Kang Hyun, Kim Beom Jin, Choi Geunjoo, Kim Jae Gyu
Department of Anesthesiology and Pain Medicine.
Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.
Medicine (Baltimore). 2018 Sep;97(39):e12574. doi: 10.1097/MD.0000000000012574.
Vonoprazan, a novel potassium-competitive acid blocking agent, is used in the management of gastroesophageal reflux disease (GERD). We aim to perform a systematic review and meta-analysis for the comparison of the effects of vonoprazan and proton pump inhibitors (PPIs) in GERD in randomized controlled trials (RCTs).
A systematic and comprehensive search will be performed using MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, and clinical trial registries, for studies published up to September 2018. Only randomized clinical trials will be included. Primary outcomes of symptoms and esophageal erosion improvement in the intention-to-treat analysis, and secondary outcomes of symptoms and esophageal erosion improvement rate in the per protocol analysis, the comparative efficacy in terms of healing rate of esophageal erosion on endoscopy, the comparative efficacy in terms of improvement of esophageal impedance-pH study, adverse events, long-term safety, and the comparative efficacy in terms of CYP2C19 metabolite levels will be studied. The quality of included studies will be assessed using the modified risk of bias tool. Heterogeneity of estimates across studies as well as publication bias will be assessed. This systematic review and meta-analysis will be performed according to the protocol recommended by the Cochrane Collaboration and reported according to the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines. All statistical analyses will be conducted using Stata SE version 15.0.
The results of this systematic review and meta-analysis will be published in a peer-reviewed journal.
To our knowledge, this systematic review and meta-analysis will be the first to evaluate existing research comparing Vonoprazan and PPIs in GERD. Our study will provide information about the effect of vonoprazan and PPIs in GERD in RCTs. The review will benefit patients, healthcare providers, and policymakers.
沃克帕唑是一种新型钾离子竞争性酸阻滞剂，用于治疗胃食管反流病（GERD）。我们旨在进行一项系统评价和荟萃分析，以比较在随机对照试验（RCT）中沃克帕唑与质子泵抑制剂（PPI）治疗GERD的效果。
将使用MEDLINE、EMBASE、Cochrane对照试验中心注册库（CENTRAL）、谷歌学术以及临床试验注册库进行系统全面的检索，以获取截至2018年9月发表的研究。仅纳入随机临床试验。在意向性分析中症状和食管糜烂改善的主要结局，在符合方案分析中症状和食管糜烂改善率的次要结局，在内镜检查中食管糜烂愈合率方面的比较疗效，食管阻抗-pH研究改善方面的比较疗效，不良事件、长期安全性以及CYP2C19代谢物水平方面的比较疗效将被研究。将使用改良的偏倚风险工具评估纳入研究的质量。将评估各研究估计值的异质性以及发表偏倚。本系统评价和荟萃分析将根据Cochrane协作网推荐的方案进行，并按照系统评价和荟萃分析的首选报告项目（PRISMA）指南进行报告。所有统计分析将使用Stata SE 15.0版进行。
本系统评价和荟萃分析的结果将发表在同行评审期刊上。
据我们所知，本系统评价和荟萃分析将是首个评估比较沃克帕唑与PPI治疗GERD的现有研究。我们的研究将提供关于在RCT中沃克帕唑与PPI治疗GERD效果的信息。该评价将使患者、医疗服务提供者和政策制定者受益。
