Efficacy of immune correction in the treatment of children with suppurative maxillofacial space infections: A prospective nonrandomized comparative trial

Background. Treatment of children with suppurative maxillofacial space infections remains an ongoing problem, which is exacerbated by the growing microbial resistance and immune response dysfunction that can prolong the recovery process.
Objective. To analyze the clinical and immunological effects of using an immunomodulator based on a synthetic hexapeptide (Imunofan) in a combination therapy of suppurative maxillofacial space infections in children.
Methods. A prospective nonrandomized comparative pilot trial was conducted. The study included 47 children aged 8–17 years with suppurative maxillofacial space infections, who were comparable in terms of the baseline data. The patients received either the standard treatment (surgical debridement + antibiotics; n = 27, Subgroup 1) or the standard treatment supplemented with Imunofan (45 µg/day intramuscularly for five days; n = 20, Subgroup 2). The comparison group comprised 13 relatively healthy children. The study assessed the subpopulations of lymphocytes (via flow cytometry), the levels of immunoglobulins, and the phagocytic activity of neutrophilic granulocytes. The obtained data were processed using Microsoft Excel 2019 (Microsoft, USA) and an online calculator (https://medstatistic.ru). In order to control the risk of Type I errors in the multiple comparisons of immunological parameters, the Holm-Bonferroni correction was used. After correction, the significance level was set at p < 0.05.
Results. Prior to treatment, the children with suppurative maxillofacial space infections were found to have combined immune disorders: decreased relative count of T lymphocytes, helper T cells (CD3+CD4+ ), and cytotoxic lymphocytes (CD3+CD8+ ), as well as incomplete phagocytosis. The standard treatment (Subgroup 1) normalized only the leukocyte level (p < 0.05 after correction), while cellular immunity and phagocytic function remained impaired. In Subgroup 2, a clear tendency was observed toward the normalization of median T-cell parameters (T lymphocytes: 76.1% in Subgroup 2 vs. 75.73% in the comparison group; helper T cells: 46.75% vs. 46.05%) and significantly improved completeness of phagocytosis; however, after correction for multiple comparisons, no statistically significant differences were found in most immunological parameters between Subgroup 2 and the comparison group. The key clinical outcome was a statistically significant reduction in the hospital length of stay in Subgroup 2 as compared to Subgroup 1 (8.70 ± 2.49 vs. 12.89 ± 1.50 days, p = 0.02).
Conclusion. The study results indicate the potential efficacy of Imunofan immunomodulator in the combination therapy of suppurative maxillofacial space infections in children, which manifests itself in the positive changes in the immunological parameters and a significant reduction in the hospital length of stay. The obtained data justify further randomized controlled effectiveness trials.

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