摘要
目的系统评价基于伏诺拉生方案根除幽门螺杆菌(Hp)的有效性及安全性。方法计算机检索PubMed、Cochrane Liarbry、EMBase、中国知网、万方和维普数据库,搜索含伏诺拉生(不限几联)与质子泵抑制剂(PPI)为基础的含铋剂四联方案根除Hp的随机对照试验(RCT),检索时间为建库至2023年3月。根据Cochrane系统评价方法对检索到的文献进行数据提取和质量评估,采用RevMan 5.4软件进行Meta分析。结果共纳入7篇文献,1615例患者,其中伏诺拉生组911例、PPI组704例。Meta分析结果显示,基于意向性分析,伏诺拉生组和PPI组Hp根除率分别为84.63%和81.52%,差异无统计学意义(RR=1.02,95%CI 0.98~1.07,P=0.37);基于符合方案分析,伏诺拉生组和PPI组Hp根除率分别为90.15%和88.38%,差异无统计学意义(RR=1.02,95%CI 0.98~1.06,P=0.32)。亚组分析结果显示,以伏诺拉生为初次治疗方案中,基于意向性分析和符合方案分析,伏诺拉生组和PPI组Hp根除率比较差异均无统计学意义(RR=1.02,95%CI 0.97~1.07,P=0.52;RR=1.02,95%CI 0.98~1.06,P=0.40);补救方案中,基于意向性分析和符合方案分析,伏诺拉生组和PPI组Hp根除率比较差异无统计学意义(RR=1.08,95%CI 0.92~1.26,P=0.35;RR=1.04,95%CI 0.92~1.18,P=0.53)。在含伏诺拉生不同方案的亚组分析中,无论是意向性分析还是符合方案分析,含伏诺拉生二联、三联方案与PPI的Hp根除率比较差异均无统计学意义(P>0.05)。基于符合方案分析,含伏诺拉生四联方案组Hp根除率高于PPI组(96.13%比87.25%)(RR=3.15,95%CI 1.50~6.61,P=0.002)。伏诺拉生组不良反应发生率低于PPI组(11.49%比19.71%)(RR=1.58,95%CI 0.45~0.74,P<0.0001)。结论以伏诺拉生为基础的Hp根除方案不劣于PPI,四联伏诺拉生的Hp根除率优于PPI,且不良反应发生率低于PPI。因纳入文献质量和数量有限,本研究结论仍需要纳入更多试验证实。
Objective To systematically review the effectiveness and safety of vonoprazan-based regimen for eradication of Helicobacter pylori(Hp).Methods Databases of PubMed,Cochrane Library,EMBase,CNKI,Wangfan and VIP were searched from inception to Mar.2023 for clinical randomized controlled trials(RCT)of vonoprazan-based therapy(no limit to the combinations)versus conventional proton pump inhibitors(PPI)-based quadruple therapy for the eradication of Hp.Data extraction and quality assessment of the included studies were conducted following the Cochrane handbook.Meta-analysis was performed by using RevMan 5.4 software.Results Seven studies with 1615 Hp-infected patients were enrolled,including 911 in the vonoprazan group and 704 in the PPI group.The results of the meta-analysis showed that based on intention-to-treat analysis,the Hp eradication rates were 84.63%and 81.52%in the vonoprazan group and the PPI group,respectively(RR=1.02,95%CI 0.98-1.07,P=0.37).Based on the per-protocol analysis,the Hp eradication rates were 90.15%and 88.38%in the vonoprazan group and the PPI group,respectively(RR=1.02,95%CI 0.98-1.06,P=0.32).The results of the subgroup analysis showed that in the initial treatment plan with vonoprazan,the comparison difference in Hp eradication rate between the vonoprazan group and the PPI group was not significant based on both intention-to-treat analysis and per-protocol analysis(RR=1.02,95%CI 0.97-1.07,P=0.52;RR=1.02,95%CI 0.98-1.06,P=0.40).In the remediation protocol,the difference in Hp eradication rate between the vonoprazan group and the PPI group was not significant based on both intention-to-treat and per-protocol analysis(RR=1.08,95%CI 0.92-1.26,P=0.35;RR=1.04,95%CI 0.92-1.18,P=0.53).In the subgroup analysis with different schemes of vonoprazan,based on either intention-to-treat or per-protocol analysis,the difference in Hp eradication rate of vonoprazon dual schemes and triple schemes with PPI was not statistically significant(P>0.05).Based on the per-protocol analysis,the Hp eradication rate of vonoprazan-bases quadruple scheme was higher than the PPI group(96.13%vs 87.25%)(RR=3.15,95%CI 1.50~6.61,P=0.002).The incidence of adverse reactions was lower in the vonoprazan group than that in the PPI group(11.49%vs 19.71%)(RR=1.58,95%CI 0.45-0.74,P<0.0001).Conclusion The vonoprazan-based Hp eradication regimen was not inferior to the PPI group,and vonoprazan-based quadruple therapy is superior to PPI in Hp eradication rate,while its incidence of adverse reactions is lower than PPI.Due to the limited quality and quantity of the included papers,the conclusions of this meta-analysis need to be confirmed by the inclusion of more RCTs.
作者
王丹丹
周璧芸
付鹏飞
许鑫鑫
王金梁
WANG Dandan;ZHOU Biyun;FU Pengfei;XU Xinxin;WANG Jinliang(College of Clinical Medicine of Henan University of Science and Technology,Luoyang 471003,China;Department of Gastroenterology,the First Affiliated Hospital of Henan University of Science and Technology,Luoyang 471003,China)
出处
《医学综述》
CAS
2023年第20期4314-4321,4330,共9页
Medical Recapitulate
基金
河南省医学科技公关计划项目(LHGJ20210891)。
关键词
伏诺拉生
质子泵抑制剂
幽门螺杆菌
随机对照试验
Vonoprazan
Proton pump inhibitor
Helicobacter pylori
Randomized controlled trial
