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美国国立卫生研究院急性呼吸窘迫综合征网络的遗产是什么?

What is the legacy of the National Institutes of Health Acute Respiratory Distress Syndrome Network?

作者信息

Kallet Richard H

机构信息

Department of Anesthesia, University of California, San Fransisco, CA, USA.

出版信息

Respir Care. 2009 Jul;54(7):912-24. doi: 10.4187/002013209793800330.

Abstract

It has been almost 15 years since the National Institutes of Health created the Acute Respiratory Distress Syndrome Clinical Trials Network (ARDS Network) and nearly a decade since the completion of the landmark low-tidal volume (V(T)) trial. In retrospect, the ARDS Network had a profound impact on the design and conduct of clinical trials in critical care. It represented the first time the federal government funded a clinical trials network devoted to Phase-III testing of important, non-pharmacologic therapies. Also the ARDS Network introduced factorial design into critical-care research, which allowed Phase-II testing of promising therapies. Other important contributions from the ARDS Network may not become apparent for many years. These include the ongoing mentoring of a new generation of critical-care researchers, as well as continued testing on an enormous store of biological samples that inevitably will advance our understanding of the pathogenesis of ARDS. Perhaps someday this may lead to another therapeutic breakthrough. Part of the ARDS Network's legacy surely will have been the opening of a dialog regarding the design of clinical trials in critical care, as well as a concerted effort to improve the protection of subjects enrolled into those trials. Finally, the respiratory care profession itself has benefited, owing both to its critical role in the successful implementation of complicated therapist-driven protocols and also to the ARDS Network's novel practice of utilizing respiratory therapists as clinical coordinators. This has raised the profile and enhanced the stature of the respiratory care profession.

摘要

美国国立卫生研究院创建急性呼吸窘迫综合征临床试验网络(ARDS网络)至今已近15年,具有里程碑意义的低潮气量(V(T))试验完成也将近10年了。回顾过去,ARDS网络对重症监护临床试验的设计和实施产生了深远影响。它代表着联邦政府首次资助一个致力于重要非药物疗法Ⅲ期试验的临床试验网络。此外,ARDS网络将析因设计引入重症监护研究,使得有前景的疗法能够进行Ⅱ期试验。ARDS网络的其他重要贡献可能在很多年后才会显现出来。这些贡献包括对新一代重症监护研究人员的持续指导,以及对大量生物样本的持续检测,这必然会增进我们对ARDS发病机制的理解。也许有一天这会带来另一个治疗突破。ARDS网络遗产的一部分肯定是开启了关于重症监护临床试验设计的对话,以及为加强对参与这些试验的受试者的保护而做出的协同努力。最后,呼吸治疗专业自身也从中受益,这既得益于其在成功实施复杂的治疗师主导方案中所起的关键作用,也得益于ARDS网络将呼吸治疗师用作临床协调员的创新做法。这提升了呼吸治疗专业的形象并提高了其地位。

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