两种三联疗法方案和一种四联疗法方案[奥美拉唑、阿莫西林、甲硝唑联合铋剂]根除消化性溃疡患者幽门螺杆菌的疗效：一项随机临床试验

The Efficacy of Two Triple Therapy Regimens and One Quadruple Regimen [Omeprazole, Amoxicillin, Metronidazole with Bismuth] in Eradicating in Patients with Peptic Ulcer: A Randomized Clinical Trial.

作者信息

Salehi Amir Mohammad, Ebrahimi Alireza, Hasanzarrini Maryam, Khanlarzadeh Elham, Bahrami Anvar

机构信息

Student Research Committee, Hamadan University of Medical Sciences School of Medicine, Hamadan, Iran.

Clinical Research Development Unit of Shahid Beheshti Hospital, Hamadan University of Medical Science, Hamadan, Iran.

出版信息

Rev Recent Clin Trials. 2025;20(2):160-166. doi: 10.2174/0115748871306001241017050020.

DOI:10.2174/0115748871306001241017050020

PMID:39482907

Abstract

BACKGROUND

() infection is the main cause of most PUD; therefore, the eradication of is extremely important in the treatment of PUD. There are several recommended treatment regimens suggested to eradicate this organism.

AIM

This study compared the efficacy of three anti- regimens in patients with dyspepsia or peptic ulcer disease (PUD).

OBJECTIVE

The objective of this study was to assess the efficacy of three anti- treatments in patients based on C14 urease breath test (C-UBT) results, drug compliance, and adverse effects.

METHODS

This randomized, open-label clinical trial included 136 H. pylori-infected patients without prior treatment. Patients were randomly divided into three groups. The OAC group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and 500 mg Clarithromycin capsules twice a day for 14 days. The OAL group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and Levofloxacin 500 mg capsules twice a day for 14 days. The OAMB group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, Metronidazole 500 mg three times a day, and Bismuth 240 mg twice a day for 14 days. Evaluation for compliance and drug-related adverse effects were assessed at the end of two weeks. H. pylori eradication was evaluated eight weeks after treatment using the C-UBT.

RESULTS

A total of 136 patients participated in this study, and their groups were matched based on age and sex. The results of the C-UBT test showed that the eradication rate of was 82.2%, 91.3%, and 97.3% for the three-drug OAC, OAMB, and OAL treatment regimens, respectively. Moreover, all the regimens showed high compliance among the patients. Only OAC and OAL showed a significant difference in the eradication rate, and no superiority was found between OAMB and OAL or OAC therapies.

CONCLUSION

The regime of OAL achieved a satisfactory rate of infection eradication with good tolerance in patients with PUD, without any acute side effects.

摘要

背景

（）感染是大多数消化性溃疡（PUD）的主要病因；因此，根除（该病原体）在PUD治疗中极为重要。有几种推荐的治疗方案可用于根除这种病原体。

目的

本研究比较了三种抗（该病原体）治疗方案对消化不良或消化性溃疡疾病（PUD）患者的疗效。

目标

本研究的目的是根据碳-14尿素呼气试验（C-UBT）结果、药物依从性和不良反应，评估三种抗（该病原体）治疗方案对患者的疗效。

方法

这项随机、开放标签的临床试验纳入了136例未经治疗的幽门螺杆菌感染患者。患者被随机分为三组。OAC组每天服用两次20毫克奥美拉唑胶囊、两次两粒500毫克阿莫西林胶囊和两次500毫克克拉霉素胶囊，疗程14天。OAL组每天服用两次20毫克奥美拉唑胶囊、两次两粒500毫克阿莫西林胶囊和两次500毫克左氧氟沙星胶囊，疗程14天。OAMB组每天服用两次20毫克奥美拉唑胶囊、两次两粒500毫克阿莫西林胶囊、每天三次500毫克甲硝唑和每天两次240毫克铋剂，疗程14天。在两周结束时评估依从性和药物相关不良反应。治疗八周后使用C-UBT评估幽门螺杆菌根除情况。

结果

共有136例患者参与本研究，各治疗组在年龄和性别方面相匹配。C-UBT检测结果显示，三联药物OAC、OAMB和OAL治疗方案的根除率分别为82.2%、91.3%和97.3%。此外，所有治疗方案在患者中均显示出高依从性。只有OAC和OAL在幽门螺杆菌根除率上存在显著差异，OAMB与OAL或OAC治疗之间未发现优越性。