Department of Gastroenterology, Xiangya Hospital, Central South University, Changsha, China.
Helicobacter. 2019 Aug;24(4):e12594. doi: 10.1111/hel.12594. Epub 2019 May 22.
Bismuth-containing quadruple therapy (BQT) is a recommended alternative first-line therapy for Helicobacter pylori (H. pylori) infection. We aim to evaluate the efficacy and safety of a new BQT with amoxicillin and doxycycline as a first-line treatment for H. pylori infection in clinical practice.
An open, prospective pilot clinical study including H. pylori-positive outpatients who had never received eradication treatment was carried out. An RADB regimen (10 mg rabeprazole, 1000 mg amoxicillin, 100 mg doxycycline, and 220 mg colloidal bismuth tartrate, all given bid for 14 days) was prescribed by gastroenterologists. H. pylori eradication was confirmed by a C-urea breath test performed at least 6 weeks after the end of treatment. Regimen efficacy was evaluated by per-protocol (PP) and intention-to-treat (ITT) analyses.
One hundred eighteen patients were included in the study. The eradication rate of RADB was 93.8% (105/112; 95% CI 89.2%-98.3%) in PP analysis and 89.8% (106/118; 95% CI 84.3%-95.4%) in ITT analysis. The patient compliance rate was 97.5% (115/118). The adverse event rate was 6.8% (8/118). Adverse events included asthenia, loss of appetite, dry mouth, heartburn, diarrhea, and abdominal pain. All adverse events disappeared after completion of therapy.
Our results suggest that 14-day BQT with amoxicillin and doxycycline can be an effective and safe eradication regimen for first-line therapy against H. pylori infection in clinical practice.
含铋四联疗法（BQT）是治疗幽门螺杆菌（H. pylori）感染的推荐一线替代疗法。我们旨在评估阿莫西林和多西环素新的 BQT 作为 H. pylori 感染的一线治疗在临床实践中的疗效和安全性。
进行了一项开放、前瞻性的试点临床研究，包括从未接受过根除治疗的 H. pylori 阳性门诊患者。胃肠病学家开具 RADB 方案（10mg 雷贝拉唑、1000mg 阿莫西林、100mg 多西环素和 220mg 胶体酒石酸铋，均每日 2 次，共 14 天）。治疗结束至少 6 周后通过 C-尿素呼气试验确认 H. pylori 根除。通过方案（PP）和意向治疗（ITT）分析评估方案疗效。
本研究共纳入 118 例患者。PP 分析中 RADB 的根除率为 93.8%（105/112；95%CI 89.2%-98.3%），ITT 分析中为 89.8%（106/118；95%CI 84.3%-95.4%）。患者的依从率为 97.5%（115/118）。不良反应发生率为 6.8%（8/118）。不良反应包括乏力、食欲不振、口干、烧心、腹泻和腹痛。所有不良反应在治疗完成后均消失。
我们的研究结果表明，阿莫西林和多西环素的 14 天 BQT 可作为治疗 H. pylori 感染的有效且安全的一线治疗方案。
