Abstract: Background　Eradication of Helicobacter pylori （H.pylori） promotes the healing of peptic ulcer and reduces the incidence of ulcer complications.However，due to increased resistance of H.pylori to antimicrobial drugs and inadequate gastric acid inhibition by some proton pump inhibitors （PPI），the eradication rate of H.pylori is often significantly reduced.Vonoprazan inhibits gastric acid secretion by competing binding sites with potassium ions，which has the characteristics of rapid onset of action，and strong and lasting effect.Objective　To assess the efficacy and safety of vonoprazan-based triple therapy （VTT） versus conventional PPI-based triple therapy （PTT） for the eradication of H.pylori.Methods　Databases of PubMed，EMBase，Cochrane Library，CNKI，VIP and Wanfang were searched from inception to June 30，2018 for clinical studies of VTT（experimental group） versus PTT（control group） for H.pylori eradication.Data extraction and quality assessment of the included studies were conducted following the Cochrane handbook.Meta-analysis was performed by using RevMan 5.2 software.Results　A total of 18 studies with 16 727 patients were included.The results indicated that the eradication rate of VTT was much higher than that of PTT when used as first-line therapy 〔OR=2.34，95%CI（1.94，2.81），P<0.000 01〕.Moreover，subgroup analysis indicated significant superiority of VTT in both patients with clarithromycin-susceptible strains 〔OR=2.03，95%CI（1.30，3.18），P=0.002〕 and those with clarithromycin-resistant strains 〔OR=5.92，95%CI（3.70，9.46），P<0.000 01〕.However，VTT did not show superiority to PTT in second-line therapy 〔OR=1.04，95%CI（0.77，1.40），P=0.81〕.Finally，randomized control trial （RCT） subgroup analysis showed the safety of VTT was better than that of PTT 〔OR=0.71，95%CI（0.53，0.95），P=0.02〕，whereas there was no significant difference in this regard for non-RCT subgroup analysis 〔OR=1.10，95%CI（0.90，1.34），P=0.34〕.Conclusion　The efficacy of vonoprazan is superior to PPI in first-line H.pylori eradication therapy but not in second-line therapy.The safety of vonoprazan appears to be equal or even superior to PPI.Adequate multicenter and high-quality RCT are needed to support our results.

Key words: Vonoprazan, Proton pump inhibitor, Helicobacter pylori, Ulcer, Eradication therapy

摘要： 背景　根除幽门螺杆菌（Hp）可促进消化性溃疡愈合，降低溃疡并发症发生率。但由于Hp对抗菌药物耐药率上升和部分质子泵抑制剂（PPI）抑酸不够充分，其根除率明显降低。沃诺拉赞通过与钾离子竞争结合部位，抑制胃酸分泌，具有起效快、抑酸作用强而持久等特点。目的　系统评价沃诺拉赞三联疗法与传统PPI三联疗法根除Hp的有效性及安全性。方法　计算机检索PubMed、EMBase、Cochrane Library、中国知网、维普网和万方数据知识服务平台等数据库，查找沃诺拉赞（试验组）与PPI（对照组）根除Hp的临床试验，检索时间为建库至2018年6月。根据Cochrane系统评价方法对检索到的文献进行数据提取和文献质量评估，采用RevMan 5.2软件进行Meta分析。结果　共纳入18篇文献，16 727例患者。Meta分析结果显示，试验组Hp初治根除率高于对照组〔OR=2.34，95%CI（1.94，2.81），P<0.000 01〕。试验组对克拉霉素敏感株/耐药株的根除率高于对照组〔OR=2.03，95%CI（1.30，3.18），P=0.002；OR=5.92，95%CI（3.70，9.46），P<0.000 01〕。试验组与对照组补救治疗Hp根除率比较，差异无统计学意义〔OR=1.04，95%CI（0.77，1.40），P=0.81〕。随机对照试验（RCT）文献中试验组不良反应发生率低于对照组〔OR=0.71，95%CI（0.53，0.95），P=0.02〕；非随机对照试验（NRCT）文献中试验组与对照组不良反应发生率比较，差异无统计学意义〔OR=1.10，95%CI（0.90，1.34），P=0.34〕。结论　沃诺拉赞对Hp初次治疗的疗效明显优于PPI，但对补救治疗无明显优势，安全性与PPI基本相当。上述结论还需大量多中心、高质量RCT进一步研究证实。

关键词: 沃诺拉赞, 质子泵抑制剂, 幽门螺杆菌, 溃疡, 根除治疗