Abstract：
OBJECTIVE: Up to 40% of gastroesophageal reflux disease (GERD) patients experience inadequate symptom relief with a proton pump inhibitor (PPI), termed PPI-resistant or refractory GERD. Vonoprazan, a potassium-competitive acid blocker, has better efficacy than PPI in suppressing gastric acid secretion. This meta-analysis summarizes the efficacy and safety of vonoprazan for treating PPI-resistant GERD (both erosive esophagitis [EE] and non-erosive reflux disease [NERD]).
METHODS: Four electronic databases (Medline, Embase, SCOPUS, and CENTRAL) were searched for studies indexed until August 1, 2023. Both observational studies and clinical trials assessing the efficacy and safety of vonoprazan in PPI-resistant GERD were included. Efficacy outcomes included healing and maintenance rates of EE and improvement of the Frequency Scale for Symptoms of GERD (FSSG) scores. Serious adverse events (SAEs) were considered a safety outcome. The modified Newcastle-Ottawa Scale (NOS) was used to assess study quality.
RESULTS: Twelve studies were included in this meta-analysis. Healing rates of PPI-resistant EE with vonoprazan 20 mg were 91.7% (95% CI 86.8-94.8%) and 88.5% (95% CI 69.7-96.2%) at weeks 4 and 8, respectively. For healed PPI-resistant EE, the overall maintenance rates with vonoprazan 10 mg were 82.6% (95% 61.2-95.0%) at week 8, 86.0% (95% CI 72.1-94.7%) at week 24, and 93.8% (95% CI 69.8-99.8%) at week 48. FSSG scores were improved in 74.6% (95% CI 65.8-81.7%) and 51.9% (95% CI 37.8-65.7%) of patients at weeks 4 and 8. Overall, no SAE was reported.
CONCLUSIONS: Vonoprazan demonstrated high efficacy in the healing and maintenance of PPI-resistant EE and moderate efficacy for the improvement of FSSG score. Vonoprazan was well tolerated in PPI-resistant GERD patients.
METHODS: Four electronic databases (Medline, Embase, SCOPUS, and CENTRAL) were searched for studies indexed until August 1, 2023. Both observational studies and clinical trials assessing the efficacy and safety of vonoprazan in PPI-resistant GERD were included. Efficacy outcomes included healing and maintenance rates of EE and improvement of the Frequency Scale for Symptoms of GERD (FSSG) scores. Serious adverse events (SAEs) were considered a safety outcome. The modified Newcastle-Ottawa Scale (NOS) was used to assess study quality.
RESULTS: Twelve studies were included in this meta-analysis. Healing rates of PPI-resistant EE with vonoprazan 20 mg were 91.7% (95% CI 86.8-94.8%) and 88.5% (95% CI 69.7-96.2%) at weeks 4 and 8, respectively. For healed PPI-resistant EE, the overall maintenance rates with vonoprazan 10 mg were 82.6% (95% 61.2-95.0%) at week 8, 86.0% (95% CI 72.1-94.7%) at week 24, and 93.8% (95% CI 69.8-99.8%) at week 48. FSSG scores were improved in 74.6% (95% CI 65.8-81.7%) and 51.9% (95% CI 37.8-65.7%) of patients at weeks 4 and 8. Overall, no SAE was reported.
CONCLUSIONS: Vonoprazan demonstrated high efficacy in the healing and maintenance of PPI-resistant EE and moderate efficacy for the improvement of FSSG score. Vonoprazan was well tolerated in PPI-resistant GERD patients.
摘要：
目的：高达40%的胃食管反流病（GERD）患者使用质子泵抑制剂（PPI）症状缓解不充分，称为PPI抗性或难治性GERD。沃诺拉赞,钾竞争性酸阻滞剂，在抑制胃酸分泌方面比PPI具有更好的疗效。这项荟萃分析总结了vonoprazan治疗PPI耐药性GERD（糜烂性食管炎[EE]和非糜烂性反流病[NERD]）的疗效和安全性。
方法：四个电子数据库(Medline，Embase,Scopus,和CENTRAL)搜索索引到2023年8月1日的研究。纳入了评估vonoprazan在PPI耐药GERD中的疗效和安全性的观察性研究和临床试验。疗效结果包括EE的愈合和维持率以及GERD症状频率量表（FSSG）评分的改善。严重不良事件(SAE)被认为是安全结果。改良的纽卡斯尔-渥太华量表（NOS）用于评估研究质量。
结果：本荟萃分析包括12项研究。在第4周和第8周，使用20mgvonoprazan的PPI抗性EE的治愈率分别为91.7％（95％CI86.8-94.8％）和88.5％（95％CI69.7-96.2％）。对于治愈的PPI抗性EE，vonoprazan10mg在第8周时的总体维持率为82.6%(95%61.2-95.0%),在第24周时为86.0%(95%CI72.1-94.7%),在第48周时为93.8%(95%CI69.8-99.8%).在第4周和第8周，74.6%(95%CI65.8-81.7%)和51.9%(95%CI37.8-65.7%)的患者FSSG评分得到改善。总的来说,没有SAE报告。
结论：Vonoprazan在治疗和维持PPI抵抗的EE方面具有很高的疗效，在改善FSSG评分方面具有中等疗效。Vonoprazan在PPI耐药的GERD患者中具有良好的耐受性。
方法：四个电子数据库(Medline，Embase,Scopus,和CENTRAL)搜索索引到2023年8月1日的研究。纳入了评估vonoprazan在PPI耐药GERD中的疗效和安全性的观察性研究和临床试验。疗效结果包括EE的愈合和维持率以及GERD症状频率量表（FSSG）评分的改善。严重不良事件(SAE)被认为是安全结果。改良的纽卡斯尔-渥太华量表（NOS）用于评估研究质量。
结果：本荟萃分析包括12项研究。在第4周和第8周，使用20mgvonoprazan的PPI抗性EE的治愈率分别为91.7％（95％CI86.8-94.8％）和88.5％（95％CI69.7-96.2％）。对于治愈的PPI抗性EE，vonoprazan10mg在第8周时的总体维持率为82.6%(95%61.2-95.0%),在第24周时为86.0%(95%CI72.1-94.7%),在第48周时为93.8%(95%CI69.8-99.8%).在第4周和第8周，74.6%(95%CI65.8-81.7%)和51.9%(95%CI37.8-65.7%)的患者FSSG评分得到改善。总的来说,没有SAE报告。
结论：Vonoprazan在治疗和维持PPI抵抗的EE方面具有很高的疗效，在改善FSSG评分方面具有中等疗效。Vonoprazan在PPI耐药的GERD患者中具有良好的耐受性。
