Method for differentiated immunomodulatory therapy of chronic tonsillitis and/or hypertrophy of palatine tonsils in preschool children

FIELD: medicine.

SUBSTANCE: pathogenetic treatment of chronic tonsillitis and/or hypertrophy of palatine tonsils in preschool children suffering from lymphoproliferative syndrome is ensured by the palatine tonsils debridement. An interleukin-1β(IL-1β) level is measured in the palatine tonsils washing. If the measured value is less than 5.8 pg/ml, recombinant interleukin-1β (IL-1β) is to be administered orally by phonophoresis with the use of the Tonsillor MM apparatus. Two courses of 10 procedures every 14 days are performed. The clinical effectiveness is assessed if observing a positive dynamics of IL-1β measured in the palatine tonsils washing 17 and 41 days after the beginning of the immunomodulatory therapy.

EFFECT: higher clinical effectiveness ensured by the differentiated selection of children for carrying out the immunomodulatory therapy, reducing a rate of infectious involvements of the palatine tonsils in the declared group of patients by the pathogenetically reasoned application of recombinant IL-1β.

3 cl, 2 tbl, 1 ex

 

The invention relates to medicine, namely to otorhinolaryngology and immunology, and is intended for pathogenetic treatment of chronic tonsillitis and/or hypertrophy of the Palatine tonsils in children of preschool age.

More than 80% of all respiratory diseases in children is accompanied by a lesion of the mucous membrane of the pharynx and lymphoproliferative rings. Chronic inflammation of the tonsils accompanied by inhibition of nonspecific factors of natural resistance of the organism, a violation of both humoral and cellular immunity.

In outpatient practice with the aim of increasing resistantanti organism is widespread non-specific immunostimulating agents of vegetable origin on the basis of Echinacea, ginseng, Rhaponticum carthamoides, chamomile, garlic, propolis and pantocrine. However, the use of systemic immunomodulatory drugs in Pediatrics without taking into account the points of application of the drug and pathogenetic bases of disease can lead to an imbalance of the immune system and the worsening of the disease.

As alternative ways of immunomodulatory therapy in chronic tonsillitis acquired methods of local effects on lymphoid tissue ring using various physical and instrumental methods, including directly the verbal high-frequency pulses, as well as delivery of drugs into the tissue of the tonsils with phonophoresis.

So there is a method of treatment of chronic tonsillitis, based on the introduction into the tissue of the tonsils using ultrasound drug "Malavit" (U.S. Pat. 2152773 Grew. Federation: IPC A61H 23/00, A61N 1/30. The method of treatment of chronic tonsillitis. No. 99102873/14; Appl. 18.02.99; publ. 20.07.00). The known method allows you to combine physical factors - low magnitude effect on the tissue of the tonsils and pharmacological effects "Malavita" on the lymphoid tissue of the tonsils. The main disadvantage of this method is the lack of criteria for selection of patients for this procedure, which severely limits the effectiveness of the method.

There is a method of treatment of chronic tonsillitis using ultrasonic sanitation Palatine tonsils apparatus "Tonsillar", where the medicinal product is used in a solution of 0.1% hydrogen peroxide followed by phonophoresis with ointment interferon-1α (Mechaniken N. In. and other Use of ultrasonic installation "Tonsillar" for the treatment of chronic tonsillitis. - M., 1984.). The method is based on rehabilitation and local delivery of anti-inflammatory cytokines in the tissue of the tonsils. The disadvantage of this method is its low efficiency and short-term effect.

poslednie studies have shown, that children with lymphoproliferative syndrome and chronic tonsillitis in mononuclear cells of the tonsils reduced level and/or functional activity of interleukin-1 beta (IL-1β). This condition is due to the prevalence of the homozygous mutant and heterozygous genotypes for the polymorphism SNP interleukin-1β (+3953 C->T).

Therefore, as the closest analogue to the claimed method the chosen method of local treatment of chronic tonsillitis recombinant interleukin-1β (beta Lakin) (Brody O. B. Clinical and immunological evaluation of the effectiveness of local treatment of chronic tonsillitis recombinant interleukin-1β (beta Lakin): author. dis. Kida. the honey. Sciences. - Saint-Petersburg, 2004. - 113 S.: ill.). The patients, before prescribing this group of patients underwent clinical and laboratory examination, and determined the concentration of cytokines in flush with the tonsils. Next was assigned treatment apparatus "Tonsillar" beta-Lakin duration of 5-8 treatments. The disadvantages of this method include the fact that it can be used only for patients aged from 14 to 42 years, with the rate of immunomodulatory therapy is prescribed to all patients without regard to their immunological status. In addition, the use of interleukin-1β in the form of a solution sposobstvuyuschim leaching it from the tissues of the tonsils and reduce therapeutic effect.

The technical result of the invention consists in a differentiated selection of children for immunomodulatory therapy, increase of efficiency of treatment of chronic tonsillitis and/or hypertrophy of the Palatine tonsils in children of preschool age, the reduction in the incidence of infectious lesions of the tonsils due to pathogenetically justified the application of recombinant interleukin-1β in gel base.

It is known that the lack of Il-1β upon antigenic stimulation leads to the violation processing and presentation of antigen to T lymphocytes and, consequently, to changes in priming T-helper cells towards activation of allergic inflammation (Immunology and Allergology, Ed. by A. A. Vorobyov, A. S. Bykov, A. C. Karaulova // Moscow, Practical medicine. - 2006. - 287 S.). While local and systemic allergic reactions determine not only the severity of chronic tonsillitis (compensation or decompensation), but also contribute to the development of hypertrophy of the tonsils, stimulating lymphoproliferative cells of the pharyngeal ring. On this basis, the increase in local levels of IL-1β in the Palatine tonsil in its original deficits in preschool children with chronic tonsillitis and/or hypertrophy of the Palatine tonsils is pathogenetically reasonable therapeutic approach. As a therapeutic drug b is l selected recombinant interleukin-1β-based gel (Kregel"). Phonophoresis of cytokines on the frequency of ultrasonic vibrations of 26.5±1.5 kHz leads to the penetration of regulatory peptide in the tissue of the tonsils without gross violations of the structure of its molecules. These data served as a starting point for a new way to treat chronic tonsillitis hypertrophy of the Palatine tonsils in children of preschool age.

To confirm the effectiveness of the proposed method, a survey of 121 children aged 5 to 7 years with chronic tonsillitis and/or hypertrophy of the Palatine tonsils II/III degree. Additionally inspected 109 conditionally healthy children of matched age, sex discreteness of the sample corresponding obsevational.

The concentration of interleukin-1β receptor antagonist interleukin-1, interleukin-4, tumor necrosis factor alpha and interferon-α in flush with the tonsils were examined by the method of enzyme-linked immunosorbent assay (ELISA) commercial kits LLC "Cytokine" , St. Petersburg according to the supplied instructions in the main program group and the comparison group. Flush with the tonsils were obtained by the method of lavage of Palatine tonsils 3 ml of physiological solution before treatment, and after the first and second courses of topical immunomodulatory therapy. The concentration of cytokines obtained in ELISA, were analyzed in PG/ml/p>

On a sample of conditionally healthy children (n=109) were defined standards of proinflammatory and proallergic interleukins rinse Palatine tonsils (Table.1).

Table 1
Norms of proinflammatory and proallergic interleukins in flush with the tonsils in children of early and preschool age
CytokinesIndicators
MinMax
Alpha TNF, PG/ml0,007,06
The receptor antagonist IL-1, PG/ml0,001246,12
IL-1 beta, PG/ml5,8057,16
IL-4, PG/ml0,0025,00
Alpha INFO, PG/ml0,0015,23
Note: Min - the lowest value in the group; Max - maximum value in the group; IL - interleukin; TNF - facto the tumor necrosis; INF - interferon.

Thus, the level of IL-1β rinse the tonsils less than 5.8 PG/ml is the lower limit of the normal range and, as a consequence, an indication for topical immunomodulatory therapy with recombinant interleukin. Combined treatment was carried out by the apparatus of Tonsillar MM, with before treatment is carried out reorganization of the crypts of the tonsils, and the course of therapy consisted of two stages for 10 sessions with a 14-day break.

To study the effectiveness of topical immunomodulatory therapy in swabs from the tonsils in children with hyperproliferative syndrome was defined by the concentration of IL-1β:

- before treatment,

- 7 days after first treatment (17 days from the first sample is taken),

- 7 days after the second course (41 days after the first studies of the local and interleukins).

Based on these data it is proved that prior to treatment the mean level of IL-1β in the sample of children with lymphoproliferative syndrome was low to 4.2 PG/ml (±0,13), while the remaining indicators concentrations of interleukins defined within normal limits (Table.2). The latter fact is explained by the fact that the levels of interleukins in flush with the tonsils enough polymorphic: low to very high rates, respectively, and the normal range is also wide.

p<0,001
Table 2
Comparison of interleukin throat before treatment "Collegel" and after one and two courses local immunotherapy using apparatus "Tonsillar-MM"
CytokinesBefore the treatmentAfter 1 yearAfter 2 coursesp1p2
M±mM±mM±m
The tumor necrosis factor-alpha, PG/ml0,180,020,310,020,370,03p>0,05p>0,05
Receptor antagonist interleukin 1, PG/ml165,317,9145,515,8116,4a 12.7P<0,05
Interleukin-1 beta, PG/ml4,220,13a 4.830,145,950,11p>0,05p<0,05
Interleukin-4, PG/ml13,77of 1.3410,750,85or 10.601,02p<0,05p<0,05
Interferon alpha, PG/ml10,320,859,130,747,300,60p>0,05p<0,05
Note: the table presents average values obtained on a sample of patients (n=121) with chronic tonsillitis, where M is the average value of the concentration of the cytokine, ±m is the average error variance, p1and p2the significance of differences in the compared groups of children after the first and second course of treatment, respectively.

After the first year of the local shall immunomoduliruushimi therapy significantly decreased the indicators receptor antagonist interleukin-1 and interleukin-4 (receptor antagonist interleukin-1: before treatment 165,29±17,99 PG/ml and after treatment 145,46±15,83 PG/ml; for interleukin-4: before treatment 13,77±1,34 PG/ml and after treatment of 10.75±0,85 PG/ml). The average level of interleukin-1β rinse the tonsils after the first course local immunomodulatory therapy has increased, but no significant differences was not received.

After the second 10-day course of phonophoresis of recombinant IL-1β in the tissue of the tonsils dynamics of secretion of interleukins preserved. So the average level of the receptor antagonist Il-1 decreased to 116,37±12,67 PG/ml against 165,29±17,99 PG/ml before treatment (p<0.001) and against 145.46±15,83 PG/ml after the first course local immunomodulatory therapy (p<0,01). Decreased the average level of local interleukin-4 to or 10.60±1,02 PG/ml against 13,77±1,34 PG/ml before treatment (p<0.05) and did not change relative to the average after the first year of immunomodulatory therapy (p>0,05).

It should be noted that after two courses local immunomodulatory therapy with recombinant interleukin-1β in children of preschool age with chronic tonsillitis and/or hypertrophy of the Palatine tonsils rinse the tonsils significantly decreased the average level of interferon-α (10,32±0,85 PG/ml before treatment, 7,30 to±0,60 PG/ml after 2 courses of immunomodulatory therapy, p<0,05). After two courses of topical immunotherapy significantly increased the average level of IL-1β and was to be achieved 5,95±0,11 is g/ml (p< 0.05), and higher than the lower limit of the normal values given for interleukin swabs from the Palatine tonsils.

Thereby, conducted by topical treatment with recombinant interleukin-1β changed the composition of local interleukin towards activation processing and antigen presentation (increase of interleukin-1β), in the direction of suppressing allergic reactions (reduction of interleukin-4 receptor antagonist interleukin-1) and towards the end of the inflammatory process (decrease of interferon-alpha).

Due to the fact that after 2 courses of therapy are all indicators of interleukins changed towards normalization, we can assume that this method of treatment of chronic tonsillitis hypertrophy of the tonsils has a 100% pathogenetic characteristics efficiency.

Below is the method of implementation of the proposed method.

In children of preschool age with chronic tonsillitis and/or hypertrophy of the Palatine tonsils examine the level of IL-1β in the flushing of the tonsils. When values of IL-1β below 5.8 PG/ml conduct topical together with immunomodulating therapy, for this purpose, we first perform sanitation and washing caseous plugs using apparatus "Tonsillar MM, after which the applicator apply a thin layer of gel with recombinant interleukin-1β (Kregel") and spend phonophoresis on the frequency of 26.5±1.5 K is C for 30 seconds. Treatment with two courses of 10 days with a 14-day break through 17 and 41 days of starting treatment control levels of Pro-inflammatory and proallergic interleukins. However, the absence of dynamics in the levels of interleukins Palatine tonsils indicates no effect of the treatment and re-treatment procedures is not appropriate.

Thereby applies not technically difficult procedure local phonophoresis "Collegel" on the palatal tonsil apparatus "Tonsillar MM, not time-consuming method of treatment, can be used as monotherapy chronic tonsillitis hypertrophy of the tonsils.

Example 1. Child F., 5 years old, came to the immunologist doctor-allergist with complaints of frequent acute respiratory morbidity more than 8 times per year. When the examination of the throat revealed hypertrophy of the Palatine tonsils of the III degree. The study of interleukin-off from the tonsils revealed demotion: interleukin-1 beta to 4.2 PG/ml Were increased interleukin-4 to 29 PG/ml, All other indicators of interleukins were normal.

After two ten-day courses of therapy apparatus "Tonsillar-MM" with "Colegiales" the level of interleukin-1 beta has risen to 11 PG/ml, and the levels of Il-4 decreased to 24 PG/ml

Thereby conducted local immunomodulatory therapy day is "Colegiales" using device "Tonsillar MM normalized level of local interleukins, a study of the tonsils 5 months after the treatment showed a decrease in its size. The frequency of respiratory diseases for six months did not exceed 2 times.

Testing method conducted on the basis of CJSC "Modern medical technologies" 121 child under school age (5-7 years), suffering from hypertrophy of the tonsils and/or chronic tonsillitis. All patients received a 30-second phonophoresis "Colleges" on the Palatine tonsil using apparatus "Tonsillar-MM" in the course of 10 sessions. Two of them are of course phonophoresis got all patients. All children underwent phonophoresis with no complications. The effectiveness of local immunomodulatory therapy, according to local cytokine status, was observed in 119 children that was 98.34 per cent. The recurrence rate of chronic tonsillitis decreased from 119 children in 2 times.

1. The method of differential immunomodulatory therapy of chronic tonsillitis and/or hypertrophy of the Palatine tonsils in children of preschool age, including a study of the level of cytokines in the ELUTIONS from the crypts of the tonsils, reorganization of the Palatine tonsils and the local introduction of recombinant interleukin-1β (IL-1β) with phonophoresis apparatus "Tonsillar MM, characterized in that the treatment of children with lymphoproliferative syndrome is carried out at lower levels of Il-1β rinse Palatine is indolin less than 5.8 PG/ml, in doing so, a two course of 10 treatments at 14-day break, and the effectiveness of therapy is evaluated on the basis of positive dynamics of the level of IL-1β determined rinse the tonsils through 17 and 41 days from the beginning of immunomodulatory therapy.

2. The method according to p. 1, characterized in that the quality of drug from the group of recombinant interleukin-1β selected "Collegel".

3. The method according to p. 1, characterized in that phonophoresis "Colegiales" is carried out for 30 seconds at a frequency of ultrasonic vibrations of 26.5±1.5 kHz.



 

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