Efficacy of Tegoprazan-Containing Sequential Eradication Treatment Compared to Esomeprazole-Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2024-10-22 DOI:10.1111/hel.13143

Jung Won Lee, Nayoung Kim, Jongchan Lee, So Young Jo, Dong Ho Lee

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引用次数: 0

Abstract

Background

Treatment with potassium-competitive acid blockers has shown acceptable efficacy in Helicobacter pylori eradication. In regions like Korea, where the clarithromycin resistance rate is high, alternative combinations like non-bismuth quadruple therapies have shown favorable results. This study compared the outcomes of sequential eradication therapy with new potassium-competitive acid blocker tegoprazan and conventional esomeprazole-containing sequential therapy.

Materials and Methods

Patients with Helicobacter pylori (H. pylori) infection were consecutively recruited. Patients were allocated to either an esomeprazole-containing sequential or a tegoprazan-containing sequential therapy group. Sequential therapy comprised esomeprazole (40 mg) or tegoprazan (50 mg) plus amoxicillin (1000 mg) twice daily for the initial 5 days, followed by esomeprazole (40 mg) or tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice daily for the remaining 5 days. Eradication rate, compliance, and adverse events were recorded.

Results

A total of 406 patients with H. pylori infection were enrolled in the trial and analyzed per protocol. Eradication rate by intention-to-treat and per-protocol was 83.8% (95% confidence interval [CI]: 78.7–88.9) for esomeprazole-containing sequential therapy, and 87.1% (95% CI: 82.5–91.8) for tegoprazan-containing sequential therapy, with no statistical significance (p = 0.399). Additionally, there was no statistically significant difference in treatment compliance between the two groups. Nausea was more prevalent (23.3%, 27/202) with sequential tegoprazans than with esomeprazole-containing sequential therapy (14.2%, 29/204; p = 0.022).

Conclusion

Tegoprazan-containing 10-day sequential eradication treatment demonstrated similar eradication efficacy compared to esomeprazole-containing treatment, even in regions with high antimicrobial resistance, such as Korea.

Trial Registration

ClinicalTrials.gov: NCT06382493

Abstract Image

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在抗菌药耐药性较高的韩国地区，含替戈拉赞的幽门螺杆菌序贯根除治疗与含埃索美拉唑的序贯根除治疗的疗效比较：一项前瞻性、随机、单一三级中心研究。

背景：钾竞争性酸阻滞剂对根除幽门螺旋杆菌具有可接受的疗效。在韩国等克拉霉素耐药率较高的地区，非铋剂四联疗法等替代组合疗法显示出良好的效果。本研究比较了新型钾竞争性酸阻滞剂替戈普拉赞和传统的含埃索美拉唑序贯疗法的根除效果：连续招募幽门螺杆菌（H. pylori）感染患者。患者被分配到含有埃索美拉唑的序贯疗法组或含有替戈普拉赞的序贯疗法组。序贯疗法包括埃索美拉唑（40 毫克）或替戈普拉赞（50 毫克）加阿莫西林（1000 毫克），最初 5 天每天两次，随后 5 天埃索美拉唑（40 毫克）或替戈普拉赞（50 毫克）加克拉霉素（500 毫克）和甲硝唑（500 毫克），每天两次。对根除率、依从性和不良反应进行了记录：共有 406 名幽门螺杆菌感染患者参加了试验，并按照方案进行了分析。按意向治疗和按方案计算，含艾司奥美拉唑序贯疗法的根除率为 83.8%（95% 置信区间 [CI]：78.7-88.9），含替戈普拉赞序贯疗法的根除率为 87.1%（95% 置信区间 [CI]：82.5-91.8），无统计学意义（P = 0.399）。此外，两组患者在治疗依从性方面也无显著统计学差异。与含埃索美拉唑的序贯疗法（14.2%，29/204；p = 0.022）相比，使用替戈普拉赞序贯疗法的恶心发生率更高（23.3%，27/202）：结论：与含埃索美拉唑的治疗相比，含替戈拉赞的10天序列根除治疗显示出相似的根除疗效，即使在韩国等抗菌药耐药性较高的地区也是如此：试验注册：ClinicalTrials.gov：试验注册：ClinicalTrials.gov：NCT06382493。

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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.