MethodsProspective multicenter study of patients in whom 1st treatment with PPI-clarithromycin-amoxicillin and 2nd with PPI-amoxicillin-levofloxacin had failed. A 3rd eradication regimen with a 7- to 14-day PPI (standard dose b.i.d.), bismuth subcitrate (120 mg q.i.d. or 240 mg b.i.d.), tetracycline (from 250 mg t.i.d. to 500 mg q.i.d.) and metronidazole (from 250 mg t.i.d. to 500 mg q.i.d.). Eradication was confirmed by (13)C-urea-breath-test 4-8 weeks after therapy. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by means of a questionnaire.ResultsTwo hundred patients (mean age 50 years, 55 % females, 20 % peptic ulcer/80 % uninvestigated-functional dyspepsia) were initially included, and two were lost to follow-up. In all, 97 % of patients complied with the protocol. Per-protocol and intention-to-treat eradication rates were 67 % (95 % CI 60-74 %) and 65 % (58-72 %). Adverse effects were reported in 22 % of patients, the most common being nausea (12 %), abdominal pain (11 %), metallic taste (8.5 %), and diarrhea (8 %), none of them severe.ConclusionA bismuth-containing quadruple regimen is an acceptable third-line strategy and a safe alternative after two previous H. pylori eradication failures with standard clarithromycin- and levofloxacin-containing triple therapies.
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