Department of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.
Pediatr Crit Care Med. 2013 Jun;14(5):474-80. doi: 10.1097/PCC.0b013e31828a8125.
To systematically review randomized controlled trials (RCTs) of steroids conducted in children with fluid and/or vasoactive medication-dependent shock and evaluate and report on the quality and clinical and methodological heterogeneity of included trials.
MEDLINE (1946 to January Week 2, 2012), Embase (1947-January 20, 2012), Cochrane Central Register of Controlled Trials (through January 2012), and reference lists of retrieved publications. No language restrictions were applied.
We included only RCTs reporting on steroid use and clinical outcomes in pediatric shock.
Study characteristics, interventions, and outcomes were retrieved by three independent reviewers. Pooled relative risks and 95% CIs were calculated using a random effects model.
We identified 535 citations from which 13 full-text articles were retrieved for assessment. Eight articles evaluating a total of 447 children were selected for review. The median trial size was 67 patients (range, 28-98). Seven of the eight trials were published prior to 1996, and all trials were conducted in the developing world, and six of eight trials were in the setting of dengue shock. We found methodological issues related to allocation concealment, blinding and reporting of co-interventions, and outcome data among the included trials along with varying types, doses, timings, and duration of steroids making it difficult to compare outcomes. The overall meta-analysis showed no difference in mortality rates between those who did and did not receive steroids (relative risks, 0.744 [95% CI, 0.475-1.165]; p = 0.197).
The literature on the use of steroids in pediatric shock is limited in amount and methodological quality and demonstrates conflicting results. The limited evidence on which current guidelines are based strongly supports the need for a well-designed, pragmatic randomized controlled trial on the use of steroids in pediatric shock to inform future guidelines.
系统评价儿童液体和/或血管活性药物依赖型休克应用类固醇的随机对照试验（RCT），评估并报告纳入研究的质量及临床和方法学异质性。
MEDLINE（1946 年至 2012 年 1 月第 2 周）、Embase（1947 年至 2012 年 1 月 20 日）、Cochrane 对照试验中心注册库（截至 2012 年 1 月）和检索文献的参考文献列表。未对语种进行限制。
仅纳入报告类固醇在儿科休克中的应用和临床结局的 RCT。
由 3 名独立评审员提取研究特征、干预措施和结局。采用随机效应模型计算汇总相对危险度和 95%CI。
从 535 篇引文中共识别出 13 篇全文进行评估。8 篇文章共纳入 447 例患儿进行综述。中位数试验规模为 67 例患者（范围：28-98 例）。8 项研究中有 7 项发表于 1996 年之前，所有研究均在发展中国家开展，6 项研究在登革热休克背景下进行。纳入研究存在与分配隐藏、盲法和合并干预措施报告、结局数据相关的方法学问题，并且类固醇的类型、剂量、时机和持续时间各不相同，使得结局难以比较。总体 meta 分析显示，应用与未应用类固醇的患儿死亡率无差异（相对危险度，0.744[95%CI，0.475-1.165]；p = 0.197）。
儿科休克应用类固醇的文献数量和方法学质量均有限，且结果存在矛盾。目前指南所依据的有限证据强烈支持开展一项精心设计的、实用的、关于儿科休克应用类固醇的 RCT，以提供未来的指南依据。
