Comparison of Helicobacter pylori eradication rates between 7 and 14 days of tailored therapy according to clarithromycin resistance test: A randomized, multicenter, non-inferiority study

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Helicobacter Pub Date : 2024-05-08 DOI:10.1111/hel.13084

Kyoungwon Jung, Sam Ryong Jee, Moon Won Lee, Myeongseok Koh, Su Jin Kim, Jin Lee, Moo In Park

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Abstract

Background

Recently, a simple tailored therapy based on clarithromycin resistance has been implemented as Helicobacter pylori (H. pylori) eradication therapy. Nonetheless, despite the tailored therapy and frequent adverse events, studies on treatment period are lacking. This study aimed to compare the H. pylori eradication rates of 7-day and 14-day tailored therapy regimens according to clarithromycin resistance.

Materials and Methods

This multicenter, prospective, randomized, noninferiority trial enrolled H. pylori-positive patients who were randomly assigned to 7-day and 14-day regimen groups, depending on the presence or absence of clarithromycin resistance by 23S rRNA gene point mutations. Standard triple therapy (STT) (20 mg rabeprazole, 1 g amoxicillin, and 500 mg clarithromycin twice daily) or bismuth quadruple therapy (BQT) (20 mg rabeprazole twice daily, 500 mg metronidazole thrice daily, 120 mg bismuth four times daily, and 500 mg tetracycline four times daily) was assigned by clarithromycin resistance. Eradication rates and adverse events were evaluated.

Results

A total of 314 and 278 patients were included in the intention-to-treat (ITT) and per-protocol (PP) analyses, respectively; however, 31 patients were lost to follow-up, whereas five patients violated the protocol. Both the 7-day and 14-day regimens showed similar eradication rates in the ITT (7-day vs. 14-day: 78.3% vs. 78.3%, p > 0.99) and PP (87.9% vs. 89.1%, p = 0.851) analyses. Non-inferiority was confirmed (p < 0.025). A subgroup analysis according to clarithromycin resistance (clarithromycin resistance rate: 28.7%) revealed no significant difference in eradication rates between the 7-day and 14-day STT (90.0% vs. 90.1%, p > 0.99) and BQT (82.5% vs. 86.5%, p = 0.757). Furthermore, adverse events did not significantly differ between the two groups.

Conclusions

The 7-day triple and quadruple therapy according to clarithromycin resistance showed similar eradication rates, as compared to the 14-day therapy.

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根据克拉霉素耐药性测试结果比较 7 天和 14 天定制疗法的幽门螺杆菌根除率：一项随机、多中心、非劣效性研究。

背景：最近，一种基于克拉霉素耐药性的简单定制疗法已被作为根除幽门螺旋杆菌（H. pylori）的疗法。然而，尽管这种定制疗法不良反应频发，但却缺乏对治疗周期的研究。本研究旨在根据克拉霉素耐药性，比较7天和14天定制治疗方案的幽门螺杆菌根除率：这项多中心、前瞻性、随机、非劣效性试验招募了幽门螺杆菌阳性患者，根据他们是否因 23S rRNA 基因点突变而对克拉霉素产生耐药性，将他们随机分配到 7 天和 14 天治疗方案组。根据克拉霉素耐药性分配标准三联疗法（STT）（20 毫克雷贝拉唑、1 克阿莫西林和 500 毫克克拉霉素，每天两次）或铋剂四联疗法（BQT）（20 毫克雷贝拉唑，每天两次；500 毫克甲硝唑，每天三次；120 毫克铋剂，每天四次；500 毫克四环素，每天四次）。对根除率和不良反应进行了评估：共有314名和278名患者分别被纳入意向治疗（ITT）和按协议（PP）分析；但有31名患者失去了随访机会，另有5名患者违反了协议。在 ITT（7 天与 14 天：78.3% 与 78.3%，p > 0.99）和 PP（87.9% 与 89.1%，p = 0.851）分析中，7 天和 14 天疗法的根除率相似。非劣效性得到证实（p 0.99），BQT（82.5% 对 86.5%，p = 0.757）。此外，两组的不良反应没有明显差异：结论：与 14 天疗法相比，根据克拉霉素耐药性采用的 7 天三联和四联疗法显示出相似的根除率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.