伏诺拉生用于幽门螺杆菌补救根除治疗的Meta分析

Meta-Analysis of Vonoprazan for Helicobacter pylori Remedy Eradication Therapy

目的:系统评价伏诺拉生(VPZ)疗法相对于质子泵抑制剂(PPI)疗法在幽门螺杆菌(Hp)感染患者补救治疗中的有效性及安全性。方法:计算机检索The Cochrane Library、Web of Science、PubMed、中国知网、CBM等,检索时限为建库起至2022年5月。如果评估了基于VPZ和基于PPI的疗法之间的根除率,则纳入这些研究,提取相关资料并采用Cochrane系统评价手册推荐的偏倚风险评估工具对随机对照试验进行质量评价,采用纽卡斯尔–渥太华量表对非随机对照试验进行质量评价,使用RevMan 5.3软件进行Meta分析。结果:共纳入7项研究,合计3013例患者。在意向治疗(ITT)分析和符合方案(PP)分析中,VPZ组患者的Hp总体根除率比PPI组显著升高,分别为87.55% vs. 79.55% [RR = 1.07, 95%CI (1.00, 1.13), P = 0.02]和94.07% vs. 87.34% [RR = 1.08, 95%CI (1.04, 1.12), P < 0.0001]。VPZ组患者的不良事件发生率和PPI组不良事件发生率差异无统计学意义,为10.98% vs. 13.03% [RR = 0.65, 95%CI (0.22, 1.95), P = 0.45]。结论:与PPI疗法相比,VPZ疗法在Hp感染患者补救根除治疗中效果更优。VPZ疗法的安全性良好,甚至优于PPI疗法。

Objective: To systematically evaluate the efficacy and safety of vonoprazan (VPZ) therapy relative to proton pump inhibitor (PPI) therapy in the remedial treatment of patients with Helicobacter pylori (Hp) infection. Methods: Computerised searches of The Cochrane Library, Web of Science, PubMed, CNKI, CBM, etc. were performed within a timeframe from the time of library construction to May 2022. Studies were included if eradication rates between VPZ-based and PPI-based therapies were assessed, relevant information was extracted and quality evaluated using the risk of bias assess-ment tool recommended by the Cochrane Handbook of Systematic Evaluation for randomised con-trolled trials, and the Newcastle-Ottawa scale for non-randomised controlled trials, and Me-ta-analyses were performed using RevMan 5.3 software. Results: Seven studies with a combined to-tal of 3013 patients were included. In the intention-to-treat (ITT) analysis and protocol-conformant (PP) analysis, patients in the VPZ group had significantly higher overall Hp eradication rates than those in the PPI group, 87.55% vs. 79.55% [RR = 1.07, 95%CI (1.00, 1.13), P = 0.02] and 94.07% vs. 87.34% [RR = 1.08, 95%CI (1.04, 1.12), P < 0.0001]. The difference between the rate of adverse events in patients in the VPZ group and the rate of adverse events in the PPI group was not statisti-cally significant at 10.98% vs. 13.03% [RR = 0.65, 95%CI (0.22, 1.95), P = 0.45]. Conclusion: VPZ therapy is more effective in remedial eradication therapy in patients with Hp infection compared to PPI therapy. The safety profile of VPZ therapy is favourable and even superior to that of PPI therapy.