脓毒症中的皮质类固醇：一项更新的系统评价和荟萃分析（方案）
Corticosteroids in sepsis: an updated systematic review and meta-analysis (protocol).
作者信息
Rochwerg Bram, Oczkowski Simon, Siemieniuk Reed Alexander, Menon Kusum, Szczeklik Wojciech, English Shane, Agoritsas Thomas, Belley-Cote Emilie, D'Aragon Frédérick, Alhazzani Waleed, Duan Erick, Gossack-Keenan Kira, Sevransky Jon, Vandvik Per, Venkatesh Bala, Guyatt Gordon, Annane Djillali
机构信息
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada.
出版信息
BMJ Open. 2017 Jun 30;7(6):e016847. doi: 10.1136/bmjopen-2017-016847.
INTRODUCTION
Sepsis is associated with a dysregulated host response to infection and impaired endogenous corticosteroid metabolism. As such, therapeutic use of exogenous corticosteroids is a promising adjunctive intervention. Despite a large number of trials examining this research question, uncertainty persists regarding the effect of corticosteroids on survival in sepsis. Several large randomised controlled trials have been published recently prompting a re-evaluation of the available literature.
METHODS AND ANALYSIS
A rigorous and reproducible search and screening process from a Cochrane review on the same topic was comprehensive to October 2014. We will search MEDLINE, EMBASE, LILACS, the Cochrane trial registry and clinicaltrials.gov for eligible randomised controlled trials investigating the use of corticosteroids in patients with sepsis from September 2014. Outcomes have been chosen by a semi-independent guideline panel, created in the context of a parallel Rapid Recommendation on the topic. This panel includes clinicians, content experts, methodologists and patient representatives, who will help identify patient-important outcomes that are critical for deciding whether to use or not use corticosteroids in sepsis. Two reviewers will independently screen and identify eligible studies; a third reviewer will resolve any disagreements. We will use RevMan to pool effect estimates from included studies for each outcome using a random-effect model. We will present the results as relative risk with 95% CI for dichotomous outcomes and as mean difference or standardised mean difference for continuous outcomes with 95% CI. We will assess the certainty of evidence at the outcome level using the Grading of Recommendations, Assessment, Development and Evaluation approach. We will conduct a priori subgroup analyses, which have been chosen by the parallel Rapid Recommendation panel.
ETHICS AND DISSEMINATION
The aim of this systematic review is to summarise the updated evidence on the efficacy and safety of corticosteroids in patients with sepsis.
TRIAL REGISTRATION NUMBER
CRD42017058537.
引言
脓毒症与宿主对感染的反应失调以及内源性皮质类固醇代谢受损有关。因此，外源性皮质类固醇的治疗性应用是一种有前景的辅助干预措施。尽管有大量试验研究了这一问题，但皮质类固醇对脓毒症患者生存的影响仍存在不确定性。最近发表了几项大型随机对照试验，促使人们对现有文献进行重新评估。
方法与分析
截至2014年10月，我们对同一主题的Cochrane系统评价进行了严格且可重复的检索和筛选过程。从2014年9月起，我们将检索MEDLINE、EMBASE、LILACS、Cochrane试验注册库和clinicaltrials.gov，以查找研究皮质类固醇在脓毒症患者中应用的合格随机对照试验。结局指标由一个半独立的指南小组选定，该小组是在关于该主题的平行快速推荐背景下组建的。该小组包括临床医生、内容专家、方法学家和患者代表，他们将协助确定对于决定是否在脓毒症中使用皮质类固醇至关重要的患者重要结局指标。两名评审员将独立筛选并确定合格研究；第三名评审员将解决任何分歧。我们将使用RevMan软件，采用随机效应模型汇总纳入研究中每个结局指标的效应估计值。对于二分结局指标，我们将结果呈现为相对风险及95%置信区间；对于连续性结局指标，我们将结果呈现为均数差值或标准化均数差值及95%置信区间。我们将使用推荐分级、评估、制定与评价方法在结局层面评估证据的确定性。我们将进行事先设定的亚组分析，这些亚组分析由平行快速推荐小组选定。
伦理与传播
本系统评价的目的是总结关于皮质类固醇在脓毒症患者中疗效和安全性的最新证据。
试验注册号
CRD42017058537。
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