Efficacy of Tetracycline Three Times Daily was Comparable to That of Four Times Daily for Helicobacter pylori Rescue Treatment: A Multicenter, Noninferiority, Randomized Controlled Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2024-06-14 DOI:10.1111/hel.13102

Zhongxue Han, Qiumei Zhang, Iqtida Ahmed Mirza, Yuming Ding, Xueping Nan, Qing Zhao, Ruili Li, Lidong Xu, Ning Zhang, Miao Duan, Shuyan Zeng, Qingzhou Kong, Wenlin Zhang, Hui Wang, Xiaoqi Wu, Xiuli Zuo, Yanqing Li, Yueyue Li

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Abstract

Background

The optimal dosage of tetracycline remains unclear for Helicobacter pylori eradication. Frequent dosing requirements may decrease patient adherence and increase the incidence of adverse events, potentially reducing treatment efficacy. This study aimed to compare the efficacy of different tetracycline dosages in rescue treatment for H. pylori infection.

Methods

A total of 406 patients needing H. pylori rescue treatment were enrolled. Patients were randomized into two groups and received bismuth-containing quadruple therapies as follows: esomeprazole 40 mg twice daily, bismuth 220 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg either three (TET-T group) or four (TET-F group) times daily. At least 6 weeks after treatment completion, a ¹³C-urea breath test was performed to evaluate H. pylori eradication.

Results

The intention-to-treat (ITT) eradication rates were 91.13% (185/203) and 90.15% (183/203) (p = 0.733), the modified ITT (MITT) eradication rates were 94.87% (185/195) and 95.31% (183/192) (p = 0.841), and the per-protocol (PP) eradication rates were 94.79% (182/192) and 95.21% (179/188) (p = 0.851) in the TET-T group and TET-F group, respectively. The eradication rates for the TET-T group were not inferior to those of the TET-F group in ITT, MITT, and PP analyses. The incidence of adverse effects was significantly lower in the TET-T group than in the TET-F group (23.65% vs. 33.50%, p = 0.028). No significant differences were observed in treatment compliance between the groups.

Conclusions

The dose of tetracycline administered three times daily showed comparable efficacy to that administered four times daily, while significantly reducing the incidence of adverse events. The combination of tetracycline and amoxicillin in bismuth-containing quadruple therapy achieved a high eradication rate in H. pylori rescue treatment.

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每日三次四环素治疗幽门螺旋杆菌的疗效与每日四次四环素治疗幽门螺旋杆菌的疗效相当：一项多中心、非劣效性、随机对照试验。

背景：四环素根除幽门螺旋杆菌的最佳剂量仍不明确。频繁给药可能会降低患者的依从性，增加不良反应的发生率，从而可能降低疗效。本研究旨在比较不同剂量的四环素在幽门螺杆菌感染抢救治疗中的疗效：方法：共招募了 406 名需要接受幽门螺杆菌抢救治疗的患者。患者被随机分为两组，接受以下含铋四联疗法：埃索美拉唑 40 毫克，每天两次；铋 220 毫克，每天两次；阿莫西林 1000 毫克，每天两次；四环素 500 毫克，每天三次（TET-T 组）或四次（TET-F 组）。治疗结束至少6周后，进行13C-尿素呼气试验，以评估幽门螺杆菌根除情况：结果：意向治疗（ITT）根除率分别为 91.13%（185/203）和 90.15%（183/203）（P = 0.733），修正 ITT（MITT）根除率分别为 94.87%（185/195）和 95.31%（183/192）（P = 0.733）。TET-T组和TET-F组的根除率分别为94.79%（182/192）和95.21%（179/188）（P = 0.851）。在 ITT、MITT 和 PP 分析中，TET-T 组的根除率并不比 TET-F 组低。TET-T组的不良反应发生率明显低于TET-F组（23.65% vs. 33.50%，P = 0.028）。两组的治疗依从性无明显差异：结论：每天服用三次四环素的疗效与每天服用四次四环素的疗效相当，同时显著降低了不良反应的发生率。四环素和阿莫西林联合使用含铋四联疗法在幽门螺杆菌抢救治疗中达到了较高的根除率。

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.