每日三次四环素与每日四次四环素用于幽门螺杆菌补救治疗的疗效相当：一项多中心、非劣效性、随机对照试验。

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.

机构信息

Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

Laboratory of Translational Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

出版信息

Helicobacter. 2024 May-Jun;29(3):e13102. doi: 10.1111/hel.13102.

DOI:10.1111/hel.13102

PMID:38873902

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 C-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.

摘要

背景

幽门螺杆菌根除治疗中，四环素的最佳剂量仍不明确。频繁的给药需求可能会降低患者的依从性，并增加不良反应的发生率，从而降低治疗效果。本研究旨在比较不同剂量四环素在幽门螺杆菌感染补救治疗中的疗效。

方法

共纳入 406 例需要进行幽门螺杆菌补救治疗的患者。患者被随机分为两组，接受含铋四联疗法治疗，具体方案如下：艾司奥美拉唑 40mg，每日 2 次；枸橼酸铋钾 220mg，每日 2 次；阿莫西林 1000mg，每日 2 次；四环素 500mg，每日 3 次（TET-T 组）或每日 4 次（TET-F 组）。治疗结束至少 6 周后，进行 C-尿素呼气试验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），改良 ITT（MITT）根除率分别为 94.87%（185/195）和 95.31%（183/192）（p=0.841），符合方案集（PP）根除率分别为 94.79%（182/192）和 95.21%（179/188）（p=0.851），TET-T 组的根除率在 ITT、MITT 和 PP 分析中均不劣于 TET-F 组。TET-T 组不良反应发生率明显低于 TET-F 组（23.65%比 33.50%，p=0.028）。两组患者的治疗依从性无显著差异。