Liang Jing Wen, Xiong Si, Jia Ye Gui, Xiao Dan, Tan Shi Yun, Cao Ji Wang, Sun Jun, Tian Xia, Li Shu Yu, Chen Rui Hong, Ruan Gui Zhen, Xiong Jian Guang, Wang Xiao Ming, Xu San Ping, Qi Li Ping, Liu Yun Hua, Zhao Yu Chong, Bai Shu Ya, Chen Wei, Cao Meng Die, Peng Wang, Li Yan Ling, Yang Yi Lei, Chen Shi Ru, Cui Hao Chen, Liu Lu Yao, Zhou Yi, Cheng Bin
Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Gastroenterology, Wuhan City Sixth Hospital, Wuhan, China.
J Gastroenterol Hepatol. 2024 Nov;39(11):2293-2298. doi: 10.1111/jgh.16679. Epub 2024 Jul 16.
Helicobacter pylori infection is linked to various gastrointestinal conditions, such as chronic active gastritis, peptic ulcers, and gastric cancer. Traditional treatment options encounter difficulties due to antibiotic resistance and adverse effects. Therefore, the aim of this study was to explore the effectiveness of a new treatment plan that combines vonoprazan (VPZ), amoxicillin, and bismuth for the eradication of H. pylori.
A total of 600 patients infected with H. pylori were recruited for this multicenter randomized controlled trial. Patients treated for H. pylori elimination were randomly assigned at a 1:1 ratio to receive 14 days of vonoprazan-based triple therapy (vonoprazan + amoxicillin + bismuth, group A) or standard quadruple therapy (esomeprazole + clarithromycin + amoxicillin + bismuth, group B). Compliance and adverse effects were tracked through daily medication and side effect records. All patients underwent a 13C/14C-urea breath test 4 weeks after treatment completion.
Intention-to-treat (ITT) and per-protocol (PP) analyses revealed no substantial differences in H. pylori eradication rates between groups A and B (ITT: 83.7% vs 83.2%; PP: 90.9% vs 89.7%). However, significant differences were observed in the assessment of side effects (13.7% vs 28.6%, P < 0.001). Specifically, group A had significantly fewer "bitter mouths" than group B did (3.7% vs 16.2%, P < 0.001).
Triple therapy comprising vonoprazan (20 mg), amoxicillin (750 mg), and bismuth potassium citrate (220 mg) achieved a PP eradication rate ≥90%, paralleling standard quadruple therapy, and had fewer adverse events and lower costs (¥306.8 vs ¥645.8) for treatment-naive patients.
幽门螺杆菌感染与多种胃肠道疾病相关，如慢性活动性胃炎、消化性溃疡和胃癌。由于抗生素耐药性和不良反应，传统治疗方案面临困难。因此，本研究的目的是探讨一种新的治疗方案（联合沃克（VPZ）、阿莫西林和铋剂）根除幽门螺杆菌的有效性。
本多中心随机对照试验共纳入600例幽门螺杆菌感染患者。接受幽门螺杆菌根除治疗的患者按1:1比例随机分配，接受为期14天的基于沃克的三联疗法（沃克+阿莫西林+铋剂，A组）或标准四联疗法（埃索美拉唑+克拉霉素+阿莫西林+铋剂，B组）。通过每日用药和副作用记录追踪依从性和不良反应。所有患者在完成治疗4周后接受13C/14C-尿素呼气试验。
意向性分析（ITT）和符合方案分析（PP）显示，A组和B组的幽门螺杆菌根除率无显著差异（ITT：83.7%对83.2%；PP：90.9%对89.7%）。然而，在副作用评估方面观察到显著差异（13.7%对28.6%，P<0.001）。具体而言，A组的“口苦”症状明显少于B组（3.7%对16.2%，P<0.001）。
由沃克（20mg）、阿莫西林（750mg）和枸橼酸铋钾（220mg）组成的三联疗法对初治患者的PP根除率≥90%，与标准四联疗法相当，且不良事件较少，治疗成本较低（306.8元对645.8元）。
