Comparação de dois regimes terapêuticos no retratamento da infecção por H. pylori: ensaio clínico aberto, prospectivo e aleatorizado

Abstract

H. pylori treatment failure is a growing problem in daily practice. Aim: toevaluate and compare the efficacy of two new regimes as second-line options in a randomized, prospective study. Methods: Patients previously submitted, without success, to clarithromycin-based regimes were included. 13C-urea breath test (UBT) was performed in all patients. The patients were randomized to receive a combination of rabeprazole 20mg, levofloxacin 500mg and furazolidone 200mg (2 tablets) administered in a single dose for 10 days (RLF) or the association of rabeprazole 20mg, bismuth subcitrate 120mg (2 tablets), doxiciclyn 100 mg and furazolidone 200 mg, twice daily, for 10 days (RBDF). Clinical examination and anew UBT was carried out 60 days after therapy. Results: 60 patients wereincluded (mean age, 46 years, 43% males, 62% peptic ulcer, 38% functional dyspepsia). Two patients were excluded: one due to adverse effects on 4th day of treatment and another due the need to use other antimicrobial before control UBT. Compliance was similar in both groups (90% took correctly all medications). Sideeffects, mostly mild, were also comparable between groups, except diarrhea in group RLF (p=0.0025). Per-protocol cure rates were 80% (95% CI, 65-95%) in the RLF group and 82% (95% CI 67-97%) in the RBDF (p=1.0). Intention-to-treat curerates were, respectively, 77% (95% CI 62-93%) and 83% (95% CI 68-97%) (p=0.750). Conclusions: Both once-daily triple (rabeprazole, levofloxacin, furazolidone) and twice-daily quadruple therapy (rabeprazole, bismuth subcitrate, doxiciclyn and furazolidone) for ten days constitute effective alternatives in patients with clarithromycin-based regime failure.