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[Blue Journal在线发表]:宿主反应检测鉴别ICU患者的全身性感染与SIRS
2018年05月06日 时讯速递, 进展交流 暂无评论

Validation of a Host Response Assay, Septicyte™ LAB, for Discriminating Sepsis from SIRS in the ICU

Russell R Miller III ; Bert K. Lopansri , John P Burke , et al

Am J Respir Crit Care Med 2018 Published Online: April 06, 2018

Rationale: 背景

A molecular test to distinguish between sepsis and systemic inflammation of non-infectious etiology could potentially have clinical utility.

分子检测鉴别全身性感染与非感染因素导致的全身炎症可能有临床意义。

Objectives: 目的

This study evaluated the diagnostic performance of a molecular host response assay (SeptiCyte™ LAB) designed to distinguish between sepsis and non-infectious systemic inflammation in critically ill adults.

研究对宿主反应的分子检测 (SeptiCyte™ LAB) 对于成年危重病患者全身性感染与非感染性全身炎症的诊断准确性进行评估。

Methods: 方法

The study employed a prospective, observational, non-interventional design, and recruited a heterogeneous cohort of adult critical care patients from seven sites in the USA (N=249). An additional group of 198 patients, recruited in the large MARS consortium trial in the Netherlands (clinicaltrials.gov identifier: NCT01905033), was also tested and analyzed, making a grand total of 447 patients in our study. Performance of SeptiCyte™ LAB was compared to retrospective physician diagnosis by a panel of three experts.

本研究是前瞻性观察,采用非干预设计,入选美国7个中心的成年危重病患者(n = 249)。另外,对荷兰的大样本MARS研究入选的198名患者 (clinicaltrials.gov identifier: NCT01905033) 也进行了检测与分析。因此,研究共入选患者447名。 根据3名专家进行的回顾性诊断结果,比较SeptiCyte™ LAB的诊断准确性。

Measurements and Main Results: 评价指标与主要结果

In receiver operating characteristic curve analysis, SeptiCyte™ LAB had an estimated area under curve of 0.82-0.89 for discriminating sepsis from non-infectious systemic inflammation. The relative likelihood of sepsis versus non-infectious systemic inflammation was found to increase with increasing test score (range 0-10). In a forward logistic regression analysis, the diagnostic performance of the assay was improved only marginally when used in combination with other clinical and laboratory variables including procalcitonin. Performance of the assay was not significantly affected by demographic variables including age, sex, or race/ethnicity.

ROC曲线分析显示,SeptiCyte™ LAB 鉴别全身性感染与非感染炎症的AUC为0.82-0.89。随着检查评分(0-10)的提高,全身性感染的相对可能性也随之增加。在前向logistic回归分析中,当与其他临床和实验室指标(包括PCT)相结合时,SeptiCyte™ LAB的诊断准确性仅有轻度改进。SeptiCyte™ LAB诊断的准确性不受人口统计学指标(包括年龄,性别和种族)的影响。

Conclusions:

SeptiCyte™ LAB appears to be a promising diagnostic tool to complement physician assessment of infection likelihood in critically ill adult patients with systemic inflammation.

SeptiCyte™ LAB 是一种有前景的诊断方法,能够帮助医生判断伴有全身炎症的成年危重病患者感染的可能性。

Clinical trial registrations available at clinicaltrials.gov, IDs NCT02127502 and NCT01905033.

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