Abstract
Background
The eradication of Helicobacter pylori infection remains a challenge, especially in the patients unsuitable to take penicillin. Cephalosporin has the potential to replace amoxicillin for H. pylori eradication.
Aims
To compare the effectiveness, safety, and compliance of amoxicillin- and cefuroxime-containing quadruple regimens in treatment-naïve patients.
Methods
In this open-label randomized control study, 400 patients with H. pylori infection were divided into amoxicillin-containing (esomeprazole 20 mg twice/day, amoxicillin 1000 mg twice/day, levofloxacin 500 mg once/day, and bismuth 220 mg twice/day for 14 days) or cefuroxime-containing (esomeprazole 20 mg twice/day, cefuroxime 500 mg twice/day, levofloxacin 500 mg once/day, and bismuth 220 mg twice/day for 14 days) quadruple therapy groups. The safety and compliance were assessed 1–3 days after eradication. Urea breath test was performed 8–12 weeks after eradication to determine treatment outcome.
Results
The baseline data including antibiotic resistance were well matched between the two groups. The eradication rates between amoxicillin- and cefuroxime-containing quadruple therapy groups were not significantly different [intention-to-treat analysis: 83.5% (95% confidence interval 78.3–88.7%) vs. 81.0% (75.5–86.5%), P = 0.513; modified intention-to-treat analysis: 90.3% (86.0–94.6%) vs. 88.5% (83.9–93.2%), P = 0.586; per-protocol analysis: 91.6% (87.5–95.7%) vs. 89.8% (85.3–94.3%), P = 0.560]. The incidence of adverse effects (18.4 vs. 20.1%, P = 0.678) and compliance (94.7 vs. 94.2%, P = 0.813) were also similar. Variate analyses showed that antibiotic resistance and poor compliance were the independent risk factors for eradication failure.
Conclusions
Esomeprazole, bismuth, levofloxacin, and amoxicillin or cefuroxime achieved similar and relatively satisfactory cure rates, safety, and compliance in first-line H. pylori eradication. Cefuroxime may be a good alternative medicine for eradication instead of amoxicillin for the patients unsuitable to take penicillin.
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Acknowledgments
The study was supported by the National Science & Technology Pillar Program of twelfth Five-Year Plan in China (2012BAI06B02) and the key laboratory for Helicobacter pylori infection and upper gastrointestinal diseases in Beijing (No. BZ0371). The sponsor of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
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WF contributed to the clinical studies and experimental studies. ZS contributed to the study concept, study design, clinical studies, and manuscript writing. LZ contributed to the study concept, study design, clinical studies, and manuscript editing. YX contributed to the clinical studies. YD contributed to the experimental studies. BS contributed to the clinical studies. XT contributed to the clinical studies. LW contributed to the clinical studies. All authors approved the final version of the manuscript.
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Fu, W., Song, Z., Zhou, L. et al. Randomized Clinical Trial: Esomeprazole, Bismuth, Levofloxacin, and Amoxicillin or Cefuroxime as First-Line Eradication Regimens for Helicobacter pylori Infection. Dig Dis Sci 62, 1580–1589 (2017). https://doi.org/10.1007/s10620-017-4564-4
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DOI: https://doi.org/10.1007/s10620-017-4564-4