基于伏诺拉生与基于质子泵抑制剂的三联疗法根除幽门螺杆菌的有效性和安全性Meta分析

Efficacy and safety of Vonoprazan-based and proton pump inhibitor-based triple therapy for eradication of Helicobacter pylori:a Meta-analysis

目的比较基于伏诺拉生(Vonoprazan,VPZ)与基于质子泵抑制剂(proton pump inhibitor,PPI)的三联疗法根除H.pylori的有效性和安全性。方法计算机检索PubMed、EmBase、Cochrane、中国知网等中英文数据库,搜索建库至2022年2月公开发表的比较VPZ与PPI在根除H.pylori感染中的相关文献,采用RevMan 5.4软件进行Meta分析。结果根据纳入及排除标准,最终共纳入10篇文献,共5622例患者;根除方案均为:VPZ 20 mg或PPI 20/30 mg+阿莫西林750 mg+克拉霉素200/400 mg;采用13C-尿素呼气试验确认根除,并通过意向性治疗(intention-to-treat,ITT)分析和按方案治疗(per-protocol,PP)分析评估根除效果,最后发现以VPZ为基础的三联疗法作为一线方案的H.pylori根除率显著高于以PPI为基础的三联疗法(ITT分析显示:综合根除率87.60%vs 77.33%,OR=2.37,95%CI:1.71~3.29,P<0.05;PP分析显示:综合根除率90.35%vs 79.26%,OR=0.12,95%CI:0.08~0.17,P<0.05)。以VPZ为基础的三联疗法的不良反应发生率与以PPI为基础的三联疗法比较,差异无统计学意义(合并发生率:11.55%vs 11.30%,OR=0.80,95%CI:0.63~1.02,P=0.07)。结论对于H.pylori感染患者,在根除H.pylori时,以VPZ为主的三联疗法疗效明显优于以PPI为主的三联疗法,且不良反应发生率无差异。因此,以VPZ为基础的三联疗法应该被推荐用于根除H.pylori的治疗。

Objective To compare the efficacy and safety of Vonoprazan(VPZ)-based and proton pump inhibitor(PPI)-based triple therapy for eradication of H.pylori.Methods Computer searched PubMed,EmBase,Cochrane and CNKI database,and searched for published comparisons between VPZ and PPI in H.pylori eradication until Jan.2022.The related literatures on H.pylori infection were analyzed by RevMan 5.4 software.Results According to the inclusion and exclusion criteria,a total of 10 literatures were finally included,with a total of 5622 patients;the eradication regimens were:VPZ 20 mg or PPI 20/30 mg+Amoxicillin 750 mg+Clarithromycin 200/400 mg;13 C-urea breath test confirmed eradication,and eradication was assessed by intent-to-treat(ITT)analysis and per-protocol(PP)analysis,and it found that VPZ-based triple therapy as the first-line regimen resulted in significantly higher H.pylori eradication rates than those with PPI-based triple therapy(ITT analysis:pooled eradication rates:87.60%vs 77.33%,OR=2.37,95%CI:1.71-3.29,P<0.05.PP analysis:pooled eradication rates:90.35%vs 79.26%,OR=0.12,95%CI:0.08-0.17,P<0.05).There was no significant difference in the incidence of adverse events between VPZ-based triple therapy and PPI(pooled incidence:11.55%vs 11.30%,OR=0.80,95%CI:0.63-1.02,P=0.07).Conclusion For H.pylori-infected patients,VPZ-based triple therapy is more effective than PPI-based triple therapy in eradicating H.pylori.There is no significantly different in the incidence of adverse effects between the two groups.In conclusion,VPZ-based triple therapy should be recommended for H.pylori eradication therapy.