Antibiotic Susceptibility-Guided Concomitant Therapy Regimen with Vonoprazan, High-Dose Amoxicillin, Clarithromycin, and Metronidazole for Helicobacter pylori Eradication as Fourth-Line Regimen: An Interventional Study.

IF 4.1 2区 生物学 Q2 MICROBIOLOGY Microorganisms Pub Date : 2024-10-21 DOI:10.3390/microorganisms12102104
Soichiro Sue, Takeshi Sato, Mao Matsubayashi, Hiroaki Kaneko, Kuniyasu Irie, Shin Maeda
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Abstract

This is the first registered intervention study for vonoprazan, high-dose amoxicillin, clarithromycin, and metronidazole 14-day concomitant therapy based on a susceptibility test of Helicobacter pylori. We conducted this study as a fourth-line rescue regimen in Japan.

Methods: Twenty patients who underwent three rounds of eradication therapies (first- or second-line 7-day triple therapy consisting of amoxicillin and clarithromycin, or metronidazole- and sitafloxacin-based third-line therapy) and had failed eradication based on a urea breath test or fecal antigen test were recruited. All patients underwent endoscopic examination and culture tests before starting eradication therapy. The intervention was concomitant therapy consisting of vonoprazan 20 mg bid, amoxicillin 500 mg qid, clarithromycin 400 mg bid, and metronidazole 250 mg bid for 14 days, which were modified based on the susceptibility test, and the resistant drugs were removed from the regimen. Patients with negative culture results were treated with quadruple therapy. The primary outcome was the eradication rate (UMIN000025765, jRCTs 031180208).

Results: The eradication rate of susceptibility-testing-based fourth-line eradication therapy was 63.2% (95%CI: 38.4-83.7%) in intent-to-treat analysis and 70.6% (95%CI: 44.0-89.7%) in per-protocol analysis. Thirteen patients received quadruple therapy, with eradication rates of 61.5% and 75.0%, respectively. No serious adverse events were reported.

Conclusions: This vonoprazan-based concomitant therapy modified by the susceptibility test is a potential option as fourth-line eradication after first-line clarithromycin-based 7-day triple, second-line metronidazole-based 7-day triple, and third-line sitafloxacin-based 7-day triple therapy failure.

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以抗生素敏感性为指导,将沃诺普拉赞、大剂量阿莫西林、克拉霉素和甲硝唑作为根除幽门螺杆菌的四线治疗方案:一项介入性研究
这是首个基于幽门螺杆菌药敏试验的登记干预研究,研究对象为冯诺普拉赞、大剂量阿莫西林、克拉霉素和甲硝唑 14 天联合疗法。我们在日本进行了这项研究,将其作为四线抢救方案:方法: 我们招募了 20 名接受过三轮根除疗法(由阿莫西林和克拉霉素组成的一线或二线 7 天三联疗法,或基于甲硝唑和西他沙星的三线疗法)且根据尿素呼气试验或粪便抗原检测结果根除失败的患者。所有患者在开始根除治疗前都接受了内窥镜检查和培养试验。根据药敏试验结果对治疗方案进行调整,并将耐药药物从治疗方案中去除,干预措施是同时使用冯诺普拉赞 20 毫克/次、阿莫西林 500 毫克/次、克拉霉素 400 毫克/次和甲硝唑 250 毫克/次,疗程为 14 天。培养结果为阴性的患者接受四联疗法。主要结果是根除率(UMIN000025765,jRCTs 031180208):结果:基于药敏试验的四线根除疗法的根除率在意向治疗分析中为 63.2%(95%CI:38.4-83.7%),在每方案分析中为 70.6%(95%CI:44.0-89.7%)。13名患者接受了四联疗法,根除率分别为61.5%和75.0%。无严重不良事件报告:在一线克拉霉素7天三联疗法、二线甲硝唑7天三联疗法和三线西他沙星7天三联疗法失败后,这种基于药敏试验的vonoprazan联合疗法是一种潜在的四线根除选择。
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来源期刊
Microorganisms
Microorganisms Medicine-Microbiology (medical)
CiteScore
7.40
自引率
6.70%
发文量
2168
审稿时长
20.03 days
期刊介绍: Microorganisms (ISSN 2076-2607) is an international, peer-reviewed open access journal which provides an advanced forum for studies related to prokaryotic and eukaryotic microorganisms, viruses and prions. It publishes reviews, research papers and communications. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. Electronic files and software regarding the full details of the calculation or experimental procedure, if unable to be published in a normal way, can be deposited as supplementary electronic material.
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