维生素C和直肠用吲哚美辛在预防和减轻内镜逆行胰胆管造影术后胰腺炎中的作用：一项临床研究
Role of vitamin C and rectal indomethacin in preventing and alleviating post-endoscopic retrograde cholangiopancreatography pancreatitis: a clinical study.
作者信息
Sadeghi Amir, Jafari-Moghaddam Rana, Ataei Sara, Asadiafrooz Mahboobe, Abbasinazari Mohammad
机构信息
Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
出版信息
Clin Endosc. 2023 Mar;56(2):214-220. doi: 10.5946/ce.2022.165. Epub 2023 Mar 6.
BACKGROUND/AIMS: This study aimed to determine whether vitamin C in addition to indomethacin decreases the occurrence and severity of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) occurrence and severity.
METHODS
This randomized clinical trial included patients undergoing ERCP. The participants were administered either rectal indomethacin (100 mg) plus an injection of vitamin C (500 mg) or rectal indomethacin (100 mg) alone just before ERCP. The primary outcomes were PEP occurrence and severity. The secondary amylase and lipase levels were determined after 24 hours.
RESULTS
A total of 344 patients completed the study. Based on intention-to-treat analysis, the PEP rates were 9.9% for indomethacin plus vitamin C plus indomethacin and 15.7% for indomethacin alone. Regarding the per-protocol analysis, the PEP rates were 9.7% and 15.7% in the combination and indomethacin arms, respectively. There was a remarkable difference between the two arms in PEP occurrence and severity on intention-to-treat and per-protocol analyses (p=0.034 and p=0.031, respectively). The post-ERCP lipase and amylase concentrations were lower in the combination arm than in the indomethacin alone arm (p=0.034 and p=0.029, respectively).
CONCLUSION
Vitamin C injection in addition to rectal indomethacin reduced PEP occurrence and severity.
背景/目的：本研究旨在确定除吲哚美辛外，维生素C是否能降低内镜逆行胰胆管造影术（ERCP）后胰腺炎（PEP）的发生率和严重程度。
方法
这项随机临床试验纳入了接受ERCP的患者。在ERCP前，参与者分别接受直肠吲哚美辛（100毫克）加维生素C注射（500毫克）或仅接受直肠吲哚美辛（100毫克）。主要结局是PEP的发生率和严重程度。24小时后测定次要结局淀粉酶和脂肪酶水平。
结果
共有344名患者完成了研究。基于意向性分析，吲哚美辛加维生素C组的PEP发生率为9.9%，吲哚美辛单独使用组为15.7%。根据符合方案分析，联合组和吲哚美辛组的PEP发生率分别为9.7%和15.7%。在意向性分析和符合方案分析中，两组在PEP发生率和严重程度上存在显著差异（分别为p = 0.034和p = 0.031）。联合组ERCP后的脂肪酶和淀粉酶浓度低于吲哚美辛单独使用组（分别为p = 0.034和p = 0.029）。
结论
除直肠吲哚美辛外，注射维生素C可降低PEP的发生率和严重程度。
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