含替戈拉赞的序贯疗法与含埃索美拉唑的序贯疗法根除幽门螺杆菌的疗效比较：韩国高耐药率地区的一项前瞻性、随机、单中心研究。

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.

机构信息

Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.

Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.

出版信息

Helicobacter. 2024 Sep-Oct;29(5):e13143. doi: 10.1111/hel.13143.

DOI:10.1111/hel.13143

PMID:39434634

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.

摘要

背景

钾竞争性酸阻滞剂的治疗已显示出在幽门螺杆菌根除方面的可接受疗效。在像韩国这样克拉霉素耐药率较高的地区，非铋四联疗法等替代组合已显示出良好的效果。本研究比较了新的钾竞争性酸阻滞剂替波拉唑和传统埃索美拉唑序贯疗法的序贯根除治疗结果。

材料和方法

连续招募了幽门螺杆菌（H. pylori）感染患者。患者被分配到埃索美拉唑序贯或替波拉唑序贯治疗组。序贯治疗包括埃索美拉唑（40mg）或替波拉唑（50mg）加阿莫西林（1000mg）每日 2 次，连用 5 天，然后埃索美拉唑（40mg）或替波拉唑（50mg）加克拉霉素（500mg）和甲硝唑（500mg）每日 2 次，连用 5 天。记录根除率、依从性和不良反应。

结果

共有 406 例幽门螺杆菌感染患者入组本试验，并按意向治疗和方案分析。埃索美拉唑序贯治疗的意向治疗和方案根除率为 83.8%（95%置信区间[CI]：78.7-88.9），替波拉唑序贯治疗为 87.1%（95% CI：82.5-91.8），差异无统计学意义（p=0.399）。此外，两组的治疗依从性差异无统计学意义。替波拉唑序贯治疗组恶心的发生率高于埃索美拉唑序贯治疗组（23.3%，27/202）与（14.2%，29/204）；差异有统计学意义（p=0.022）。