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前瞻性随机对照试验比较奥美拉唑和法莫替丁预防内镜黏膜下剥离术后迟发性出血和促进溃疡愈合的效果。

Prospective randomized controlled trial to compare the effects of omeprazole and famotidine in preventing delayed bleeding and promoting ulcer healing after endoscopic submucosal dissection.

机构信息

Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.

出版信息

J Gastroenterol Hepatol. 2012 Sep;27(9):1441-6. doi: 10.1111/j.1440-1746.2012.07144.x.

DOI:10.1111/j.1440-1746.2012.07144.x
PMID:22497427
Abstract

BACKGROUND AND AIMS

Proton pump inhibitors (PPIs) are generally used to prevent delayed bleeding after endoscopic submucosal dissection (ESD) and to heal the artificial ulcers. However, it remains controversial whether PPIs or histamine-2 receptor antagonists (H(2) RAs) are more effective in preventing delayed bleeding after ESD. We prospectively compared the effects of omeprazole and famotidine in preventing delayed bleeding and promoting artificial ulcer healing after ESD.

METHODS

A total of 158 patients (155 early gastric cancers and three adenomas) were randomly assigned to the PPI group (omeprazole 20 mg/day) or H(2) RA group (famotidine 40 mg/day) in a prospective randomized controlled trial. The primary end point was the incidence of hematemesis, melena, and/or a decrease in hemoglobin level of 2 g/dL or more requiring endoscopic hemostatic treatment. ESD-induced ulcer healing and changes in ulcer size were also compared at 6 weeks after ESD as a secondary end point.

RESULTS

Of the 158 patients, two were excluded from analysis because they had been treated with a PPI before the present study. Accordingly, data from 77 PPI and 79 H(2) RA subjects were included for analysis. Delayed bleeding after ESD occurred in 6.5% of subjects (PPI group) and in 6.3% (H(2) RA group); there was no significant difference between the two groups. Likewise, the two groups were not significantly different with respect to ulcer stage or ulcer size reduction rate.

CONCLUSIONS

Proton pump inhibitors are not superior to H(2) RAs for the prevention of delayed bleeding or the healing of artificially induced ulcers after ESD.

摘要

背景与目的

质子泵抑制剂(PPIs)通常用于预防内镜黏膜下剥离(ESD)后延迟性出血,并促进人工溃疡愈合。然而,PPIs 与组胺 2 受体拮抗剂(H2RAs)在预防 ESD 后延迟性出血方面哪个更有效仍存在争议。我们前瞻性比较了奥美拉唑和法莫替丁在预防 ESD 后延迟性出血和促进人工溃疡愈合方面的效果。

方法

158 例患者(155 例早期胃癌和 3 例腺瘤)被随机分配至 PPI 组(奥美拉唑 20mg/天)或 H2RA 组(法莫替丁 40mg/天),进行前瞻性随机对照试验。主要终点是呕血、黑便和/或血红蛋白水平下降 2g/dL 或以上需要内镜止血治疗的发生率。次要终点是比较 ESD 后 6 周时 ESD 诱导的溃疡愈合和溃疡大小的变化。

结果

158 例患者中,有 2 例因在本研究前已接受 PPI 治疗而被排除在分析之外。因此,有 77 例 PPI 和 79 例 H2RA 患者的数据被纳入分析。ESD 后延迟性出血的发生率为 6.5%(PPI 组)和 6.3%(H2RA 组),两组间无显著差异。同样,两组在溃疡分期或溃疡缩小率方面也无显著差异。

结论

质子泵抑制剂在预防 ESD 后延迟性出血或人工诱导溃疡愈合方面并不优于 H2RAs。

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