Abstract

Aim To evaluate the eradication rate, safety, and compliance of minocycline-containing bismuth quadruple regimens in patients with an untreated Helicobacter pylori (H. pylori) infection. Methods A total of 360 patients with an untreated H. pylori infection were enrolled in this study between June 2017 and October 2018. Patients were randomly divided into a minocycline/amoxicillin (RMAB) group, a minocycline/metronidazole (RMMB) group, or an amoxicillin/clarithromycin (RACB) group, and all groups received a combined treatment approach with rabeprazole and bismuth to create a quadruple regimen for 14 days. A 3 to 5-day follow-up was adopted to evaluate the safety and compliance of medications after medicine administration. 13C-urea breath test was performed to confirm the eradication of H. pylori 4-12 weeks after therapy. Results No significant differences were observed at baseline data among the three groups (p > 0.05). Based on the intent-to-treat analysis, the eradication rates of the RMAB group, RMMB group, and RACB control group were 85.7% (102/119), 77.1% (91/118), and 71.7% (86/120), respectively, with significant difference (χ2 = 7.015, p = 0.030). According to per protocol analysis, the eradication rates of RMAB group, RMMB group, and RACB group were 89.5% (102/114), 84.3% (91/108), and 76.8% (86/112), respectively, with statistically significant differences (χ2 = 6.673, p = 0.036). The eradication rates of the RMAB group and RACB group were significantly different (p < 0.05). The overall incidences of adverse events in the three groups were 30.0%, 37.5%, and 40.0%, respectively (p > 0.05). Nausea, epigastric discomfort, and dizziness were more obvious in patients in the RMMB group compared to the other two groups (p < 0.05). Moreover, two patients discontinued due to severe dizziness and nausea in the RMMB group. A taste disorder was more prominent in patients in the RACB group compared to patients in the other two groups (p < 0.05), and one patient discontinued because of the bitterness in the mouth. Soon after discontinuation of the medicine, all adverse events disappeared. Conclusion. The bismuth quadruple regimen using minocycline/amoxicillin showed a better eradication effect with fewer side effects in patients with untreated H. pylori infections. The bismuth quadruple regimen with minocycline/metronidazole had a good eradication effect with more obvious side effects and might be recommended to patients with penicillin allergy.

Highlights

  • Helicobacter pylori (H. pylori) infection is a global disease, which has attracted increased attention due to its correlation with diseases, including peptic ulcer, gastric cancer, mucosaassociated lymphoid tissue (MALT) lymphoma, and other intra- and extragastric diseases [1]

  • RMMB might be recommended to patients with an H. pylori infection who are allergic to penicillin

  • We evaluated the efficacy of the minocycline/amoxicillin bismuth quadruple regimen in patients who were retreated with H. pylori treatment and showed that the eradication rate was 79.4% (ITT analysis) and 84.1% (PP analysis), with a good efficacy and safety profile [15, 16]

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Summary

Introduction

Helicobacter pylori (H. pylori) infection is a global disease, which has attracted increased attention due to its correlation with diseases, including peptic ulcer, gastric cancer, mucosaassociated lymphoid tissue (MALT) lymphoma, and other intra- and extragastric diseases [1]. In recent years, due to the increase in resistance of H. pylori to various antibiotics, it is increasingly challenging to be eradicated. Since the eradication rate of H. pylori by the standard triple regimen is significantly reduced, its empirical applications are no longer recommended [2]. The latest domestic and international consensus [1, 2] recommends using the bismuth quadruple regimen as the first-line treatment. China faces a more serious problem of antibiotic resistance of H. pylori: the primary resistance rates of nitroimidazole, fluoroquinolone, and macrolide antibiotics are all high. Tetracycline and furazolidone show more severe side effects and cannot be obtained in most hospitals in China.

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