# Method for predicting complications of immunotherapy with allergens in case of seasonal allergic rhinitis

FIELD: medicine, immunology, allergology.

SUBSTANCE: one should detect the parameters of immune state and objective anamnesis, before carrying out specific immunotherapy (SIT) with allergens one should detect IgM level (g/l), the quantity of monocytes (Mon), lymphocytes (Lymph) in total blood analysis in %, the quantity of B lymphocytes in % (CD19), immunoregulatory index (IRI) (CD4/CD8), phagocytic value in % (PhV), IgE serumal level in IU/ml, the quantity of points in evaluating accompanying nonallergic anamnesis (Point) {one point in case of one chronic disease, 2 points in case of two, etc.}, then one should calculate the changes in immunity parameters on the 7^{th} d of SIT-therapy, obtained values should be applied in the following equation of regression (Y= -195.4 + 117.3·IgM + 10.8·Mon - 0.35·IgE - 17.1·Point + 7.8·Dlymph + 20.4·Dmon + 3·Dbl + 22.8·Diri) and calculating the possibility of complications it is necessary to perform by the following formula: P = 100/(1+Exp(-Y)).

EFFECT: higher accuracy of prediction and improved quality of therapy.

3 ex

The invention relates to immunology, and more particularly to Allergology.

Specific allergen immunotherapy (SIT) is the only way antiallergic treatment, affecting all pathogenetically important links in the allergic process and has long-term preventive effect after completion of the treatment course. The classical scheme of immunotherapy with allergens is a method of treatment of allergic diseases, consisting of subcutaneous injection into a patient over a long period of time, gradually increasing doses of allergen to which he has revealed hypersensitivity.

As the main argument restrictions on the use of SIT is the possibility of systemic side effects from the injection of therapeutic forms of allergens. Systemic reactions occur usually after one or two months from the start of treatment, the infusion of large doses of allergen and is characterized by generalized signs and symptoms that are not related to the injection site. In the event of systemic reactions shown revaluation program immunotherapy.

Systemic reactions accompanying SIT, it is not always possible to determine, based only on indicators of clinical status of the patients, despite the high qualification BP is whose and observance of all of the rules of procedure of immunotherapy. This is due to the fact that complications of immunotherapy occur on the soil altered immune status in patients with allergies.

The known method prognostic evaluation of the effectiveness of immunotherapy with allergens and the likelihood of complications of treatment, which consists in the careful collection of clinical history, status, immune status on the level of total IgE, allergen specific immunoglobulins E and G, results of skin allergodil and subsequent empirical decision doctor about the possibility of the procedure of immunotherapy with allergens (Gushchin I.S., ilina NI, Pollner S.A. Allergic rhinitis (manual for doctors). - M., 2002. - 72 C.). This method does not give a quantitative risk assessment is subjective in nature, and therefore its use often leads to less accurate estimation of the risk of complications of the SITH.

The aim of the present invention is to improve the accuracy assessment of the risk of systemic reactions when conducting SIT and thereby increase the quality of treatment.

This goal is achieved by computing the discriminatory function, arguments which are data of immunological indexes and objective history of the patients received prior to the SIEVES and after 7 or 30 days from the start of treatment. On the obtained value of the function calculates the probability of developing complications of immunotherapy.

Patent-pending formula for calculating the probability of the risk of complications of immunotherapy with allergens was calculated on the basis of the analysis of indicators of immune status 120 patients with allergic diseases. During treatment, patients were divided into two groups: group 1 - patients well endured treatment, and group 2 - patients with side effects of treatment (which develop in 2-4 months from the beginning of immunotherapy). All patients were 40 different definition of indicators of immune status before treatment and one week after the first injection of therapeutic doses of allergen. After collecting all the data the survey results were subjected to statistical analysis using standard stepwise discriminant analysis (Computer biometrics. Edited Vinnova. - M., 1990. - 262 C.), where to calculate the probability of the classification function was used logistic regression (Cadets V., Grigoriev YEAR Multivariate methods of statistical analysis of categorized data for medical research. - SPb.:Military medical Academy, 2001. - S).

A typical logistic regression equation is:

Y=100·exp(c+bx)/(1+exp(c+bx)).

Where Y is the probability of occurrence of the effect (in our case, the complications of the SITH) (0=<Y>=100), C is a constant, b is the coefficient of X factor, x is the current value of factor X. the Curve function lo is eticheskoi regression is a smooth curve, continuously increasing from 0 to 1. Forecast the likelihood of take effect:

is positive when Y>50%;

negative when Y<50%.

In our case, investigated the effect of several factors - parameters of the immune status, anamnesis, results of skin tests. The regression equation takes the form:

Y=exp(c+b1·x1+b2·x2+...+Dk·xk)/(1+exp(c+b1·x1+b2·x2+...+Dk·xk)).

The coefficients of the logistic regression equation is determined by the maximum likelihood method, based on the principle of maximizing the probability of compliance, the adequacy of the projected distribution of the patients into groups according to the model with the observed in the sample. Important factors to include in the model are selected using a critical value of the Fisher criterion F>4, providing a level of significance of p<0,05.

After statistical processing remained only the parameters of the immune status, which significantly affect the classification results, they are presented in a patent pending formula.

CALCULATIONS

Estimated parameters of the immune status before conducting the SITH: the level of IgM (g/l), the number of monocytes (Mon), lymphocytes (Lymph) in the General analysis of blood in %, number of b-lymphocytes in % (SD), immunoregulatory index (IRI)(CD4/CD8), phagocytic index in % (AF), the level of IgE in sivaram the e in IU/ml, the number of points in the evaluation of collateral is not allergic anamnesis (Ball) {one point with one chronic disease two points at two and so forth}.

Calculated changes of the parameters of immunity on the 7th day of therapy: immunoregulatory index (CD4/CD8) diri=(IRI on the 7th day - IRI before treatment), the number of lymphocytes (%) Dlim=(Limp on the 7th day - Limp before treatment), monocytes (%) Dmon=(Mon 7 day Mon before treatment), b-lymphocytes VCC=(SD on the 7th day - SD before treatment).

The regression equation is:

Y=-195,4+117,3·IgM+10,8·Mon-0,35·IgE-17,1·Bal+7,8·Dlim+20,4·Dmon+3·VCC+22,8·diri

Calculating the probability of complications:

In those cases where it was not possible to conduct an examination of a patient on the 7th day of therapy, or when the calculated probability of complications according to SIT, and after a week of allergological takes a value close to 50%, conduct probability, risk of complications, using the value of indicators of immune status before and 30 days of treatment SITH. This is estimated parameters of the immune status before conducting the SITH: the level of IgM (g/l), the number of monocytes (Mon), lymphocytes (Lymph) in the General analysis of blood in %, number of b-lymphocytes in % (SD), immunoregulatory index (IRI)(CD4/CD8), phagocytic index in % (AF), the level of IgE in the serum IU/ml, if estvo points in the evaluation of collateral is not allergic anamnesis (Ball) {one point if you have one chronic disease, two points in two and so on}. Calculated changes of the parameters of immunity in a month from the beginning of the SITH: the change in the level of lymphocytes (%) VCC=(SD 30 day SD before treatment), phagocytic index sequential function=(AF 30 day - OP before treatment), immunoregulatory index (CD4/8) diri=(IRI 30 day - IRI before treatment).

The logistic regression equation: Y=-178,9+39,6·IgM-32,7·MES-2·IgE+97,3·Bal+11,1·VCC-2,15·Suite+125,6·diri

Calculating the probability of complications:

Example 1:

Patient A. Seasonal allergic rhinitis, sensitization to pollen of Artemisia. History of chronic pyelonephritis, gastritis.

These immunological indexes

To SIT: IgM=1.2 g/l; IgE=59 IU/ml; points in history =2; IRI=0,7; b-lymphocytes =3%; lymphocytes =22%; monocytes =6%; FP=83%

On the 7th day of the SITH: IRI=0,9; b-lymphocytes =4%; monocytes =7%; lymphocytes =30%

30 day SIT: IRI=1,07; b-lymphocytes =4%; FP=29%. The calculated changes of the parameters of immunity on the 7th day of therapy:

- immunoregulatory index (CD4/CD8) diri=(IRI on the 7th day - IRI before treatment)=0,9-0,7=0,2

- the number of lymphocytes (%) Dlim=(Limp on den - Limp before treatment)=30-22=8

- monocytes (%) Dmon=(Mon to deny Mont before treatment)=7-6=1

- B-lymphocytes VCC=(SD on den - SD before treatment)=4-3=1

The regression equation is:

Y=-195,4+117,3·IgM+10,8·Mon-0,35·IgE-17,1·Bal+7,8·Dlim+20,4·Dmon+3·D is l+22,8· Diri=-195,4+117,3·1,2+10,8·6-0,35·59-17,1·2+7,8·8+20,4·1+3·1+22,8·0,2=50,36

Complications:

The calculated changes of the parameters of immunity in a month from the beginning of the SITH:

- change level In lymphocytes (%) VCC=(SD 30 day SD before treatment)=4-3=1

- phagocytic index sequential function=(AF 30 day - OP before treatment)=83-29=54

- immunoregulatory index (CD4/8) diri=(IRI 30 day - IRI before treatment)=1,07-0,7=0,37

The logistic regression equation:

Y=-178,9+39,6·IgM-32,7·MES-2·IgE+97,3·Bal+11,1·VCC-2,15·Suite+125,6·diri=-178,9+39,6·1,2-32,7·6-2·59+97,3·2+11,1·1-2,15·54+125,6·0,37=366

Complications:

Thus, the probability of occurrence of systemic complications in terms of immunity to SIT and 7 and 30 day immunotherapy equal 100%. In this regard, the patient is recommended to perform the treatment on the background of anti-allergic farmcrest.

Example 2:

Patient B. Seasonal allergic rhinitis with sensitization to pollen of Artemisia. There is a history of co-morbidities.

These immunological indexes

To SIT: Ig M=1.1 g/l; IgE=510 IU/ml; Points in history=0; IRI=1,4; b-lymphocytes =5%; Lymphocytes =35%; Monocytes =2%; OP - 73%

On the 7th day of the SITH: IRI=1,1: b-lymphocytes =6%; Monocytes =4%; Lymphocytes =36%

30 day SIT: CD4/CD8=1.3: In-limpot the tov =6%; OP - 63%

The calculated changes of the parameters of immunity on the 7th day of therapy:

Correlation of IRI: diri=(7 day - before treatment)=1,4-1,1=0,3

lymphocytes: GLIMP=(7 day - before treatment)=35-36=-1

monocytes: Dmon=(Dene - before treatment)=2-4=-2

B-lymphocytes: VCC=(Dene - before treatment)=5-6=-1

The regression equation is:

Y=-195,4+117,3·IgM+10,8·Mon-0,35·IgE-17,1·Bal+7,8·Dlim+3·VCC+20,8·Dmon+22,8·diri=-195,4+117,3·1,1+10,8·2-0,35·510-17,1·0+7,8·(-1)+3·(-1)+20,8·(-2)+22,8·0,3=-195,4+129+21,6-178,5-7,8-3-41,6+6,84=-265,86

Complications:

The calculated changes of the parameters of immunity in a month from the beginning of the SITH:

In lymphocytes VCC=(30 day - before treatment)=5-6=-1

phagocytic index sequential function=(30 day - before treatment)=63-73=-10

the ratio of CD4/CD8 diri=(30 day - before treatment)=1,4-1,3=0,1

The logistic regression equation:

Y=-178,9+39,6·IgM-32,7·MES-2·IgE+97,3·Bal+11,1·VCC-2,15·Suite+125,6·diri=-178,9+39,6·1,1-32,7·2-2·510+97,3·0+11,1·(-1)-2,15-(-10)+125,6·0,1=-178,9+43,56-65,4-1020-11,1+21,5+12,56=-1198,34

Complications:

Thus, the predictive probability of the occurrence of systemic complications in terms of immunity to SIT and 7 and 30 day immunotherapy is close to 0%.

Subsequently, the patient did not experience any problems with immunotherapy.

Example 3:

These immunological indexes

To SIT: Ig M=1.5 g/l; IgE=47 IU/ml; Points in history=3; IRI=1,2; b-lymphocytes =3%; Lymphocytes =25%; Monocytes =7%; FP - 63%

On the 7th day of the SITH: IRI=1,37; b-lymphocytes =3%; Monocytes =7%; Lymphocytes =26%

30 day SIT: IRI=1,2; b-lymphocytes =1,2%; FP - 66%

The calculated changes of the parameters of immunity on the 7th day of therapy:

Correlation of IRI: diri=(7 day - before treatment)=1,37-1,2=0,17

lymphocytes: GLIMP=(7 day - before treatment)=26-25=1

monocytes: Dmon=(Dene - before treatment)=7-7=0

B-lymphocytes: VCC=(Dene - before treatment)=3-3=0

The regression equation is:

Y=-195,4+117,3·IgM+10,8·Mon-0,35·IgE-17,1·Bal+7,8·Dlim+3·VCC+20,8·Dmon+22,8·diri=-195,4+117,3·1,5+10,8·7-0,35·47-17,1·3+7,8·1+3·0+20,8·0+22,8·0,17=0,076

Complications:

The calculated changes of the parameters of immunity in a month from the beginning of the SITH:

In lymphocytes VCC=(30 day - before treatment)=1,2-3=-1,8

phagocytic index sequential function=(30 day - before treatment)=66-63=3

the ratio of CD4/CD8 diri=(30 day - before treatment)=1,2-1,2=0

The logistic regression equation:

Y=-178,9+39,6·IgM-32,7·MES-2·IgE+97,3·Bal+11,1·VCC-2,15·Suite+125,6·D is ri=-178,9+39,6· 1,5-32,7·1,5-2·47+97,3·3+11,1·(-1,8)-2,15·3+125,6·0=2,92

Complications:

Thus, the predictive probability of the risk of systemic complications SIT on indicators of immunity before treatment and on day 7 is 48%, which is not possible to confidently predict the choices of the patient's condition during the SITH. According to the 30 day immunotherapy risk of complications is quite high of 94.9%.

You need to change the scheme of introducing allergens and to SIT on the background of anti-allergic drugs.

1. The method of prediction of complications of immunotherapy with allergens for seasonal allergic rhinitis, including determination of the parameters of the immune status and objective history, wherein define before SIT level of IgM (g/l), the number of monocytes (Mon), lymphocytes (Lymph) in the General analysis of blood in %, number of b-lymphocytes in % (SD), immunoregulatory index (IRI)(CD4/CD8), phagocytic index in %(AF), the level of IgE in the serum IU/ml, the number of points in the evaluation of concomitant non-allergic anamnesis (Bal) (one point if you have one chronic disease, two points for two, and so on), calculate the changes of the parameters of immunity on the 7th day of therapy SIT immunoregulatory index (CD4/CD8) diri=(IRI on the 7th day - IRI before treatment), the number of lymphocytes (%) Dlim=(lim is on den - Limp before treatment), monocytes (%) Dmon=(Mon 7 day Mon before treatment), b-lymphocytes VCC=(SD on the 7th day - SD before treatment), the obtained values are substituted into the regression equation (Y=-195,4+117,3·IgM+10,8·Mon-0,35·IgE-17,1·Bal+7,8·Dlim+20,4·Dmon+3·VCC+22,8·diri) and calculate the probability of complications is conducted according to the formula: R=100/(1+Exp(-Y)).

2. The method according to claim 1, characterized in that the calculated changes of the parameters of immunity in a month from the beginning of the SIT - level change In lymphocytes (%) VCC=(SD 30 day SD before treatment), phagocytic index sequential function=(AF 30 day - OP before treatment), immunoregulatory index (CD4/CD8) diri=(IRI 30 day - IRI before treatment), the obtained values are substituted into the regression equation (Y=-178,9+39,6·IgM-32,7·MES-2·IgE+97,3·Bal+11,1·VCC-2,15·Suite+125,6·diri) and calculate the probability of complications is conducted according to the formula: R=100/(1+Exp(-Y)).

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