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目的系统评价沃诺拉赞(VPZ)清除幽门螺杆菌(Hp)的有效性与安全性。方法计算机检索截至2018年3月PubMed、EMbase、the Cochrane Library和ClinicalTrials.gov数据库中VPZ对比质子泵抑制剂(PPI)清除Hp的临床研究,对文献进行筛选及质量评价,使用RevMan 5.3软件对数据进行Meta分析。结果共纳入17项研究,共计16 596例患者。Meta分析结果显示,VPZ联合方案一线清除率显著高于PPI组(86.9%vs 68.0%,P<0.000 01);针对克拉霉素的亚组分析同样显示了此优势(敏感组:94.1%vs 88.6%,P=0.002;耐药组:81.5%vs 40.9%,P<0.000 01)。然而,VPZ并未在二线清除(83.4%vs 81.4%,P=0.72)及青霉素过敏人群(94.1%vs 86.2%,P=0.19)中展现优势。此外,随机对照试验(RCT)亚组显示VPZ组安全性高于PPI组(32.7%vs 40.5%,P=0.02),而观察性研究(OS)亚组中两者差异无统计学意义(6.2%vs 5.0%,P=0.25)。结论 VPZ联合方案具有明显的一线清除率优势,可推荐用于克拉霉素耐药患者;二线清除率则与PPI相当。总体上,VPZ安全性良好。鉴于纳入研究的文献证据水平有限,需要开展更多高质量、大样本的RCT对此加以证实。
Abstract：AIM To evaluate the efficacy and safety of vonoprazan(VPZ) in eradication of Helicobacter pylori(Hp). METHODS PubMed, EMbase, the Cochrane Library and the ClinicalTrials.gov database were systematically searched. All databases had been searched from up to March 2018. All the clinical researches of VPZ compared with proton pump inhibitor(PPI)-containing regimens for Hp eradication were selected.The literature was screened and the quality of the trials was evaluated, the results of the studies were reviewed and analyzed using RevMan 5.3 software. RESULTS A total of 17 studies with 16 596 patients were included in this Meta-analysis.The results showed that the eradication rate of VPZ-containing regimens was much higher than that of PPI-containing regimens in first-line therapies(86.9% vs 68.0%,P<0.000 01).Subgroup analysis also showed significant superiority of VPZ in the patients with clarithromycin-susceptible strains(94.1% vs 88.6%,P=0.002)or with clarithromycin-resistant strains(81.5% vs 40.9%,P<0.000 01).However, VPZ did not show superiority in second-line therapies(83.4% vs 81.4%,P=0.72)and the group of patients allergic to penicillin(94.1% vs 86.2%,P=0.19).In addition, the randomized controlled trial(RCT)subgroup showed that the safety of the VPZ group was higher than that of the PPI group(32.7% vs 40.5%,P=0.02), while there was no significant difference in the observational study(OS)subgroup(6.2% vs 5.0%,P=0.25). CONCLUSION The efficacy of VPZ is superior to PPI in first-line Hp triple eradication therapies, especially in clarithromycin-resistant patients, but not in second-line therapies. In total, the safety of VPZ is similar or even better than PPI.In view of the limited level of literature evidence in the study, more high-quality and large sample RCT is needed to confirm our results.
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基本信息:
DOI：10.19577/j.1007-4406.2019.05.011
中图分类号:R969
引用信息:
[1]赵世峰,姚冲,汪荣华,等.沃诺拉赞清除幽门螺杆菌有效性与安全性的Meta分析[J].中国临床药学杂志,2019,28(05):367-373.DOI:10.19577/j.1007-4406.2019.05.011.
基金信息:
浙江省医药卫生非平台计划(适宜技术项目,编号2014ZHA010)
2019-09-25
2019-09-25