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一项关于伐地考昔和硝酸甘油预防 ERCP 后胰腺炎的随机对照试验。

A randomized controlled trial of valdecoxib and glyceryl trinitrate for the prevention of post-ERCP pancreatitis.

机构信息

Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.

出版信息

J Clin Gastroenterol. 2011 Feb;45(2):170-6. doi: 10.1097/MCG.0b013e3181eb600e.

DOI:10.1097/MCG.0b013e3181eb600e
PMID:20717044
Abstract

BACKGROUND

Efforts to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis have been largely unsuccessful. Cyclo-oxygenase-2 enzyme-mediated inflammatory pathway has been suggested in the pathophysiology of acute pancreatitis. Glyceryl trinitrate (GTN) might prevent post-ERCP pancreatitis by relaxing the sphincter of Oddi.

OBJECTIVE

To evaluate the efficacy of valdecoxib, a cyclo-oxygenase-2 inhibitor, and GTN transdermal patch for the prevention of post-ERCP pancreatitis.

METHODS

Patients undergoing first ERCP procedure from October 2003 to August 2005 were randomized to receive either 20 mg intravenous valdecoxib or GTN patch (10 mg/h) at the start of ERCP, or assigned to control group. The study followed CONSORT guidelines. Primary outcome measure was frequency of post-ERCP pancreatitis in the 3 groups.

RESULTS

A total of 380 patients were randomized; 121 patients in valdecoxib (group 1), 124 in GTN (group 2), and 126 in the control arm (group 3) were analyzed. There was no difference in the frequency of post-ERCP pancreatitis between the groups (12 each in groups 1 and 2, and 13 in group 3; P=0.986). None of the patients had severe pancreatitis. The frequency of post-ERCP pain and amylase levels were also similar in the 3 groups (P=0.769 and P=0.947, respectively). Pancreatic duct cannulation, cholecystectomy, difficult cannulation, and pre-cut were risk factors for pancreatitis on univariate analysis. On multivariate analysis, pancreatic duct cannulation was the only independent risk factor for pancreatitis (P≤0.001; odds ratio 5.67; 95% confidence interval: 2.76-11.63).

CONCLUSIONS

Valdecoxib and GTN were not effective for the prevention of post-ERCP pancreatitis.

摘要

背景

预防内镜逆行胰胆管造影术(ERCP)后胰腺炎的努力基本没有成功。环氧化酶-2 酶介导的炎症途径已被提出用于急性胰腺炎的病理生理学。甘油三硝酸酯(GTN)通过放松 Oddi 括约肌可能预防 ERCP 后胰腺炎。

目的

评估环氧化酶-2 抑制剂伐地考昔和 GTN 透皮贴剂预防 ERCP 后胰腺炎的疗效。

方法

2003 年 10 月至 2005 年 8 月期间接受首次 ERCP 手术的患者随机分为静脉注射伐地考昔 20mg 组或 ERCP 开始时 GTN 贴剂(10mg/h)组,或分配至对照组。该研究遵循 CONSORT 指南。主要观察指标是 3 组中 ERCP 后胰腺炎的发生率。

结果

共随机分配了 380 例患者;伐地考昔组(第 1 组)121 例,GTN 组(第 2 组)124 例,对照组(第 3 组)126 例。3 组间 ERCP 后胰腺炎的发生率无差异(第 1 组和第 2 组各 12 例,第 3 组 13 例;P=0.986)。没有患者发生严重胰腺炎。3 组间 ERCP 后疼痛和淀粉酶水平也相似(P=0.769 和 P=0.947)。胰管插管、胆囊切除术、困难插管和预切开是单因素分析中胰腺炎的危险因素。多因素分析显示,胰管插管是胰腺炎的唯一独立危险因素(P≤0.001;优势比 5.67;95%置信区间:2.76-11.63)。

结论

伐地考昔和 GTN 对预防 ERCP 后胰腺炎无效。

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