Different Doses of Ilaprazole for Dual Therapy Versus Bismuth-Quadruple Therapy for Helicobacter pylori Infection: A Three-Arm, Randomized Clinical Trial

IF 4.6 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-11-10 DOI:10.1111/hel.70086

Qiang Han, Ming Zu, Shiyu Du, Yinyan Guo, Yuanmin Zhu, Yali Wang, Xiuqing Liu, Hongwei Guo, Yanli Cheng, Shigang Ding

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Abstract

Background

Current Helicobacter pylori (H. pylori) eradication regimens—standard triple, bismuth-containing quadruple, and non-bismuth quadruple therapies—still face issues such as adverse effects and poor compliance. High-dose dual therapy, with its simplicity, lower pill burden, and comparable efficacy, has recently gained attention. However, existing studies are largely single-center with small sample sizes and lack sufficient evidence-based support. This study aims to further evaluate the efficacy and safety of ilaprazole-based dual and quadruple therapies for H. pylori eradication.

Methods

This was a prospective, multicenter, randomized controlled, non-inferiority clinical trial conducted at five hospitals from January to November 2023. A total of 480 patients were randomly assigned to one of three treatment groups for 14 days: Group A (ilaprazole 5 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all administered twice daily), Group B (ilaprazole 5 mg twice daily and amoxicillin 1 g three times daily), and Group C (ilaprazole 10 mg twice daily and amoxicillin 1 g three times daily). The eradication rates, adverse events, and patient compliance were recorded.

Results

The eradication rates of H. pylori in Groups A, B, and C were 76.9%, 88.1%, and 88.7% (p = 0.004) by intention-to-treat analysis, respectively, and 78.3%, 90.4%, and 91.0% (p = 0.001) using modified intention-to-treat analysis, and 81.8%, 92.1%, 92.2% (p = 0.005) by per-protocol analysis. The adverse event rates were 28.0%, 10.2%, 10.8% in Groups A, B, and C, respectively (p < 0.001), while patient compliance rates were 91.1%, 98.1%, 98.7%, respectively (p = 0.001). Sex, smoking history, alcohol intake, and sharing tableware or cups did not affect the efficacy of the three treatment regimens.

Conclusions

The standard- or high-dose dual therapy with ilaprazole demonstrated superior efficacy, safety, and patient compliance compared to quadruple therapy. No significant differences were observed between these dual therapies, which are expected to become promising alternatives for the primary treatment of H. pylori infection.

Trial Registration

Chinese Clinical Trial Registry: ChiCTR2400086862

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不同剂量伊拉唑双重治疗与铋四联治疗幽门螺杆菌感染：一项三组随机临床试验

背景：目前的幽门螺杆菌根除方案-标准三联、含铋四联和非铋四联治疗-仍然面临不良反应和依从性差等问题。高剂量双重治疗因其简单、药丸负担低和疗效相当而最近受到关注。然而，现有的研究大多是单中心的，样本量小，缺乏足够的证据支持。本研究旨在进一步评价以伊拉唑为基础的双重和四联疗法根除幽门螺杆菌的有效性和安全性。方法：这是一项前瞻性、多中心、随机对照、非劣效性临床试验，于2023年1月至11月在五家医院进行。共有480名患者被随机分配到三个治疗组中的一个，为期14天：A组（伊拉拉唑5 mg，阿莫西林1 g，克拉霉素500 mg，柠檬酸铋钾220 mg，每天两次），B组（伊拉拉唑5 mg，每天两次，阿莫西林1 g，每天3次），C组（伊拉拉唑10 mg，每天两次，阿莫西林1 g，每天3次）。记录根除率、不良事件和患者依从性。结果：A、B、C组幽门螺杆菌根除率意向治疗分析分别为76.9%、88.1%、88.7% (p = 0.004)，改进意向治疗分析分别为78.3%、90.4%、91.0% (p = 0.001)，按方案分析分别为81.8%、92.1%、92.2% （p = 0.005）。A、B、C组的不良事件发生率分别为28.0%、10.2%、10.8% (p)。结论：与四联治疗相比，标准剂量或高剂量伊拉唑双药治疗的疗效、安全性和患者依从性均优于四联治疗。这些双重疗法之间没有观察到显着差异，这有望成为幽门螺杆菌感染的主要治疗有希望的替代方案。试验注册：中国临床试验注册中心：ChiCTR2400086862。

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.