替戈拉生联合米诺环素双联对比含铋四联疗法根除幽门螺杆菌的随机对照研究

Tegoprazan combined with minocycline dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a randomized controlled trial

摘要

目的 探讨替戈拉生米诺环素(TM)双联疗法根除幽门螺杆菌(Hp)的疗效与安全性。方法 本研究为前瞻性随机对照试验。将Hp感染初治患者按1∶1随机分配至TM组和含铋四联疗法(BQT)组, 疗程均为14 d。主要观察指标为Hp根除率, 次要观察指标为不良事件发生率和依从性。采用意向性治疗(ITT)分析和遵循研究方案(PP)分析评价疗效。结果 ITT分析中, TM组根除率为73.1%(76/104), BQT组为72.1%(75/104), 差异无统计学意义(P=0.876); PP分析中, TM组根除率为81.7%(76/93), BQT组为87.2%(75/86), 差异亦无统计学意义(P=0.312)。TM组不良事件总发生率低于BQT组(21.2% vs 43.3%, P<0.001)。两组依从性均为97.1%(P=1.000)。结论 在西安地区Hp感染初治人群中, TM双联与BQT的根除效果总体相近, 且TM组不良事件总数更少、依从性与BQT组相当。然而, 两组绝对根除率均未达到理想的经验治疗水平, 提示TM目前尚不足以作为本地区常规经验性替代方案, 其临床价值仍需在更大样本、多中心及药敏分层研究中进一步验证。

Abstract

Objective To explore the efficacy and safety of the tegoprazan-minocycline (TM) dual therapy in eradicating Helicobacter pylori (Hp). Methods In this prospective randomized controlled trial, initial Hp-infected patients were randomly assigned in a 1∶1 ratio to the TM group and the bismuth-containing quadruple therapy (BQT) group, with a treatment course of 14 d for both groups. The primary endpoint was the eradication rate of Hp, while secondary endpoints included the incidence of adverse events and patient compliance. The therapeutic effect was evaluated by intention-to-treat (ITT) analysis and per-protocol (PP) analysis. Results In the ITT analysis, the eradication rate was 73.1% (76/104) in the TM group and 72.1% (75/104) in the BQT group, and the difference was not statistically significant (P=0.876). In the PP analysis, the eradication rate was 81.7% (76/93) in the TM group and 87.2% (75/86) in the BQT group, and the difference was not statistically significant (P=0.312). The total incidence of adverse events in the TM group was lower than that in the BQT group (21.2% vs 43.3%, P<0.001). The compliance rates of both groups were 97.1% (P=1.000). Conclusion In the treatment-naive population with Hp infection in the Xi'an region, the eradication efficacy of the TM dual therapy is generally similar to that of BQT. Moreover, the TM group experiences fewer overall adverse events and demonstrates compliance comparable to that of the BQT group. However, the absolute eradication rates in both groups do not reach the ideal level for empirical therapy, suggesting that TM is not yet suitable as a routine empirical alternative in this region. Its clinical value still requires further validation in larger-sample, multicenter studies and those stratified by drug susceptibility.

关键词

幽门螺杆菌 / 替戈拉生 / 米诺环素 / 阿莫西林 / 克拉霉素 / 双联疗法 / 耐药性 / 根除治疗

Key words

Helicobacter pylori / tegoprazan / minocycline / amoxicillin / clarithromycin / dual therapy / drug resistance / eradication therapy

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基金资助

国家科技重大专项(2025ZD0545301)

陕西省卫生健康科研创新能力提升计划团队支持项目(2024TD-06)