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替戈拉赞和雷贝拉唑联合疗法治疗幽门螺杆菌感染的疗效和安全性:真实世界证据。

Efficacy and safety of tegoprazan- and rabeprazole-based concomitant therapies for Helicobacter pylori infection: Real-world evidence.

作者信息

Jung Byung Wook, Park Chan Hyuk, Jung Yoon Suk

机构信息

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

Department of Medicine, Graduate School, Yonsei University College of Medicine, Seoul, Republic of Korea.

出版信息

J Gastroenterol Hepatol. 2024 Nov;39(11):2409-2416. doi: 10.1111/jgh.16719. Epub 2024 Aug 26.

DOI:10.1111/jgh.16719
PMID:39188111
Abstract

BACKGROUND AND AIM

Tegoprazan, a novel potassium-competitive acid blocker, has been approved for Helicobacter pylori eradication in Korea. We compared the efficacy and safety of tegoprazan- and rabeprazole-based concomitant therapies for H. pylori eradication in real-world clinical practice.

METHODS

We retrospectively analyzed data from patients with H. pylori infection treated with tegoprazan- or rabeprazole-based concomitant therapies. The primary endpoint was H. pylori eradication rate. The secondary endpoint was adverse events.

RESULTS

Among the 1474 included patients, 620 and 854 received tegoprazan- and rabeprazole-based concomitant therapies, respectively. Intention-to-treat analysis showed no significant difference in the eradication rates between the tegoprazan- and rabeprazole-based concomitant therapy groups (74.7% [95% confidence interval [CI], 71.1-78.0%] vs 72.7% [95% CI, 69.7-75.6%], P = 0.400). Per-protocol analysis also demonstrated similar eradication rates for the groups (tegoprazan vs rabeprazole: 88.0% [95% CI, 85.0-90.6%] vs 85.9% [95% CI, 83.2-88.3%], P = 0.288). Although the overall adverse event rate did not differ between groups (tegoprazan vs rabeprazole, 39.2% vs 40.6%, P = 0.578), abdominal discomfort was less frequent in the tegoprazan group than in the rabeprazole group (1.3 vs 4.8%, P = 0.001).

CONCLUSIONS

Tegoprazan- and rabeprazole-based concomitant therapies for H. pylori eradication showed comparable efficacy and overall safety. The effect of tegoprazan on dose increases or other regimens, such as bismuth-containing quadruple therapy, should be further evaluated, because the efficacy of tegoprazan-based concomitant therapy may be suboptimal in regions where the clarithromycin resistance rate is high.

摘要

背景与目的

替戈拉赞是一种新型钾离子竞争性酸阻滞剂,已在韩国被批准用于根除幽门螺杆菌。我们在真实世界临床实践中比较了基于替戈拉赞和雷贝拉唑的联合疗法根除幽门螺杆菌的疗效和安全性。

方法

我们回顾性分析了接受基于替戈拉赞或雷贝拉唑联合疗法治疗的幽门螺杆菌感染患者的数据。主要终点是幽门螺杆菌根除率。次要终点是不良事件。

结果

在纳入的1474例患者中,分别有620例和854例接受了基于替戈拉赞和雷贝拉唑的联合疗法。意向性分析显示,基于替戈拉赞和雷贝拉唑的联合治疗组之间的根除率无显著差异(74.7%[95%置信区间[CI],71.1 - 78.0%]对72.7%[95%CI,69.7 - 75.6%],P = 0.400)。符合方案分析也显示两组的根除率相似(替戈拉赞对雷贝拉唑:88.0%[95%CI,85.0 - 90.6%]对85.9%[95%CI,83.2 - 88.3%],P = 0.288)。虽然两组的总体不良事件发生率无差异(替戈拉赞对雷贝拉唑,39.2%对40.6%,P = 0.578),但替戈拉赞组腹部不适的发生率低于雷贝拉唑组(1.3%对4.8%,P = 0.001)。

结论

基于替戈拉赞和雷贝拉唑的联合疗法根除幽门螺杆菌显示出相当的疗效和总体安全性。由于在克拉霉素耐药率高的地区,基于替戈拉赞的联合疗法疗效可能不理想,因此应进一步评估替戈拉赞对剂量增加或其他方案(如含铋四联疗法)的效果。

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引用本文的文献

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Tegoprazan dual and quadruple therapy for eradication: a prospective, randomized controlled trial in Beijing, China.替戈拉赞双联和四联疗法根除幽门螺杆菌:中国北京的一项前瞻性随机对照试验
Front Med (Lausanne). 2025 Aug 12;12:1629567. doi: 10.3389/fmed.2025.1629567. eCollection 2025.
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Comparison of tegoprazan-based and proton pump inhibitor-based regimens for eradication: a meta-analysis and systematic review.基于替戈拉赞和基于质子泵抑制剂的根除方案比较:一项荟萃分析和系统评价。
Front Med (Lausanne). 2025 Jun 18;12:1580203. doi: 10.3389/fmed.2025.1580203. eCollection 2025.