伏诺拉生二联和经典四联根除幽门螺杆菌临床研究  

Studies on the eradication of Helicobacter pylori in dual therapy based on vonoprazan and high-dose amoxicillin and classical four-combination

作　　者：李高忠[1] 贾晴 曹京梅[1] LI Gaozhong;JIA Qing;CAO Jingmei(Department of Gastroenterology,Zibo Central Hospital,Zibo 255000,Shandong,China)

机构地区：[1]淄博市中心医院消化内科,山东淄博255000

出　　处：《中国现代医生》2023年第26期125-128,共4页China Modern Doctor

摘　　要：目的比较伏诺拉生联合高剂量阿莫西林(二联方案)与以伏诺拉生为基础四联方案根除幽门螺杆菌的效果及安全性。方法选取2021年5月11日至2021年10月17日在淄博市中心医院就诊的130例幽门螺杆菌阳性患者,采用随机数字表法分为伏诺拉生二联组(伏诺拉生20mg bid+阿莫西林0.75g q6h,n=65)和伏诺拉生四联组(拉生伏诺拉生+阿莫西林1.0 bid+另一种抗生素+铋剂,n=65),疗程均为14d,疗程结束至少1个月后复查13C呼气试验,应用意向性分析(intention-to-treat,ITT)和符合方案分析(per-protocol analysis,PP)两种方法比较两组间根除率,并比较不良反应。结果二联组失访1例,四联组失访2例,按ITT分析,二联组和四联组根除率分别为87.7%(57/65)和89.2%(58/65),两组比较,差异无统计学意义(χ^(2)=0.075,P=0.784)。按PP分析,二联组和四联组根除率分别为89.1%(57/64)和92.1%(58/63),两组比较,差异无统计学意义(χ^(2)=0.334,P=0.563)。四联组整体不良反应发生率(35.9%,23/64)高于二联组(17.5%,11/63),差异有统计学意义(P=0.014)。结论与标准四联方案相比,伏诺拉生二联方案幽门螺杆菌根除率无差异;二联不良反应发生率更低。伏诺拉生二联方案值得临床推广。Objective To compare the eradication rate of helicobacter pylori and safety of vonoprazan and high-dose amoxicillin dual therapy with and vonorasen-based quadruple regimen.Methods A total of 130 patients with helicobacter pylori were selected from the outpatient department of Zibo Central Hospital from May 2021 to July 2021.The patients were randomly divided into two groups:dual therapy group(vonoprazan 20mg bid+amoxicillin 0.75g q6h,n=65)and quadruple therapy group(vonoprazan+amoxicillin 1.0 bid+another antibiotic+bismuth agent,n=65)for 14 days.The 13C breath test was repeated at least 1 month after the treatment.intention-to-treat(ITT)and per-protocol analysis(PP)were used to compare the eradication rate between the two groups.The rate of adverse reactions was recorded.Results One case was lost to follow-up in the dual therapy group,and two cases were lost to follow-up in the quadruple therapy group.According to ITT analysis,the eradication rates in the dual therapy group and the quadruple therapy group were 87.7%(57/65)and 89.2%(58/65),respectively.There was no difference in the eradication rates between the two groups(χ^(2)=0.075,P=0.784).On analysis by PP,the eradication rates of the dual therapy group and the quadruple therapy group were 89.1%(57/64)and 92.1%(58/63),respectively,and there was no difference between the two groups(χ^(2)=0.334,P=0.563).The rate of adverse reactions of quadruple therapy group(35.9%,23/64)was higher than that of dual therapy group(17.5%,11/63)(P=0.014).Conclusion There was no difference in H.pylori eradication rates in dual therapy group compared with the standard quadruple regimen,but the incidence of adverse reactions is less.Dual therapy group(vonoprazan 20mg bid+amoxicillin 0.75g q6h)for eradication of Helicobacter pylori is worthy of clinical promotion.

关 键 词：幽门螺杆菌 伏诺拉生 二联疗法 根除率 阿莫西林 不良反应 

分 类 号：R573.4[医药卫生—消化系统]