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基于替戈拉赞的联合疗法与铋剂四联疗法根除幽门螺杆菌的疗效比较:一项真实世界证据

Comparative efficacy of Helicobacter pylori eradication therapy between tegoprazan-based concomitant and bismuth quadruple therapies: A real-world evidence.

作者信息

Jung Yoon Suk, Jung Byung Wook, Park Chan Hyuk

机构信息

Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.

Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.

出版信息

J Gastroenterol Hepatol. 2025 Jan;40(1):159-165. doi: 10.1111/jgh.16798. Epub 2024 Nov 18.

Abstract

BACKGROUND AND AIM

Tegoprazan, a potassium-competitive acid blocker, can be used as a substitute for proton pump inhibitors in Helicobacter pylori eradication therapy; some studies have reported improved efficacy. In Korea, where clarithromycin resistance rates are high, we aimed to compare the efficacies of tegoprazan-based concomitant and bismuth quadruple therapies.

METHODS

We retrospectively analyzed data from patients with H. pylori infection who received either 10-day tegoprazan-based concomitant therapy or 14-day tegoprazan-based bismuth quadruple therapy as first-line treatment. The primary outcome was H. pylori eradication rate, with secondary outcomes including adverse events and insufficient medication rates.

RESULTS

Among the 1082 patients included in the study, 620 and 462 were treated with tegoprazan-based concomitant and bismuth quadruple therapies, respectively. Intention-to-treat analysis demonstrated no difference in eradication rates between the tegoprazan-based concomitant and bismuth quadruple therapy groups (74.7% [95% confidence interval-CI, 71.1-78.0%] vs 74.7% [95% CI, 70.6-78.5%], P = 0.999). Per-protocol analysis also showed similar eradication rates between the two groups (88.0% [95% CI, 85.0-90.6%] vs 89.7% [95% CI, 86.3-92.5%], P = 0.424). The overall adverse event rates (49.6% vs 39.2%, P = 0.001) and insufficient medication rates (4.8% vs 2.4%, P = 0.036) were higher in the bismuth quadruple therapy group than in the concomitant therapy group.

CONCLUSIONS

The eradication rates of tegoprazan-based 10-day concomitant therapy and 14-day bismuth quadruple therapy were comparable. However, because of its shorter treatment duration, better medical adherence, and lower incidence of adverse events, tegoprazan-based concomitant therapy may be preferable in regions with high rates of clarithromycin and metronidazole resistance.

摘要

背景与目的

替戈拉赞是一种钾离子竞争性酸阻滞剂,在幽门螺杆菌根除治疗中可替代质子泵抑制剂;一些研究报告称其疗效有所提高。在克拉霉素耐药率较高的韩国,我们旨在比较基于替戈拉赞的联合疗法和铋剂四联疗法的疗效。

方法

我们回顾性分析了接受10天基于替戈拉赞的联合疗法或14天基于替戈拉赞的铋剂四联疗法作为一线治疗的幽门螺杆菌感染患者的数据。主要结局是幽门螺杆菌根除率,次要结局包括不良事件和用药不足率。

结果

在纳入研究的1082例患者中,分别有620例和462例接受了基于替戈拉赞的联合疗法和铋剂四联疗法。意向性分析表明,基于替戈拉赞的联合疗法组和铋剂四联疗法组的根除率无差异(74.7%[95%置信区间-CI,71.1-78.0%]对74.7%[95%CI,70.6-78.5%],P=0.999)。符合方案分析也显示两组的根除率相似(88.0%[95%CI,85.0-90.6%]对89.7%[95%CI,86.3-92.5%],P=0.424)。铋剂四联疗法组的总体不良事件发生率(49.6%对39.2%,P=0.001)和用药不足率(4.8%对2.4%,P=0.036)高于联合疗法组。

结论

基于替戈拉赞的10天联合疗法和14天铋剂四联疗法的根除率相当。然而,由于其治疗疗程较短、药物依从性更好且不良事件发生率较低,在克拉霉素和甲硝唑耐药率较高的地区,基于替戈拉赞的联合疗法可能更可取。

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