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手术与非手术治疗小于两岁新生儿及婴儿单侧输尿管肾盂连接部梗阻的对比

Surgery versus non-surgical management for unilateral ureteric-pelvic junction obstruction in newborns and infants less than two years of age.

作者信息

Weitz Marcus, Portz Suniva, Laube Guido F, Meerpohl Joerg J, Bassler Dirk

机构信息

Pediatric Nephrology, Children's Hospital Tuebingen, Hoppe-Seyler-Strasse 1, Tuebingen, Germany, 72076.

出版信息

Cochrane Database Syst Rev. 2016 Jul 14;7(7):CD010716. doi: 10.1002/14651858.CD010716.pub2.

Abstract

BACKGROUND

Unilateral ureteric-pelvic junction obstruction (UPJO) is the most common cause of obstructive uropathy and may lead to renal impairment and loss of renal function. The current diagnostic approach with renal imaging cannot reliably determine which newborns and infants less than two years of age have a significant obstruction and are at risk for permanent kidney damage. There is therefore no consensus on optimal therapeutic management of unilateral UPJO.

OBJECTIVES

To assess the effects of surgical versus non-surgical treatment options for newborns and infants less than two years of age with unilateral UPJO.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 6, 2016), MEDLINE/Ovid, and EMBASE/Ovid databases from their inception to 13 June 2016. We searched the reference lists of potentially relevant studies without using any language restriction. We also searched the following trial registers for relevant registered studies: www.clinicaltrials.gov/; ISRCTN registry (controlled-trials.com/); www.trialscentral.org/; apps.who.int/trialsearch/; www.drks.de/; and www.anzctr.org.au/trialSearch.aspx.

SELECTION CRITERIA

We selected randomised and quasi-randomised controlled trials comparing surgical with non-surgical interventions for the treatment of unilateral UPJO.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed study eligibility and risk of bias of included studies and extracted data. In case of disagreements we consulted a third review author. The data reported in the two included studies did not allow us to perform a meta-analysis.

MAIN RESULTS

We found only two studies at high risk of bias that were eligible for inclusion in this review. The total sample size, including both trials, was small (n = 107 participants less than six months of age from the UK and USA), and not all prespecified outcome measures were assessed. Reported measures only accounted for the short-term follow-ups. The mean split renal function was not statistically different between the surgical and non-surgical group at the six-month or one-year time point (very low-quality evidence). The surgical group showed a significantly less obstructed drainage pattern and a lower urinary tract dilatation than the non-surgical group (very low-quality evidence). Transfer from the non-surgical group to the surgical group was reported for about one out of five participants. Split renal function after secondary surgical intervention was reported with variable results, but most of the participants reverted to pre-deteriorated values. The studies either provided no or insufficient data on the following outcome measures: postoperative complications, UPJO-associated clinical symptoms, costs of interventions, radiation exposure, quality of life, and adverse effects.

AUTHORS' CONCLUSIONS: We found limited evidence assessing the benefits and harms of surgical compared to non-surgical treatment options for newborns and infants less than two years of age with unilateral UPJO. The majority of participants in the non-surgical treatment group did not experience any significant deterioration of split renal function, and only about 20% of them underwent secondary surgical intervention, with minor risk of permanent deteriorated split renal function. The study follow-up period was too short to assess the long-term effects on split renal function in both treatment groups. We need further randomised controlled trials with sufficient statistical power and an adequate follow-up period to determine the optimal therapy for newborns and infants less than two years of age with unilateral UPJO.

摘要

背景

单侧输尿管肾盂连接部梗阻(UPJO)是梗阻性肾病最常见的病因,可能导致肾功能损害和肾功能丧失。目前的肾脏影像学诊断方法无法可靠地确定哪些2岁以下的新生儿和婴儿存在严重梗阻并面临永久性肾损伤的风险。因此,对于单侧UPJO的最佳治疗管理尚无共识。

目的

评估手术与非手术治疗方案对2岁以下单侧UPJO新生儿和婴儿的效果。

检索方法

我们检索了Cochrane对照试验中心注册库(CENTRAL)(2016年第6期)、MEDLINE/Ovid以及EMBASE/Ovid数据库,检索时间从各数据库建库至2016年6月13日。我们检索了潜在相关研究的参考文献列表,未设语言限制。我们还检索了以下试验注册库以查找相关注册研究:www.clinicaltrials.gov/;ISRCTN注册库(controlled-trials.com/);www.trialscentral.org/;apps.who.int/trialsearch/;www.drks.de/;以及www.anzctr.org.au/trialSearch.aspx。

入选标准

我们选择了比较手术与非手术干预治疗单侧UPJO的随机对照试验和半随机对照试验。

数据收集与分析

两位综述作者独立评估研究的入选资格和纳入研究的偏倚风险,并提取数据。如有分歧,我们会咨询第三位综述作者。两项纳入研究报告的数据不允许我们进行Meta分析。

主要结果

我们仅发现两项偏倚风险高的研究符合纳入本综述的条件。两项试验的总样本量较小(来自英国和美国的107名6个月以下参与者),并非所有预先设定的结局指标都进行了评估。报告的指标仅涉及短期随访。在6个月或1年时间点,手术组和非手术组的平均分肾功能无统计学差异(极低质量证据)。手术组的引流梗阻模式明显低于非手术组,尿路扩张程度也更低(极低质量证据)。据报告,约五分之一的参与者从非手术组转为手术组。二次手术干预后的分肾功能报告结果不一,但大多数参与者恢复到术前恶化前的值。这些研究在以下结局指标上要么未提供数据,要么数据不足:术后并发症、UPJO相关临床症状、干预成本、辐射暴露、生活质量和不良反应。

作者结论

我们发现,关于手术与非手术治疗方案对2岁以下单侧UPJO新生儿和婴儿的利弊评估证据有限。非手术治疗组的大多数参与者分肾功能未出现任何显著恶化,其中只有约20%接受了二次手术干预,永久性分肾功能恶化风险较小。研究随访期过短,无法评估两个治疗组对分肾功能的长期影响。我们需要进一步的随机对照试验,具备足够的统计效力和足够的随访期,以确定2岁以下单侧UPJO新生儿和婴儿的最佳治疗方法。

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