Abstract

Objective — to study the effectiveness and safety of the use of Natubiotin drug in the treatment of patients with onychomycosis. Materials and methods. 198 people were included in the study, of which 136 were diagnosed with onychomycosis. Depending on the method of treatment, patients with onychomycosis were divided into two groups: the main group, which consisted of a comparison group (71 patients), in which standard therapy was carried out, and an experimental group (65 people), in which, in addition to standard therapy, they received Natubiotin in a dose of 5 mg once a day for 6 months. The control group included 62 persons without signs of onychomycosis. To assess the severity of onychomycosis, the Onychomycosis Severity Index (OSI) was used, which included the area of the lesion, the localization of the pathological process relative to the matrix, the presence of dermatophytoma or subungual hyperkeratosis. To assess the effectiveness of treatment of onychomycosis, we used the point assessment of the severity of the disease according to Y.F. Kutasevich and T.V. Zimina. In order to assess the quality of life, the Dermatology Life Quality Index (Ukrainian version — Dermatology Life Quality Index, DLQI) was used. The state of skin microcirculation was studied using biomicroscopy of the blood vessels of the nail bed of the affected finger. The growth and body weight of patients, body mass index, blood pressure level were determined. Concentrations of cholesterol, high-density lipoprotein cholesterol, triglycerides, and glucose were studied. Results and discussion. The additional prescription of Natubiotin in the treatment scheme of patients with onychomycosis for 6 months led to statistically significantly better results based on the scale assessment of the shape of the nail plates, the number of affected nails, the area of the affected nail, and the average OSI values compared to standard therapy. The use of Natubiotin in the complex therapy of patients with onychomycosis reliably positively affected the quality of life. DLQI index was less than 5 points in 68.3 % of patients of the experimental group, while only 48.6 % of patients of the comparison group had such values. 6 months after the start of treatment, the patients of the experimental group, in contrast to the subjects of the standard therapy group, had a statistically significantly lower concentration of cholesterol, triglycerides and glucose and a higher content of high-density lipoprotein cholesterol, which indicates the positive effect of Natubiotin on lipid metabolism and glucose level. The number of functioning capillaries per 1 mm3 increased by 46 %, the frequency of microcirculation disorders decreased by 28 %, vascular disorders — by 19 %, and intravascular changes – by 35 % in patients of the experimental group during the 6-month course of treatment. Conclusions. It is recommended to assess the effectiveness of treatment of onychomycosis by the scale assessment of the severity of the disease according to Ya.F. Kutasevich, T.V. Zimina and by OSI index. The use of Natubiotin for 6 months in patients with onychomycosis showed a significant improvement in the clinical picture, particularly in relation to the damage to the nail plates, the number of affected nails, the area of the affected nail, the presence of concomitant mycosis of the skin and subungual changes. Due to the use of Natubiotin, the quality of life of patients significantly improved. After 6 months, most of the patients in the experimental group had DLQI less than 5 points, which indicates a slight impact of the disease on their quality of life after the therapy with the inclusion of Natubiotin. The inclusion of Natubiotin in the course of therapy for 6 months contributed to a significant decrease in the frequency of microcirculation disorders of the nail bed, an increase in the number of functioning capillaries per 1 mm3, a decrease in the percentage of existing microcirculation disorders, vascular disorders and intravascular changes. The results of the study give reasons to recommend the use of Natubiotin in practical work for the treatment of patients with onychomycosis.

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