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 

作者机构：Department of GastroenterologyShengli Clinical Medical College of Fujian Medical UniversityFuzhou 350000Fujian ProvinceChina Department of GastroenterologyFujian Provincial HospitalFuzhou 350001Fujian ProvinceChina Department of GastroenterologyThe First Affiliated Hospital of Fujian Medical UniversityFuzhou 350000Fujian ProvinceChina School of Public HealthFujian Medical UniversityFuzhou 350000Fujian ProvinceChina Department of GastroenterologyThe Third People’s Hospital of Fujian ProvinceFuzhou 350000Fujian ProvinceChina Department of GastroenterologyFujian Provincial Hospital North Brance Fujian Provincial Geriatric HospitalFuzhou 350000Fujian ProvinceChina Department of GastroenterologyXiaoao HospitalFuzhou 350000Fujian ProvinceChina Department of GastroenterologyThe General Hospital of Fujian Energy GroupFuzhou 350000Fujian ProvinceChina Department of GastroenterologyThe Second Hospital of ZhangzhouZhangzhou 363000Fujian ProvinceChina Department of GastroenterologyAnxi Country HospitalQuanzhou 362000Fujian ProvinceChina Department of GastroenterologyZhangzhou Municipal Hospital of TCMZhangzhou 363000Fujian ProvinceChina Department of GastroenterologyZhangpu HospitalZhangzhou 363000Fujian ProvinceChina Department of GastroenterologyThe Affiliated Dongnan Hospital of Xiamen UniversityZhangzhou 363000Fujian ProvinceChina Department of GastroenterologyFirst Hospital of Nanping CityNanping 353000Fujian ProvinceChina Department of GastroenterologyFujian Nanping Second HospitalNanping 353000Fujian ProvinceChina Department of GastroenterologyWuyishan Municipal HospitalNanping 353000Fujian ProvinceChina Department of GastroenterologyFuzhou Changle District HospitalFuzhou 350000Fujian ProvinceChina Department of GastroenterologyChangle City Second HospitalFuzhou 350000Fujian ProvinceChina Department of GastroenterologyJinjiang Municipal HospitalQuanzhou 362000Fujian ProvinceChina Department of GastroenterologyFuding Hospital Affiliated to Fujian University of Traditional Chinese MedicineNingde 352000Fujian ProvinceChina Department of GastroenterologyLiancheng HospitalLongyan 364000Fujian ProvinceChina Department of GastroenterologyXiapu County HospitalNingde 352000Fujian ProvinceChina Department of GastroenterologyJinjiang Second HospitalQuanzhou 362000Fujian ProvinceChina Department of GastroenterologyThe First Hospital of Putian CityPutian 351100Fujian ProvinceChina Department of GastroenterologyPutian Fude HospitalPutian 351100Fujian ProvinceChina Department of GastroenterologyThe 5th Affiliated Hospital of Sun Yat-sen UniversityZhuhai 519000Guangdong ProvinceChina 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2024年第30卷第27期

页      面：3304-3313页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

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 

主　　题：Helicobacter pylori Vonoprazan Amoxicillin Dual therapy Bismuth quadruple therapy 

摘      要：BACKGROUND The efficacy of Vonoprazan-amoxicillin dual therapy(VAT)in the treatment of Helicobacter pylori(***)is *** To evaluate the efficacy of VAT in the Chinese *** This prospective,multicenter,randomized,open-label,and two-stage study was conducted at 23 centers in Fujian,China(May 2021-April 2022).***-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)*** primary endpoint was the *** eradication *** secondary endpoint was the frequency of adverse *** study was registered with the Chinese Clinical Trial Registry,*** In the first stage,VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were *** 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 *** 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;P0.001).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 ***-infected patients in *** XP et *** for *** eradication.