Abe Hiroko, Hatta Waku, Ogata Yohei, Koike Tomoyuki, Saito Masahiro, Jin Xiaoyi, Nakagawa Kenichiro, Kanno Takeshi, Uno Kaname, Asano Naoki, Imatani Akira, Nakamura Tomohiro, Nakaya Naoki, Tarasawa Kunio, Fujimori Kenji, Fushimi Kiyohide, Masamune Atsushi
Division of Gastroenterology, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Department of Health Record Informatics, Tohoku Medical Megabank Organization, Tohoku University, Sendai, Japan.
J Gastroenterol. 2021 Jul;56(7):640-650. doi: 10.1007/s00535-021-01781-4. Epub 2021 Apr 19.
Delayed bleeding is the major adverse event in upper gastrointestinal endoscopic treatment (UGET). We aimed to investigate the efficacy of vonoprazan, which is the novel strong antisecretory agent, to reduce the risk for delayed bleeding in comparison with proton pump inhibitors (PPIs) in UGET.
This retrospective population-based cohort study used the Diagnosis Procedure Combination database in Japan. We included patients on vonoprazan or PPI in UGET between 2014 and 2019. The primary outcome was delayed bleeding. We conducted propensity score matching to balance the comparison groups, and logistic regression analyses to compare the bleeding outcomes.
We enrolled 124,422 patients, in which 34,822 and 89,600 were prescribed with vonoprazan and PPI, respectively. After propensity score matching, the risk for delayed bleeding was lower in vonoprazan than in PPI (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.71-0.80), consistent with sensitivity analysis results. In the subgroup analyses of seven UGET procedures, vonoprazan was significantly advantageous in esophageal endoscopic submucosal dissection (E-ESD) (OR, 0.71; 95% CI, 0.54-0.94) and gastroduodenal endoscopic submucosal dissection (GD-ESD) (OR, 0.70; 95% CI, 0.65-0.75), although correction for multiple testing of the outcome data removed the significance in E-ESD. These results were also consistent with sensitivity analysis results. In the five other procedures, no significant advantage was found.
This nationwide study found that, compared with PPI, vonoprazan can reduce delayed bleeding with approximately 30% in GD-ESD. Vonoprazan has the possibility to become a new treatment method for preventing delayed bleeding in this procedure.
延迟性出血是上消化道内镜治疗（UGET）中的主要不良事件。我们旨在研究新型强效抑酸剂沃克（富马酸伏诺拉生）与质子泵抑制剂（PPIs）相比，在UGET中降低延迟性出血风险的疗效。
这项基于人群的回顾性队列研究使用了日本的诊断程序组合数据库。我们纳入了2014年至2019年间接受UGET并使用沃克或PPI的患者。主要结局是延迟性出血。我们进行倾向得分匹配以平衡比较组，并进行逻辑回归分析以比较出血结局。
我们纳入了124422例患者，其中分别有34822例和89600例患者使用了沃克和PPI。倾向得分匹配后，沃克组延迟性出血的风险低于PPI组（比值比[OR]，0.75；95%置信区间[CI]，0.71 - 0.80），与敏感性分析结果一致。在七种UGET手术的亚组分析中，沃克在食管内镜黏膜下剥离术（E - ESD）（OR，0.71；95% CI，0.54 - 0.94）和胃十二指肠内镜黏膜下剥离术（GD - ESD）（OR，0.70；95% CI，0.65 - 0.75）中具有显著优势，尽管对结局数据进行多重检验校正后，E - ESD的显著性消失。这些结果也与敏感性分析结果一致。在其他五种手术中，未发现显著优势。
这项全国性研究发现，与PPI相比，沃克可使GD - ESD中的延迟性出血减少约30%。沃克有可能成为该手术中预防延迟性出血的新治疗方法。
