Sadeghi Amir, Samar Hesamoddin, Abbasinazari Mohammad, Mohammadi Parvaneh, Abazarikia Ali, Ziaie Shadi
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.
JGH Open. 2025 Jan 19;9(1):e70083. doi: 10.1002/jgh3.70083. eCollection 2025 Jan.
Oxidative stress has been considered a factor in the development of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). The present clinical trial evaluated whether adding intravenous mesna to rectal indomethacin could prevent or alleviate PEP.
An open-labeled clinical trial was done on 698 participants undergoing endoscopic retrograde cholangiopancreatography (ERCP). Eligible patients received 100 mg indomethacin suppository 30 min before undergoing ERCP. Randomly, the participants received 400 mg intravenous mesna or nothing 30 min before doing the procedure. The PEP incidence and degree were measured in the patients as the main outcome.
The total rate of PEP was equal to 13.7%. No significant difference was seen in the rate and severity of PEP between the mesna plus indomethacin and indomethacin alone arms (14% vs. 13.4%, respectively, = 0.671). In high-risk patients, PEP rate and severity were lower in the mesna plus indomethacin group compared with indomethacin alone group and the statistical analysis showed that the difference was significant (41.7% vs. 51.8%, respectively, = 0.033).
In high-risk patients undergoing ERCP, a combination of intravenous mesna plus rectal indomethacin may decrease the PEP rate and severity.
氧化应激被认为是内镜逆行胰胆管造影术后胰腺炎(PEP)发生发展的一个因素。本临床试验评估了在直肠给予吲哚美辛的基础上加用静脉注射美司钠是否能预防或减轻PEP。
对698例行内镜逆行胰胆管造影术(ERCP)的参与者进行了一项开放标签的临床试验。符合条件的患者在接受ERCP前30分钟接受100mg吲哚美辛栓剂。在操作前30分钟,参与者随机接受400mg静脉注射美司钠或不接受任何治疗。以患者的PEP发生率和严重程度作为主要观察指标。
PEP的总发生率为13.7%。美司钠加吲哚美辛组和单纯吲哚美辛组之间的PEP发生率和严重程度无显著差异(分别为14%和13.4%,P = 0.671)。在高危患者中,美司钠加吲哚美辛组的PEP发生率和严重程度低于单纯吲哚美辛组,统计分析显示差异有统计学意义(分别为41.7%和51.8%,P = 0.033)。
在接受ERCP的高危患者中,静脉注射美司钠联合直肠给予吲哚美辛可能会降低PEP的发生率和严重程度。