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儿童急性呼吸窘迫综合征的临床试验及未来方向

Clinical trials and future directions in pediatric acute respiratory distress syndrome.

作者信息

Allareddy Veerajalandhar, Cheifetz Ira M

机构信息

Section Chief Pediatric Cardiac ICU, Duke Children's Hospital, Duke University Medical Center, Durham, NC, USA.

出版信息

Ann Transl Med. 2019 Oct;7(19):514. doi: 10.21037/atm.2019.09.14.

Abstract

The pediatric acute respiratory distress syndrome (PARDS), a description specific for children with acute respiratory distress syndrome (ARDS), was proposed in the recent Pediatric Acute Lung Injury Consensus Conference (PALICC, 2015). This recent standardization of PARDS diagnosis is expected to aid in uniform earlier recognition of the entity, enable use of consistent management strategies and potentially increase the ease of enrollment in future PARDS clinical trials-all of which are expected to optimize outcomes in PARDS. Clinical trials in PARDS are few but ongoing studies are expected to lay the foundation for future clinical studies. The Randomized Evaluation of Sedation Titration for Respiratory Failure trial (RESTORE) trial has revealed that a goal directed sedation protocol does not reduce the duration of invasive ventilation in critically ill children. PROSpect trial is a large multi-institute clinical trial that is expected to reveal optimal ventilation strategies and patient positioning (supine prone) in patients with severe PARDS. The PARDS neuromuscular blockade (NMB) study is expected to yield important information about the impact of active NMB on PARDS outcomes. Information from these studies could be used to design future clinical trials in PARDS and to lessen the anecdotal or extrapolated experiences from adult clinical studies that often guide clinical practices in PARDS management. Finally, it is expected that these definitions and management strategies will be revised periodically as our understanding of PARDS evolves. Emerging data on PARDS subtypes suggest that patient heterogeneity is an important factor in designing these clinical trials.

摘要

小儿急性呼吸窘迫综合征(PARDS)是急性呼吸窘迫综合征(ARDS)在儿童中的一种特定描述,是在最近的小儿急性肺损伤共识会议(PALICC,2015)中提出的。PARDS诊断的这一最新标准化有望有助于统一对该疾病的早期识别,使一致的管理策略得以应用,并可能提高未来PARDS临床试验的入组便利性,所有这些都有望优化PARDS的治疗结果。PARDS的临床试验较少,但正在进行的研究有望为未来的临床研究奠定基础。呼吸衰竭镇静滴定随机评估试验(RESTORE)表明,目标导向镇静方案并不能缩短重症儿童有创通气的持续时间。PROSpect试验是一项大型多机构临床试验,有望揭示重度PARDS患者的最佳通气策略和患者体位(仰卧位 俯卧位)。PARDS神经肌肉阻滞(NMB)研究有望得出关于主动NMB对PARDS治疗结果影响的重要信息。这些研究的信息可用于设计未来的PARDS临床试验,并减少成人临床研究中常常指导PARDS管理临床实践的轶事性或推断性经验。最后,随着我们对PARDS的认识不断发展,预计这些定义和管理策略将定期修订。关于PARDS亚型的新数据表明,患者异质性是设计这些临床试验的一个重要因素。

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