Gastroenterology Department, Hospital da Senhora da Oliveira, Guimarães, Portugal.
Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal.
Helicobacter. 2023 Jun;28(3):e12962. doi: 10.1111/hel.12962. Epub 2023 Feb 24.
Currently, bismuth quadruple therapy (BQT) is indicated as a first-line treatment for Helicobacter pylori eradication in areas with high dual metronidazole and clarithromycin resistance, with its use being limited by its low tolerability and significant cost. A novel regimen with high-dose amoxicillin dual therapy (HDADT) has emerged as an alternative. The aim of this study was to compare the results of these two treatments on HP eradication.
Prospective randomized study including 100 consecutive patients undergoing H. pylori eradication. Each patient was randomized (in a 1:1 ratio) to one group of treatment: BQT (bismuth 140 mg + metronidazole 125 mg + tetracycline 125 mg, four times a day, for 10 days) or HDADT (amoxicillin 1000 mg alternating with amoxicillin 500 mg, four times a day, for 14 days), both associated with esomeprazole 40 mg twice a day. The primary aim was to compare treatments' efficacies. Secondary aims were to assess symptoms persistence and tolerability.
A total of 100 patients were included, 54% women, with a mean age of 55 ± 14 years. From these, five were lost to follow-up. Effective eradication proven by negative stool antigen test was significantly higher in patients randomized to HDADT when compared to BQT for both intention-to-treat (ITT) (96.2% vs. 81.4%; p = .022) and per-protocol (PP) (95.9% vs. 81%; p = .025) analysis. These differences were even more pronounced when only considering second line treatment (100% vs. 62.5%; p = .028). Side effects did not differ significantly between BQT and HDADT groups for both ITT (7.0% vs. 2.0%; p = .254) and PP (4.8% vs. 0%; p = .210) analysis.
When compared to BQT, treatment with HDADT presented higher and near 100% efficacy in eradicating H. pylori, without differences in reported side effects or compliance. This treatment represents an important alternative for populations with increasing incidences of resistance to the currently recommended antibiotic regimens.
目前，铋四联疗法（BQT）被推荐为高甲硝唑和克拉霉素耐药地区幽门螺杆菌根除的一线治疗方法，但由于其耐受性低和成本高，其应用受到限制。一种新的高剂量阿莫西林双联疗法（HDADT）已成为一种替代方案。本研究旨在比较这两种治疗方法对 HP 根除的结果。
这是一项包括 100 例连续接受幽门螺杆菌根除治疗的患者的前瞻性随机研究。每位患者按 1:1 的比例随机分为两组治疗：BQT（枸橼酸铋 140mg+甲硝唑 125mg+四环素 125mg，每日 4 次，共 10 天）或 HDADT（阿莫西林 1000mg 与阿莫西林 500mg 交替使用，每日 4 次，共 14 天），均与埃索美拉唑 40mg 每日 2 次联合使用。主要目的是比较两种治疗方法的疗效。次要目的是评估症状持续时间和耐受性。
共纳入 100 例患者，其中 54%为女性，平均年龄为 55±14 岁。其中 5 例失访。通过阴性粪便抗原检测证实的有效根除率在随机接受 HDADT 治疗的患者中明显高于接受 BQT 治疗的患者，无论是意向治疗（ITT）（96.2%比 81.4%；p=0.022）还是按方案分析（PP）（95.9%比 81%；p=0.025）。当仅考虑二线治疗时，这些差异更为明显（100%比 62.5%；p=0.028）。ITT（7.0%比 2.0%；p=0.254）和 PP（4.8%比 0%；p=0.210）分析中，BQT 和 HDADT 两组的不良反应发生率无显著差异。
与 BQT 相比，HDADT 治疗幽门螺杆菌的根除率更高，接近 100%，且不良反应和依从性无差异。这种治疗方法代表了目前推荐的抗生素方案耐药率不断上升的人群的一个重要替代方案。
