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伏诺拉生根除幽门螺杆菌有效性和安全性系统评价

Effectiveness and Safety of Vonoprazan in Eradicating Helicobacter Pylori:A Systematic Review

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【作者】 马靖罗婕刘凯军苟小霜李晨

【Author】 MA Jing;LUO Jie;LIU Kaijun;GOU Xiaoshuang;LI Chen;Army Medical Center of the PLA;

【通讯作者】 李晨;

【机构】 中国人民解放军陆军特色医学中心

【摘要】 目的 为临床合理使用伏诺拉生(VPZ)提供参考。方法 检索The Cochrane Library、Web of Science、PubMed、Embase、ClinicalTrials、中国知网、万方、维普数据库,搜集VPZ与质子泵抑制剂(PPI)对比治疗幽门螺杆菌(HP)感染有效性和安全性的随机对照试验(RCT),检索时限为各数据库自建库起至2023年1月。采用Review Manager 5.4. 1软件进行Meta分析。结果 纳入11项研究,均为英文文献,涉及2 644例患者。Meta分析结果显示,HP总体根除率试验组显著高于对照组(87.92%比77.96%,P=0.000 6);三联方案HP根除率试验组显著高于对照组(88.47%比78.07%,P=0.004),而四联方案两组无显著差异(85.06%比78.28%,P=0.93);日本患者HP根除率试验组均显著高于对照组(89.64%比73.89%,P <0.000 01),亚洲其他国家(或地区)和欧美国家患者HP根除率试验组均显著高于对照组(84.73%比78.82%,P <0.001;87.81%比81.36%,P=0.004);治疗7 d与14 d时,HP根除率试验组均显著高于对照组(89.65%比73.87%,P <0.000 01;85.64%比78.15%,P=0.000 8),而试验组治疗7 d与对照组治疗14 d时无显著差异(90.55%比88.17%,P=0.47)。试验组和对照组不良反应发生率相当(29.72%比38.73%,P=0.14)。结论 现有证据表明,基于VPZ方案根除HP具有较好的有效性和安全性,不同治疗方案、不同国家(或地区)、不同疗程之间的疗效存在差异,基于VPZ的三联方案(另含2种抗菌药物)的7 d疗程是一种潜在的替代PPI的治疗方案。

【Abstract】 Objective To provide a reference for the rational use of vonoprazan(VPZ) in clinical practice.Methods Randomized controlled trials(RCTs) on the comparison of effectiveness and safety of VPZ and proton pump inhibitors(PPIs) in the treatment of Helicobacter pylori(HP) infection in The Cochrane Library,Web of Science,PubMed,Embase,ClinicalTrials,CNKI,WanFang and VIP databases were searched from the inception of each database to January 2023. The RevMan 5. 4. 1 software was used for Meta-analysis.Results A total of 11 studies were included,all of which were in English,involving 2 644 patients. Meta-analysis showed that the total eradication rate of HP in the test group was significantly higher than that in the control group(87. 92% vs.77. 96%,P = 0. 000 6). In the triple treatment regimen based on VPZ,the HP eradication rate in the test group was significantly higher than that in the control group(88. 47% vs. 78. 07%,P = 0. 004),while in the quadruple treatment regimen based on VPZ,the above indicator in the test group was similar to that in the control group(85. 06% vs. 78. 28%,P = 0. 93). The HP eradication rate in the test group from Japan was significantly higher than that in the control group(89. 64% vs. 73. 89%,P < 0. 000 01),and the above indicator in the test group from other Asian countries or regions,European and American countries was significantly higher than that in the control group(84. 73% vs. 78. 82%,P < 0. 001;87. 81% vs. 81. 36%,P = 0. 004). The HP eradication rate in the test group was significantly higher than that in the control group on the 7th and 14th days of treatment respectively(89. 65% vs. 73. 87%,P < 0. 000 01;85. 64% vs. 78. 15%,P = 0. 000 8),while the above indicator in the test group on the 7th day of treatment was similar to that in the control group on the 14th day of treatment(90. 55% vs. 88. 17%,P = 0. 47). The incidence of adverse reactions in the test group was similar to that in the control group(29. 72% vs. 38. 73%,P = 0. 14).Conclusion The present evidence shows that the VPZ regimen in eradicating HP is effective and safe,and there are differences in efficacy among different treatment regimens,countries or regions and treatment courses. The triple regimen based on VPZ(containing two additional antibacterial drugs) with seven-day treatment course is a potential alternative to PPIs.

【基金】 重庆市临床药学重点专科建设项目[渝卫办发[2020]68号]
  • 【文献出处】 中国药业 ,China Pharmaceuticals , 编辑部邮箱 ,2023年22期
  • 【分类号】R573
  • 【下载频次】12
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