背景:临床前动物研究先于大多数临床试验。虽然脓毒症的临床定义和推荐的治疗方法会定期更新,尚未对脓毒症临床前模型进行系统评价,也缺乏明确的建模指南.
目标:为了解决这一赤字,Wiggers-Bernard临床前脓毒症建模会议于2017年5月在维也纳举行.会议的目标是确定临床前败血症模型的局限性,并提出一套指南,定义为“临床前脓毒症研究中的最低质量阈值”(MQTiPSS),提高这些模型的转化价值。
方法:共有来自13个国家的31名专家参加,并分为6个专题工作组(WG):(1)研究设计,(2)人性化造型,(3)感染类型,(4)器官衰竭/功能障碍,(5)液体复苏,和(6)抗菌治疗终点。作为MQTiPSS讨论的基础,参与者对被引次数最多的260篇关于脓毒症模型的科学文章(2002-2013)进行了文献综述.
结果:总体而言,与会者就29点达成共识;20点在“建议”(R),9点在“考虑”(C)强度。本执行摘要提供了MQTiPSS共识的概要(表1、2和3)。对所有Rs和Cs的详细评论同时发表在三篇独立的全长论文中。
结论:我们相信这些建议和考虑将有助于提高脓毒症临床前模型的标准化水平,并最终改善临床前发现的翻译。这些指导要点被建议作为应实施的败血症动物模型的“最佳实践”。为了鼓励其广泛传播,这篇文章可以在震惊中免费访问,感染和重症监护医学实验。
BACKGROUND: Pre-clinical animal studies precede the majority of clinical trials. While the clinical definitions of sepsis and recommended treatments are regularly updated, a systematic review of pre-clinical models of sepsis has not been done and clear modeling
guidelines are lacking.
OBJECTIVE: To address this deficit, a Wiggers-Bernard Conference on pre-clinical sepsis modeling was held in Vienna in May 2017. The goal of the conference was to identify limitations of pre-clinical sepsis models and to propose a set of
guidelines, defined as the \"Minimum Quality Threshold in Pre-Clinical Sepsis Studies\" (MQTiPSS), to enhance translational value of these models.
METHODS: A total of 31 experts from 13 countries participated and were divided into 6 thematic working groups (WG): (1) study design, (2) humane modeling, (3) infection types, (4) organ failure/dysfunction, (5) fluid resuscitation, and (6) antimicrobial therapy endpoints. As basis for the MQTiPSS discussions, the participants conducted a literature review of the 260 most highly cited scientific articles on sepsis models (2002-2013).
RESULTS: Overall, the participants reached
consensus on 29 points; 20 at \"recommendation\" (R) and 9 at \"consideration\" (C) strength. This executive summary provides a synopsis of the MQTiPSS
consensus (Tables 1, 2, and 3). Detailed commentaries to all Rs and Cs are simultaneously published in three separate full-length papers.
CONCLUSIONS: We believe that these recommendations and considerations will serve to bring a level of standardization to pre-clinical models of sepsis and ultimately improve translation of pre-clinical findings. These
guideline points are proposed as \"best practices\" for animal models of sepsis that should be implemented. In order to encourage its wide dissemination, this article is freely accessible in Shock, Infection and Intensive Care Medicine Experimental.