Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population:A prospective,multicenter,randomized,two-stage study  

作　　者：Xue-Ping Huang Zhi-Hui Lin Yi-Juan Liu Shao-Wei Lin Yan-Feng Shao Feng Qiu Qing-Wu Qiu Zhang-Kun Xu Jin-Xian Chen Liang-Huo Chen Zhen-Qun Lin Wen-Hua Dai Ming-Qing Zhang Qi Jiang Zhong-Qin Xiao Xian-Xing Cheng Xiang-Fei Zhang Wen-Bin You Wei Chen Long-Qin Li Wei-Xing Lin Yong-Fu Wang Fu-Jin Lai Long-Qun Chen Zhong-Hua Huang Wen-Qi Zheng Jin-Qi Wei 

机构地区：[1]Department of Gastroenterology,Shengli Clinical Medical College of Fujian Medical University,Fuzhou 350000,Fujian Province,China [2]Department of Gastroenterology,Fujian Provincial Hospital,Fuzhou 350001,Fujian Province,China [3]Department of Gastroenterology,The First Affiliated Hospital of Fujian Medical University,Fuzhou 350000,Fujian Province,China [4]School of Public Health,Fujian Medical University,Fuzhou 350000,Fujian Province,China [5]Department of Gastroenterology,The Third People’s Hospital of Fujian Province,Fuzhou 350000,Fujian Province,China [6]Department of Gastroenterology,Fujian Provincial Hospital North Brance Fujian Provincial Geriatric Hospital,Fuzhou 350000,Fujian Province,China [7]Department of Gastroenterology,Xiaoao Hospital,Fuzhou 350000,Fujian Province,China [8]Department of Gastroenterology,The General Hospital of Fujian Energy Group,Fuzhou 350000,Fujian Province,China [9]Department of Gastroenterology,The Second Hospital of Zhangzhou,Zhangzhou 363000,Fujian Province,China [10]Department of Gastroenterology,Anxi Country Hospital,Quanzhou 362000,Fujian Province,China [11]Department of Gastroenterology,Zhangzhou Municipal Hospital of TCM,Zhangzhou 363000,Fujian Province,China [12]Department of Gastroenterology,Zhangpu Hospital,Zhangzhou 363000,Fujian Province,China [13]Department of Gastroenterology,The Affiliated Dongnan Hospital of Xiamen University,Zhangzhou 363000,Fujian Province,China [14]Department of Gastroenterology,First Hospital of Nanping City,Nanping 353000,Fujian Province,China [15]Department of Gastroenterology,Fujian Nanping Second Hospital,Nanping 353000,Fujian Province,China [16]Department of Gastroenterology,Wuyishan Municipal Hospital,Nanping 353000,Fujian Province,China [17]Department of Gastroenterology,Fuzhou Changle District Hospital,Fuzhou 350000,Fujian Province,China [18]Department of Gastroenterology,Changle City Second Hospital,Fuzhou 350000,Fujian Province,China [19]Department of Gastroenterology,Jinjiang Municipal Hospital,Quanzhou 362000,Fujian Province,C

出　　处：《World Journal of Gastroenterology》2024年第27期3304-3313,共10页世界胃肠病学杂志（英文版）

基　　金：Supported by the Natural Science Foundation of Fujian Province,No.2020J011087 and No.2022J011025;Medical Innovation Project of Fujian Provincial Health Commission,No.2020CXA006;Zhuhai Science and Technology Project,No.20181117E030040.

摘　　要：BACKGROUND The efficacy of Vonoprazan-amoxicillin dual therapy(VAT)in the treatment of Helicobacter pylori(H.pylori)is controversial.AIM To evaluate the efficacy of VAT in the Chinese population.METHODS This prospective,multicenter,randomized,open-label,and two-stage study was conducted at 23 centers in Fujian,China(May 2021-April 2022).H.pylori-infected patients were randomized to bismuth quadruple therapy(BQT),BQT-Vonoprazan(BQT-V),seven-day VAT(VAT-7),ten-day VAT(VAT-10),and fourteen-day VAT(VAT-14)groups.The primary endpoint was the H.pylori eradication rate.The secondary endpoint was the frequency of adverse events.This study was registered with the Chinese Clinical Trial Registry,ChiCTR2100045778.RESULTS In the first stage,VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated.In the second stage,the eradication rates for BQT,VAT-10,and VA-14 were 80.2%[95%confidence interval(95%CI):71.4%-86.8%],93.2%(86.6%-96.7%),92.2%(85.3%-96.0%)in the intention-to-treat(ITT)analysis,and 80.9%(95%CI:71.7%-87.5%),94.0%(87.5%-97.2%),and 93.9%(87.4%-97.2%)in the per-protocol analysis.The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group(P=0.022 and P=0.046,respectively).The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group(25.27%and 13.73%vs 37.62%,respectively;P<0.001).CONCLUSION VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT,with a more tolerable safety profile in H.pylori-infected patients in Fujian.Huang XP et al.VAT for H.pylori eradication.

关 键 词：Helicobacter pylori Vonoprazan AMOXICILLIN Dual therapy Bismuth quadruple therapy 

分 类 号：R573[医药卫生—消化系统]