RU2756562C1 - Method for evaluating effectiveness of pharmacotherapy in patients with bronchial asthma - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to clinical pharmacology, and can be used in conducting an evaluation of the effectiveness of pharmacotherapy of bronchial asthma. For this purpose, the forced exhalation volume (FEV1, %), the vital capacity (VC, l), the results of the AST test are evaluated. Additionally, the coefficients of modification (Mi) of indicators are determined by the formulas: M_FEV1 = (A_i – 15)/83; M_VC = (A_i – 0.4)/5.2; M_AST = (A_i – 5)/20, wherein A_i is the current value of the indicator in the patient. The course severity index (CSI) is calculated: CSI=(M_FEV1+M_VC+M_AST)/3. The first and the subsequent measurements are taken at intervals of three to four months. The CSI values are compared in the first and the repeated measurements. If the value has not changed or has decreased, then the course of therapy for bronchial asthma is not effective and requires correction. If the value has increased, then the taken course of pharmacotherapy is effective and no correction is required.

EFFECT: method provides a possibility of evaluating the effectiveness of a course of therapy for bronchial asthma, using a minimum set of evaluated indicators, not highly time-consuming and not requiring a highly qualified doctor.

1 cl, 6 tbl, 3 ex

Description

The invention relates to medicine, in particular to clinical pharmacology.

Bronchial asthma is a serious problem in clinical medicine. A significant proportion of patients do not achieve control over the course of the disease, which determines the need for an objective assessment of the patient's condition in order to timely change the treatment regimen.

Clinical methods for assessing the need to change the treatment regimen for patients with asthma are known, for example, a stepwise approach, which provides for a comprehensive assessment of clinical indicators - the number of attacks, the frequency of taking short-acting beta-agonists, determination of respiratory function parameters [Clinical guidelines of the Ministry of Health of the Russian Federation "Bronchial asthma", 2019].

The disadvantage of this method is the assessment of the totality of a significant number of indicators, which limits the possibility of rapid correction of the course of pharmacotherapy in clinical practice.

A method for evaluating the effectiveness of treatment of bronchial asthma is proposed, in which the number of peripheral blood lymphocytes with Fas-L expression is used as an indicator [patent RU 2389023]. With an increase in the number of lymphocytes expressing Fas-L at the end of antigen-specific immunotherapy by 3 or more times compared to the level before immunotherapy, the treatment is assessed as effective.

The disadvantage of this method is the control of the effectiveness of treatment only for patients receiving antigen-specific immunotherapy.

A method has been developed for evaluating the effectiveness of therapy for severe bronchial asthma [patent RU 2530616], including the determination of the integral cytokine index as the sum of the arithmetic mean of the indices of pro-inflammatory interleukins and the arithmetic mean of the indices of anti-inflammatory interleukins, the concentration of which is determined at the time of exacerbation of severe bronchial asthma and after its relief

The disadvantage of this method is the need to control laboratory parameters, namely pro-inflammatory and anti-inflammatory cytokines, the determination of which requires special laboratory equipment and expensive reagent kits, which limits the use of the proposed method.

The purpose of the invention is to evaluate the effectiveness of a course of therapy for bronchial asthma using a minimum set of assessed indicators, which does not require a lot of time, resources, high qualifications of a doctor.

This goal is achieved using a new diagnostic criterion - the severity index (ITT), which is determined by the formula (1):

(1),

(1),

where

M _FEV1 - coefficient of forced expiratory volume modification (FEV _1, %)

M _VC - coefficient of modification of the vital capacity of the lungs (VC, l)

M _AST - coefficient of modification of the results of disease control according to the AST test.

In turn, the modification coefficients (M _i ) of each of the above indicators are determined by the formula (2):

(2)

(2)

where: М _i - coefficient of modification of the studied indicator,

And _i is the value of this indicator in the patient,

A _max and A _min are the maximum and minimum values of the investigated indicator, obtained during the examination of 50 practically healthy individuals without pathology of the respiratory system and 190 patients with BA, the age of the examined from 30 to 68 years, the study was carried out at the clinical base of the V.G. N.N. Burdenko of the Ministry of Health of the Russian Federation at the ChUZ KB "Medicine of the Russian Railways", Voronezh. The values of the indicators are shown in Table 1.

Table 1

The limits of changes in the studied parameters in healthy individuals and patients with bronchial asthma

Index healthy patients with asthma A _min A _max A _min -A _max Min Max Min Max FEV 1, sec 90 98 15 88 15 98 83 VC, l / min 5.2 5.6 0,4 5.4 0,4 5.6 5.2 AST test, points 25 25 5 eighteen 5 25 twenty

With the help of formula (2), the patient's indicators are reduced to a single measurement scale, which allows comparing the degree of deviation of the studied values. As a result of the transformations, the modification coefficients are obtained:

Using the developed modification coefficients and the integral ITT index in the period 2018 - 2020. the calculations of the effectiveness of pharmacotherapy for 190 patients with asthma were performed.

For clinical confirmation of the effectiveness of the received course of treatment, we additionally took into account the data of the anamnesis, including the timing of remission of the disease after the previous hospitalization. The functions of external respiration were monitored, the AST test was determined, general and biochemical blood tests were performed with the determination of CRP, IgE on the first day of inpatient treatment and three to four months after the start of the course of pharmacotherapy.

Patients with asthma received pharmacotherapy with inhaled corticosteroid drugs, long-acting beta-agonists, drugs of the xanthine group, M-anticholinergics, mucolytics.

The study found that the value of ITT changed in patients depending on the overall assessment of the severity of asthma and the individual response to the course of therapy.

For patients with clinically confirmed effective BA pharmacotherapy, the integral ITT index increases during the follow-up period, positive dynamics of the condition and the possibility of continuing pharmacotherapy according to the selected treatment regimen are noted.

For patients with ineffective BA pharmacotherapy, the integral ITT index did not change or decreased, which is confirmed by a deterioration in respiratory function parameters and a decrease in BA control.

Example 1: GNS, 28 years old, examined. Diagnosis: healthy.

The results of calculating the modification coefficients are presented in Table 2.

Survey results G.N.S., 28 years old

Indicators of the subject Modification coefficients of indicators (M) FEV 1, sec 90 0.904 VC, l / min 5.4 0.962 AST test, points twenty 0.750 ITT 0.872

The value of the calculated integral ITT index approaches one, which is typical for healthy individuals.

Example 2: Patient BAE, 55 years old, diagnosis: Bronchial asthma mixed, moderate, uncontrolled.

The patients were twice admitted to the pulmonary department (5.11.2019-11.11.2019 and 7.03.2020-17.03.2020). The results of calculating the modification coefficients on the basis of indicators of the function of external respiration and AST-test at the first hospitalization (Table 3), upon re-hospitalization (Table 4).

Table 3

The results of the examination of the patient B.A.E., 55 years old,

at the first hospitalization (5.11.2019-11.11.2019)

Current value of the indicator Modification coefficients of indicators (M) FEV 1, sec 55 0.482 VC, l / min 1.49 0.210 AST test, points ten 0.250 ITT 0.314

Table 4

The results of the examination of the patient B.A.E., 55 years old,

upon re-hospitalization (03/07/2020 - 03/17/2020)

Current value of the indicator Modification coefficients of indicators (M) FEV 1, sec 37.8 0.275 VC, l / min 1.02 0.119 AST test, points eight 0.150 ITT 0.181

Reduction of ITT in patient B.A.C. from 0.314 conventional units up to 0.181 conventional units indicates the lack of effect from the therapy and is associated with negative dynamics of indicators of the function of external respiration and the AST test.

Example 3: Patient B.E.A., 55 years old, diagnosis: Bronchial asthma mixed, moderate, uncontrolled.

She was hospitalized in the pulmonary department twice (17.12. The results of calculating the modification coefficients are presented in table 5 and table 6.

Table 5

Results of examination of patient B.E.A, 55 years old, at the first hospitalization (17.12.2019-27.12.2019)

Current value of the indicator Indicator modification factors FEV 1, sec 45.9 0.372 VC, l / min 2.66 0.435 AST test, points ten 0.250 ITT 0.352

Table 6

The results of the examination of the patient B.A.E., 55 years old,

upon re-hospitalization (03/19/2020 - 03/31/2020)

Current value of the indicator Indicator modification factors FEV 1, sec 59.8 0.540 VC, l / min 2.82 0.465 AST test, points 12 0.350 ITT 0.352

Increased ITT in patient B.A.E from 0.352 conv. units up to 0.452 conventional units against the background of ongoing pharmacotherapy indicates the effectiveness of the prescribed treatment.

Thus, we have developed an easy-to-use method based on the use of indicators that are standardly determined during hospitalization of BA patients and does not require additional examinations to assess the effectiveness of the prescribed course of pharmacotherapy. EFFECT: method allows timely correction of BA treatment in stepwise therapy mode.

Claims (1)

A method for assessing the effectiveness of pharmacotherapy of bronchial asthma with an assessment of the forced expiratory volume (FEV1,%), vital capacity of the lungs (VC, l), the results of disease control according to the AST test, characterized in that the modification coefficients (Мi) of indicators are determined by the formulas: М _FEV1 = (And _i - 15) / 83; M _VC = (A _i - 0.4) / 5.2; M _AST = (A _i - 5) / 20, where A _i is the current value of the patient's indicator; then the severity index (ITT) is calculated: ITT = (M _OFV1 + M _VC + M _AST ) / 3; the first and subsequent measurements are performed with an interval of three to four months, the ITT values are compared for the first and repeated measurements, if the value has not changed or decreased - the course of bronchial asthma therapy is not effective, requires correction; if the value has increased, the course of pharmacotherapy is effective, no correction is required.