Qian Hai-Sheng, Li Wen-Jie, Dang Yi-Ni, Li Lu-Rong, Xu Xiao-Bing, Yuan Lin, Zhang Wei-Feng, Yang Zhen, Gao Xin, Zhang Min, Li Xuan, Zhang Guo-Xin
Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China.
Department of Gastroenterology, The First School of Clinical Medicine of Nanjing Medical University, Nanjing, Jiangsu Province, China.
Am J Gastroenterol. 2023 Apr 1;118(4):627-634. doi: 10.14309/ajg.0000000000002086. Epub 2022 Dec 2.
No study has investigated the efficacy and safety of vonoprazan-amoxicillin dual therapy compared with bismuth quadruple therapy (B-quadruple). This study aimed to evaluate the efficacy and safety of 10-day vonoprazan-amoxicillin dual therapy as a first-line treatment of Helicobacter pylori infection compared with B-quadruple and to explore the optimal dosage of amoxicillin in the dual therapy.
A total of 375 treatment-naive, H. pylori -infected subjects were randomly assigned in a 1:1:1 ratio into 3 regimen groups including VHA-dual (vonoprazan 20 mg twice/day + amoxicillin 750 mg 4 times/day), VA-dual (vonoprazan 20 mg + amoxicillin 1,000 mg twice/day), and B-quadruple (esomeprazole 20 mg + bismuth 200 mg + amoxicillin 1,000 mg + clarithromycin 500 mg twice/day). Eradication rates, adverse events (AEs), and compliance were compared between 3 groups.
The eradication rates of B-quadruple, VHA-dual, and VA-dual were 90.9%, 93.4%, and 85.1%, respectively, by per-protocol analysis; 89.4%, 92.7%, and 84.4%, respectively, by modified intention-to-treat analysis; 88.0%, 91.2%, and 82.4%, respectively, by intention-to-treat analysis. The efficacy of the VHA-dual group was not inferior to the B-quadruple group ( P < 0.001), but VA-dual did not reach a noninferiority margin of -10%. The AEs rates of the B-quadruple group were significantly higher than those of the VHA-dual ( P = 0.012) and VA-dual ( P = 0.001) groups. There was no significant difference in medication compliance among 3 treatment groups ( P = 0.995).
The 10-day VHA-dual therapy provided satisfactory eradication rates of >90%, lower AEs rates, and similar adherence compared with B-quadruple therapy as a first-line therapy for H. pylori infection. However, the efficacy of VA-dual therapy was not acceptable.
尚无研究比较沃克帕唑-阿莫西林双联疗法与铋剂四联疗法（B-四联疗法）的疗效和安全性。本研究旨在评估10天的沃克帕唑-阿莫西林双联疗法作为幽门螺杆菌感染一线治疗方案相对于B-四联疗法的疗效和安全性，并探索双联疗法中阿莫西林的最佳剂量。
总共375例未接受过治疗的幽门螺杆菌感染受试者按1:1:1的比例随机分为3个治疗组，包括VHA双联组（沃克帕唑20mg，每日2次+阿莫西林750mg，每日4次）、VA双联组（沃克帕唑20mg+阿莫西林1000mg，每日2次）和B-四联组（埃索美拉唑20mg+铋剂200mg+阿莫西林1000mg+克拉霉素500mg，每日2次）。比较3组的根除率、不良事件（AE）和依从性。
按符合方案分析，B-四联组、VHA双联组和VA双联组的根除率分别为90.9%、93.4%和85.1%；按改良意向性分析分别为89.4%、92.7%和84.4%；按意向性分析分别为88.0%、91.2%和82.4%。VHA双联组的疗效不劣于B-四联组（P<0.001），但VA双联组未达到-10%的非劣效界值。B-四联组的AE发生率显著高于VHA双联组（P=0.012）和VA双联组（P=0.001）。3个治疗组之间的用药依从性无显著差异（P=0.995）。
作为幽门螺杆菌感染的一线治疗方案，10天的VHA双联疗法根除率>90%，令人满意，不良事件发生率较低，依从性与B-四联疗法相似。然而，VA双联疗法的疗效不可接受。
