Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China.
Laboratory of Translational Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China.
J Dig Dis. 2023 Jan;24(1):19-27. doi: 10.1111/1751-2980.13166. Epub 2023 Apr 22.
This study aimed to evaluate the efficacy and safety of vonoprazan (VPZ) versus proton pump inhibitor (PPI) in clarithromycin-based bismuth-containing quadruple therapy (C-BQT) for the treatment of Helicobacter pylori (H. pylori) eradication.
Medical records of patients in whom H. pylori was eradicated between 1 July 2018 and 31 December 2021 were retrieved retrospectively from the Outpatient Unit of Qilu Hospital. Efficacy, safety, and compliance were compared between VPZ-based and PPI-based C-BQT, containing vonoprazan 20 mg or proton pump inhibitors (lansoprazole 30 mg or esomeprazole 20 mg), bismuth 220 or 200 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, twice daily for 2 weeks by 1:1 propensity score matching analysis. The trial was registed on ClinicalTrials.gov (registration no. NCT05301725).
The H. pylori eradication rates of VPZ-based and PPI-based therapies were 88.8% (151/170) and 87.6% (149/170) in the intention-to-treat analysis, 94.1% (144/153) and 91.1% (144/158) in the per-protocol analysis, respectively. The noninferiority of VPZ to PPI was confirmed in all analyses (P < 0.001). The incidence of adverse events was 30.0% (51/170) and 27.1% (46/170) in the VPZ-based and PPI-based groups, respectively. VPZ-based and PPI-based therapies were well tolerated and showed good patient compliance without significant differences.
VPZ-based therapy resulted in a satisfactory eradication rate and was well tolerated for H. pylori eradication, which are comparable to PPIs in C-BQT as a first-line treatment for H. pylori infection.
本研究旨在评估沃诺拉赞(VPZ)与质子泵抑制剂(PPI)在含克拉霉素的铋四联疗法(C-BQT)治疗幽门螺杆菌(H. pylori)根除中的疗效和安全性。
回顾性检索 2018 年 7 月 1 日至 2021 年 12 月 31 日齐鲁医院门诊患者的病历。采用 1:1 倾向评分匹配分析,比较 VPZ 组和 PPI 组(含沃诺拉赞 20mg 或质子泵抑制剂[兰索拉唑 30mg 或埃索美拉唑 20mg]、铋 220 或 200mg、阿莫西林 1000mg 和克拉霉素 500mg,每日 2 次,疗程 2 周)的疗效、安全性和依从性。该试验在 ClinicalTrials.gov 上注册(注册号:NCT05301725)。
意向治疗分析中,VPZ 组和 PPI 组的 H. pylori 根除率分别为 88.8%(151/170)和 87.6%(149/170),按方案分析分别为 94.1%(144/153)和 91.1%(144/158)。所有分析均证实 VPZ 不劣于 PPI(P<0.001)。VPZ 组和 PPI 组不良反应发生率分别为 30.0%(51/170)和 27.1%(46/170)。VPZ 组和 PPI 组均耐受良好,患者依从性好,差异无统计学意义。
VPZ 治疗方案可获得满意的根除率,且在根除 H. pylori 方面耐受性良好,与 PPI 相比,作为 H. pylori 感染的一线治疗,VPZ 治疗方案是一种有效的治疗选择。