Comparison of the Dual Therapy of Ilaprazole-Amoxicillin and the Bismuth Quadruple Therapy of Ilaprazole-Amoxicillin-Furazolidone-Bismuth Glycyrrhizinate for Eradication of Helicobacter pylori

Objective: The present study aims to compare the safety and efficacy of an amoxicillin/ilaprazole regimen with a bismuth quadruple regimen as the first-line treatment for eradicating Helicobacter pylori (H. pylori) infection.Methods: This was an open-label, randomized, single-center study involving...

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Main Authors: Min Niu, Yan Zhou, Yunqian Xie, Xue Li, Yonggang Tian, Li Yao, Ximei Li, Hengjun Gao, Feihu Bai
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-04-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2022.771876/full
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author Min Niu
Yan Zhou
Yan Zhou
Yunqian Xie
Xue Li
Yonggang Tian
Li Yao
Ximei Li
Ximei Li
Hengjun Gao
Hengjun Gao
Feihu Bai
Feihu Bai
author_facet Min Niu
Yan Zhou
Yan Zhou
Yunqian Xie
Xue Li
Yonggang Tian
Li Yao
Ximei Li
Ximei Li
Hengjun Gao
Hengjun Gao
Feihu Bai
Feihu Bai
author_sort Min Niu
collection DOAJ
description Objective: The present study aims to compare the safety and efficacy of an amoxicillin/ilaprazole regimen with a bismuth quadruple regimen as the first-line treatment for eradicating Helicobacter pylori (H. pylori) infection.Methods: This was an open-label, randomized, single-center study involving 450 patients with untreated H. pylori infection who were randomly assigned to an Ilaprazole-amoxicillin-furazolidone-bismuth glycyrrhizinate (IAFB) quadruple therapy group for 14 days, a bismuth quadruple therapy group for 10 days, or Ilaprazole-amoxicillin (IA) dual therapy group for 14 days. The 13C urea breath test determined that H. pylori had been eliminated 4–6 weeks after treatment. For patients who failed the first treatment, mucosal tissues (two gastric antrum and one gastric body) were taken under gastroscope for the culture of H. pylori, drug sensitivity, the CYP2C19 gene, and globular degeneration.Results: In the intention-to-treat analysis, the eradication rates of H. pylori in the IAFB-14-day group, the IAFB-10-day group, and the IA-14-day group were 84.0, 79.3, and 88.0%, respectively. In the per-protocol analysis, the eradication rates in the three groups were 94.7, 87.5, and 93.0%, respectively. The resistance rates of patients who failed H. pylori eradication were 68.9% (22/32) for amoxicillin, 90.6% (29/32) for clarithromycin, 68.9% (22/32) for metronidazole, and 87.5% (28/32) for levofloxacin, and the extensive metabolizers of CYP2C19 polymorphism were 59.3% (19/32), the intermediate metabolizers were 34.4% (11/32), and the poor metabolizers were 6.3% (2/32).Conclusion: For newly treated patients with H. pylori infection in China, the efficacy of IA therapy for 14 days was similar to IAFB quadruple therapy for 10 or 14 days with better compliance and less cost. Therefore, these therapies can be considered first-line regimens for empirical treatment.Clinical Trial Registration: [http://www.chictr.org.cn/searchproj.aspx], identifier [ChiCTR2100052308].
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spelling doaj.art-6d2255034b5d4a79b1bd42a48bfc8a2d2022-12-22T02:21:22ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-04-011310.3389/fphar.2022.771876771876Comparison of the Dual Therapy of Ilaprazole-Amoxicillin and the Bismuth Quadruple Therapy of Ilaprazole-Amoxicillin-Furazolidone-Bismuth Glycyrrhizinate for Eradication of Helicobacter pyloriMin Niu0Yan Zhou1Yan Zhou2Yunqian Xie3Xue Li4Yonggang Tian5Li Yao6Ximei Li7Ximei Li8Hengjun Gao9Hengjun Gao10Feihu Bai11Feihu Bai12Department of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, ChinaDepartment of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, ChinaSchool of Clinical Medicine, Ningxia Medical University, Yinchuan, ChinaDepartment of Gastroenterology, The Second Affiliated Hospital of Hai Nan Medical College, Haikou, ChinaDepartment of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, ChinaDepartment of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, ChinaDepartment of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, ChinaDepartment of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, ChinaSchool of Clinical Medicine, Ningxia Medical University, Yinchuan, ChinaTongji Hospital, Institute of Digestive Disease, School of Medicine, Tongji University, Shanghai, ChinaChina Center for Helicobacter Pylori Molecular Medicine, Shanghai, ChinaDepartment of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, ChinaDepartment of Gastroenterology, The Second Affiliated Hospital of Hai Nan Medical College, Haikou, ChinaObjective: The present study aims to compare the safety and efficacy of an amoxicillin/ilaprazole regimen with a bismuth quadruple regimen as the first-line treatment for eradicating Helicobacter pylori (H. pylori) infection.Methods: This was an open-label, randomized, single-center study involving 450 patients with untreated H. pylori infection who were randomly assigned to an Ilaprazole-amoxicillin-furazolidone-bismuth glycyrrhizinate (IAFB) quadruple therapy group for 14 days, a bismuth quadruple therapy group for 10 days, or Ilaprazole-amoxicillin (IA) dual therapy group for 14 days. The 13C urea breath test determined that H. pylori had been eliminated 4–6 weeks after treatment. For patients who failed the first treatment, mucosal tissues (two gastric antrum and one gastric body) were taken under gastroscope for the culture of H. pylori, drug sensitivity, the CYP2C19 gene, and globular degeneration.Results: In the intention-to-treat analysis, the eradication rates of H. pylori in the IAFB-14-day group, the IAFB-10-day group, and the IA-14-day group were 84.0, 79.3, and 88.0%, respectively. In the per-protocol analysis, the eradication rates in the three groups were 94.7, 87.5, and 93.0%, respectively. The resistance rates of patients who failed H. pylori eradication were 68.9% (22/32) for amoxicillin, 90.6% (29/32) for clarithromycin, 68.9% (22/32) for metronidazole, and 87.5% (28/32) for levofloxacin, and the extensive metabolizers of CYP2C19 polymorphism were 59.3% (19/32), the intermediate metabolizers were 34.4% (11/32), and the poor metabolizers were 6.3% (2/32).Conclusion: For newly treated patients with H. pylori infection in China, the efficacy of IA therapy for 14 days was similar to IAFB quadruple therapy for 10 or 14 days with better compliance and less cost. Therefore, these therapies can be considered first-line regimens for empirical treatment.Clinical Trial Registration: [http://www.chictr.org.cn/searchproj.aspx], identifier [ChiCTR2100052308].https://www.frontiersin.org/articles/10.3389/fphar.2022.771876/fullHelicobacter pyloribismuth quadruple therapydouble therapyclinical trialeradication rate
spellingShingle Min Niu
Yan Zhou
Yan Zhou
Yunqian Xie
Xue Li
Yonggang Tian
Li Yao
Ximei Li
Ximei Li
Hengjun Gao
Hengjun Gao
Feihu Bai
Feihu Bai
Comparison of the Dual Therapy of Ilaprazole-Amoxicillin and the Bismuth Quadruple Therapy of Ilaprazole-Amoxicillin-Furazolidone-Bismuth Glycyrrhizinate for Eradication of Helicobacter pylori
Frontiers in Pharmacology
Helicobacter pylori
bismuth quadruple therapy
double therapy
clinical trial
eradication rate
title Comparison of the Dual Therapy of Ilaprazole-Amoxicillin and the Bismuth Quadruple Therapy of Ilaprazole-Amoxicillin-Furazolidone-Bismuth Glycyrrhizinate for Eradication of Helicobacter pylori
title_full Comparison of the Dual Therapy of Ilaprazole-Amoxicillin and the Bismuth Quadruple Therapy of Ilaprazole-Amoxicillin-Furazolidone-Bismuth Glycyrrhizinate for Eradication of Helicobacter pylori
title_fullStr Comparison of the Dual Therapy of Ilaprazole-Amoxicillin and the Bismuth Quadruple Therapy of Ilaprazole-Amoxicillin-Furazolidone-Bismuth Glycyrrhizinate for Eradication of Helicobacter pylori
title_full_unstemmed Comparison of the Dual Therapy of Ilaprazole-Amoxicillin and the Bismuth Quadruple Therapy of Ilaprazole-Amoxicillin-Furazolidone-Bismuth Glycyrrhizinate for Eradication of Helicobacter pylori
title_short Comparison of the Dual Therapy of Ilaprazole-Amoxicillin and the Bismuth Quadruple Therapy of Ilaprazole-Amoxicillin-Furazolidone-Bismuth Glycyrrhizinate for Eradication of Helicobacter pylori
title_sort comparison of the dual therapy of ilaprazole amoxicillin and the bismuth quadruple therapy of ilaprazole amoxicillin furazolidone bismuth glycyrrhizinate for eradication of helicobacter pylori
topic Helicobacter pylori
bismuth quadruple therapy
double therapy
clinical trial
eradication rate
url https://www.frontiersin.org/articles/10.3389/fphar.2022.771876/full
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