Kern Adam, Grimsby Gwen, Mayo Helen, Baker Linda A
Anne Arundel Medical Center, Annapolis, MD, USA.
Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011252. doi: 10.1002/14651858.CD011252.pub2.
Nephrolithiasis, or urinary stone disease, in children causes significant morbidity, and is increasing in prevalence in the North American population. Therefore, medical and dietary interventions (MDI) for recurrent urinary stones in children are poised to gain increasing importance in the clinical armamentarium.
To assess the effects of medical and dietary interventions (MDI) for the prevention of idiopathic urinary stones in children aged from one to 18 years.
We searched multiple databases using search terms relevant to this review, including studies identified from the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 1), MEDLINE OvidSP (1946 to 14 February 2017), Embase OvidSP (1980 to 14 February 2017), International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. Additionally, we handsearched renal-related journals and the proceedings of major renal conferences, and reviewed weekly current awareness alerts for selected renal journals. The date of the last search was 14 February 2017. There were no language restrictions.
Randomized controlled trials of at least one year of MDI versus control for prevention of recurrent idiopathic (non-syndromic) nephrolithiasis in children.
We used standard methodologic procedures expected by Cochrane. Titles and abstracts were identified by search criteria and then screened for relevance, and then data extraction and risk of bias assessment were carried out. We assessed the quality of evidence using GRADE.
The search identified one study of 125 children (72 boys and 53 girls) with calcium-containing idiopathic nephrolithiasis and normal renal morphology following initial treatment with shockwave lithotripsy (SWL). Patients were randomized to oral potassium citrate 1 mEq/kg per day for 12 months versus no specific medication or preventive measure with results reported for a total of 96 patients (48 per group). This included children who were stone-free (n = 52) or had residual stone fragments (n = 44) following SWL. Primary outcomes:Medical therapy may lower rates of stone recurrence with a risk ratio (RR) of 0.19 (95% confidence interval (CI) 0.06 to 0.60; low quality evidence). This corresponds to 270 fewer stone recurrences per 1000 (133 fewer to 313 fewer) children. We downgraded the quality of evidence by two levels for very serious study limitations related to unclear allocation concealment (selection bias) and a high risk of performance, detection and attrition bias. While the data for adverse events were incomplete, they reported that six of 48 (12.5%) children receiving potassium citrate left the trial because of adverse effects. This corresponds to a RR of 13.0 (95% CI 0.75 to 224.53; very low quality evidence); an absolute effect size estimate could not be generated. We downgraded the quality of evidence for study limitations and imprecision.We found no information on retreatment rates.
We found no evidence on serum electrolytes, 24-hour urine collection parameters or time to new stone formation.We were unable to perform any preplanned secondary analyses.
AUTHORS' CONCLUSIONS: Oral potassium citrate supplementation may reduce recurrent calcium urinary stone formation in children following SWL; however, our confidence in this finding is limited. A substantial number of children stopped the medication due to adverse events. There is no trial evidence on retreatment rates. There is a critical need for additional well-designed trials in children with nephrolithiasis.
儿童肾结石,即泌尿系统结石病,会导致严重发病,且在北美人群中的患病率呈上升趋势。因此,针对儿童复发性泌尿系统结石的医学和饮食干预(MDI)在临床手段中将变得越来越重要。
评估医学和饮食干预(MDI)对预防1至18岁儿童特发性泌尿系统结石的效果。
我们使用与本综述相关的检索词搜索了多个数据库,包括从Cochrane对照试验中央注册库(CENTRAL,2017年第1期)、MEDLINE OvidSP(1946年至2017年2月14日)、Embase OvidSP(1980年至2017年2月14日)、国际临床试验注册平台(ICTRP)搜索入口和ClinicalTrials.gov中识别出的研究。此外,我们手工检索了肾脏相关期刊和主要肾脏会议的论文集,并查阅了选定肾脏期刊的每周最新文献通报。最后一次检索日期为2017年2月14日。无语言限制。
针对预防儿童复发性特发性(非综合征性)肾结石进行至少一年MDI与对照比较的随机对照试验。
我们采用了Cochrane期望的标准方法程序。通过检索标准识别标题和摘要,然后筛选相关性,接着进行数据提取和偏倚风险评估。我们使用GRADE评估证据质量。
检索到一项针对125名儿童(72名男孩和53名女孩)的研究,这些儿童患有含钙特发性肾结石且初始接受冲击波碎石术(SWL)治疗后肾脏形态正常。患者被随机分为每天口服1 mEq/kg柠檬酸钾共12个月组与未采取特定药物或预防措施组,共报告了96名患者(每组48名)的结果。这包括SWL治疗后结石清除的儿童(n = 52)或有残留结石碎片的儿童(n = 44)。主要结局:药物治疗可能降低结石复发率(RR = 0.19,95%置信区间(CI)0.06至0.60;低质量证据)。这相当于每1000名儿童中结石复发减少270例(减少133例至313例)。由于与分配隐藏不明确(选择偏倚)以及实施、检测和失访偏倚风险高相关的非常严重的研究局限性,我们将证据质量下调了两个等级。虽然不良事件数据不完整,但他们报告称,48名接受柠檬酸钾治疗的儿童中有6名(12.5%)因不良反应退出试验。这相当于RR为13.0(95%CI 0.75至224.53;极低质量证据);无法得出绝对效应量估计值。由于研究局限性和不精确性,我们下调了证据质量。我们未找到关于再次治疗率的信息。
我们未找到关于血清电解质、24小时尿液收集参数或新结石形成时间的证据。我们无法进行任何预先计划的次要分析。
口服柠檬酸钾补充剂可能降低儿童SWL治疗后复发性钙性泌尿系统结石的形成;然而,我们对这一发现的信心有限。相当数量的儿童因不良事件停止用药。没有关于再次治疗率的试验证据。迫切需要针对肾结石儿童进行更多设计良好的试验。