【作者】 周波；

【导师】 胡奕；

【作者基本信息】 南昌大学 ， 临床医学硕士（专业学位）， 2025， 硕士

【摘要】 研究背景及目的:我们前期优化了伏诺拉生和阿莫西林二联疗法的持续时间和剂量。伏诺拉生阿莫西林二联疗法与含伏诺拉生的四联疗法相比作为幽门螺杆菌（Helicobacter pylori,Hp）感染的一线治疗的疗效尚未得到充分评估。本研究旨在比较及探讨14天的伏诺拉生联合阿莫西林二联疗法及含伏诺拉生的四联疗法根除Hp的疗效及安全性。方法:本研究纳入在2022年6月9日至2023年4月6日就诊于南昌大学第一附属医院深圳医院消化内科的18-70岁的初治Hp感染者,共计245例,190名患者以1:1随机化方式分别接受为期14天的伏诺拉生阿莫西林二联治疗（伏诺拉生20 mg+阿莫西林1 g,2次/天）或含铋剂四联治疗（伏诺拉生20 mg+阿莫西林1g+呋喃唑酮100 mg+枸橼酸铋钾600 mg,每日2次）。停用4周后用¹³C尿素呼气试验或粪便抗原试验评估Hp感染状态。主要结局是Hp根除率。次要结局是两种方案的药物依从性及不良反应。结果:通过意向性分析,伏诺拉生二联和四联治疗的根除率分别为87.4%和92.6%（P=0.23）,通过符合方案分析,分别为96.5%和97.7%（P=0.63）。在符合方案分析中,伏诺拉生二联治疗的疗效非劣效于含伏诺拉生的四联治疗（P<0.001;90%置信区间:-5.4%至3.0%）。结论:14天疗程的伏诺拉生联合阿莫西林二联疗法提供了与含伏诺拉生的四联疗法相似的令人满意的疗效,可作为中国根除Hp的一线治疗。更多还原

【Abstract】 Background and objectives:Hu et al previously optimized the duration and dose of vonoprazan andamoxi-cillin dual therapy in China.The efficacy of vonoprazan with b.i.d.amoxicillin incomparison with vonoprazan-containing quadruple therapy as the first-line treatment of Helicobacter pylori infection has not been adequately evaluated.In this study,we aimed to explore the efficacy of VA dual therapy for 14 days as a first-line treatment for H.pylori infection.Methods:Consecutive H.pylori-infected subjects aged from 18 to 70years without previous eradication history were eligible for enrollment from the Department of Gastroenterology,Shenzhen hospital of The First Affiliated Hospital of Nanchang University between June 9,2022 and April 6,2023.In this non-inferiority,randomized clinicaltrial,190 H.pylori infected and treatmentna(?)ve patients were randomly assigned to receive 14days of either vonoprazan dual(vonoprazan 20mg and amoxicillin 1gtwice daily)or quadruple therapy(vonoprazan 20mg+amoxicillin1g+furazolidone 100mg+bismuth potassium citrate 600mg twice daily).H.pylori status was confirmed using 13C-urea breath tests or fecal antigen test.The primary outcome was the H.pylori eradication rate following vonoprazan dual and quadruple therapy at 4–12weeks.We also compared drug compliance to either regimen and documented their side effect.Results:A total of 245 patients were assessed and 190 subjects were included and randomized.The eradication rate and incidence of adverse events were not different between the two groups.(P>0.05).The eradication rate of vonoprazan dual and quadruple therapy were 87.4%and 92.6%(p=0.23)by intention-to-treat analysis,respectively,and 96.5%and 97.7%(p=0.63)by per-protocol analysis,respectively.The efficacy of vonoprazan dual therapy was non-inferior to vonoprazancontaining quadruple therapy in per-protocol analysis(p<0.001;90%confidence interval:-5.4%to 3.0%).Conclusion:Vonoprazan with b.i.d.amoxicillin for 14days provided similar satisfactory efficacy with vonoprazan-containing quadruple therapy as a first-line H.pylori treatment in China.更多还原