CN108931658A - For diagnosis of heart failure complication and the serum markers of prognosis evaluation - Google Patents
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Abstract
The invention discloses the blood serum designated objects for diagnosis of heart failure complication and prognosis evaluation, blood serum designated object is the composite marker object of IL-34 and at least three kinds of serum markers, wherein at least a kind of neurohormone marker, at least one kind of Inflammation Marker, at least one kind of renal function marker.The method for merging renal insufficiency for diagnosing heart failure and/or danger level layering being carried out to patients with heart failure is also disclosed, serum markers are combined to the patient to be investigated --- the measurement of IL-34 and at least three kinds of serum markers.In addition, additionally providing kits for accomplishing the methods, can be applied in emergency ward, ward or intensive care unit, ambulance or doctor's office.
Description
Technical field
The invention belongs to the diagnosis of heart disease, prevent and treat field, and in particular to one kind is used for diagnosis of heart failure
The serum markers of complication and prognosis evaluation.
Background technique
Heart failure (abbreviation heart failure) is the terminal stage of various heart diseases, and disease incidence, illness rate and case fatality rate are close
All journey ascendant trend over year, seriously threatens the health of the mankind.In China, heart failure illness rate is about 0.9% in adult at present,
And disease incidence is still in rising trend, it is contemplated that the disease incidence to the year two thousand thirty heart failure will increase by 25% compared with 2010, and chronic heart failure is suffered from
The death rate in person 10 years is up to 90%.
When heart failure due to cardiac output decline, circulation excess load, Renal vascular extravasated blood etc., often make cardiac insufficiency
Patient merges renal insufficiency, and the two forms vicious circle, and aggravate disease development, seriously affects the pre- of clinical patients with heart failure
Afterwards.
Heart failure merges a series of regulation of the renal insufficiency by Neurohormonal factors, including systemic inflammation condition and exempts from
The activation of epidemic disease reaction finds the important factor and biology of influence renal function and inflammatory conditions during heart failure as target spot
Marker has good estimated value for patients with heart failure prognosis.In view of this, still lacking easily and effectively in clinical position at present
Marker.
Known a variety of markers can be used for diagnosing and assessing severity of heart failure, such as brain natriuretic peptide (BNP) and brain natriuretic peptide
Precursor (NT-proBNP), the anti-albumen of C (CRP), the concentration of these markers increase a possibility that occurring with heart failure and seriously
Degree is related.However lack the efficiency index that energy EARLY RECOGNITION heart failure merges potential renal insufficiency patient in above-mentioned label, use a kind
Or successfully patient's prognosis cannot be assessed using 2 kinds of labels simultaneously.
Interleukin-13 4 (Interleukin 34, IL-34) is the protein containing 241 amino acid, its conduct
CSF-1R new ligand was found in 2008 for the first time, can wide expression in human multiple tissue organ, it is main to play to monokaryon
Macrophage proliferation, migration, differentiation and the regulation of survival, also controllable inherent immunity reaction.Meanwhile IL-34 can be released by secretion
It is put into blood, the severity with some chronic inflammation diseases and autoimmune disease such as Sjogren syndrome, inflammatory bowel disease
Correlation, while can also aggravate the generation of ischemia-reperfusion injury of kidney and chronic renal insufficiency.However so far, for
Effect of the IL-34 in cardiovascular field, especially heart failure is still not clear.
As a result, the target that is based on of the present invention be develop a kind of patient for merging renal insufficiency for diagnosing heart failure, and
To the method that the generation of patients with heart failure adverse cardiac events carries out danger level layering, the method can preferably identify high-risk trouble
Person simultaneously assesses prognosis.
Summary of the invention
In view of the deficiency of the prior art, the technical problem to be solved in the present invention is to provide one kind for diagnosing mental and physical efforts
The serum markers of failure complication and prognosis evaluation, and merge renal insufficiency and/or to patients with heart failure for diagnosing heart failure
Carry out the method and kit of danger level layering.
It provides one of to achieve the above object a kind of for diagnosis of heart failure complication and the serum marker of prognosis evaluation
Object, the invention adopts the following technical scheme：
For diagnosis of heart failure complication and the serum markers of prognosis evaluation, it is characterised in that：The serum marker
Object is the composite marking object of IL-34 and at least three kinds of serum markers, wherein at least a kind of neurohormone marker, at least one kind of
Inflammation Marker, at least one kind of renal function marker.
Preferably, the neurohormone marker is selected from the N- of atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP) ANP propetide
The N- terminal fragment NT-proBNP of terminal fragment NT-proANP and BNP propetide.
Further, the neurohormone marker is NT-proBNP.
Preferably, the Inflammation Marker is selected from c reactive protein (CRP), high-sensitive C-reactive protein (hsCRP) and cell
Factor IL-6, TNF-α and IL-10.
Further, the Inflammation Marker is hsCRP.
Preferably, the renal function marker is selected from blood urea nitrogen (BUN), serum creatinine and serum cystatin C.
Further, the renal function marker is selected from serum creatinine or serum cystatin C.
Realization of the invention includes carrying out outside open in-heart operation under pulsating detection to the patient studied, while measuring at least
3 kinds of serum markers, wherein at least a kind of neurohormone, at least one kind of markers of inflammation, at least one kind of renal function index；And simultaneously
Measure IL-34.It is found by experiment that NT-proBNP, hsCRP, serum creatinine or cystatin C and IL-34 is the bad thing of patients with heart failure
The independent hazard factor that part occurs, therefore when hazard recognition degree increases and/or when the patients with heart failure of prognosis mala, according to the present invention
The detection for carrying out These parameters, can effectively improve sensibility and specificity, so that EARLY RECOGNITION high-risk patient and guides treatment.Tool
Body, in above-mentioned technical proposal, patient can be carried out well using IL-34 and heart failure index NT-proBNP use in conjunction
Layering；And if increasing after hsCRP and cystatin C dangerous point on the basis of IL-34 and heart failure index NT-proBNP are united
Layer model will be more perfect, can preferably overall merit renal function of patients is horizontal and inflammatory conditions, to guarantee that effective assessment is pre-
After and guide treatment.Certainly, neurohormone marker NT-proBNP therein use instead atrial natriuretic peptide ANP, brain natriuretic peptide BNP,
NT-proANP；Inflammation Marker hsCPR uses CPR, cell factor IL6, TNF-α or IL-10 instead；Renal function marker serum Guang
Chalone C uses blood urea nitrogen (BUN), serum creatinine instead, can obtain similar above-mentioned conclusion.
Two to achieve the above object provide a kind of for diagnosis of heart failure complication and the method for prognosis evaluation, this hair
It is bright to use following technical scheme：
The method for merging renal insufficiency for diagnosing heart failure and/or danger level layering being carried out to patients with heart failure, to being wanted
The patient of investigation is combined serum markers --- the measurement of IL-34 and at least three kinds of serum markers, wherein measuring
At least one kind of neurohormone marker, at least one kind of Inflammation Marker, at least one kind of renal function marker.
Preferably, danger level increases and/or the patients with heart failure of prognosis mala the above method for identification.
Preferably, the composite marking object of aforementioned present invention is surveyed in parallel in one or more samples of taken patient
It is fixed.It is preferred that the one or more samples for being derived from patient are studied in one or many tests simultaneously.
Marker determination can be carried out in principle based on any of method, and it is as complete in used can also to carry out common business measurement
Automatic analyzer or quick detection kit measurement, can be in emergency ward, ward or intensive care unit, ambulance or doctor's office
Middle application.
In addition, the present invention also provides one kind for diagnosing heart failure merging renal function not and/or endangering to patients with heart failure
The kit of dangerous degree layering, it includes the detection reagents for measuring IL-34 and at least three kinds of markers, wherein having at least one
Kind to the detection reagent of neurohormone marker, the detection reagent of at least one kind of pair of Inflammation Marker, at least one kind of pair of renal function mark
Remember the detection reagent of object.
The beneficial effects of the present invention are：
1) -34 level of serum IL is used for clinical patients with heart failure prognosis evaluation for the first time by the present invention, it was demonstrated that IL-34 level is higher
Its cardiovascular death of patient and the adverse cardiac events incidence such as heart failure readmission is higher, prognosis is worse, initiative tests
Application value of the IL-34 in the diagnosis and prognosis evaluation that clinical patients with heart failure merges renal insufficiency is demonstrate,proved.
2) present invention can know clinical heart failure patient in early days compared with the existing method for measuring individual indexs
Not and handles more danger levels and increase and/or the patient of prognosis mala.Composite marking object according to the present invention can early detection
The patient of renal insufficiency and early intervention may be merged in heart failure, be further reduced the bad painstaking effort such as dead and heart failure readmission
It runs affairs the generation of part, there is important value of clinical studies.
3) compared with prior art, the present invention can be detected by the modes such as kit or full-automatic analyzer, detection side
Method is convenient and efficient.At the same time, the higher prompt patient of IL-34 level is easier to merge renal insufficiency, and IL-34 merges in heart failure
There is better prognosis directive significance, thus the perfect existing detection means that the present invention is initiative in the patient of renal insufficiency
Deficiency in this respect has special meaning.
Detailed description of the invention
Fig. 1 is the level of the IL-34 that is detected by ELISA method in patients with heart failure, and display IL-34 merges kidney in heart failure
It is significantly increased in insufficiency patient.
Fig. 2 is the level of the hsCRP that is detected by ELISA method in patients with heart failure, and display hsCRP merges kidney in heart failure
It is significantly increased in insufficiency patient.
Fig. 3 is the level of the NT-proBNP that is detected by ELISA method in patients with heart failure, shows NT-proBNP in the heart
It declines to merge in potential renal insufficiency patient and significantly increase.
Fig. 4 is the level of the cystatin C that is detected by ELISA method in patients with heart failure, and display cystatin C is closed in heart failure
And it is significantly increased in potential renal insufficiency patient.
Fig. 5 is Kaplan-Meier survivorship curve.Wherein, patient carries out quartile grouping by IL-34 level, passes through existence
Between comparing each group Primary Endpoint event (A), cardiovascular death (B), heart failure readmission occur for tracing analysis and log-rank inspection
(C) and the difference of All-cause death (D).
Fig. 6 is Kaplan-Meier survivorship curve, shows that IL-34 can be more preferable in the patient that heart failure merges renal insufficiency
Predict the generation of Primary Endpoint event.Glomerular filtration rate (eGFR)=60ml/min/1.73m is wherein pressed respectively2(A) and Guang presses down
Plain C Median levels (B) evaluate the relationship that the horizontal height of IL-34 occurs with Primary Endpoint event to triage respectively.
Fig. 7 is the ROC curve figure for merging potential renal insufficiency patient for heart failure.
110.4pg/ml is the important cut off value of IL-34 assessment patients with heart failure prognosis in Fig. 8.Wherein, (A) is to all patients
Be grouped by 110.4pg/ml level, be respectively compared two groups of patient's Primary Endpoint events and cardiovascular death, heart failure readmission and
The incidence of All-cause death, while Cox regression analysis is carried out, as a result with digital representation on histogram；(B) 110.4pg/ml pairs is pressed
Row K-M survivorship curve is analyzed after triage.
Fig. 9 is horizontal by NT-proBNP tertile and IL-34 tertile level carries out risk stratification to patient, relatively more each
The incidence of group Primary Endpoint event.
Specific embodiment
The invention will now be further described with reference to specific embodiments, but these examples are merely exemplary, it is not right
The scope of the present invention constitutes any restrictions.Those skilled in the art, which should be understood that, is not departing from the present invention
Under the premise of principle, several improvements and modifications can also be made, these modifications and embellishments should also be considered as the scope of protection of the present invention.
Embodiment 1
Study the IL-34, hsCPR detected into a group clinical patients with heart failure by ELISA method in peripheral blood in patients serum,
NT-proBNP and cystatin C are horizontal, acquire peripheral blood in patients using solidifying pipe is promoted, separate serum after 2000rpm centrifugation 20min,
Using IL-34ELISA kit according to illustrate to require detection it is horizontal (Human IL-34Quantikine ELISAKit,
D3400；R&D Systems) history-taking, physical examination, routine biochemistry index and the detection of heart function level etc. are carried out simultaneously.
Testing result is as shown in Figures 1 to 4, and IL-34, hsCRP, NT-proBNP and cystatin C are in heart failure as the result is shown
Merge and significantly increased in potential renal insufficiency patient, shows that IL-34, hsCRP, NT-proBNP and cystatin C can distinguish heart failure
Renal insufficiency and normal renal function person in patient.
In addition, as shown in table 1 below, by logistic regression analysis determined 3 parameters (hsCRP,
NT-proBNP and cystatin C) independently of one another.As it can be seen that IL-34 is 1.277 (1.024- to the odds ratio that it is predicted in model 2
1.593), IL-34 is divided for after tertile, the generation wind of the minimum quartile person's renal insufficiency of patient in highest quartile
Danger increases by 2.036 (1.183-3.502) times.Especially confirm IL-34 be predict heart failure merge renal insufficiency increased risk because
Element.
Table 1.IL-34 merges the single factor test and multivariate logistic regression analysis result of renal insufficiency to heart failure
Note：IL-34 is respectively with Log transformed continuous variable format, and presses after tertile is layered with ordered set
Form and calibration model is included in without classified variable form.Model 1 includes age and gender；Model 2 include the age, gender,
BMI, diabetes, hypertension, hemoglobin, albumin, hsCRP, NT-proBNP, cystatin C, New York cardiac functional grading and medicine
Object uses.
Embodiment 2
Follow-up is carried out to all patients in previous embodiment 1 and acquires endpoint information, Primary Endpoint is cardiovascular death
With the composite end points of heart failure readmission, secondary endpoints are cardiovascular death, heart failure readmission and All-cause death.
HsCRP is measured, using 2.89mg/L as cutoff value；For NT-proBNP, made using 1721.00pg/ml
For cutoff value；For cystatin C, using 1.155mg/L as cutoff value.As shown in figure 5, it is bent to be survived by Kaplan-Meier
Line analysis and log-rank are examined, and P < 0.05 has statistical significance, it was demonstrated that These parameters angiocarpy bad for patients with heart failure
The predictive value of event, while further by comparing quartile, the horizontal high patient's adverse cardiac events of verifying IL-34
Incidence is higher.
Using Analyzed by Cox Model, the results are shown in Table 2, and hsCRP, NT-proBNP and Guang suppression are corrected in model 2
Plain C is independent hazard factor respectively.Moreover, the HR value and P value in model 2 confirm that Primary Endpoint occurs for IL-34
HR is 1.301 (being included in continuous variable)；1.314 (are divided into after quartile ordered set is included in)；2.205 (are divided into four points
Behind position, occurrence risk of the highest quartile relative to minimum quartile), and the HR that other secondary endpoints occur for IL-34 also has phase
As relationship.To confirm that serum IL -34, hsCRP, NT-proBNP and cystatin C are patients with heart failure adverse cardiac events hairs
Raw independent hazard factor.Therefore it when hazard recognition degree increases and/or the patients with heart failure of prognosis mala, carries out according to the present invention
The detection of These parameters can effectively improve sensibility and specificity, so that EARLY RECOGNITION high-risk patient and guides treatment.
Single factor test and multifactor Cox regression result of the table 2.IL-34 to heart failure endpoints
Note：IL-34 is respectively with Log transformed continuous variable format, and presses after quartile is layered with ordered set
Form and calibration model is included in without classified variable form.Model 1 includes age and gender；Model 2 include the age, gender,
BMI, smoking history, diabetes, hypertension, hemoglobin, albumin, eGFR, hsCRP, NT-proBNP, cystatin C New York heart function
It can be classified and drug uses.
As shown in fig. 6, pressing glomerular filtration rate (eGFR)=60ml/min/1.73m respectively2(A) and cystatin C (i.e. blood
Clear cystatin C, Cys C) Median levels (B) are to triage, as shown in Figure 6A, for eGFR<60 patient, IL-34 water
The occurrence risk for equalling high person its Primary Endpoint event significantly increases (log rank P=0.004) compared with the horizontal junior of IL-34；And
For the patient of eGFR >=60, the risk that Primary Endpoint event occurs for IL-34 high person is bigger, but the two there is no statistical significance (P
=0.088).And when distinguishing renal function level height by cystatin C to all patients (Fig. 6 B), for cystatin C height, i.e. kidney function
Patient that can not be complete, the horizontal height of IL-34 influence bigger (P to the generation of adverse events<0.001)；And it is lower for cystatin C
Patient, IL-34 has no significant effect (P=0.651).
In conjunction with the Cox regression result in the following table 3, patient is layered by renal function level, merges renal function in heart failure
Infull patient, IL-34 for Primary Endpoint occurrence risk HR value be 1.345 (1.117-1.619), P=0.002, and
Normal renal function person, HR are 1.275 (0.973-1.670), P=0.078, it is shown that IL-34 merges renal function not in heart failure
There is stronger prognostic value in full patient.At the same time, corresponding HR value also shows IL-34 for each terminal
The estimated value of (including cardiovascular death, heart failure readmission and All-cause death) merges in potential renal insufficiency patient more in heart failure
By force.After table 3. is layered patient by renal function level, IL-34 returns the single factor test of heart failure endpoints and multifactor Cox
Sum up fruit
Note：IL-34 is included in calibration model respectively with Log transformed continuous variable format.Model include the age, gender,
BMI, smoking history, diabetes, hypertension, hemoglobin, albumin, eGFR, hsCRP, NT-proBNP, New York cardiac functional grading
It is used with drug.
It is found simultaneously using ROC curve and C-statistic analysis, the patient of renal insufficiency is merged for heart failure, such as
Shown in Fig. 7, black lines are that conventional risk factors model does not add IL-34, and grey is the ROC curve that joined IL-34, is shown
The predictive value that IL-34 can make conventional risk factors model that patients with heart failure Primary Endpoint event occur is by 0.724 (0.641-
0.808) it is increased to 0.768 (0.687-0.848) (P=0.033).
As shown in figure 8,110.4pg/ml is the important cut off value that IL-34 level judges patient's prognosis, by two groups of tests,
(A) all patients are grouped by 110.4pg/ml level, be respectively compared two groups of patient's Primary Endpoint events and cardiovascular death,
The incidence of heart failure readmission and All-cause death, while carrying out Cox regression analysis can be with as a result with digital representation on histogram
It obtains：The occurrence risk that IL-34 level is higher than patient's Primary Endpoint event of cut off value increases by 2.295 times；(B) 110.4pg/ is pressed
Ml analyzes row K-M survivorship curve after triage, the results showed that IL-34 level is higher than patient's Primary Endpoint event of cut off value
Occurrence risk with lower than cut off value patient compared with obviously increase.
As shown in figure 9, IL-34 and heart failure index NT-proBNP level are higher, the incidence of Primary Endpoint event is higher,
IL-34 can well be layered patient with heart failure index NT-proBNP use in conjunction.And if in IL-34 and heart failure
Risk stratification model will be more perfect after increasing hsCRP and cystatin C on the basis of index NT-proBNP is united, can be preferably
Overall merit renal function of patients level and inflammatory conditions, so that effectively assessment prognosis and guides treatment.
It should be noted that when the composite marking object involved in above-described embodiment carries out any replacement by following selection：
Neurohormone marker NT-proBNP uses atrial natriuretic peptide ANP, brain natriuretic peptide BNP, NT-proANP instead；Inflammation Marker
HsCPR uses CPR, cell factor IL6, TNF-α or IL-10 instead；Renal function marker serum cystatin C uses blood urea nitrogen instead
(BUN), serum creatinine can obtain similar above-mentioned conclusion.
The above-described embodiments merely illustrate the principles and effects of the present invention, and is not intended to limit the present invention.It is any ripe
The personage for knowing this technology all without departing from the spirit and scope of the present invention, carries out modifications and changes to above-described embodiment.Cause
This, institute is complete without departing from the spirit and technical ideas disclosed in the present invention by those of ordinary skill in the art such as
At all equivalent modifications or change, should be covered by the claims of the present invention.
Claims (10)
1. for diagnosis of heart failure complication and the serum markers of prognosis evaluation, it is characterised in that：The serum markers are
It is composite marking object comprising IL-34 and at least three kinds of serum markers, wherein at least a kind of neurohormone marker, at least one kind of
Inflammation Marker, at least one kind of renal function marker.
2. serum markers as described in claim 1, it is characterised in that：The neurohormone marker is selected from atrial natriuretic peptide
ANP, brain natriuretic peptide BNP, ANP propetide N- terminal fragment NT-proANP and BNP propetide N- terminal fragment NT-proBNP.
3. serum markers as described in claim 1, it is characterised in that：The Inflammation Marker is selected from c reactive protein CRP,
High-sensitive C-reactive protein hsCRP, cell factor IL-6, TNF-α and IL-10.
4. serum markers as described in claim 1, it is characterised in that：The renal function marker be selected from blood urea nitrogen BUN,
Serum creatinine and serum cystatin C.
5. serum markers as claimed in claim 4, it is characterised in that：The renal function marker is serum creatinine or serum Guang
Chalone C.
6. the method for merging renal insufficiency for diagnosing heart failure and/or carrying out danger level layering to patients with heart failure, feature exist
In：Marker is combined to the patient to be investigated --- the measurement of IL-34 and at least three kinds of serum markers,
It is middle to measure at least one kind of neurohormone marker, at least one kind of Inflammation Marker, at least one kind of renal function marker.
7. method as claimed in claim 6, danger level increases and/or the patients with heart failure of prognosis mala for identification.
8. method as claimed in claim 6, it is characterised in that：It is surveyed in parallel in one or more samples of taken patient
It is fixed.
9. method as claimed in claim 6, it is characterised in that：It is measured on fully-automatic analyzer.
10. merge renal insufficiency for diagnosing heart failure and/or carries out the kit of danger level layering to patients with heart failure, it includes
For measuring the detection reagent of IL-34 and at least three kinds of serum markers, wherein there are at least one kind of pair of neurohormone markers
Detection reagent, the detection reagent of at least one kind of pair of Inflammation Marker, the detection reagent of at least one kind of pair of renal function marker.
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| CN113348368A (en) * | 2019-03-29 | 2021-09-03 | B.R.A.H.M.S有限公司 | Remote patient management prescription based on biomarkers |
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