对严重肺炎的裁决协议
Chiagozie I Pickens1, Catherine A Gao1, Justin Bodner1
1Division of Pulmonary and Critical Care Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Open forum infectious diseases
|July 31, 2023
概括
开发严重肺炎的临床终点方案显示中等程度的同意. 7-8天的临床治愈与更好的患者结果有关,这表明它在重症肺炎研究中的有效性.
科学领域:
- 肺部和重症监护医学 肺部和重症监护医学
- 临床试验方法论 临床试验方法论
- 传染性疾病 传染性疾病
背景情况:
- 定义严重肺炎的成功治疗是具有挑战性的,因为潜在的偏见.
- 在重症肺炎中确定有意义的临床终点的结构化方案的有效性需要进一步研究.
研究的目的:
- 开发和评估严重细菌和/或病毒性肺炎的裁决方案.
- 评估严重肺炎管理中的临床终点的可靠性和有效性.
主要方法:
- 一个单中心前性队列研究,涉及医疗重症监护室中患有严重肺炎的患者.
- 由两名,如果需要,三名肺部和重症监护医生对肺炎发作进行独立审查.
- 对于未解决的裁决者之间的差异,共识审查.
主要成果:
- 通过裁决协议,获得了适度的观察者间协议 (48.1%至78.8%).
- 较低的协议与多次肺炎发作和共感染有关.
- 在细菌性肺炎的第7至8天内获得的临床治愈与更高的活体分泌率相关 (OR,6.3;95% CI,3.5-11.6).
结论:
- 一项针对重症肺炎的综合评判方案只产生了适度的观察者间共识.
- 7-8天的临床治愈似乎是判断协议的有效和有意义的终点.
- 这一发现支持使用早期临床治疗作为严重肺炎研究中有利结果的替代品.
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