Journal Article

Randomized Clinical Trial: Esomeprazole, Bismuth, Levofloxacin, and Amoxicillin or Cefuroxime as First-Line Eradication Regimens for Helicobacter pylori Infection

Wang, Li, Song, Zhiqiang, Tian, Xueli, Zhou, Liya, Suo, Baojun, Ding, Yu, Fu, Wei, Xue, Yan

2017

Overview

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.

• Publisher: Springer US,Springer,Springer Nature B.V
• Subject: Adult / Alternative medicine / Amoxicillin / Amoxicillin - therapeutic use / Antacids - adverse effects / Antacids - therapeutic use / Anti-Bacterial Agents - adverse effects / Anti-Bacterial Agents - therapeutic use / Antibacterial agents / Antibiotics / Biochemistry / Bismuth / Bismuth - adverse effects / Bismuth - therapeutic use / Breath Tests / Cefuroxime / Cefuroxime - therapeutic use / Cefuroxime axetil / Clinical trials / Compliance / Drug resistance / Drug resistance in microorganisms / Drug Resistance, Bacterial / Drug Therapy, Combination - adverse effects / Esomeprazole - adverse effects / Esomeprazole - therapeutic use / Female / Gastroenterology / Health aspects / Helicobacter infections / Helicobacter Infections - drug therapy / Helicobacter pylori / Hepatology / Humans / Infection / Infections / Intention to Treat Analysis / Levofloxacin / Levofloxacin - therapeutic use / Male / Medical research / Medication Adherence / Medicine / Medicine & Public Health / Medicine, Experimental / Metronidazole / Microbial Sensitivity Tests / Middle Aged / Oncology / Original Article / Penicillin / Proton pump inhibitors / Proton Pump Inhibitors - adverse effects / Proton Pump Inhibitors - therapeutic use / Risk factors / Safety regulations / Tetracycline / Tetracyclines / Transplant Surgery / Treatment Failure / Urea / Urea - analysis