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内镜黏膜下剥离术后胃出血患者中应用 vonoprazan 与质子泵抑制剂的对比:一项多中心基于人群的对照研究。

Vonoprazan versus proton pump inhibitors for postendoscopic submucosal dissection bleeding in the stomach: a multicenter population-based comparative study.

机构信息

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.

出版信息

Gastrointest Endosc. 2022 Jan;95(1):72-79.e3. doi: 10.1016/j.gie.2021.06.032. Epub 2021 Jul 6.

Abstract

BACKGROUND AND AIMS

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

Vonoprazan has a lower post-ESD bleeding rate than PPIs. Further prospective studies are required to confirm these results.

摘要

背景和目的

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。

方法

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。

结果

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。

结论

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。

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