Abstract
BackgroundAfter the failure of clarithromycin- and bismuth-based quadruple therapy (CBQT), levofloxacin- and bismuth-based quadruple therapy (LBQT) is recommended for Helicobacter pylori eradication. We compared the efficacies of second-line tailored bismuth-based quadruple therapy (TBQT) and empirical LBQT.MethodsPatients with CBQT failure were randomly assigned to receive TBQT or LBQT for 14 days. All patients underwent endoscopy for culture-based antibiotic susceptibility testing. Patients in the TBQT group exhibiting levofloxacin susceptibility were randomized to receive amoxicillin, levofloxacin, esomeprazole, and colloidal bismuth pectin (ALEB) or amoxicillin, furazolidone, esomeprazole, and colloidal bismuth pectin (AFEB) for 14 days; patients with levofloxacin resistance received AFEB.ResultsFrom May 2016 to June 2019, 364 subjects were enrolled. Eradication rates were significantly higher in the TBQT group (n = 182) than in the LBQT group (n = 182) according to both intention-to-treat (ITT) analysis (89.6% vs. 64.8%, P < 0.001) and per protocol (PP) analysis (91.1% vs. 67.8%, P < 0.001). Among patients in the TBQT group with levofloxacin susceptibility, eradication rates were similar in the ALEB (n = 51) and AFEB (n = 50) subgroups according to both the ITT (86.3% vs. 90.0%, P = 0.56) and PP (88.0% vs. 90.0%, P = 0.75) analyses. Isolated clarithromycin and levofloxacin resistance rates were 57.7% and 44.5%, respectively. The total clarithromycin and levofloxacin resistance rate in strains with dual or triple resistance was 35.7%.ConclusionsTBQT was more effective than LBQT as a second-line strategy after CBQT failure. In the absence of antibiotic susceptibility testing, AFEB therapy might be used as a rescue therapy to eradicate H. pylori and avoid levofloxacin resistance.Trial registration: Chinese Clinical Trial Registry (www.chictr.org.cn): ChiCTR1900027743.
Highlights
After the failure of clarithromycin- and bismuth-based quadruple therapy (CBQT), levofloxacin- and bismuth-based quadruple therapy (LBQT) is recommended for Helicobacter pylori eradication
271 did not meet the selection criteria, including 93 patients with prior fluoroquinolone use and 106 patients with a history of more than one anti-H. pylori treatment regimen; the remaining 364 patients were randomly assigned to the tailored bismuth-based quadruple therapy (TBQT) (n = 182) or LBQT group (n = 182)
In the TBQT group, patients without levofloxacin resistance were randomly assigned in a 1:1 ratio to either the ALEB therapy subgroup (n = 51) or the AFEB therapy subgroup (n = 50)
Summary
After the failure of clarithromycin- and bismuth-based quadruple therapy (CBQT), levofloxacin- and bismuth-based quadruple therapy (LBQT) is recommended for Helicobacter pylori eradication. The success rate of standard H. pylori eradication treatment has decreased to 60% due to increasing levels of unrecognized antibiotic resistance, high intragastric bacterial loads before treatment, poor compliance, and the rapid metabolism of proton pump inhibitors (PPIs) [5, 10]. In regions with a high clarithromycin resistance rate (26.12%), the administration of tailored colloidal bismuth pectin-containing quadruple therapy to patients for 14 days has achieved eradication rates of 85.99% and 91.22% according to intention-totreat (ITT) and per protocol (PP) analyses, respectively [12]. The eradication rates of susceptibility-guided therapies have been reported to exceed 90%, according to PP analyses, in regions with high clarithromycin resistance rates (> 15%), even when these therapies were used as rescue treatments [2, 11,12,13,14]
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