Department of Gastroenterology, Machida Municipal Hospital, Tokyo, Japan.
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan.
Dig Endosc. 2017 Jul;29(5):576-583. doi: 10.1111/den.12857. Epub 2017 Apr 5.
Proton pump inhibitors are effective for the treatment of gastric ulcers after endoscopic submucosal dissection (ESD). However, the most excellent therapy is controversial. Vonoprazan, an active potassium-competitive acid blocker, has a strong gastric acid secretion inhibitory effect, but its efficacy for the treatment of post-ESD gastric ulcers is unclear. Herein, we aimed to determine the healing effect of vonoprazan on post-ESD gastric ulcers.
We carried out a prospective randomized controlled trial examining 92 patients who had undergone ESD for the treatment of gastric neoplasms between April 2015 and June 2016 at Machida Municipal Hospital. Patients were treated with 20 mg/day vonoprazan (V group) or 20 mg/day esomeprazole (E group) for 8 weeks. We evaluated the 8-week cure rate for artificial ulcers and any complications after ESD.
A total of 80 patients (median age, 73.5 years; 71.3% male) were analyzed. Cure rate for the V group was significantly higher than that for the E group (94.9% [37/39] vs 78.0% [32/41], respectively; P = 0.049). In a multivariate analysis, only vonoprazan was correlated with ulcer healing (odds ratio = 6.33; 95% CI = 1.21-33.20; P = 0.029). Delayed bleeding was experienced only in the E group (7.3% [3/41]), but no significant difference compared with the V group was observed (P = 0.241).
Vonoprazan was significantly superior to esomeprazole for the healing of post-ESD gastric ulcers and should be considered as a treatment of first choice.
质子泵抑制剂（PPI）对内镜黏膜下剥离术（ESD）后胃溃疗效确切。然而，最佳治疗方案仍存在争议。沃诺拉赞是一种有效的钾离子竞争性酸阻滞剂，具有很强的胃酸分泌抑制作用，但治疗 ESD 后胃溃的疗效尚不清楚。本研究旨在探讨沃诺拉赞治疗 ESD 后胃溃的疗效。
我们开展了一项前瞻性随机对照试验，纳入 2015 年 4 月至 2016 年 6 月在町田市医院接受 ESD 治疗的胃肿瘤患者 92 例。患者分别接受沃诺拉赞 20mg/d（V 组）或埃索美拉唑 20mg/d（E 组）治疗 8 周。评估 8 周时人工溃疡的愈合率和 ESD 后并发症。
共 80 例患者（中位年龄 73.5 岁，71.3%为男性）纳入分析。V 组的愈合率显著高于 E 组（94.9%[37/39] vs. 78.0%[32/41]，P=0.049）。多因素分析显示，只有沃诺拉赞与溃疡愈合相关（比值比=6.33，95%CI=1.21-33.20，P=0.029）。E 组仅发生延迟性出血（7.3%[3/41]），但与 V 组比较差异无统计学意义（P=0.241）。
沃诺拉赞治疗 ESD 后胃溃的愈合率显著优于埃索美拉唑，应作为首选治疗药物。
