Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-04-24 DOI:10.1111/hel.70036

Xue-Ping Nan, Hong-Yu Zhao, Lei-Na Guo, Rui-Qi Zheng, Xi-Lan Wang, Yong-Fen Wang, Yan-Hua Su, Wen-Rong Geng, Xiu-Lan Liu, Hai-Miao Xu, Ke-Lun Zhou, Yu-Ting Guo, Jian-Hua Cao, Zhong-Xue Han, Qing-Zhou Kong, Xiu-Li Zuo, Yan-Qing Li, Yue-Yue Li

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引用次数: 0

Abstract

Background and Aims

Tegoprazan, a new class of drugs, is a potassium-competitive acid blocker (P-CAB) that inhibits gastric H+/K+-ATPase through a different mechanism than proton pump inhibitor. Tetracycline also has anti-Helicobacter pylori properties. However, only a few randomized controlled trials (RCTs) have investigated the efficacy of tegoprazan and tetracycline-containing quadruple therapy (TTQT) for treating H. pylori infections, which this RCT explored.

Methods

This multicenter RCT included treatment-naïve adults with H. pylori infection who received 7 or 14 days of TTQT (50-mg tegoprazan, 220-mg bismuth potassium citrate, and 1000-mg amoxicillin twice daily with 500-mg tetracycline four times daily). The primary outcome was the eradication rate; secondary endpoints included the incidence of adverse events, treatment compliance, and regimen costs.

Results

The study included 258 patients. The eradication rates in the 7- and 14-day groups were 90.70% (117/129, 95% confidence interval [CI]: 83.98%–94.89%) and 91.47% (118/129, 95% CI: 84.90%–95.45%), respectively, in the intention-to-treat analysis (difference: −0.78%; −7.01%–8.58%; noninferiority p < 0.001); 92.86% (117/126, 95% CI: 86.50%–96.48%) and 93.65% (118/126, 95% CI: 87.47%–97.02%), respectively, in the modified intention-to-treat analysis (difference: 0.79%; 95% CI: −6.36%–7.99%; noninferiority p < 0.001); and 94.35% (117/124, 95% CI: 88.29%–97.50%) and 95.12% (117/123, 95% CI: 89.24%–98.00%), respectively, in the per-protocol analysis (difference: −0.77%; 95% CI: −5.91%–7.48%; noninferiority p < 0.001). Significantly fewer adverse events occurred in the 7-day group than in the 14-day group (22.48% vs. 35.67%, p = 0.020). Treatment compliance did not differ between the two groups.

Conclusions

The 7- and 14-day TTQT efficacies for the first-line treatment of H. pylori infection were comparable, and fewer adverse effects occurred in the 7-day group. This trial has been registered at Clinical Trials.gov (NCT05997433).

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背景和目的 Tegoprazan 是一种新型药物，属于钾竞争性胃酸阻滞剂 (P-CAB)，通过与质子泵抑制剂不同的机制抑制胃 H+/K+-ATP 酶。四环素还具有抗幽门螺旋杆菌的作用。然而，只有少数随机对照试验（RCT）研究了替高普拉赞和含四环素的四联疗法（TTQT）治疗幽门螺杆菌感染的疗效，本研究对此进行了探讨。方法这项多中心 RCT 研究纳入了对幽门螺杆菌感染治疗不敏感的成人患者，他们接受了 7 天或 14 天的 TTQT 治疗（50 毫克替戈普拉赞、220 毫克枸橼酸铋钾、1000 毫克阿莫西林，每天两次，加上 500 毫克四环素，每天四次）。主要结果是根除率；次要终点包括不良反应发生率、治疗依从性和治疗费用。结果该研究共纳入 258 名患者。7天组和14天组的根除率分别为90.70%（117/129，95% 置信区间[CI]：83.98%-94.89%）和91.47%（118/129，95% 置信区间[CI]：84.90%-95.45%）。在意向治疗分析中，分别为92.86%（117/126，95% CI：86.50%-96.48%）和93.65%（118/126，95% CI：87.在修正的意向治疗分析中，分别为92.86%（117/126，95% CI：86.50%-96.48%）和93.65%（118/126，95% CI：87.47%-97.02%）（差异：0.79%；95% CI：-6.36%-7.99%；非劣效P< 0.001）；以及94.35%（117/124，95% CI：88.29%-97.50%）和95.12%（117/123，95% CI：89.24%-98.00%）（差异：-0.77%；95% CI：-5.91%-7.48%；非劣效性 p <；0.001）。7 天组发生的不良事件明显少于 14 天组（22.48% 对 35.67%，P = 0.020）。两组的治疗依从性没有差异。结论 7天和14天TTQT一线治疗幽门螺杆菌感染的疗效相当，7天组发生的不良反应较少。该试验已在 Clinical Trials.gov (NCT05997433) 上注册。

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.