质子泵抑制剂对预防内镜下括约肌切开术后延迟出血无效：一项前瞻性随机对照试验。
Proton pump inhibitor has no effect in the prevention of post-endoscopic sphincterotomy delayed bleeding: a prospective randomized controlled trial.
作者信息
Yu Zhengping, He Jinli, Cao Ronglai, Yang Zhenzhen, Li Baolian, Hong Junbo, Chen Youxiang, Zhu Liang
机构信息
Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Jiangxi Clinical Research Center for Gastroenterology, Nanchang, China.
出版信息
Front Med (Lausanne). 2023 Jun 2;10:1179512. doi: 10.3389/fmed.2023.1179512. eCollection 2023.
BACKGROUND AND AIMS
Bleeding is one of the common adverse events of endoscopic retrograde cholangiopancreatography (ERCP), which is mainly caused by endoscopic sphincterotomy (EST). At present, it remains unclear whether proton pump inhibitor (PPI) should be used to prevent post-EST bleeding. Therefore, we performed a randomized controlled trial to investigate whether PPI is effective in the prevention of post-EST delayed bleeding.
METHODS
Consecutive eligible patients were randomly assigned (1:1) to experimental group (PPI group) or control group (normal saline, NS group). The patients in PPI group received intravenous esomeprazole 40 mg and normal saline 100 mL every 12 h for 2 days after ERCP immediately, and followed by oral esomeprazole (Nexium) 20 mg once a day for 7 days. Correspondingly, patients in the control group received intravenous normal saline 100 mL and did not take PPIs or any acid-suppressing drugs during hospitalization and after discharge. All patients were followed up for 30 days after ERCP. The primary endpoint was the incidence and severity of post-EST delayed bleeding.
RESULTS
Between July 2020 and July 2022, 290 patients were randomly assigned to PPI group ( = 146) or NS group ( = 144). 5 patients from each group were excluded from the final analysis. There were 6 patients with post-EST delayed bleeding, with an incidence rate of 2.14%. The median time of delayed bleeding was 2.5 days after ERCP. 3 cases (2.12%, 3/141) occurred in the PPI group, with 1 case of mild and 2 cases of moderate bleeding. 3 cases (2.16%, 3/139) occurred in the NS group, with 2 cases of mild and 1 case of moderate bleeding. There was no significant difference in the incidence and the severity of post-EST delayed bleeding between the two groups ( = 1.000).
CONCLUSION
Prophylactic use of PPI after EST does not reduce the incidence and severity of post-EST delayed bleeding in patients.
CLINICAL TRIAL REGISTRATION
https://www.chictr.org.cn/searchproj.aspx, identifier ChiCTR2000034697.
背景与目的
出血是内镜逆行胰胆管造影术（ERCP）常见的不良事件之一，主要由内镜下括约肌切开术（EST）引起。目前，质子泵抑制剂（PPI）是否应用于预防EST术后出血尚不清楚。因此，我们进行了一项随机对照试验，以研究PPI在预防EST术后延迟出血方面是否有效。
方法
连续入选的合格患者被随机（1:1）分配至试验组（PPI组）或对照组（生理盐水，NS组）。PPI组患者在ERCP术后立即每12小时静脉注射艾司奥美拉唑40mg和生理盐水100mL，共2天，随后口服艾司奥美拉唑（耐信）20mg，每日1次，共7天。相应地，对照组患者静脉注射生理盐水100mL，住院期间及出院后未服用PPI或任何抑酸药物。所有患者在ERCP术后随访30天。主要终点是EST术后延迟出血的发生率和严重程度。
结果
2020年7月至2022年7月期间，290例患者被随机分配至PPI组（n = 146）或NS组（n = 144）。每组5例患者被排除在最终分析之外。有6例EST术后延迟出血患者，发生率为2.14%。延迟出血的中位时间为ERCP术后2.5天。PPI组发生3例（2.12%，3/141），其中轻度出血1例，中度出血2例。NS组发生3例（2.16%，3/139），其中轻度出血2例，中度出血1例。两组之间EST术后延迟出血的发生率和严重程度无显著差异（P = 1.000）。
结论
EST术后预防性使用PPI并不能降低患者EST术后延迟出血的发生率和严重程度。
临床试验注册
https://www.chictr.org.cn/searchproj.aspx，标识符ChiCTR2000034697。
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