Division of Gastroenterology, Chung-Ang University College of Medicine, Seoul, Korea.
Gastrointest Endosc. 2011 Sep;74(3):556-62. doi: 10.1016/j.gie.2011.04.047. Epub 2011 Jul 28.
Udenafil, a phosphodiesterase-5 inhibitor, may decrease sphincter of Oddi tone and allow efficient cannulation.
To determine whether prophylactic udenafil reduces the rates of occurrence of post-ERCP pancreatitis.
Prospective, randomized, double-blind, placebo-controlled, multicenter study.
Three academic medical centers.
From November 2008 to November 2010, a total of 278 patients who underwent ERCP were analyzed.
ERCP.
Rate of post-ERCP pancreatitis.
Demographic features, indications for ERCP, and therapeutic procedures were similar in each group. The overall rate of pancreatitis was 7.9% (22/278). There was no significant difference in the rate (8.0% [11/137] vs 7.8% [11/141], P = .944) and severity of post-ERCP pancreatitis between the udenafil and placebo groups. Severe pancreatitis developed in 1 patient in the placebo group. On both univariate and multivariate analyses, age 40 years or younger, suspected sphincter of Oddi dysfunction, complete pancreatic duct opacification, and failed cannulation were associated with post-ERCP pancreatitis. Only mild udenafil-related complications occurred, including flushing (n = 3) and headache (n = 3).
Unselected patient group, overestimation of the rate of pancreatitis in the placebo group.
Udenafil was not effective for prevention of post-ERCP pancreatitis in this study. (
KCT0000021.).
磷酸二酯酶-5 抑制剂乌地那非可能会降低 Oddi 括约肌张力，从而更有效地进行插管。
确定预防性使用乌地那非是否会降低 ERCP 后胰腺炎的发生率。
前瞻性、随机、双盲、安慰剂对照、多中心研究。
三家学术医疗中心。
2008 年 11 月至 2010 年 11 月，共有 278 例行 ERCP 的患者进行了分析。
ERCP。
ERCP 后胰腺炎的发生率。
每组患者的人口统计学特征、ERCP 适应证和治疗程序均相似。总体胰腺炎发生率为 7.9%（22/278）。乌地那非组和安慰剂组的胰腺炎发生率（8.0%[11/137]与 7.8%[11/141]，P =.944）和严重程度均无显著差异。安慰剂组有 1 例发生严重胰腺炎。在单因素和多因素分析中，年龄 40 岁或以下、疑似 Oddi 括约肌功能障碍、胰管完全显影和插管失败与 ERCP 后胰腺炎相关。仅发生轻度乌地那非相关并发症，包括潮红（n = 3）和头痛（n = 3）。
未选择患者群体，安慰剂组胰腺炎发生率偏高。
在这项研究中，乌地那非对预防 ERCP 后胰腺炎无效。（临床试验注册号：KCT0000021。）
