PDF(Pubmed)
Abstract：
Background and Objective: Rescue Helicobacter pylori eradication can be challenging. Rifabutin (RBT) demonstrates high activity against Helicobacter pylori and is incorporated into various rescue eradication regimens. This exploratory study was performed to evaluate the efficacy and safety of a rescue regimen comprising RBT, metronidazole (MNZ), and vonoprazan (VPZ). Methods: This prospective, single-center, single-arm, interventional study was performed in Japan. Eligible patients were those who underwent failed primary eradication treatment (7-day treatment with three drugs: VPZ or a proton pump inhibitor [PPI], amoxicillin [AMPC], and clarithromycin) and secondary eradication treatment (7-day treatment with three drugs: VPZ or a PPI, AMPC, and MNZ) and those who were unable to receive first- and second-line therapy because of penicillin allergy. Twenty Helicobacter pylori-positive patients were treated with RBT (150 mg twice daily), MNZ (250 mg twice daily), and VPZ (20 mg twice daily) for 10 days (RBT-MNZ-VPZ therapy). Eradication success was evaluated using the urea breath test. Drug susceptibility test results were available in 16 patients. This study is registered in the Japan Registry of Clinical Trials (jRCT031220504). Results: The intention-to-treat (ITT) and per-protocol (PP) eradication rates of RBT-MNZ-VPZ therapy were 70% (90% confidence interval [CI]: 49.2%-86.0%) and 72.2% (95% CI: 50.2%-88.4%), respectively. In the MNZ-susceptible subgroup, the ITT (n = 8) and PP (n = 7) eradication rates were 100% (90% CI: 68.8%-100%) and 100% (90% CI: 65.2%-100%). In the MNZ-resistant subgroup, the ITT (n = 8) and PP (n = 7) eradication rates were both 62.5% (90% CI: 28.9%-88.9%). All infections were RBT-susceptible. Conclusions: These findings suggest that RBT-MNZ-VPZ therapy may be a promising rescue regimen, especially in MNZ- and RBT-susceptible infections or patients with penicillin allergy.
摘要：
背景和目的：挽救根除幽门螺杆菌可能具有挑战性。利福布汀（RBT）对幽门螺杆菌具有高活性，并被纳入各种挽救性根除方案。进行这项探索性研究是为了评估包括RBT，甲硝唑（MNZ），和vonoprazan（VPZ）。方法：本前瞻性，单中心,单臂,介入研究在日本进行。符合条件的患者是接受了失败的主要根除治疗的患者（使用三种药物进行7天治疗：VPZ或质子泵抑制剂[PPI]，阿莫西林[AMPC]，和克拉霉素）和继发性根除治疗（使用三种药物进行7天治疗：VPZ或PPI，AMPC,和MNZ）以及由于青霉素过敏而无法接受一线和二线治疗的人。20例幽门螺杆菌阳性患者接受RBT治疗（150毫克，每日两次），MNZ（250毫克，每日两次），和VPZ(20mg,每日两次)持续10天(RBT-MNZ-VPZ治疗)。使用尿素呼气试验评估根除成功。16例患者均有药敏试验结果。本研究在日本临床试验注册中心(jRCT031220504)注册。结果：RBT-MNZ-VPZ治疗的意向治疗（ITT）和符合方案（PP）根除率分别为70％（90％置信区间[CI]：49.2％-86.0％）和72.2％（95％CI：50.2％-88.4％），分别。在MNZ易感亚组中，ITT(n=8)和PP(n=7)根除率分别为100%(90%CI:68.8%-100%)和100%(90%CI:65.2%-100%)。在MNZ抗性亚组中，ITT(n=8)和PP(n=7)根除率均为62.5%(90%CI:28.9%-88.9%)。所有感染都是RBT易感的。结论：这些发现表明RBT-MNZ-VPZ治疗可能是一种有希望的挽救方案。特别是在MNZ和RBT易感感染或青霉素过敏患者中。
