Eradication efficacy of empiric bismuth quadruple therapy containing amoxicillin in the first-line treatment of Helicobacter pylori in Ningxia, China.

BACKGROUND: This study aimed to evaluate the eradication rate and safety of bismuth quadruple therapy containing amoxicillin as a first-line empiric treatment in patients with high resistance to Helicobacter pylori (H. pylori) in China. METHODS: This retrospective study included 874 patients with H. pylori infection who attended the outpatient clinic of the Department of Gastroenterology of the People’s Hospital of Ningxia Hui Autonomous Region from June 2021 to October 2022 and met the criteria for exclusion, including the Esomeprazole-Bismuth-Amoxicillin-Clarithromycin (EBAC) group, the Esomeprazole-Bismuth-Amoxicillin-Levofloxacin (EBAL) group, the Esomeprazole-Bismuth-Amoxicillin-Furazolidone (EBAF) group, the Esomeprazole-Bismuth-Amoxicillin-Tetracycline (EBAT) group, and the duration of treatment was 14 days. Eradication of H. pylori was determined using a repeat 14-carbon urease breath test (14 C-UBT) at weeks 4–6 after the end of treatment. RESULTS: In the intention-to-treat analysis (ITT), the eradication rates of H. pylori in the EBAC, EBAL, EBAF, and EBAT groups were 73.2% (198.5/271), 69.0% ( 184.9/268), 71.8% (109.2/152), and 71.5% (130.2/183), respectively; and in the per-protocol (PP) analysis, the PP analysis eradication rates were 83.2% (203.9/245), 81.2% (193.3/238), 90.0% (124.3/138), and 82.5% (136.1/165), and the differences in the eradication rates of the four groups for ITT and PP analysis were not statistically significant (ITT: P = 0.845; PP: P = 0.470). The incidence rates of adverse event(AE) in the EBAC, EBAL, EBAF, and EBAT groups were 15.0% (40.6/271), 8.0% (21.3/268), 23.2% (35.3/152), and 24.8% (45.1/183), respectively, with statistically significant differences (P < 0.001). CONCLUSION: The eradication rates of four amoxicillin-containing bismuth quadruple therapy regimens in Ningxia were not significantly different. However, the EBAF regimen showed favorable trends in terms of increased eradication rate, better cost-effectiveness, and controllable adverse events, its efficacy and tolerability should be weighed, and the monitoring of drug use should be strengthened.