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梗阻性黄疸的术前胆道引流

Preoperative biliary drainage for obstructive jaundice.

作者信息

Wang Qin, Gurusamy Kurinchi Selvan, Lin He, Xie Xiaodong, Wang Chaohua

机构信息

Endocrinology Department, West China Hospital, Sichuan University, No 37 Guo Xue Xiang, Chengdu, Sichuan Province, China, 610041.

出版信息

Cochrane Database Syst Rev. 2008 Jul 16(3):CD005444. doi: 10.1002/14651858.CD005444.pub2.

Abstract

BACKGROUND

Obstruction in the biliary drainage system causes a rise in serum bilirubin levels (obstructive jaundice). Studies have shown that surgery for severe obstructive jaundice is associated with high peri-operative mortality and morbidity. Jaundice has been considered as a potential risk factor for poor outcome, and pre-operative biliary drainage has been proposed as a method of reversing the pathophysiologic disturbance seen in patients with obstructive jaundice.

OBJECTIVES

To determine the benefits and harms of pre-operative biliary drainage (ie, endoscopic sphincterotomy with stent insertion or percutaneous transhepatic biliary drainage) in obstructive jaundice.

SEARCH STRATEGY

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (CHBG), the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, the Chinese BioMedical Literature on disc (CBM disc), and the Chinese Medical Current Contents (CMCC). All databases were searched up to October 2006.

SELECTION CRITERIA

We considered for inclusion randomised clinical trials comparing biliary drainage followed by surgery and direct surgery performed for obstructive jaundice.

DATA COLLECTION AND ANALYSIS

We collected the available data on the characteristics of the trial, methodological quality of the trials, mortality, morbidity, and hospital stay as reported in each trial. We analysed the data with both the fixed-effect and the random-effects models, using RevMan Analysis. For each outcome, we calculated the odds ratio (OR) with 95% confidence intervals (CI) based on intention-to-treat analysis.

MAIN RESULTS

Five trials with 320 patients (160 in each group) were included. Four trials (n = 235) compared percutaneous transhepatic biliary drainage with direct surgery, and one trial (n = 85) compared pre-operative endoscopic drainage with direct surgery. All trials were of low methodological quality. There was no significant difference in mortality (OR 1.14, 95% CI 0.60 to 2.10) between the pre-operative biliary drainage group and the direct surgery group. No significant difference was found in mortality (OR 1.16, 95% CI 0.56 to 2.41), overall morbidity (OR 1.35, 95%CI 0.48 to 3.83), and in different complications between the percutaneous transhepatic biliary drainage group and the direct surgery group. The trial comparing pre-operative endoscopic drainage and direct surgery showed no significant difference in mortality (OR 1.09, 95% CI 0.32 to 3.68), but found higher morbidity in the endoscopic drainage group. The overall hospital stay was 8 to 17 days shorter in the direct surgery group.

AUTHORS' CONCLUSIONS: Our analyses neither supports nor refutes pre-operative biliary drainage for patients with obstructive jaundice needing surgery. In some specific lesion site it may cause more complications. Pre-operative biliary drainage also prolonged hospital stay and increased cost. However, the strength of evidence is low because of the poor quality of the included trials. More rigorously designed randomised clinical trials with larger sample size and advanced techniques and drugs are needed.

摘要

背景

胆道引流系统梗阻会导致血清胆红素水平升高(梗阻性黄疸)。研究表明,严重梗阻性黄疸手术的围手术期死亡率和发病率较高。黄疸一直被视为预后不良的潜在危险因素,术前胆道引流已被提出作为一种逆转梗阻性黄疸患者病理生理紊乱的方法。

目的

确定术前胆道引流(即内镜括约肌切开术加支架置入或经皮经肝胆道引流)在梗阻性黄疸中的益处和危害。

检索策略

我们检索了Cochrane肝胆组对照试验注册库(CHBG)、Cochrane图书馆中的Cochrane临床对照试验中心注册库(CENTRAL)、医学索引数据库(MEDLINE)、荷兰医学文摘数据库(EMBASE)、中国生物医学文献光盘数据库(CBM disc)和中国医学现刊(CMCC)。所有数据库检索至2006年10月。

入选标准

我们纳入了比较梗阻性黄疸患者先行胆道引流再手术与直接手术的随机临床试验。

数据收集与分析

我们收集了每个试验中报告的关于试验特征、试验方法学质量、死亡率、发病率和住院时间的可用数据。我们使用RevMan分析软件,采用固定效应模型和随机效应模型对数据进行分析。对于每个结局,我们基于意向性分析计算了比值比(OR)及95%置信区间(CI)。

主要结果

纳入了5项试验,共320例患者(每组160例)。4项试验(n = 235)比较了经皮经肝胆道引流与直接手术,1项试验(n = 85)比较了术前内镜引流与直接手术。所有试验的方法学质量均较低。术前胆道引流组与直接手术组在死亡率方面无显著差异(OR 1.14,95%CI 0.60至2.10)。经皮经肝胆道引流组与直接手术组在死亡率(OR 1.16,95%CI 0.56至2.41)、总体发病率(OR 1.35,95%CI 0.48至3.83)及不同并发症方面均未发现显著差异。比较术前内镜引流与直接手术的试验在死亡率方面无显著差异(OR 1.09,95%CI 0.32至3.68),但内镜引流组发病率较高。直接手术组的总体住院时间短8至17天。

作者结论

我们的分析既不支持也不反驳对需要手术的梗阻性黄疸患者进行术前胆道引流。在某些特定病变部位,它可能会导致更多并发症。术前胆道引流还延长了住院时间并增加了费用。然而,由于纳入试验质量较差,证据强度较低。需要设计更严谨、样本量更大、采用先进技术和药物的随机临床试验。

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