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

IF 1.4 Q4 PHARMACOLOGY & PHARMACY Reviews on recent clinical trials Pub Date : 2024-10-30 DOI:10.2174/0115748871306001241017050020
Amir Mohammad Salehi, Alireza Ebrahimi, Maryam Hasanzarrini, Elham Khanlarzadeh, Anvar Bahrami
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Abstract

Background: Helicobacter pylori [H. pylori] infection is the main cause of most PUD; therefore, the eradication of H. pylori 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-Helicobacter pylori regimens in patients with dyspepsia or peptic ulcer disease [PUD].

Objective: The objective of this study was to assess the efficacy of three anti-H Pylori 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 500mg 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 H. Pylori 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 H. Pylori eradication rate, and no superiority was found between OAMB and OAL or OAC therapies.

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

Clinical trial registration number: IRCT201605189014N100.

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两种三联疗法和一种四联疗法[奥美拉唑、阿莫西林、甲硝唑加铋剂]根除消化性溃疡患者幽门螺旋杆菌的疗效:随机临床试验
背景:幽门螺杆菌感染是大多数 PUD 的主要病因;因此,根除幽门螺杆菌对治疗 PUD 极其重要。目的:本研究比较了三种抗幽门螺杆菌治疗方案对消化不良或消化性溃疡病(PUD)患者的疗效:本研究旨在根据C14尿素酶呼气试验[C-UBT]结果、服药依从性和不良反应评估三种抗幽门螺杆菌疗法对患者的疗效:这项随机、开放标签临床试验纳入了136名未接受过治疗的幽门螺杆菌感染患者。患者被随机分为三组。OAC组服用20毫克奥美拉唑胶囊,一天两次;服用两粒500毫克阿莫西林胶囊,一天两次;服用500毫克克拉霉素胶囊,一天两次,共14天。OAL 组服用 20 毫克奥美拉唑胶囊,每天两次;两粒 500 毫克阿莫西林胶囊,每天两次;500 毫克左氧氟沙星胶囊,每天两次,共服用 14 天。OAMB组服用20毫克奥美拉唑胶囊,一天两次;两粒500毫克阿莫西林胶囊,一天两次;甲硝唑500毫克,一天三次;铋剂240毫克,一天两次,共14天。两周后对依从性和药物相关不良反应进行评估。治疗八周后使用 C-UBT 评估幽门螺杆菌根除情况:共有 136 名患者参与了这项研究,根据年龄和性别对他们进行了分组。C-UBT检测结果显示,OAC、OAMB和OAL三药治疗方案的幽门螺杆菌根除率分别为82.2%、91.3%和97.3%。此外,所有治疗方案在患者中的依从性都很高。只有OAC和OAL在幽门螺杆菌根除率上有显著差异,OAMB和OAL或OAC疗法之间没有发现优越性:临床试验注册号:IRCT201605189014N100。
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来源期刊
Reviews on recent clinical trials
Reviews on recent clinical trials PHARMACOLOGY & PHARMACY-
CiteScore
3.10
自引率
5.30%
发文量
44
期刊介绍: Reviews on Recent Clinical Trials publishes frontier reviews on recent clinical trials of major importance. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: important Phase I – IV clinical trial studies, clinical investigations at all stages of development and therapeutics. The journal is essential reading for all researchers and clinicians involved in drug therapy and clinical trials.
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