Method for treatment of bronchial asthma in children suffering from acute respiratory viral infection (arvi) often and/or for a long time

FIELD: medicine, pediatrics, pulmonology, allergology.

SUBSTANCE: method involves administration of viferon by rectal way. Viferon-1 is dosed to children of age 3-6 years (150000 IU in one suppository), and viferon-2 is dosed to children of age 7-14 years (500000 IU in one suppository) every day, twice per a day, for 10 days and then for 4 weeks in every other day. Proposed invention promotes to decrease numbers of bronchial asthma exacerbation, diminishing degree of bronchial asthma severe attack, decreasing frequency of bronchial asthma, increasing period of bronchial asthma remission due to activation of the interferon system. Invention can be used in treatment of bronchial asthma in children suffering from ARVI often and/or for a long time.

EFFECT: enhanced effectiveness of treatment.

6 tbl, 3 ex

 

The invention relates to medicine and can be used for treatment of bronchial asthma in children, frequent and/or long-term ill SARS.

In recent years all over the world there is a trend towards an increased incidence of bronchial asthma (BA) in children and increase its severity(1, 2, 3, 5). Currently, this problem has become not only medical, but also socio-economic importance (5).

The most effective asthma treatment is the elimination of the cause-significant allergen, but in practice it is probably extremely rare. Currently developed and implemented a comprehensive anti-inflammatory (basic) therapy BA, the choice of which depends on the severity of the disease (5). Basic therapy is primarily aimed at the suppression of allergic inflammation, however, concomitant viral infection contributes to the development of frequent exacerbations BA and worsens the course and prognosis of the disease (1, 2).

It is known that control development of the inflammatory response is a complex of some cytokines and interferon, in particular. Our results suggest that in children with BA has been a violation of functioning of system of interferon, which is consistent with literature data (1, 2, 3). This is the basis for the development of several new approaches to integrated treatment is s BA using interferon or inductors.

The essence of the invention is that proposed a new method for the treatment of ad in children, frequent and/or long-term ill SARS, in remission BA by drug Viferon in addition to the basic anti-inflammatory therapy appropriate to the severity of the disease.

Viferon® is a complex of recombinant α2b interferon and preparations antioxidant action (α-tocopherol acetate and ascorbic acid) in rectal suppositories. Viferon has antiviral, immunomodulatory and protective effects. The drug has no side effects of recombinant interferon, administered parenterally, it has not produced inactivating antibodies. Viferon is the only drug class recombinant IFN is approved pharmacological Committee of Ministry of health of Russian Federation for the treatment of children, including newborns. The drug is available in three versions which differ by the amount included in its composition of recombinant IFN: Viferon®-1 contains 150000 ME in one candle, Viferon®-2 contains 500000 ME in one candle, Viferon®-3 - 1000000 ME in one candle. The form of the drug in the form of rectal suppositories ensures its effectiveness when taken with an interval of 12 hours and is more convenient in Pediatrics, compared with parenteral SPO is Obama introduction.

To evaluate the effectiveness of the new method of treatment of ad in children, we conducted a randomized placebo controlled trial in accordance with international GCP standards. Viferon was used in combination with the basic therapy appropriate to the severity of the disease among 30 children with asthma in remission of the disease. 18 children with bronchial asthma in remission received basic therapy and placebo (suppositories of cocoa butter). The groups were comparable by age, sex and severity of the disease. The intermediate form of BA was installed in half of all patients, patients with severe and mild forms of BA was distributed approximately equally.

Viferon-1 was administered to children aged 3-6 years, Viferon-2 - children aged 7-14 years. We developed the original scheme is the introduction of the drug: Viferon used in the form of rectal suppositories 2 times in day of 10 days daily, then 4 weeks through the day. Study of interferon status was conducted for all children until the appointment Viferon, 6 weeks after initiation of therapy and the children at follow-up (after 3 and 6 months after initiation of therapy with Viferon).

The evaluation of the severity of ad and the purpose of the treatment was carried out taking into account the recommendations of the "National program "Bronchial asthma in children. The strategy of treatment and prevention" (5). Objective indicator of the degree to which osenia bronchial obstruction in older children, was the study of respiratory function (respiratory function) method pneumotachometer (LSM) and perfluorotri (PFM) in the dynamics. Clinical, laboratory and allergological examination corresponded to the standard examination of patients with BA, also included the study of interferon status in the dynamics.

Interferon status was studied by the method Grigoryan (4). The state of the IFN system was evaluated by the total number of serum IFN, the level of production by leukocytes INFα in response to viral inducers (Newcastle disease virus, strain Kansas (VBN)) and the level of production by lymphocytes INFγ in response to mitogens (phytohemagglutinin (PHA) and staphylococcal enterotoxin(sea)). The study used a diploid culture of human fibroblasts M19.

The essential features of the proposal is the use of recombinant interferon α-2b in complex therapy of children with asthma in remission of the disease, developed dose and mode of administration. This gave the opportunity to get a new result is to reduce the frequency of exacerbations of ad in children, often suffering acute respiratory viral infections (ARVI), to reduce the severity of the attack, to reduce the incidence of viral respiratory infections, prolong the period of remission BA.

For disclosure of the invention the results of the clinical studies Savino is on the way:

1. Clinical effects decreased the frequency of exacerbations of ad in children, often suffering from SARS, decreased the severity of the attack lasted remission BA.

2. Economic effect - decreased frequency of hospitalizations, decreased cost of therapy assault period.

3. Favorable effect on interferon status - ability to the production by leukocytes α-INF effectively increased to the level of healthy and kept most of the children within six months of observation.

4. Protective effect - reduce the frequency of subsequent SARS.

Table 1.
The clinical efficacy of the claimed method in comparison with the known (observation continued for 6 months, M+m).
Clinical symptoms ofBasic therapy + ViferonBasic cheapie + placebo
The frequency of exacerbations of ASTHMA(6 months)0,5±0,11,7±0,3
The severity of the attack (in points)3,4±0,55,2±0,1
The duration of remission (months)5,± 0.62,3±0,8
The incidence of acute respiratory viral infections (6 months)1,2±0,24,9±0,1
Table 2.
Dynamics of IFN status of patients with bronchial asthma in remission, received therapy Viferon, depending on the severity of the disease (M+m IU/ml)
IFN serumIFN αIFN γ
The severity BABefore the treatmentAfter the treatmentBefore the treatmentAfter the treatmentBefore the treatmentAfter the treatment
Easy N=83,96±1,283,16±1,2666,07±1,3890,79±1,8**of 6.31±1,187,08±1,18
Average N=153,72±1,123,09±1,1274,13±1,3184,14±1,23**7,94±1,2312,3±1,5*
Heavy N=73,76±1,192,81±1,1274,99±1,45100±1,48**6.68�B1; 1,238,32±1,18
*P<0,05 **p<0,001

Table 3.
Dynamics of IFN status of patients with bronchial asthma in remission who received therapy with placebo, depending on the severity of the disease (M+m IU/ml)
IFN serumIFN αIFN γ
The severity BABefore the treatmentAfter the treatmentBefore the treatmentAfter the treatmentBefore the treatmentAfter the treatment
Easy N=53,78±1,023,48±1,2567,27±1,4566,89±1,056,48±1,087,01±1,15
Average N=93,74±1.223,23±1,0872,25±1,1874,18±1,317,54±1,128,3±0,5
Heavy N=43,78±1,293,02±1,0870,87±1,6772,15±1,336.98±1,037,22±1,14

The invention is illustrated by the following examples:

Example 1. Kites Paul, 12 years old, IB. No. 1125, was in the office with 22.03.0. on 12.04.00. Clinical diagnosis: Bronchial asthma, atopic, severe, remission. Sensitization to domestic, pollen allergens. Chronic gastroduodenitis with high acid-forming function of the stomach, partial remission. Came again, for planning, for further evaluation.

When inspecting the condition is satisfactory. Physical development by age. Pale skin, clean. The mucous membranes of the oral cavity clean. Nasal breathing is difficult. In the lungs, the breath is held in all departments symmetrically vesicular, no wheezing. heart tones are distinct, rhythmic. HR-88, AD-110/60. Belly during deep palpation b/painful. The liver is not enlarged. Symptom of Pasternack negative on both sides. Urination free. Chair daily. Sexual development by age.

From the anamnesis it is known that the child was born from the first pregnancy occurring with toxemia of the first half, I childbirth, urgent, physiological. At birth, the length 56 see, weight 4400,, score Apgar 8/9 points. Heredity is not burdened. Were breastfed up to 6 months. In the first year of life suffered ARI, in subsequent years - ARI 6-7 times a year. At the age of 1 year, there were manifestations of atopic dermatitis. Diagnosed with cow's milk protein intolerance.

The first occurrence of obstructive syndrome is at the age of 10, in the background of SARS. Further, the frequency of attacks 8-9 times per year, aggravation often associated with emotional stress, weather changes, ARI. In the past year marked a continuously relapsing disease - weekly nocturnal attacks of breathlessness. Basic therapy nonsteroidal anti-inflammatory drugs (sodium cromoglycate) effect is not given. Repeatedly hospitalized. The last 3 months received basic therapy srednestatisticheskij doses of inhaled steroids (flixotide) in combination with Topeka with a moderate positive effect on background ORVI, which occur almost every month, deteriorate the performance of peak flow reading, celebrated the attacks of difficult breathing, which requires the application of inhalation sympathomimetics. Sometimes it is necessary the intervention of the Ambulance.

Therapy Viferon-2 started in remission BA in addition to the basic therapy. Interferon status investigated before treatment, 6 weeks, 3 months and 6 months from the beginning of teppei.

Table 4
Examination periodsIndicators of IFN-status (IU/ml)
Serum IFNIFN αIFN γ
28.03.00 (before treatment)4 164
15.05.0041284
27.06.002648
26.09.00.4644

During the observation period (6-month follow-up period) severe episodes BA was not, bouts of moderate severity was observed three times (on the background of physical activity twice and once in the background Ari), were stopped by a single inhalation of salbutamol. ARI mentioned once. Clinical improvement within BA can be associated with a decrease intercurrent viral infections, which in this child trigger exacerbation of BA.

Example 2.

Parfenov, Sasha, 4 years, IB. No. 11099, was admitted to the hospital 15.02.00 with recurrent broncho-obstructive syndrome in the acute stage. Clinical diagnosis: bronchial asthma, atopic, for moderate, paroxysmal period. Atopic dermatitis, acute stage. From the anamnesis it is known that the child is burdened with a family history of atopy (my mother - bronchial asthma) with 3 months are manifestations of atopic dermatitis. From 6 months of age, in the background of SARS that are 3-4 times per year, auscultation listen wheezing. Three times was celebrated bouts of shortness wheezing. Consequently the those conducted clinical laboratory and allergological examination the child was diagnosed with bronchial asthma, atopic, for moderate, paroxysmal period and assigned to basic therapy: inhalation of tiled through the spacer 2 times per day, inhalation of salbutamol via nebulizer 3 times a day, then on demand.

In the postictal period in adjuvant therapy was appointed Viferon-1. Interferon status investigated before treatment, 6 weeks, 3 months and 6 months after initiation of therapy.

Table 5
Examination periodsIndicators of IFN-status (IU/ml)
Serum IFNIFN αIFN γ
02.03.00. (before treatment)8328
10.04.0043204
06.06.004648
14.09.00.41284

During the observation period (6-month follow-up period) attacks BA was not. ARI moved once. Clinical improvement within BA can be associated with an adequate anti-inflammatory (basic) therapy and reduction of intercurrent viral infections, which in this child trigger exacerbation of BA.

Example 3.

Fetisov Kate, 8 is no, I.B. No. 11246, was admitted to the hospital 12.05.00 for planned hospitalization. Clinical diagnosis: bronchial asthma, atopic, easy for remission. From the anamnesis it is known that the child is burdened with a family history of atopy (my grandmother hay fever) from 6 months of age is celebrated recurrent obstructive syndrome, usually on the background of SARS that are 3-4 times per year. At the age of 6 years old baby was diagnosed with bronchial asthma, atopic, easy flow. Receives basic therapy: inhalation intala 4 times a day, with satisfactory effect, however, on the background Ari always deteriorate the performance of peak flow reading. In combination with the basic anti-inflammatory therapy, the child was assigned Viferon-2. Interferon status investigated before treatment, 6 weeks, 3 months and 5.5 months after initiation of therapy.

8
Table 6
Examination periodsIndicators of IFN-status (IU/ml)
Serum IFNIFN αIFN γ
15.05.00. (before treatment)2328
27.06.00412816
28.08.00864
31.10.00.41284

During the observation period (6-month follow-up period) attacks BA was not. ARI moved once. Clinical improvement within BA can be associated with a decrease intercurrent viral infections, which in this child trigger exacerbation of BA.

Thus, from the presented data it follows that the claimed method allows to objectively improve the treatment of children with asthma, frequent and/or long-term upper respiratory infection. The claimed method has several advantages:

Clinical effects decreased the frequency of exacerbations of ad in children, often suffering from SARS, decreased the severity of the attack lasted remission BA.

Economic effect - decreased frequency of hospitalizations, decreased cost of therapy assault period

A positive effect on interferon status - ability to the production by leukocytes α-INF effectively increased to the level of healthy and kept most of the children within six months of observation.

- Protective effect is a reduction in the frequency of subsequent SARS.

Sources of information

1. Allergische disease in children. A guide for physicians / edited Mastogeniini, Ben. M, M, 1998, 344 S.

2. Bronchial asthma in children. Edited Soukhanov. M, M, 1999 (prototype).

<> 3. Bronchial asthma. Edited Achocalla. In 2 volumes. M., 1997.

4. Grigoryan S. Inducers of interferons: effects on interferon status in norm and pathology. // Abstract. dis ... KMN - Moscow. - 1992.

5. The national programme of Bronchial asthma in children. The strategy of treatment and prevention". M., 1997.

A method of treating bronchial asthma in children, frequent and/or long-term upper respiratory infection, including basic therapy, characterized in that it further in remission administered rectally Viferon, and children aged 3-6 enter Viferon-1 (150000 ME in one candle), and children 7-14 years - Viferon-2 (500000 ME in one candle), daily 2 times a day for 10 days and continuing for 4 weeks through the day.



 

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