伏诺拉生和高剂量阿莫西林双联疗法首次根除幽门螺杆菌安全性和有效性的Meta分析  

Safety and efficacy of Vonoprazan and high-dose Amoxicillin dual therapy for the initial treatment of Helicobacter pylori:a Meta-analysis

作　　者：张聚 张欢 尹菊梅 姚诺 朱晓静 时永全 ZHANG Ju;ZHANG Huan;YIN Jumei;YAO Nuo;ZHU Xiaojing;SHI Yongquan(State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers and National Clinical Research Center for Digestive Diseases,Department of Gastroenterology,the First Affiliated Hospital,Air Force Medical University,Xi′an 710032;Department of Gastroenterology,Pingdingshan Medical District,989th Hospital of PLA Joint Logistics Support Force,China)

机构地区：[1]空军军医大学第一附属医院消化内科,国家消化系统疾病临床医学研究中心和消化系肿瘤整合防治全国重点实验室,陕西西安710032 [2]中国人民解放军联勤保障部队第九八九医院平顶山医疗区消化内科

出　　处：《胃肠病学和肝病学杂志》2025年第1期44-48,共5页Chinese Journal of Gastroenterology and Hepatology

基　　金：陕西省重点研发计划(2023-ZDLSF-35);陕西省卫生健康科研创新团队(2024TD-06)。

摘　　要：目的评价与铋剂四联疗法(Bismuth quadruple therapy,BQT)相比,伏诺拉生和高剂量阿莫西林双联疗法(Vonoprazan and high-dose Amoxicillin dual therapy,VHA)在首次治疗幽门螺杆菌(Helicobacter pylori,H.pylori)感染中的有效性和安全性。方法检索中国知网、万方、维普、PubMed、EmBase、Cochrane Library等数据库,收集自建库至2023年8月公开发表的对比VHA与BQT治疗H.pylori感染的随机对照试验。采用RevMan 5.3软件进行Meta分析。结果共纳入4篇文献,包括868例患者。结果显示,在意向性(intention-to-treat,ITT)分析中VHA组的根除率高于BQT组,但差异无统计学意义(90.8%vs 85.0%,OR=1.71,95%CI:0.83~3.54,P=0.14);在符合方案(per-protocol,PP)分析中VHA组的根除率高于BQT组,但差异也无统计学意义(96.1%vs 91.3%,OR=2.30,95%CI:0.84~6.28,P=0.11)。VHA组的不良反应发生率明显低于BQT组(15.1%vs 35.2%,OR=0.31,95%CI:0.22~0.44,P<0.01)。VHA组和BQT组依从性相当(97.1%vs 96.0%,OR=1.44,95%CI:0.68~3.06,P=0.34)。结论与BQT相比,VHA疗效和依从性相当,且不良事件发生率显著降低,可作为根除H.pylori的一线方案应用于临床。Objective To evaluate the efficacy and safety of Vonoprazan and high-dose Amoxicillin dual therapy(VHA)in the treatment of Helicobacter pylori(H.pylori)infection compared with Bismuth quadruple therapy(BQT).Methods Retrieve databases such as CNKI,WanFang,VIP,PubMed,EmBase,Cochrane Library,and collect randomized controlled trials comparing VHA and BQT in the initial treatment of H.pylori infection,up to Aug.2023.Meta-analysis was conducted by RevMan 5.3 software.Results Four articles with 868 patients were included.In intention-to-treat(ITT)analysis,the eradication rate of the VHA group was higher than that of the BQT group,but the difference was not statistically significant(90.8%vs 85.0%,OR=1.71,95%CI:0.83-3.54,P=0.14).In the per-protocol(PP)analysis,the eradication rate of the VHA group was not statistically higher than that of the BQT group(96.1%vs 91.3%,OR=2.30,95%CI:0.84-6.28,P=0.11).The incidence of adverse reactions in the VHA group was significantly lower than that in the BQT group(15.1%vs 35.2%,OR=0.31,95%CI:0.22-0.44,P<0.01).The compliance of the VHA group and that of the BQT group were comparable(97.1%vs 96.0%,OR=1.44,95%CI:0.68-3.06,P=0.34).Conclusion VHA has the similar efficacy and compliance compared with BQT,with fewer adverse events.It can be used as a first-line regimen for eradicating H.pylori in clinical practice.

关 键 词：伏诺拉生 阿莫西林 幽门螺杆菌 META分析 

分 类 号：R378[医药卫生—病原生物学]