Institute of Therapeutic Innovations and Outcomes (ITIO), College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.
Department of Bariatric and Metabolic Surgery, Fudan University Affiliated Huadong Hospital, Shanghai, China.
Helicobacter. 2024 May-Jun;29(3):e13094. doi: 10.1111/hel.13094.
This study aims to evaluate the efficacy and safety of vonoprazan-amoxicillin (VA), vonoprazan-amoxicillin-clarithromycin (VAC), vonoprazan-based bismuth-containing quadruple therapy (VBQT), and PPI-based triple (PAC) or quadruple therapy (PBQT) for H. pylori infection with the consideration of duration of therapy and amoxicillin dose (H: high; L: low).
PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched for eligible randomized controlled trials (RCTs) up to December 15, 2023. The efficacy outcome was eradication rate, and safety outcomes included the rates of adverse events and treatment discontinuation.
Twenty-seven RCTs were included. The pooled eradication rates were 82.8% for VA, 89.1% for VAC, and 91.8% for VBQT, which increased with the higher amoxicillin frequency of administration and extended duration of therapy within each regimen. There were no significant differences in eradication rate when comparing 7-VA versus 7-VAC and 14-VA versus 14-VAC. VA was at least comparable to PAC. The eradication rate did not differ significantly between 10-H-VA or 14-H-VA versus 14-PBQT. 7-L-VAC demonstrated higher eradication rate versus 7-PAC and comparable rate to 14-PAC. 14-VBQT showed higher eradication rates versus 14-PBQT. The adverse events rate was 19.3% for VA, 30.6% for VAC, and 38.4% for VBQT. VA had similar risk of adverse events versus VAC and significantly fewer adverse events compared to PBQT. The treatment discontinuation rate did not differ significantly between treatments.
The eradication rate of VBQT was the highest at above 90% followed by VAC and VA. VA was as effective as VAC and superior to PPI-based therapies with favorable safety, highlighting the potential of VA therapy as a promising alternative to traditional PPI-based therapies. VPZ-based triple or quadruple therapies was more effective than PPI-based therapies. Further studies are needed to establish the optimal treatment regimen especially in the western countries.
本研究旨在评估沃诺拉赞-阿莫西林（VA）、沃诺拉赞-阿莫西林-克拉霉素（VAC）、沃诺拉赞为基础的含铋四联疗法（VBQT）和质子泵抑制剂（PPI）为基础的三联（PAC）或四联（PBQT）疗法治疗 H. pylori 感染的疗效和安全性，并考虑了治疗持续时间和阿莫西林剂量（H：高；L：低）。
截至 2023 年 12 月 15 日，我们在 PubMed、Embase 和 Cochrane 中央对照试验注册库中检索了合格的随机对照试验（RCT）。疗效结局为根除率，安全性结局包括不良事件发生率和治疗中断率。
共纳入 27 项 RCT。VA、VAC 和 VBQT 的总体根除率分别为 82.8%、89.1%和 91.8%，且随着每种方案中阿莫西林给药频率的增加和治疗持续时间的延长而增加。7-VA 与 7-VAC 和 14-VA 与 14-VAC 相比，根除率无显著差异。VA 与 PAC 至少相当。10-H-VA 或 14-H-VA 与 14-PBQT 相比，根除率无显著差异。7-L-VAC 的根除率高于 7-PAC，与 14-PAC 相当。14-VBQT 的根除率高于 14-PBQT。VA 的不良事件发生率为 19.3%，VAC 为 30.6%，VBQT 为 38.4%。VA 的不良事件风险与 VAC 相似，且明显低于 PBQT。各治疗组间的治疗中断率无显著差异。
VBQT 的根除率最高，超过 90%，其次是 VAC 和 VA。VA 与 VAC 同样有效，且优于 PPI 为基础的治疗方法，安全性良好，突显了 VA 治疗作为传统 PPI 为基础的治疗方法的替代方案的潜力。VPZ 为基础的三联或四联疗法比 PPI 为基础的疗法更有效。需要进一步的研究来确定最佳的治疗方案，特别是在西方国家。
