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内镜黏膜下剥离术后治疗人工胃溃疡:Vonoprazan 与兰索拉唑的随机、开放标签试验。

Vonoprazan versus lansoprazole in the treatment of artificial gastric ulcers after endoscopic submucossal dissection: a randomized, open-label trial.

机构信息

Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan.

出版信息

BMC Gastroenterol. 2021 May 22;21(1):236. doi: 10.1186/s12876-021-01822-5.

DOI:10.1186/s12876-021-01822-5
PMID:34022796
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8141195/
Abstract

BACKGROUND

Vonoprazan is more potent and longer acting than traditional proton pump inhibitor. Although vonoprazan is expected to be superior to proton pump inhibitor, its efficacy in the treatment of gastric ulcers following endoscopic submucosal dissection (ESD) is not fully understood. The aim of this study was to evaluate the effectiveness of vonoprazan in artificial ulcer healing following ESD.

METHODS

Patients with gastric tumors were randomly assigned to the vonoprazan group (group V) or lansoprazole group (group L) after ESD. Patients received intravenous lansoprazole (30 mg) twice on the day of ESD. Thereafter, patients were treated with vonoprazan (20 mg/day) in group V or lansoprazole (30 mg/day) in group L. Esophagogastroduodenoscopy was performed 4 and 8 weeks after the ESD.

RESULTS

A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in group V versus group L (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups. Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD.

CONCLUSIONS

Vonoprazan might not be superior to lansoprazole in the healing of artificial gastric ulcer after ESD.

TRIAL REGISTRATION

University hospital Medical Information Network (registration number: UMIN000016642), Registered 27 February 2015, https://www.umin.ac.jp/ctr/index-j.htm.

摘要

背景

沃诺拉赞比传统质子泵抑制剂作用更强、作用时间更长。尽管沃诺拉赞有望优于质子泵抑制剂,但它在治疗内镜黏膜下剥离(ESD)后的胃溃疡方面的疗效尚不完全清楚。本研究旨在评估沃诺拉赞在 ESD 后人工溃疡愈合中的疗效。

方法

在 ESD 后,胃肿瘤患者被随机分配到沃诺拉赞组(V 组)或兰索拉唑组(L 组)。患者在 ESD 当天接受静脉注射兰索拉唑(30mg)两次。此后,V 组患者接受沃诺拉赞(20mg/天)治疗,L 组患者接受兰索拉唑(30mg/天)治疗。ESD 后 4 周和 8 周进行食管胃十二指肠镜检查。

结果

共分析了 168 例患者。V 组与 L 组人工溃疡的 4 周愈合率无显著差异(分别为 17/85,20.0%和 14/83,16.9%)。此外,两组的 4 周缩小率无显著差异。V 组患者均无术后出血,L 组患者中有 3 例发生术后出血。V 组中有 1 例患者在 ESD 后 2 天出现迟发性穿孔。

结论

沃诺拉赞在 ESD 后人工胃溃疡的愈合方面可能不如兰索拉唑。

试验注册

大学医院医疗信息网络(注册号:UMIN000016642),注册于 2015 年 2 月 27 日,https://www.umin.ac.jp/ctr/index-j.htm。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0474/8141195/acee943d21c2/12876_2021_1822_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0474/8141195/e9d4bc7f4fc1/12876_2021_1822_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0474/8141195/d03483f6d685/12876_2021_1822_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0474/8141195/acee943d21c2/12876_2021_1822_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0474/8141195/e9d4bc7f4fc1/12876_2021_1822_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0474/8141195/d03483f6d685/12876_2021_1822_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0474/8141195/acee943d21c2/12876_2021_1822_Fig3_HTML.jpg

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