[Efficacy of moxifloxacin-based triple therapy to eradicate Helicobacter pylori infection].

ABSTRACT

OBJECTIVE: To evaluated the efficacy of 9-day moxifloxacin-based triple therapy as first- or second-line treatment to eradicate Helicobacter pylori (H. pylori). METHODS: Three hundred and thirteen H. pylori-positive patients without previous treatment (Group A), 51 Hp-positive patients with once-failed treatment (Group B) and 32 with twice-failed treatment (Group C) were recruited to receive moxifloxacin, esomeprazole and tinidazole (MET) for 9 days.H. pylori status was re-assessed 4 weeks after the end of therapy by urea breath test. The eradication rate and its 95% confidence interval (95%CI) were calculated in intention-to-treat (ITT) and per-protocol (PP) analyses respectively. RESULTS: In ITT analysis, the Hp-eradication rate was 89.8% (95%CI 86.7% - 93.0%) in Group A, 81.2% (75.3% - 90.9%) in Group B and 81.2% (66.1% - 92.6%) in Group C, among which no significant difference was observed (chi(2) = 4.339, P > 0.05). However, in PP analysis there was a significant difference among them [93.9% (90.9% - 96.4%) in Group A, 84.8% (79.1% - 93.6%) in Group B and 81.2% (66.1% - 92.6%) in Group C (chi(2) = 9.294, P < 0.01)]. The rates were significantly lower respectively in Group B (chi(2) = 4.885, P < 0.05) and in Group C (chi(2) = 7.023, P < 0.01) than that observed in Group A according to PP analysis. But there was no significant difference between the patients with first-treated active ulceration and with first-treated gastritis (chi(2) = 1.670, P > 0.05 in ITT, or chi(2) = 0.030, P > 0.05 in PP analysis). Eradication rate in patients with 3rd-treated gastritis was lower than that in patients with first-treated gastritis according to PP analysis (chi(2) = 8.076, P < 0.01). The compliance rate was 95.99% in all patients. CONCLUSION: Nine-day moxifloxacin-based triple therapy provides an optimal eradication rate with a good compliance as first-line or second-line eradication of Hp.