Eradication rates of Helicobacter pylori in treatment-naive patients following 14-day vonoprazan-amoxicillin dual therapy: A multicenter randomized controlled trial in China

作者全名："Hu, Jie; Mei, Hao; Su, Na-yun; Sun, Wen-jing; Zhang, De-kui; Fan, Li-lin; He, Ping; Pan, Jie; Wang, Xing-wei; Zou, Pei-ying; Liu, Yu-xiang; Guo, Yan; Lan, Chun-Hui"

作者地址："[Hu, Jie; Mei, Hao; Su, Na-yun; Wang, Xing-wei; Zou, Pei-ying; Liu, Yu-xiang; Guo, Yan; Lan, Chun-Hui] Army Med Univ, Daping Hosp, Dept Gastroenterol, Chongqing, Peoples R China; [Sun, Wen-jing] 13th Peoples Hosp Chongqing, Dept Gastroenterol, Chongqing, Peoples R China; [Zhang, De-kui] Lanzhou Univ, Dept Gastroenterol, Hosp 2, Lanzhou, Peoples R China; [Fan, Li-lin] Second Peoples Hosp Chongqing, Dept Gastroenterol, Chongqing, Peoples R China; [He, Ping] Chongqing Med Univ, Dept Gastroenterol, Yongchuan Hosp, Chongqing, Peoples R China; [Pan, Jie] Wenzhou Cent Hosp, Dept Gastroenterol, Wenzhou, Peoples R China; [Guo, Yan; Lan, Chun-Hui] Army Med Univ, Daping Hosp, Dept Gastroenterol, 10 Changjiang Branch Rd, Chongqing 400042, Peoples R China"

通信作者："Guo, Y; Lan, CH (通讯作者)，Army Med Univ, Daping Hosp, Dept Gastroenterol, 10 Changjiang Branch Rd, Chongqing 400042, Peoples R China."

来源：HELICOBACTER

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000985059000001

JCR分区：Q1

影响因子：4.3

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：amoxicillin; bacterial infection; breath tests; Helicobacter pylori; patient compliance; vonoprazan

摘要："BackgroundPotassium-competitive acid blockers (P-CAB) are recommended for the treatment of Helicobacter pylori infections, but dual therapy of P-CAB with amoxicillin has been poorly studied. The current study compared the efficacy, adverse reactions, compliance, and effects on gut microbiota of 14-day vonoprazan-amoxicillin (VA) dual therapy with esomeprazole, bismuth potassium citrate, amoxicillin, and metronidazole (EBAM) quadruple therapy in treatment-naive patients with H. pylori. Materials and MethodsThis was a multicenter, open-label, randomized, and controlled, non-inferiority study. Patients (n = 194) enrolled from six centers were randomly divided into either the VA or EBAM group. H. pylori eradication was determined using C-13 urea breath tests (UBT) 4-6 weeks post-treatment. Fecal samples were collected, and gut microbial populations were analyzed by 16S rDNA and metagenomic sequencing technology. ResultsEradication rates of H. pylori in the VA and EBAM groups were 88.7% and 91.8%, respectively, according to intention-to-treat (ITT) analysis; 95.6% and 96.7% with per-protocol (PP) analysis; and 94.5% and 96.7% with modified ITT (mITT) analysis (all p > 0.05). The incidence of adverse reactions in the VA group was significantly lower compared to the EBAM group, and compliance within both groups was good. There was no difference in alpha-diversity or microbial composition in the VA and EBAM groups at one-month post-treatment compared to baseline, except for a markedly reduced abundance of Bacteroides in the EBAM group. ConclusionVA therapy achieved excellent eradication rates with low adverse reactions, good compliance, and little impact on gut microbiota. VA therapy should be recommended as a first-line treatment against H. pylori."

基金机构：National Science Foundation of China [82072253]; Training Program of Clinical Medical Technology Innovation Ability of the Army Medical Center [2019CXLCB003]

基金资助正文："The National Science Foundation of China, Grant/Award Number: 82072253; The Training Program of Clinical Medical Technology Innovation Ability of the Army Medical Center, Grant/Award Number: 2019CXLCB0 03"