Barreto Lenka, Jung Jae Hung, Abdelrahim Ameera, Ahmed Munir, Dawkins Guy P C, Kazmierski Marcin
Department of Urology, King's College Hospital NHS Foundation Trust, Denmark Hill, London, UK.
Cochrane Database Syst Rev. 2018 Jun 2;6(6):CD010784. doi: 10.1002/14651858.CD010784.pub2.
Urolithiasis is a condition where crystalline mineral deposits (stones) form within the urinary tract. Urinary stones can be located in any part of the urinary tract. Affected children may present with abdominal pain, blood in the urine or signs of infection. Radiological evaluation is used to confirm the diagnosis, to assess the size of the stone, its location, and the degree of possible urinary obstruction.
To assess the effects of different medical and surgical interventions in the treatment of urinary tract stones of the kidney or ureter in children.
We searched the Cochrane Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid) as well as the World Health Organization International Clinical Trials Registry Platform Search Portal and ClinicalTrials.gov. We searched reference lists of retrieved articles and conducted an electronic search for conference abstracts for the years 2012 to 2017. The date of the last search of all electronic databases was 31 December 2017 and we applied no language restrictions.
We included all randomised controlled trials (RCTs) and quasi-RCTs looking at interventions for upper urinary tract stones in children. These included shock wave lithotripsy, percutaneous nephrolithotripsy, ureterorenoscopy, open surgery and medical expulsion therapy for upper urinary tract stones in children aged 0 to 18 years.
We used standard methodological procedures according to Cochrane guidance. Two review authors independently searched and assessed studies for eligibility and conducted data extraction. 'Risk of bias' assessments were completed by three review authors independently. We used Review Manager 5 for data synthesis and analysis. We used the GRADE approach to assess the quality of evidence.
We included 14 studies with a total of 978 randomised participants in our review, informing eight comparisons. The studies contributing to most comparisons were at high or unclear risk of bias for most domains.Shock wave lithotripsy versus dissolution therapy for intrarenal stones: based on one study (87 participants) and consistently very low quality evidence, we are uncertain about the effects of SWL on stone-free rate (SFR), serious adverse events or complications of treatment and secondary procedures for residual fragments.Slow shock wave lithotripsy versus rapid shock wave lithotripsy for renal stones: based on one study (60 participants) and consistently very low quality evidence, we are uncertain about the effects of SWL on SFR, serious adverse events or complications of treatment and secondary procedures for residual fragments.Shock wave lithotripsy versus ureteroscopy with holmium laser or pneumatic lithotripsy for renal and distal ureteric stones: based on three studies (153 participants) and consistently very low quality evidence, we are uncertain about the effects of SWL on SFR, serious adverse events or complications of treatment and secondary procedures.Shock wave lithotripsy versus mini-percutaneous nephrolithotripsy for renal stones: based on one study (212 participants), SWL likely has a lower SFR (RR 0.88, 95% CI 0.80 to 0.97; moderate quality evidence); this corresponds to 113 fewer stone-free patients per 1000 (189 fewer to 28 fewer). SWL may reduce severe adverse events (RR 0.13, 95% CI 0.02 to 0.98; low quality evidence); this corresponds to 66 fewer serious adverse events or complications per 1000 (74 fewer to 2 fewer). Rates of secondary procedures may be higher (RR 2.50, 95% CI 1.01 to 6.20; low-quality evidence); this corresponds to 85 more secondary procedures per 1000 (1 more to 294 more).Percutaneous nephrolithotripsy versus tubeless percutaneous nephrolithotripsy for renal stones: based on one study (23 participants) and consistently very low quality evidence, we are uncertain about the effects of SWL on SFR, serious adverse events or complications of treatment and secondary procedures.Percutaneous nephrolithotripsy versus tubeless mini-percutaneous nephrolithotripsy for renal stones: based on one study (70 participants), SFR are likely similar (RR 1.03, 95% CI 0.93 to 1.14; moderate-quality evidence); this corresponds to 28 more per 1,000 (66 fewer to 132 more). We did not find any data relating to serious adverse events. Based on very low quality evidence we are uncertain about secondary procedures.Alpha-blockers versus placebo with or without analgesics for distal ureteric stones: based on six studies (335 participants), alpha-blockers may increase SFR (RR 1.34, 95% CI 1.16 to 1.54; low quality evidence); this corresponds to 199 more stone-free patients per 1000 (94 more to 317 more). Based on very low quality evidence we are uncertain about serious adverse events or complications and secondary procedures.
AUTHORS' CONCLUSIONS: Based on mostly very low-quality evidence for most comparisons and outcomes, we are uncertain about the effect of nearly all medical and surgical interventions to treat stone disease in children.Common reasons why we downgraded our assessments of the quality of evidence were: study limitations (risk of bias), indirectness, and imprecision. These issues make it difficult to draw clinical inferences. It is important that affected individuals, clinicians, and policy-makers are aware of these limitations of the evidence. There is a critical need for better quality trials assessing patient-important outcomes in children with stone disease to inform future guidelines on the management of this condition.
尿石症是指在尿路中形成结晶矿物质沉积物(结石)的病症。尿路结石可位于尿路的任何部位。患病儿童可能出现腹痛、血尿或感染迹象。放射学评估用于确诊、评估结石大小、位置以及可能的尿路梗阻程度。
评估不同药物和手术干预措施对儿童肾或输尿管尿路结石的治疗效果。
我们检索了Cochrane对照试验注册库(CENTRAL)、医学期刊数据库(MEDLINE,Ovid平台)、荷兰医学文摘数据库(Embase,Ovid平台)以及世界卫生组织国际临床试验注册平台检索入口和美国国立医学图书馆临床试验数据库(ClinicalTrials.gov)。我们检索了所获文章的参考文献列表,并对2012年至2017年的会议摘要进行了电子检索。所有电子数据库的最后检索日期为2017年12月31日,且未设语言限制。
我们纳入了所有针对儿童上尿路结石干预措施的随机对照试验(RCT)和半随机对照试验。这些干预措施包括冲击波碎石术、经皮肾镜碎石术、输尿管肾镜检查、开放手术以及针对0至18岁儿童上尿路结石的药物排石疗法。
我们根据Cochrane指南采用标准方法程序。两位综述作者独立检索并评估研究的纳入资格,进行数据提取。“偏倚风险”评估由三位综述作者独立完成。我们使用Review Manager 5进行数据合成与分析。我们采用GRADE方法评估证据质量。
我们的综述纳入了14项研究,共978名随机分组参与者,涉及八项比较。对大多数比较有贡献的研究在大多数领域存在高偏倚风险或偏倚风险不明确。
基于一项研究(87名参与者)且证据质量始终极低,我们不确定冲击波碎石术对结石清除率(SFR)、严重不良事件或治疗并发症以及残留碎片二次治疗的影响。
基于一项研究(60名参与者)且证据质量始终极低,我们不确定冲击波碎石术对结石清除率、严重不良事件或治疗并发症以及残留碎片二次治疗的影响。
基于三项研究(153名参与者)且证据质量始终极低,我们不确定冲击波碎石术对结石清除率、严重不良事件或治疗并发症以及二次治疗的影响。
基于一项研究(212名参与者),冲击波碎石术可能结石清除率较低(风险比0.88,95%置信区间0.80至0.97;中等质量证据);这相当于每1000例中结石清除的患者少113例(少189例至少28例)。冲击波碎石术可能减少严重不良事件(风险比0.13,95%置信区间0.02至0.98;低质量证据);这相当于每1000例中严重不良事件或并发症少66例(少74例至少2例)。二次治疗率可能更高(风险比2.50,95%置信区间1.01至6.20;低质量证据);这相当于每1000例中二次治疗多85例(多1例至多294例)。
基于一项研究(23名参与者)且证据质量始终极低,我们不确定冲击波碎石术对结石清除率、严重不良事件或治疗并发症以及二次治疗的影响。
基于一项研究(70名参与者),结石清除率可能相似(风险比1.03,95%置信区间0.93至1.14;中等质量证据);这相当于每1000例中多28例(少66例至多132例)。我们未找到与严重不良事件相关的数据。基于极低质量证据,我们不确定二次治疗情况。
α受体阻滞剂与安慰剂加或不加镇痛药治疗输尿管下段结石:基于六项研究(335名参与者),α受体阻滞剂可能提高结石清除率(风险比1.34,95%置信区间1.16至1.54;低质量证据);这相当于每1000例中结石清除的患者多199例(多94例至多317例)。基于极低质量证据,我们不确定严重不良事件或并发症以及二次治疗情况。
基于大多数比较和结局的证据质量大多极低,我们不确定几乎所有治疗儿童结石病的药物和手术干预措施的效果。我们降低证据质量评估等级的常见原因包括:研究局限性(偏倚风险)、间接性和不精确性。这些问题使得难以得出临床推论。受影响的个体、临床医生和政策制定者了解这些证据的局限性非常重要。迫切需要开展质量更高的试验,评估结石病患儿重要的患者结局,以为未来该病的管理指南提供依据。