Department of Gastroenterology, St Luke's International Hospital, Tokyo, Japan.
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Gastroenterological Endoscopy, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.
Gastrointest Endosc. 2022 Jan;95(1):72-79.e3. doi: 10.1016/j.gie.2021.06.032. Epub 2021 Jul 6.
The effectiveness of vonoprazan relative to that of proton pump inhibitors (PPIs) after gastric endoscopic submucosal dissection (ESD) is unclear. Although previous studies used post-ESD ulcer healing as the outcome measure, post-ESD bleeding rate is the most objective and appropriate outcome measure because it has less ascertainment bias. We aimed to compare the post-ESD bleeding rates between vonoprazan and PPIs.
This nationwide population-based retrospective cohort study was conducted between 2014 and 2018 and involved 9 hospitals. After 2 days of intravenous PPI administration, either vonoprazan or PPI was administrated from postoperative day 2 to 30.
Overall, data of 1715 patients (627 patient pairs) were analyzed through propensity score matching. The vonoprazan group had significantly lower post-ESD bleeding rates than the PPI group (overall, 11.9% vs 17.2%, P = .008; bleeding between days 2 and 30, 7.8% vs 11.8%, P = .015). The readmission rate because of post-ESD bleeding was lower in the vonoprazan group (2.4% vs 4.1%, P = .081). Blood transfusion (2.1% vs 3.0%, P = .15) and additional surgery because of delayed perforation (.5% vs 1.0%, P = .32) were not significantly different between the 2 groups. No deaths within 30 days occurred in both groups. On Cox regression analysis, vonoprazan use, lesion location (antrum), aspirin use, direct oral anticoagulant use, and Charlson Comorbidity Index (≥2) were associated with an increased risk of post-ESD bleeding within 30 days.
Vonoprazan has a lower post-ESD bleeding rate than PPIs. Further prospective studies are required to confirm these results.
在胃内镜黏膜下剥离术（ESD）后，沃诺拉赞相对于质子泵抑制剂（PPIs）的疗效尚不清楚。虽然之前的研究使用 ESD 后溃疡愈合作为结局指标，但 ESD 后出血率是最客观和合适的结局指标，因为它的确定偏倚较小。我们旨在比较沃诺拉赞和 PPIs 之间 ESD 后出血率。
这是一项全国范围内基于人群的回顾性队列研究，于 2014 年至 2018 年进行，涉及 9 家医院。静脉注射 PPI 给药 2 天后，从术后第 2 天至 30 天给予沃诺拉赞或 PPI。
总体而言，通过倾向评分匹配分析了 1715 例患者（627 对患者）的数据。沃诺拉赞组 ESD 后出血率明显低于 PPI 组（总体为 11.9% vs. 17.2%，P=0.008；术后 2 至 30 天出血率为 7.8% vs. 11.8%，P=0.015）。沃诺拉赞组因 ESD 后出血而再入院率较低（2.4% vs. 4.1%，P=0.081）。输血（2.1% vs. 3.0%，P=0.15）和因延迟穿孔而进行的额外手术（0.5% vs. 1.0%，P=0.32）在两组之间无显著差异。两组均无 30 天内死亡病例。Cox 回归分析显示，沃诺拉赞使用、病变位置（胃窦）、阿司匹林使用、直接口服抗凝剂使用和 Charlson 合并症指数（≥2）与 30 天内 ESD 后出血风险增加相关。
沃诺拉赞的 ESD 后出血率低于 PPIs。需要进一步的前瞻性研究来证实这些结果。
