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中华胃食管反流病电子杂志

中华胃食管反流病电子杂志 ›› 2022, Vol. 09 ›› Issue (02) : 95 -102. doi: 10.3877/cma.j.issn.2095-8765.2022.02.004

论著

伏诺拉生治疗胃食管反流病的疗效Meta分析
娄伦生1, 黄玉荣2, 何磊2, 陈冬梅2, 莫国毅1, 杨杰3,†()   
  1. 1. 553001　贵州省六盘水市人民医院全科医学科
    2. 550004　贵阳，贵州医科大学附属医院消化内科
    3. 消化内科
  • 收稿日期:2022-04-12 出版日期:2022-05-15
  • 通信作者: 杨杰
  • 基金资助:
    六盘水市人民医院院士工作站培育项目(52020-2020-0911)

Efficacy of Vonoprazan in the treatment of gastroesophageal refluxe disease: A meta-analysis

Lunsheng Lou1, Yurong Huang2, Lei He2, Dongmei Chen2, Guoyi Mo1, Jie Yang3()   

  1. 1. General Medicine Department, Guizhou Province, 553001 China
    2. Digestive Department of Liupanshui People's Hospital, Guizhou Province, 553001 China
    3. Department of the Affiliated Hospital of Guizhou Medical University Digestive, Guiyang 550004, China
  • Received:2022-04-12 Published:2022-05-15
  • Corresponding author: Jie Yang
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娄伦生, 黄玉荣, 何磊, 陈冬梅, 莫国毅, 杨杰. 伏诺拉生治疗胃食管反流病的疗效Meta分析[J]. 中华胃食管反流病电子杂志, 2022, 09(02): 95-102.

Lunsheng Lou, Yurong Huang, Lei He, Dongmei Chen, Guoyi Mo, Jie Yang. Efficacy of Vonoprazan in the treatment of gastroesophageal refluxe disease: A meta-analysis[J]. Chinese Journal of Gastroesophageal Reflux Disease(Electronic Edition), 2022, 09(02): 95-102.

目的

评价伏诺拉生对胃食管反流病（GERD）的临床疗效。

方法

通过计算机检索电子数据库The Cochrane Library、PubMed、EMBASE、中国生物医学文献数据库（CBM）、中国知网（CNKI）和万方数据库（WanFang Data）发表的有关伏诺拉生治疗胃食管反流病随机对照试验。检索词包括“Vonoprazan”，“TAK-438”，“gastroesophageal reflux”，“GERD”，“erosive esophagitis”，“non-erosive reflux disease”，“reflux esophagitis”，“沃诺拉赞”，“伏诺拉生”，“富马酸沃诺拉赞”，“糜烂性食管炎”，“非糜烂性反流病”，“反流性食管炎”等。由2名评价者独立对纳入文献进行数据提取、质量评价，应用RevMan5.4统计学软件进行数据分析。

结果

在数据库中搜索到107篇文献，通过追查其参考文献，又得到一项研究添加到分析中。共108篇文献，筛选后最终有10篇文献纳入分析。在主要分析中，伏诺拉生与对照组之间的疗效（RR=1.07，95%CI：1.01~1.13），无明显差异（P＞0.05）。在基线分析中，严重食管炎（LA分级C/D级）患者的亚组分析疗效比质子泵抑制剂（PPIs）显著（RR=1.14，95%CI：1.06~1.22；P＜0.05）。不同剂量的伏诺拉生作为对照组，分析结果显示（RR=1.36，95%CI：1.03~1.79），无明显差异（P＞0.05）。

结论

伏诺拉生治疗GERD疗效优于PPIs，尤其在严重食管炎（LA分级C/D级）中更具优势。其安全性类似于PPIs。10、20、40 mg不同剂量的伏诺拉生对GERD疗效无差异。

关键词: 胃食管反流病, 伏诺拉生, Meta分析, 反流性食管炎
Objective

To evaluate the efficacy of Vonoprazan to treat gastroesophageal reflux disease (GERD).

Methods

The randomized controlled trials of Vonoprazan in the treatment of gastroesophageal reflux disease were retrieved in the Cochrane Library, PubMed, EMBASE, China Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), and WanFang Data. The key words included "Vonoprazan", "TAK-438","gastroesophageal reflux", "GERD", "erosive esophagitis", "non-erosive reflux disease", "reflux esophagitis". Data extraction and the evaluation of the inclusive literature quality were conducted independently by 2 reviewers . Meta-analysis was carried out by the RevMan software5.4.

Results

we obtained 108 publications through searching the literature dababase and cited references. And after removal of the study with the exclusive criteria, 10 remained. In the main analysis, there was no significant difference (P>0.05) in the efficacy between Vonoprazan and the control group (RR=1.07, 95%CI: 1.01-1.13). In the baseline analysis, the subgroup analysis showed significant effective therapy in the severe esophagitis (LA grade C/D) compared with the proton pump inhibitors (PPIs) (RR=1.14, 95%CI: 1.06-1.22; P<0.05). however, the analysis results indicated that no significant difference cound be seen in different doses of vonoprazan as a therapy in GERD. (P>0.05) (RR=1.36, 95% CI: 1.03-1.79).

Conclusion

Vonoprazan is more effective than PPIs in the treatment of GERD, especially in severe esophagitis (LA grade C/D). The safety is similar to PPIs. And 10mg, 20mg, or 40 mg vonoprazan present with the same efficacy in the treatment of GERD.

Key words: gastroesophageal reflux disease, Vonoprazan, meta-analysis, reflux esophagitis
图1 文献筛选流程图及结果
表1 纳入研究的基本特征
作者 国家 出版年份 干预措施 持续时间 有效率 结局指标 病例数（I/C）
Ashida et al［5］ 日本 2015 Vo 20 mg vs Lan 30 mg 8 周 96.5% vs 95.5% 愈合率 276（144/132）
Ashida et al［6］ 日本 2016 Vo 20 mg vs Lan 30 mg 8 周 99% vs 96% 愈合率 404（205/199）
Iwakiri et al［7］ 日本 2017 Vo 20 mg vs Vo 40 mg 8 周 60% vs 71.4% 愈合率 12（5/7）
Ashida et al［8］ 日本 2018 Vo 20 mg vs Lan 15 mg 24 周 98% vs 83.2% 愈合率 397（201/196）
Oshima et al［9］ 日本 2019 Vo 20 mg vs Lan 30 mg 1 周 68.8% vs 25% 症状缓解 32（16/16）
Sakurai et al［10］ 日本 2019 Vo 20 mg vs Es 20 mg 4 周 81.8% vs 88% 症状缓解 47（22/25）
Xiao et al［11］ 中国 2020 Vo 20 mg vs Lan 30 mg 8 周 92.4% vs 91.3% 愈合率 468（238/230）
Okanobu et al［12］ 日本 2021 Vo 20 mg vs Vo 10 mg 4 周 64.6% vs 94.4% 愈合率 72（37/36）
黄博等［13］ 中国 2021 Vo 20 mg vs Eso20 mg 4 周 93.3% vs 63.3.% 愈合率 60（30/30）
MatsudaS et al［14］ 日本 2022 Vo 10 mg vs Lan 15 mg 8 周 59.8% vs 54.5% 症状缓解 224（67/61）
图2 纳入研究的偏倚风险评价结果
图3 伏诺拉生治疗胃食管反流病的整体疗效的Meta分析
图4 伏诺拉生治疗胃食管反流病不良事件的Meta分析
图5 伏诺拉生4或8周标准治疗疗效的Meta分析
图6 伏诺拉生治疗不同严重程度反流性食管炎的Meta分析：a为C/D级亚组分析，b为A/B级亚组分析
图7 不同剂量的伏诺拉生为对照组治愈率的Meta分析
图8 伏诺拉生治疗胃食管反流病症状缓解情况的Meta分析（通过FSSG评分评估）
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