Gotoh Yasuhiko, Ishibashi Emiko, Honda Shunichiro, Nakaya Tomohisa, Noguchi Chishio, Kagawa Koichi, Murakami Kazunari
Department of Gastroenterology, Shin Beppu Hospital, Beppu.
Department of Gastroenterology, Oita University Hospital, Yufu, Oita, Japan.
Medicine (Baltimore). 2020 Mar;99(11):e19520. doi: 10.1097/MD.0000000000019520.
Proton pump inhibitors (PPIs) have been the first line treatment for gastroesophageal reflux disease (GERD). The aim of this study was to evaluate the efficacy of vonoprazan (VPZ), a potassium-competitive acid blocker for reflux esophagitis (RE), nonerosive reflux disease (NERD), and PPI-resistant GERD patients.An open-label, single-center, observational study in our hospital was performed from August 2016 to August 2017. All patients diagnosed with GERD were asked to self-report a questionnaire of frequency scale for the symptoms of GERD (FSSG) and rate their degree of satisfaction with the treatment of GERD during outpatient visit. A total of 200 (RE 47, NERD 49, PPI-resistant GERD 104) patients were included in the present study. The primary endpoint was the change of FSSG and the proportion of degree of satisfaction with the treatment at the end of the initial therapy. A percentage of improvement (improvement rate) and resolution (resolution rate) at the end of the initial therapy were evaluated. Secondary endpoint included the proportion of patients with symptomatic relapse in the 24-week maintenance phase.FSSG and the degree of satisfaction were significantly improved after the initial therapy in every group. Improvement and resolution rate after the initial therapy were 83.0% and 67.0% in RE, 66.7% and 60.4% in NERD, and 76.0% and 60.4% in PPI-resistant group. There was no significance between after the initial therapy and 24 weeks in improvement and resolution rate. Thirty-two of the total 48 patients did not take VPZ at 24 weeks. Total FSSG score in each group was 1.67 ± 1.97, 2.71 ± 4.91, and 4.0 ± 4.93. The nonrelapse rate at 24 weeks in each group was 66.7%, 60.0%, and 50.0%. The resolution rate at 24 weeks in each group was 38.9%, 45.0%, and 30.0%.The VPZ therapy is effective for initial and maintenance therapy and improves heartburn and patient's satisfaction significantly in all 3 groups. Among patients who stopped taking VPZ during the maintenance period, 42.0% of RE and NERD group and 30% of PPI-resistant group experience complete remission from GERD at 24 weeks by introduction of VPZ.
质子泵抑制剂（PPIs）一直是胃食管反流病（GERD）的一线治疗药物。本研究旨在评估沃克米唑（VPZ），一种钾离子竞争性酸阻滞剂，对反流性食管炎（RE）、非糜烂性反流病（NERD）以及对PPI耐药的GERD患者的疗效。2016年8月至2017年8月在我院进行了一项开放标签、单中心的观察性研究。所有被诊断为GERD的患者被要求自行填写一份GERD症状频率量表问卷（FSSG），并在门诊就诊时对GERD治疗的满意度进行评分。本研究共纳入200例患者（RE 47例、NERD 49例、对PPI耐药的GERD 104例）。主要终点是初始治疗结束时FSSG的变化以及治疗满意度的比例。评估了初始治疗结束时的改善百分比（改善率）和缓解百分比（缓解率）。次要终点包括24周维持期内症状复发患者的比例。每组在初始治疗后FSSG和满意度均有显著改善。RE组初始治疗后的改善率和缓解率分别为83.0%和67.0%，NERD组为66.7%和60.4%，PPI耐药组为76.0%和60.4%。初始治疗后与24周时的改善率和缓解率无显著差异。48例患者中有32例在24周时未服用VPZ。每组的FSSG总分分别为1.67±1.97、2.71±4.91和4.0±4.93。每组24周时的无复发率分别为66.7%、60.0%和50.0%。每组24周时的缓解率分别为38.9%、45.0%和30.0%。VPZ治疗对初始治疗和维持治疗均有效，且在所有三组中均能显著改善烧心症状和患者满意度。在维持期停止服用VPZ的患者中，RE组和NERD组有42.0%、PPI耐药组有30%在24周时通过重新引入VPZ实现了GERD的完全缓解。
