Comparison of Therapeutic Outcomes Between Concomitant Therapy and Tailored Therapy for Helicobacter pylori: A Multicenter, Prospective, and Randomized Study

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-05-21 DOI:10.1111/hel.70040

Young Sin Cho, Sun Moon Kim, Sun Hyung Kang, Hee Seok Moon, Jae Kyu Sung, Ki Bae Bang, Sung Hyeok Ryou, Ki Bae Kim, Hae Joung Sul, Seung-Woo Lee

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引用次数: 0

Abstract

Background

The increasing trend of clarithromycin resistance in Helicobacter pylori (H. pylori) is the primary cause of failure of standard triple therapy. Concomitant therapy is recommended as an alternative in regions with high rates of clarithromycin resistance. Recently, tailored therapies based on resistance testing have emerged as viable treatment approaches. We aimed to compare the eradication rates and adverse effects of concomitant and tailored therapies.

Materials and Methods

We enrolled 319 patients diagnosed with H. pylori infection using dual-priming oligonucleotide (DPO) polymerase chain reaction (PCR) tests conducted in six hospitals across the Daejeon and Chungcheong regions of Korea. Based on DPO-PCR results, patients were randomly assigned to either the concomitant therapy group (non-bismuth quadruple therapy) or the tailored therapy group (standard triple therapy for clarithromycin-sensitive cases and bismuth quadruple therapy for clarithromycin-resistant cases). Demographics, eradication success rates, adverse effects, and patient compliance were assessed. Data were analyzed using modified intention-to-treat (mITT) and per-protocol (PP) analyses.

Results

The eradication rate was significantly higher in the tailored therapy group than in the concomitant therapy group in PP analysis (92.62% vs. 85.21%, p = 0.026). The severity of adverse effects was significantly greater in the concomitant therapy group than in the tailored therapy group (p = 0.025).

Conclusion

Considering the high eradication success rate and low severity of adverse effects, tailored therapy based on DPO-PCR is preferable to concomitant therapy without resistance testing for the treatment of H. pylori infection.

Trial Registration

Clinical Research Information Service (CRIS): KCT0004162

查看原文本刊更多论文

幽门螺杆菌联合治疗与定制治疗的疗效比较：一项多中心、前瞻性和随机研究

背景幽门螺杆菌（Helicobacter pylori， H. pylori）对克拉霉素耐药性的上升趋势是标准三联治疗失败的主要原因。在克拉霉素耐药率高的地区，建议采用联合治疗。最近，基于耐药性测试的量身定制疗法已成为可行的治疗方法。我们的目的是比较伴随治疗和定制治疗的根除率和不良反应。材料与方法采用双引物寡核苷酸（DPO）聚合酶链反应（PCR）方法，对大田和忠清地区6家医院诊断为幽门螺杆菌感染的319例患者进行了研究。根据DPO-PCR结果，患者被随机分配到合并治疗组（非铋四联治疗）或定制治疗组（克拉霉素敏感病例标准三联治疗，克拉霉素耐药病例铋四联治疗）。对人口统计学、根除成功率、不良反应和患者依从性进行了评估。使用改进的意向治疗（mITT）和方案分析（PP）对数据进行分析。结果在PP分析中，定制治疗组的根除率明显高于伴随治疗组（92.62% vs. 85.21%, p = 0.026）。合并治疗组不良反应严重程度显著高于定制治疗组（p = 0.025）。结论考虑到根除成功率高、不良反应严重程度低，基于DPO-PCR的个体化治疗比不进行耐药检测的联合治疗更适合幽门螺杆菌感染的治疗。临床研究信息服务中心（CRIS）： KCT0004162

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.