Li Juan, Lv Lin, Zhu Yongjun, Zhou Zhihang, He Song
Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing City, People's Republic of China.
Infect Drug Resist. 2023 Aug 28;16:5637-5645. doi: 10.2147/IDR.S417711. eCollection 2023.
The emergence of resistant strains has greatly reduced the eradication rate of (HP) in conventional bismuth-containing quadruple therapy. Meanwhile, the new 7-day dual therapy with vonoprazan (VPZ) and amoxicillin (AMO) failed to achieve the expected therapeutic effect in China.
A total of 256 untreated HP-infected patients are included in this non-inferiority clinical trial. The patients were randomly divided into three groups: 14-day dual therapy group (VPZ 20mg b.i.d + AMO 750mg t.i.d for 14 days, VA14), 14-day modified triple therapy group (VA14 + Jinghua Weikang Capsule 160mg t.i.d, VAC), and conventional bismuth-containing quadruple therapy group for 14 days (BCQ). Eradication rates, drug-related adverse events (AEs), patient compliance, and drug costs were compared among the three groups.
The eradication rates in the BCQ, VA14, and VAC were 78.67, 77.33%, and 86.49% by intention-to-treat analysis, respectively, and 96.72%, 90.63%, and 92.75% by pre-protocol or modified intention-to-treat analysis, respectively. VA14 therapy indicated a non-inferiority eradication rate and advanced safety and economics to BCQ therapy. JWC further improved the eradication rate and reduced the incidence of AEs.
A modified 14-day dual therapy with VPZ and AMO provides satisfied efficacy as the first-line treatment for HP infection in China.
耐药菌株的出现大大降低了传统含铋四联疗法中幽门螺杆菌（HP）的根除率。同时，新型的沃克（VPZ）与阿莫西林（AMO）7天双联疗法在中国未达到预期治疗效果。
本非劣效性临床试验共纳入256例未经治疗的HP感染患者。患者被随机分为三组：14天双联疗法组（VPZ 20mg，每日2次+AMO 750mg，每日3次，共14天，VA14）、14天改良三联疗法组（VA14+荆花胃康胶囊160mg，每日3次，VAC）和传统含铋四联疗法组，疗程均为14天（BCQ）。比较三组的根除率、药物相关不良事件（AE）、患者依从性和药物成本。
意向性分析显示，BCQ、VA14和VAC组的根除率分别为78.67%、77.33%和86.49%，符合方案分析或改良意向性分析的根除率分别为96.72%、90.63%和92.
