RU2698451C1 - Agent and method for treating sensorineural hearing loss - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to otorhinolaryngology, and concerns treating neurosensory hearing loss. Method involves administration of etiotropic and symptomatic therapy in accordance with international and national recommendations, in combination with the Semax drug preparation in the form of nasal drops, which is introduced into each half of the patient's nose cavity in dose of 1–1.5 mg 3 times a day for three days, then 0.5–1 mg for two weeks and then 150–300 mcg for two weeks.

EFFECT: invention provides reducing a threshold of auditory perception of the patient, improving speech intelligibility and reducing the probability of undesired reactions.

1 cl, 3 dwg, 1 ex

Description

The invention relates to medicine, otorhinolaryngology, to means and methods for the treatment of sensorineural hearing loss.

Sensorineural hearing loss is understood to mean an increase in the thresholds of sound perception associated with damage to the sound-perceiving sections of the auditory analyzer [1]. Up to 90% of all types of hearing impairment are referred to neurosensory. In addition to prevalence, sensorineural hearing loss is distinguished by the complexity, complexity and often insufficient effectiveness of existing methods of treatment [12].

A known method of treating sensorineural hearing loss with a protein preparation [2]. A biochemical blood test is preliminarily carried out for the content of ceruloplasmin and substances with a molecular weight of 300-5000 D in it, and human ceruloplasmin is used as a protein preparation, which is administered when the content of substances with a molecular weight of 300-5000D is more than 0.250 units. and ceruloplasmin - not more than 65 mg%, and it is administered intravenously dropwise in an amount of 1.5 mg / kg daily for 5-7 days. The method is complex and time-consuming to implement requires special equipment, high treatment costs.

There is a method of treating sensorineural hearing loss by magnetic stimulation in the projection of the auditory cortex zone alternately on both sides and in the region of the roots of the cervical thickening of the spinal cord at the level of the spinous process of the C7 vertebra and subsequent pneumatic massage of the tympanic membrane [3]. The method has numerous contraindications, it is complicated and time-consuming to implement, it requires special equipment, high treatment costs.

There is a method of treating sensorineural hearing loss by percutaneous electrical stimulation of the auditory nerve, taking into account the initial functional state of the auditory system [4]. The method is complex and time-consuming to implement requires special equipment, high treatment costs.

A known method of treating sensorineural hearing loss through reflexology and massage [5]. The method has dubious effectiveness, time-consuming implementation requires high treatment costs.

A known method of treating sensorineural hearing loss with acupuncture in combination with bee sting and the use of beekeeping products [6]. The method is complex and time-consuming to implement, has a potentially high risk of adverse reactions.

There is a method of treating sensorineural hearing loss through a combination of acupuncture and autohemotherapy [7]. The method has dubious effectiveness, time-consuming implementation requires high treatment costs.

A known method of treating sensorineural hearing loss through the simultaneous use of integrated audiovisual exposure in combination with electromagnetic radiation [8]. The method has dubious effectiveness, time-consuming implementation requires high treatment costs.

Known agent for the treatment of acute and sudden sensorineural hearing loss and deafness, containing as an active substance nicotinic acid having a vasodilating effect [13]. Known tool for the treatment of acute and sudden sensorineural hearing loss and deafness Phenibut, with a sedative effect [14]. A known tool for the treatment of acute and sudden sensorineural hearing loss and deafness containing adenosine triphosphate (ATP) as an active substance [15]. All of these tools have a common drawback - the low effectiveness of the treatment of acute and sudden sensorineural hearing loss and deafness.

Closest to the claimed is a method of treating sensorineural hearing loss using an agent containing the active substance - dihydrochloride monohydrate 3- (2-morpholinoethylthio) -1,2,4-triazino [5,6-b] indole [9]. Due to the fact that the drug is not officially released, the method is complex and time-consuming to implement requires high treatment costs.

A new technical result is an increase in the effectiveness of the treatment of neurosensory hearing loss, expressed in lowering the thresholds of auditory perception, improving speech intelligibility and eliminating undesirable reactions.

To achieve a new technical result, the drug Semax is used in the form of nasal drops 1-1.5 mg in each half of the nose 3 times a day for 3 days, then 0.5-1 mg for 2 weeks, then 150-300 mcg for 2 weeks for the treatment of sensorineural hearing loss in combination with standard etiotropic and symptomatic therapy

The method is as follows. After the diagnosis is established, the patient is prescribed medication in accordance with international and national recommendations [12], including glucocorticoids, in case of acute or sudden hearing loss, for example, Dexamethasone (Prednisolone), antioxidants and antihypoxants, for example, ethyl methylhydroxypyridine succinate (Mexidol), for example, histamine analogues , Betahistin, in recommended dosages in combination with the drug Semax in the form of nasal drops, which is administered at a dose of 1-1.5 mg in each half of the nose in the patient's position enta lying with his head thrown back 3 times a day for 3 days, then 0.5-1 mg for 2 weeks, then 150-300 μg for 2 weeks, if there is a known etiological factor, etiotropic therapy is simultaneously carried out by prescribing glucocorticoids , hemorheological, vasoactive drugs.

In the presence of a known etiological factor, etiotropic therapy is simultaneously carried out by prescribing glucocorticoids, hemorheological, vasoactive drugs [12]. So, glucocorticoids (Dexamethasone, Prednisolone) [1], ethylmethylhydroxypyridine succinate (Mexidol) have proven clinical efficacy against neurosensory hearing loss [12]. Also recommended are histamine analogues, for example Betagistin [1], Ginkgo Beal extracts both [1], nootropic drugs, such as Vinpocetine, Piracetam [1].

The drug Semax (methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline) belongs to the class of regulatory peptides and has a nootropic, psychostimulating, neuroprotective, antioxidant and antihypoxic effect (reg. LS-002553). In Russia, it is included in the list of vital and essential medicines. [ten]

It is known the use of the drug Semax in the treatment of the following conditions [11]:

- Stroke, including treatment of acute stroke

- The initial phase of the recovery period after a stroke

- Transient ischemic attacks

- Migraine

- trigeminal neuralgia

- Atrophy of the optic nerve and prevention of its progression;

- Opticoneuropathy of the vascular and other genesis and its prevention;

- Glaucoma and prevention of damage to the optic nerve against the background of glaucoma and symptomatic ophthalmic hypertension;

- Edema of the optic nerve

- Recovery after brain operations;

- Prevention of acute ischemic stroke;

- The recovery period after a stroke;

- Transient ischemic attacks: prevention and treatment;

- Chronic disorders of cerebral circulation;

- Intellectual-mnestic (cognitive) violations of various origins;

- Post-narcotic disorders and recovery after them;

- Astheno-neurotic disorders of various origins, including as a result of sudden severe stress, after exposure to ionizing radiation

- memory impairment, distraction, forgetfulness;

- Reduced mood background, emotional lability;

- Prevention of complications of chronic diseases from the nervous system

- Prevention of senile dementia

- Relief of acute intoxication and overdose of ethanol

- Treatment of withdrawal symptoms

In FIG. 1 shows the chemical structure of the active component of the drug "methionyl-glutamyl-histidyl-phenylalanil-prolyl-glycyl-proline" ("Semax")

A new property of the drug, which is the possibility of using it in the treatment of sensorineural hearing loss, was discovered as a result of clinical observations in the treatment of 10 patients with this pathology.

When studying the prior art in the sources of information there was no information indicating the use of the drug "Semax" and drugs with a similar formula for the treatment of sensorineural hearing loss.

The following clinical example demonstrates the effectiveness of the method.

Example. Patient C, 19 years old, turned to the emergency room of the ENT department of the City Clinical Hospital No. 3 in Tomsk with complaints of a sharp decrease and high-frequency noise in the left ear during the day. From the anamnesis it is known that on the eve he suffered stress in connection with exams at the university and preparation for them. A visual examination of the ENT organs did not reveal any abnormalities. Functional examination using tonal threshold and suprathreshold audiometry revealed an increase in auditory perception thresholds (by the type of neurosensory loss) in the medium-high frequency range to the left to 50 dB NPS. In FIG. 2 shows the results of tonal audiometry of a patient aged 19 years before the start of treatment. Whisper speech intelligibility was 3 meters to the left, versus 6 meters to the right.

He was diagnosed with H90.4 Acute left-sided sensorineural hearing loss with normal hearing on the opposite side. In connection with the upcoming exams, the patient refused emergency hospitalization, so it was decided to use the proposed method of treatment described above. Informed consent was obtained from the patient to use the new method of treatment. According to the clinical recommendations of the Ministry of Health and the national guidelines for otorhinolaryngology, the following were prescribed:

1. Ethylmethylhydroxypyridine succinate (Mexidol) intravenously 5% solution 4 ml per 16 ml saline 10 days

2. Dexamethasone intravenously according to the previously recommended scheme: 24 mg-24 mg-16 mg-16 mg-8 mg-4 mg-0-4 mg

3. Betagistin (Betaserc) 24 mg orally at 1 t 2 r / day for 1 month

4. Protective mode and sparing diet. The patient refused hospitalization, treatment was carried out in a day hospital.

In addition to all of the above treatment, the patient was prescribed Semax in the form of nasal drops, which was administered at a dose of 1-1.5 mg in each half of the nose in the patient's position lying with his head thrown back 3 times a day for 3 days, then 0.5 -1 mg for 2 weeks, then 150-300 mcg for 2 weeks.

3 days after the start of treatment, the patient felt improvement, subjective noise on the left decreased, a tendency to restore speech intelligibility appeared. It was decided to continue treatment. After 1 month, the course of treatment was discontinued and the patient underwent a complete objective and functional examination. It was noted that the intelligibility of whispering speech was fully restored, according to the results of tonal threshold audiometry.

In FIG. 3 shows the results of tonal audiometry of Patient S. 19 years after treatment using the above method. A complete normalization of the thresholds of auditory perception on the left was ascertained, which made it possible to diagnose the patient's recovery.

The proposed method is based on the analysis of clinical observations of 10 patients in the City Clinical Hospital No. 3 of Tomsk with sudden, acute and subacute forms of sensorineural hearing loss from 19 to 67 years old. All patients received standard, recommended etiotropic and symptomatic therapy according to clinical recommendations; informed consent was obtained from all patients for prescribing Semaks according to a fundamentally new indication and in a new dosing regimen: at a dose of 1-1.5 mg in each half of the nose in 3 once a day for 3 days, then 0.5-1 mg for 2 weeks, then 150-300 μg for 2 weeks, which was optimal for obtaining a stable therapeutic effect.

Evaluation of the clinical recovery parameters of the examined patients confirms the effectiveness of the proposed method for the treatment of sensorineural hearing loss. The advantages of the proposed method are as follows: the method is simple, affordable has high efficiency with conservative outpatient treatment. The absence of undesirable effects when using the drug Semax in all examined indicates a good tolerability and safety of the drug.

Sources of information taken into account when compiling the description:

1. Otorhinolaryngology. National leadership. 2nd edition / ed. V.T. Palchuna - M .: GEOTAR-Media, 2016 .-- 1064 p.

2. 3 application for invention No. 96111557/14 dated 06/20/1996

3. RF patent No.2626702, published July 31, 2017

4. RF patent No. 2181060, published April 10, 2002

5. RF patent No. 2181276, published on 04/20/2002

6. RF patent No. 2286761 published November 10, 2006

7. RF patent No. 2207103, published on June 27, 2003 B

8. RF patent No. 2297856, published 04/27/2007

9. RF patent No. 2119335, published September 27, 1998

10. https: // ra. wikipedia.org/wiki/Semax

11. Neuropeptide Semax - a medicine of the XXI century. Skvortsova V.I., Zhuravleva E.Yu., Andreeva L.A. Pharmacotherapy issues. 1998. No. 4, p. 39.

12. Sensoneural hearing loss in adults. Clinical recommendations. Ministry of Health of the Russian Federation, 2016

13. Aslamazova V.L., Bogomilsky M.R. Complamin in the treatment of acute cochlear hearing loss. Abstracts of reports of the Plenum of the All-Union Scientific Society of Otolaryngologists. - M., 1978, p. 160-167

14. Loginov V.N., Uskova V.V. The use of phenibut in the treatment of sensorineural hearing loss. Materials of the conference of otorhinolaryngologists. - Irkutsk, 1983, p. 273-274

15. Maksimova M.S. Treatment of patients with acute cochlear neuritis with adenosine triphosphoric acid. Bulletin of otorhinolaryngology. - 1986, - p. 104-105

application

FIG. 1 The chemical structure of the active component of the drug "methionyl-glutamyl-histidyl-phenylalanil-prolyl-glycyl-proline", ("Semax")

FIG. 2 Results of tonal audiometry of patient C. 19 years before treatment

FIG. 3 The results of tonal audiometry of patient C. 19 years after treatment using the above method

Claims (1)

A method for the treatment of sensorineural hearing loss, including etiotropic and symptomatic therapy, in combination with the introduction of the drug Semax into the nasal cavity at a dosage of 1-1.5 mg in each half of the nose 3 times a day for three days, then 0.5-1 mg for two weeks, then 150-300 mcg for two weeks.

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