Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.
Helicobacter. 2022 Aug;27(4):e12900. doi: 10.1111/hel.12900. Epub 2022 May 29.
Rifabutin-based regimens are used as rescue therapy for refractory Helicobacter pylori infection; however, the duration for which treatment is required and side effects are concerning. This study assessed the efficacy and safety of 7-day rifabutin, amoxicillin, and vonoprazan triple therapy as third- or later-line treatment for H. pylori infection.
Patients who did not respond to second-line therapy were enrolled. After H. pylori infection was confirmed with the culture method, the patients received rifabutin-containing triple therapy (20 mg vonoprazan b.i.d., 500 mg amoxicillin q.i.d., and 150 mg rifabutin q.d.) for 7 days. Twelve weeks after the eradication therapy, successful eradication was confirmed using a C urea breath test or the H. pylori stool antigen test. The results obtained from our previous study that reported a 10-day or 14-day esomeprazole based rifabutin-containing triple therapy as a third- or fourth-line rescue therapy treated patients were used as historical control. We determined the minimum inhibitory concentrations of amoxicillin and rifabutin. We also evaluated whether the patients were positive for the mutation of the rpoB gene.
Intention-to-treat and per-protocol analyses showed that our regimen resulted in a high eradication rate (91.2%, 95% CI: 84%-99% and 92.7%, 95% CI: 86%-100%, respectively). Adverse events occurred in 31.6% of the patients, and two patients discontinued the therapy.
This is the first study to evaluate the efficacy and safety of a 7-day low-dose rifabutin-based triple therapy with vonoprazan and amoxicillin. Our results suggest that our regimen was effective and safe as a third- or later-line H. pylori eradication regimen. To clarify what component in this regimen are critical, subsequent studies using a factorial design (comparing vonoprazan-amoxicillin dual therapy vs. vonoprazan-rifabutin triple therapy) will be needed.
利福布汀为基础的方案被用作难治性幽门螺杆菌感染的挽救性治疗；然而，所需的治疗时间和副作用令人担忧。本研究评估了 7 天利福布汀、阿莫西林和沃诺拉赞三联疗法作为三线或更后线治疗幽门螺杆菌感染的疗效和安全性。
纳入对二线治疗无反应的患者。在通过培养方法确认幽门螺杆菌感染后，患者接受含利福布汀的三联治疗（每天 2 次 20mg 沃诺拉赞、每天 4 次 500mg 阿莫西林和每天 150mg 利福布汀）7 天。在根除治疗后 12 周，使用 C 尿素呼气试验或幽门螺杆菌粪便抗原试验确认成功根除。我们使用了之前报道的 10 天或 14 天埃索美拉唑为基础的利福布汀三联疗法作为三线或四线挽救性治疗的研究结果作为历史对照。我们测定了阿莫西林和利福布汀的最低抑菌浓度。我们还评估了患者是否存在 rpoB 基因突变。
意向治疗和按方案分析均显示，我们的方案具有较高的根除率（91.2%，95%CI：84%-99%和 92.7%，95%CI：86%-100%）。31.6%的患者发生不良反应，2 例患者停止治疗。
这是第一项评估含沃诺拉赞和阿莫西林的低剂量利福布汀三联疗法治疗幽门螺杆菌的疗效和安全性的研究。我们的结果表明，作为三线或更后线的幽门螺杆菌根除方案，我们的方案是有效和安全的。为了明确该方案中的哪个成分是关键的，需要进行后续的析因设计研究（比较沃诺拉赞-阿莫西林双联治疗与沃诺拉赞-利福布汀三联治疗）。
