Abstract

Acute tonsillopharyngitis (ATP) in children is an actual and not fully solved problem, which has interdisciplinary importance and requires optimization of diagnosis and treatment to improve the prognosis of the disease and the quality of life of children. Purpose - to optimize the tactics of treatment of children with ATP by supplementing the complex of therapy with drugs of anti-inflammatory and immunomodulatory action with the evaluation of clinical and immunological markers of the effectiveness of the proposed treatment. Materials and methods. We monitored 51 hospitalized children with a clinical diagnosis of ATP. All children underwent a complex clinical and paraclinical examination with the determination of C-reactive protein (CRP) in the blood serum upon admission to the hospital, and on the 7th day of treatment, the serum concentration of interleukin (IL) -4, -6, -8, tumor necrosis factor α (TNFα), and interferon-γ (γ-IFN) as markers of therapy effectiveness. The patients were randomly divided into 2 clinical groups: the Group 1 was formed by 28 patients (average age - 8.0±0.9 years, the share of boys - 53.5±6.1%) with ATP, who received standard treatment and standardized extract of Pelargonium sidoides EPs® 7630 (Umckalor) and the complex homeopathic drug Tonsilotren in age-related doses according to the instructions. The remaining 23 children formed the clinical Group 2 (average age - 8.7±1.0 years (p>0.05), the share of boys - 56.5±8.3% (p>0.05), and received the same standard treatment for ATP and served as a comparison group. The groups were matched for the main clinical characteristics. Results. We obtained significantly better results of treatment of children with ATP when using the combination of the drugs Umckalor and Tonsilotren in complex therapy, which are proven by the presence of statistically reliable chances of a milder clinical course of the disease on the 3rd day of treatment (assessment of the severity of ATP - <26 points): attribute risk - 59.8%, relative risk - 2.8 (95% CI: 1.1-7.2), odds ratio - 25.6 (9.0-72.6). The effectiveness of the proposed therapy was confirmed on the 7th day of treatment by the probably lower content of pro-inflammatory markers IL-8 (15.2±5.4 pg/ml vs 37.6±7.6 pg/ml) and γ-IFN (21.8±2.3 pg/ml vs. 30.0±1.2 pg/ml) compared to standard treatment, as well as twice lower TNF-α concentration (2.1±0.5 pg/ml vs. 4.5±2.5 pg/ml). The use of the combination of the drugs Umckalor and Tonsilotren was accompanied by a statistically significant reduction in the risk of maintaining a high serum concentration of pro-inflammatory cytokines (CRP - >10.0 mg/l, γ-IFN and IL-8>10.0 pg/ml) in relation to the standard treatment: absolute risk reduction - 20.8%, relative risk reduction - 32.3% with the minimum required number of patients to treat - 3.1. Conclusions. In the complex treatment of children with ATP, the use of a combination of the standardized extract of Pelargonium sidoides EPs® 7630 (Umckalor) and the complex homeopathic drug Tonsilotren demonstrated better effectiveness compared to the same standard treatment. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.

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