Abstract:
Background. Drug treatment of Sensorineural Hearing Loss (SHL) is characterized by: administration
of preparations from various pharmacological groups (nootropics, antioxidants, corticosteroids, etc.),
combined prescription of drugs. The mentioned aspects indicate the need to use combined products in
SHL pharmacotherapy.
Objectives. Determination of harmlessness and preclinical pharmacological efficacy in SHL of the
combined product containing as active principle active principles – taxifolin, glycine (CAF-01).
Material and method. Acute toxicity and subchronic toxicity was performed on 72 mice and 54 male
and female white rats by peroral and intraperitoneal administration with determination of
physiological, hematological, biochemical and morpho-histological indices. Modeling of SHL induced
by administration of gentamicine i/m and the determination of otoprotective effects was performed on
18 white rats with evaluation of Preyer's reflex, impedancemetry and otoacoustic emission (OAE). The
research was carried out in collaboration with the Laboratory of Biochemistry and the Laboratory of
Tissue Engineering and Cell Culture.
Results. The researched product shows reduced acute toxicity, being classified according to the Acute
Toxic Class Method in toxicity class 5 with the average lethal dose (LD50) > 5000 mg/kg - practically
non-toxic. In the context of subchronic toxicity, we determined that CAF-01 does not possess
cumulative properties. There was a statistically significant increase (p<0.01) in the content of SH-
groups of proteins and serum albumins. CAF-01 improves the balance between the pro- and antioxidant
systems, the importance of dysfunctions in the respective systems for the etiology of SHL is known.
The improvement of the Preyer reflex and the OEA parameters (p<0.01) was found, which indicates
the improvement of the function of the inner ear of the animals that received the studied preparation.
CAF-01 inhibits POL (lipid peroxidation) hyperactivation and increases antioxidant activity by
restoring glutathione, antioxidant enzyme activity (catalase, glutathione peroxidase and superoxide
dismutase). Through the respective mechanisms, as well as through the elimination of the spasm of the
arterioles and capillaries of the vascular stria from the membranous labyrinth, the beneficial
otoprotective action on the sensorineural components of the organ of Corti, the auditory nerve, is
distinctly outlined.
Conclusions. Estimating the effectiveness of drug treatment presents an innovative and forward-
looking element in hearing recovery in patients with hearing loss. An important direction for the
treatment of auricular diseases is the development and use in medical practice of combined medicinal
preparations, which contain synthetic and natural substances. The researched combined medicinal
product shows a high degree of harmlessness, does not lead to the development of toxic processes and
at the same time has an otoprotective effect.
