伏诺拉生用于幽门螺杆菌根除治疗的系统评价

Systematic review of vonoprazan as Helicobacter pylori eradication therapy

目的系统评价伏诺拉生(VPZ)用于幽门螺杆菌(Hp)根除治疗的有效性和安全性,为临床治疗Hp感染提供参考。方法计算机检索The Cochrane Library、Embase、PubMed、中国知网、维普网和万方数据等,检索时限为建库起至2022年7月。收集VPZ根除治疗(试验组)且以质子泵抑制剂(PPI)作为对照(对照组)的随机对照试验,提取资料并采用Cochrane系统评价手册5.1.0推荐的偏倚风险评估工具进行质量评价,使用RevMan 5.3软件进行Meta分析。结果共纳入9项研究、合计2134例患者。在意向治疗(ITT)分析和符合方案(PP)分析中,试验组患者的Hp总体根除率均较对照组显著升高,分别为87.5%vs.76.2%[RR=1.14,95%CI(1.06,1.21),P<0.001]和92.4%vs.80.5%[RR=1.11,95%CI(1.03,1.21),P<0.01]。在初始治疗亚组的ITT和PP分析中,试验组患者的Hp总体根除率均较对照组显著升高,分别为88.4%vs.76.5%[RR=1.15,95%CI(1.09,1.22),P<0.00001]和92.8%vs.80.9%[RR=1.12,95%CI(1.03,1.23),P<0.05];在补救治疗亚组的ITT和PP分析中,两组患者的Hp总体根除率比较差异均无统计学意义(P>0.05)。在三联疗法亚组ITT和PP分析中,试验组患者的Hp总体根除率均较对照组显著升高,分别为88.3%vs.75.6%[RR=1.16,95%CI(1.08,1.25),P<0.0001]和92.6%vs.77.6%[RR=1.15,95%CI(1.04,1.28),P<0.01];在四联疗法亚组ITT和PP分析中,两组患者的Hp总体根除率比较差异均无统计学意义(P>0.05)。试验组患者的总体不良事件发生率较对照组显著降低,分别为34.2%vs.40.9%[RR=0.84,95%CI(0.70,0.99),P<0.05];两组患者的严重不良事件发生率比较差异无统计学意义(P>0.05)。结论与PPI疗法比较,含VPZ的三联治疗方案效果更优,尤其对于初治患者而言;但在补救治疗及含铋剂四联方案中,VPZ无显著优势。含VPZ抗Hp治疗方案的安全性及耐受性良好,甚至优于PPI。

OBJECTIVE To systematically evaluate the efficacy and safety of vonoprazan(VPZ)for Helicobacter pylori(Hp)eradication therapy.METHODS Retrieved from The Cochrane Library,Embase,PubMed,CNKI,VIP and Wanfang database,randomized controlled trials about VPZ for Hp eradication therapy(trial group)versus proton pump inhibitor(PPI)(control group)were collected during the inception to July 2022.After data extraction and quality evaluation with bias risk assessment tool recommended by Cochrane System Evaluation Manual 5.1.0,meta-analysis was performed by using RevMan5.3 software.RESULTS Nine studies with 2134 patients were included.Compared with control group,the overall Hp eradication rate of trial group increased significantly in either the ITT analysis or PP analysis,being 87.5%vs.76.2%[RR=1.14,95%CI(1.06,1.21),P<0.001]and 92.4%vs.80.5%[RR=1.11,95%CI(1.03,1.21),P<0.01],respectively.According to ITT and PP analysis of primary treatment subgroup,compared with control group,the overall Hp eradication rate of trial group increased significantly,being 88.4%vs.76.5%[RR=1.15,95%CI(1.09,1.22),P<0.00001]and 92.8%vs.80.9%[RR=1.12,95%CI(1.03,1.23),P<0.05];according to ITT and PP analysis of rescue therapy subgroup,there was no significant difference in the overall Hp eradication rate between control group and trial group(P>0.05).According to ITT and PP analysis of triple therapy subgroup,compared with control group,overall Hp eradication rate of trial group increased significantly,being 88.3%vs.75.6%[RR=1.16,95%CI(1.08,1.25),P<0.0001]and 92.6%vs.77.6%[RR=1.15,95%CI(1.04,1.28),P<0.01];according to ITT and PP analysis of quadruple therapy subgroup,there was no significant difference in the overall Hp eradication rate between control group and trial group(P>0.05).Compared with control group,the incidence of adverse events in trial group decreased significantly,being 34.2%vs.40.9%[RR=0.84,95%CI(0.70,0.99),P<0.05].There was no statistical significance in the incidence of serious adverse events between 2 groups(P>0.05).CONCLUSIONS Compared with PPI therapy,the efficacy of VPZ-based triple therapy is better,particularly in primary treatment patients.However,VPZ has no significant advantage in rescue treatment and bismuth-containing quadruple regimen.And the safety and tolerance of VPZ for Hp eradication therapy are well,even better than PPI.