Mizuno Hideki, Inagaki Shingo, Yamada Kazutoshi, Kamiyamamoto Shinji
Department of Gastroenterology, Toyama City Hospital, Toyama 939-8511, Japan.
Biomed Rep. 2025 Jul 30;23(4):160. doi: 10.3892/br.2025.2038. eCollection 2025 Oct.
Vonoprazan is a potassium-competitive acid blocker that provides more potent and sustained acid suppression than conventional proton pump inhibitors (PPIs). Vonoprazan may serve a role in the long-term management of gastroesophageal reflux disease (GERD), particularly in patients with reflux esophagitis (RE) who are unresponsive to PPIs. The present study aimed to evaluate the safety, tolerability and efficacy of vonoprazan over a 96-week period in patients with PPI-refractory RE. Initially, 74 patients received vonoprazan 20 mg once daily for 4 weeks. Patients who demonstrated mucosal healing transitioned to vonoprazan 10 mg once daily for a 48-week maintenance phase. Of these, 43 patients continued therapy for an additional 48 weeks. Endoscopic evaluation, symptom scores using the Frequency Scale for the Symptoms of GERD and serum gastrin levels were monitored to assess treatment outcomes and safety. By the end of the 96-week maintenance period, 85.7% of patients who completed follow-up showed no recurrence of mucosal lesions. Among those who discontinued therapy following symptom resolution, 45.8% experienced symptom relapse; however, these patients responded well to reintroduction of vonoprazan. Although serum gastrin levels in the continuous maintenance therapy remained elevated, no adverse events such as carcinoid tumors were reported. These findings suggested that vonoprazan was both effective and well-tolerated as a long-term maintenance therapy for RE and may serve as a viable on-demand treatment strategy for relapse management. While the results are promising, they stem from a highly selected population. Therefore, further randomized, controlled trials are warranted to confirm the generalizability and long-term safety of vonoprazan in broader GERD populations.
沃克（富马酸伏诺拉生）是一种钾离子竞争性酸阻滞剂，与传统质子泵抑制剂（PPI）相比，它能提供更强效、更持久的抑酸作用。沃克在胃食管反流病（GERD）的长期管理中可能发挥作用，特别是在对PPI无反应的反流性食管炎（RE）患者中。本研究旨在评估沃克在PPI难治性RE患者中96周的安全性、耐受性和疗效。最初，74例患者接受每日一次20mg沃克治疗4周。表现出黏膜愈合的患者进入为期48周的维持期，改为每日一次10mg沃克治疗。其中，43例患者继续治疗48周。通过内镜评估、使用GERD症状频率量表进行症状评分以及监测血清胃泌素水平来评估治疗效果和安全性。在96周维持期结束时，完成随访的患者中有85.7%未出现黏膜病变复发。在症状缓解后停药的患者中，45.8%出现症状复发；然而，这些患者再次使用沃克后反应良好。虽然持续维持治疗中的血清胃泌素水平仍保持升高，但未报告类癌肿瘤等不良事件。这些发现表明，沃克作为RE的长期维持治疗既有效又耐受性良好，并且可作为复发管理的一种可行的按需治疗策略。虽然结果很有前景，但它们来自高度选择的人群。因此，有必要进行进一步的随机对照试验，以确认沃克在更广泛的GERD人群中的普遍性和长期安全性。
