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Sepsis blood biomarker system

A biomarker, sepsis technology, applied in the field of cal, biomarker, can solve problems such as incorrect identification, macrophage exhaustion, inappropriate iNOS enzyme, etc.

Inactive Publication Date: 2014-07-23
罗伯特·韦伯
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0024] 1. Apoptotic cells containing iNOS did not correctly label themselves with the "eat me" sign;
[0025] 2. Macrophages did not correctly recognize the "eat me" marker on apoptotic cells containing iNOS, or;
[0026] 3. Local depletion of macrophages occurs and other macrophages are not recruited to a site quickly enough to clear apoptotic cells containing iNOS
[0029] [3] Ultimately, leading to the life-threatening sepsis cascade
However, the iNOS enzyme is now a component of cells that were never induced, the iNOS enzyme is in an inappropriate location, and the host "recipient" cells are detached from normal cellular regulation

Method used

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Examples

Experimental program
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Effect test

Embodiment I

[0112] To date, three clinical studies focused on answering basic scientific questions have been conducted. Conducted the first pilot study on 10 ICU patients and 8 normal healthy volunteers; the second study on 47 ICU patients and 11 normal healthy volunteers; and on 238 ICU patients and 36 healthy volunteers The third clinical study of the patient. The new discovery was initially made on samples obtained from 10 ICU patients enrolled in the first pilot clinical study that the normal intracellular protein iNOS was detectable and measurable in plasma using the diagnostics of US Patent 6,531,578. In this first pilot clinical study, iNOS was not detected in any plasma samples obtained from normal healthy volunteers as controls. In three combined clinical studies, the onset of sepsis pathology as judged by the presence of iNOS in plasma samples preceded the onset of physiological symptoms of sepsis in more than 65 ICU patients and in more than 100 severely injured trauma patient...

Embodiment II

[0114] Analysis of data obtained from trauma patients and normal healthy volunteer controls enrolled in the third clinical pilot study of Example 1 for the IVD tests of US Patents 6,531,578 and 7,198,904 was performed. Analyzes focused on predicting hemodynamic, pulmonary, and renal dysfunction associated with sepsis pathology in trauma patients ( Figure 4 Table 3). These analyzes determined the predictive value of this IVD test, where:

[0115] [1] Hemodynamic dysfunction is defined as mean arterial pressure (MAP) ≤ 70 mm Hg or patients receiving one or more vasoconstrictor drugs;

[0116] [2] Pulmonary dysfunction defined as a diagnosis of respiratory failure or >24 hours of mechanical ventilation or SIMV with changes in blood gas and pH; and

[0117] [3] Renal dysfunction is defined as blood urea nitrogen (BUN)>20mg / dl.

[0118] The results of these analyzes showed that the plasma iNOSIVD test of US patents 6,531,578 and 7,198,904 had a positive predictive value (PPV) o...

Embodiment III

[0120] Using the data collected in the third clinical study of Example 1, the extent of correlation between plasma iNOS and other potential biochemical markers of sepsis was determined. In addition to plasma iNOS, plasma levels of NOx (which is the combination of plasma nitrate and nitrite, two breakdown products of nitric oxide), and procalcitonin were measured. No correlation was found between plasma iNOS and plasma nitrate plus nitrite (NOx). This is thought to indicate that iNOS in plasma is not an active enzyme, since plasma does not contain the two cofactors required for its enzymatic activity, Figure 4 Table 3. Therefore, there is no nitric oxide produced by circulating iNOS to break down to nitrate or nitrite. Plasma levels of procalcitonin, an IVD test approved by the FDA for the diagnosis of sepsis, are not associated with sepsis pathology ( Figure 4 Table 3 and Figure 5 The test results of iNOS EIA and procalcitonin EIA). Only the detection of plasma iNOS pr...

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Abstract

A panel of blood biomarkers for assessing a sepsis condition utilizing an iNOS indicator in combination with one or more indicators of patient predisposition to becoming septic, the existence of organ damage, or the worsening or recovering from a sepsis episode.

Description

[0001] Cross References to Related Applications [0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 61 / 403,919, filed September 22, 2010, the contents of which are incorporated herein by reference in their entirety. Background of the invention [0003] The present invention relates to a novel and useful panel of biomarkers indicative of the propensity, onset, progression of sepsis, and organ damage due to the presence of sepsis pathology, the sepsis condition. [0004] Each year at least 7 million patients enter the early stages of sepsis pathology, a medical condition called systemic inflammatory response syndrome (SIRS), which causes more than 250,000 annual deaths in the United States and more than 750,000 annual deaths worldwide . As the population ages, more people are expected to develop SIRS. Sepsis develops from a variety of bacterial and fungal sources from a patient's inability to fight infection, and is usua...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53G01N33/577A61B5/00
CPCG01N33/573G01N2333/90254G01N2800/26G01N33/6893
Inventor 罗伯特·韦伯
Owner 罗伯特·韦伯
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