Tool and method for the treatment of optic neuritis inflammatory, toxic-allergic, vascular etiology and atrophy of the optic nerve

 

(57) Abstract:

The invention relates to ophthalmology and is intended for the treatment of optic neuritis inflammatory, toxic-allergic, vascular etiology and atrophy of the optic nerve. Use of 0.1% solution of the drug Semax by intranasal administration in the form of instillation of 2 to 4 drops 2 - 3 times a day for 7 to 14 days and the method of endonasal electrophoresis on 8 - 12 drops to split the positive electrode 1 time per day for 7 to 10 days. The method allows to improve visual function, having a positive effect on the severity and rate of recovery processes. 2 C.p. f-crystals, 3 tables.

The invention relates to medicine and relates to a means and method of treatment of diseases of the optic nerve.

For normalization of metabolic processes and to activate anabolic reparative processes in the defeat of the optic nerve, the use of vitamins and their combinations (B1, B6, B12), glutamic acid, piracetam, and means of activation of energy metabolism in the cell (ATP, Riboxin).

For acceleration of reparative processes are applied biogenic stimulators of plant five autohemotherapy, pyrotherapy (pyrogenes, prodigiozan, PAREXEL), oxygen therapy. However, the data obtained do not allow us to reconsider these methods are quite effective for the treatment of optic nerve atrophy and neuropathy of various etiologies.

Known means for stimulation plastic processes in the structures of the brain and the visual analyzer is Cerebrolysin containing free amino acids and peptides with low molecular weight.

However, the diversity included in the preparation of peptides (molecular weight, formula and properties) is not possible with certainty to link the positive effects of the drug with a specific component of the substance. In addition, the strong dependence of the efficiency of Cerebrolysin on the adequacy of the selected dose. Uncontrolled excessive dose of Cerebrolysin often has a negative impact on the pace and extent of recovery processes.

Known drug Semax, representing heptapeptide Met-Glu-His-Phe-Pro-Gly-Pro which is a stimulant memory prolonged action (patent USSR N 939440, C 07 C 103/52, 1981).

However, the applicability of this famous ven is olivani optic nerve through the use of Cerebrolysin - the prototype for the method, the disadvantages of which are described above.

The technical result achieved during the implementation of the present invention is the recommendation of the new highly effective means of treatment of diseases of the optic nerve, the effective use of it in practice, as in the early stages of the disease, and the deferred period, the positive dynamics objective eye care indicators for patients.

This is achieved by the fact that as a means of treatment of atrophy of the optic nerve and optic neuritis different etiology drug use Semax. This technical result is also achieved by the fact that in the method of treatment of diseases of the optic nerve by applying a solution of peptides distinctive feature is that use a solution of Semax by the intranasal route. In the specific case of Semax recommend dose of 600-1200 mg/day during the treatment period, 400-600 mcg/day with introduction by endonasal electrophoresis for 8-10 days. Upon instillation into the nose of 0.1% solution of the Peptide is administered 2-4 drops in each nostril 2-4 times per day. When the war of the positive electrode impose wool, soaked medicinal product, and the electrodes are injected into the middle nasal passages. The second electrode with gasket 8x10 sm have in the neck. Current is 1.0 mA, duration of exposure from 8 to 12-15 minutes

Below are examples of implementation of the invention.

Example 1. Patient A., aged 40, was observed with a diagnosis of OI partial atrophy of the optic nerves, the traumas in childhood meningoencephalitis. The disease began 25 years ago, was characterized by a gradual decrease in visual acuity and a narrowing of the field of view. Entered the Institute with complaints of decreased vision in both eyes, impairment of peripheral vision. When entering visual acuity of the right eye of 0.04, left - 0,4, not corrects. Horizontal melcorazmashisty nystagmus in extreme abduction of the eyeballs. The reaction of pupils to light sluggish. The fundus of the eye: the disks of optic nerves pale, flattened, boundaries clear, the arteries narrow, the manul dissociation of pigment. The field of vision of both eyes concentrically narrowed, more to the right, bilateral Central relative places absolute scotomas. Congenital color vision disorder. On the background of basic therapy has been appointed as a 0.1% solution of the Peptide in the increased right up to 0.1, left to 0.9, not KOR. The total field of view 8 radii increased right from 150 to 195 gr., left with 265 425 gr. Out of sight on the left disappeared scotoma to the right dimensions scotomas are smaller. Improved electrophysiological indicators: decreased threshold electrical sensitivity from 180 to 120 µa right, from 75 to 55 µa left, increased critical frequency of flicker fusion (ccsm) from 15 to 30 Hz on the right. Subjectively, the patient reported improvement in brightness, color items.

Example 2. Patient L., 16 years old, was admitted to the Institute with a diagnosis of contusion retro-bulbar neuritis of the left eye, the right eye is healthy. The disease began a month ago, when the patient also got hit by the ball on the left eye. Neurotrophic and anti-inflammatory therapy was received on an outpatient basis. At admission were noted pain with motion of the left eye, reduced visual acuity on the left to 0.5, not KOR. When ophthalmoscopy left eye optic disc pale pink, clear contours, veins are enlarged, twisted. The macula and the visible periphery unchanged. The peripheral field of view at a white object in the normal narrowing of the total boundaries of the field of view of the green color to 180 gr. on red - 240 gr. In the Central field of view relative scotum days. By the end of treatment pain with motion of the left eye was gone, visual acuity recovered to 0.9. The field of view on color objects recovered fully disappeared Central scotoma.

Example 3. Patient M., 51, entered the Institute with a diagnosis of partial atrophy of the optic nerve of the right eye, the outcome of optic neuritis viral etiology. Myopia of an average degree of both eyes. The disease began a year ago, when fever, SARS began to decline in visual acuity of the right eye. Received a course of traditional therapy at the research Institute GB RAMS with a certain positive outcome: visual acuity of 0.03, with SF. - 3,75 = 0,5 eccentric, Central and paracentral absolute and relative positive scotoma. With these functions, the patient was admitted to the hospital to undergo a repeated course of therapy. Field of view a total of 8 radii narrowed to 425 gr., the green object to 135, the red object is to 235. On the background of basic therapy was prescribed course endonasal electrophoresis with a 0.1% solution of Semax 400 mcg per day. On the background of therapy is already on the 3rd day, the patient began to notice improvement in visual acuity, decrease in density and size of the scotoma. The patient was discharged from staticobject - up to 200 gr., the red object to 275 gr. The area of the scotoma significantly decreased, remained small paracentral scotoma. Improved electrophysiological indices: the lability of the optic nerve has increased from 34 to 38 Hz, kcsm increased from 36 to 40-42 Hz.

Example 4. Patient B. , aged 30, was admitted to the hospital with a diagnosis of optic neuritis in the left eye of viral etiology. Myopia of an average degree of both eyes. The illness started after the SARS and was characterized by the usual symptoms: decreased vision, to 0.01, with SF. - 5,0 = 0,02, severe pain during movement of the eyeball and in the left half of the head. Within 2 weeks of undergoing traditional treatment in the clinic at the place of residence without visible speakers. At ophthalmoscopy of the optic disc monotonous, waxy with a small stosowanej borders, peripapillary retinal edema, Vienna full, the arteries are narrowed. Field of view at a white object narrowed to 355 gr., the absolute and relative scotoma, color objects with perimetric studies was not determined. On the background of basic therapy was prescribed course endonasal electrophoresis with a 0.1% solution of the Peptide in a dose of 400 mcg per day, 7 procedures. Objective and subjective dynamics has been said is but a vision of 0.05, with SF. - 5,0 = 0,8. At ophthalmoscopy of the optic disc pale pink with grey shade, border, clear, arteries of normal caliber. Field of view fully recovered, disappeared Central scotoma. When perimetric studies was to determine the red object, field of view at a red object 80 gr. The treatment has improved electrophysiological indices: threshold electrical sensitivity decreased from 100 µa 60 µa.

Example 5. Patient H., 67 years old, was admitted to the Institute with a diagnosis of: artiphakia right eye, initial age-related cataract in the left eye. Complicated and high myopia, Central chorioretinal dystrophy of the retina of both eyes. Partial atrophy of the optic nerves of both eyes. Upon receipt of the complaint to the deterioration of color sense (the patient was a professional artist), reduced visual acuity. Visual acuity at admission right - 0,03 with SF. - 1.0 cyl. -2,5 ax 90 = 0,1 -0,2 left - 0,03 with SF. -8,0 = 0,1. When ophthalmoscopy disks of optic nerves pale, clear boundaries, expressed angiosclerosis, in the macula, the dissociation of the pigment. The narrowing of the field of view on color objects. Colour vision in tables Rabkin: ONE does not read 18 tables, OS - does not read 12 tables. Within 2 weeks p is achala blurred vision. He was appointed endonasal electrophoresis with a 0.1% solution of the Peptide in a dose of 400 mcg per day, 7 procedures. The patient noticed an improvement in visual acuity after the 2nd procedure of electrophoresis. After treatment, the visual acuity OD of 0.1, with correction of SF. of-1.0 cyl. - 2,5 ax 90= a-0.7 0,6; OS - 0,04, with SF. -8,0 = 0.3. Significantly improved colour vision in tables Rabkin: ONE does not read 6 tables, OS - does not read 1 table. Subjectively, the patient reported improvement of color sense and color saturation. Field of view at a white object remained within the normal range, the total field of vision of the right eye on the green object is increased by 40 gr., the red object on the 35 gr., dynamics of the total field of view on color objects left eye was less significant.

Example 6. To determine therapeutic efficacy of the drug Semax used optimal doses were examined 74 patients (98 eyes) aged from 16 to 84 years: 31 women, men - 43 diseases of the optic nerve vascular (25,5%), toxic-allergic (16,3%), inflammatory etiology (24,5%), with partial atrophy of the optic nerve (33,7%).

To examine the effectiveness of Semax patients were divided into 3 groups depending on the method of introduction of the ro in the nose. The 2nd group consisted of 29 patients (38 eyes) that the Peptide was obtained in the form of endonasal electrophoresis. group 3 - control, it consisted of 20 patients (29 eyes). Each group was divided into subgroups depending on the initial visual acuity. The distribution of patients into groups based on etiology was almost identical. All patients received a standardized basis neurotrophic and anti-inflammatory therapy.

In the 1st group of 0.1% solution of the Peptide was applied intranasally in the form of nose drops. The drug was administered with the patient lying with the eyedroppers in amounts not exceeding 2-3 drops in each nostril. Single dose was 200 to 300 micrograms. Solution of the drug was administered 3-4 times a day. Daily doses of 600-1200 mg. The course of treatment from 7 days to 2 weeks at a daily dose of the drug.

In the 2nd group of the Peptide was administered to patients in the form of endonasal electrophoresis 1 time per day. Single dose was 400 to 600 mcg. Electrophoresis was carried out as follows: forked positive electrode was put cotton wool moistened with the medicinal product. The electrodes were introduced in the middle of the nasal passages. The second electrode with gasket 8x10 cm was placed in the neck. Current strength is erachem position of the patient.

Ophthalmologic examination of patients was performed according to the General scheme, which included the study of Central visual acuity, biomicroscopy, ophthalmoscopy, the study of peripheral vision on the projection perimeter Carl Zeiss Jena on white and color objects (red, green), a study of the Central visual field on campimetry, macular tests (Amsler grid test 9 points), the study of colour vision using polychromatic and pigment tables E. B. Rabkin, critical frequency of flicker fusion. The function of the inner layers of the retina and axial beam optic nerve was evaluated by the method of determining thresholds electrical sensitivity and electrical lability.

The results of the study.

In the 1st group of patients positive dynamics of visual acuity was observed in 83,9% (26 eyes) cases. In patients with initially low visual acuity (0.1 and below) the visual acuity improved on average from 0.07 0.07 0.01 to 0,17 0,02 (P<0,01) (table. 1).

In patients with relatively high visual acuity before treatment (0.2 and above) visual acuity increased from 0,330,03 to 0,630,07 (P<0,01). While visual acuity in individual patients was increased from 0.05 to 0.5, 0.1 to 0.8.

In the 2nd grudu subgroups, respectively. Reduction of visual acuity was observed. In 5 patients (5 eyes) visual acuity improved to 1.0.

The most pronounced increase in visual acuity during treatment was observed in patients in the acute period of the disease with neuritis, ischemic neuropathy. At a later time in the development of atrophic processes in the optic nerve, as well as in patients with partial atrophy of the optic nerve of the effectiveness of the treatment was less pronounced.

A control group of patients the visual acuity improved in 20 eyes (68.9%) and from 0.09 0.01 to 0,130,01 and from 0.39 0.06 to 0,510,11 respectively subgroups, but the difference was not statistically significant (P> 0,1). In 8 eyes after a course of neurotrophic and anti-inflammatory therapy change in visual acuity practically not installed.

Noted a direct correlation between the improvement of visual acuity on a background of treatment from the initial visual acuity in all groups.

In the study the patients field of vision before treatment was noted the presence of sectoriality defects, concentric narrowing, limiting boundaries of the field of view of irregular shape, having a Central, paracentral scotomas in both absolute and relative. Most patients scotomas t was saved (in the 1st group of 6 eyes, in the 2nd group of 8 eyes). Peripheral border color objects was studied in 66 of the 69 eyes, as in 3 patients was identified congenital disturbance of colour vision. In 22 eyes (71%) in the 1st group and in 30 eyes (79%) in the 2nd group revealed a narrowing of the boundaries for the green color. In 4 eyes in group 1 and 6 eyes in group 2 green object when perimetric studies was not determined. Peripheral border for the red object has been strained in 18 eyes (58,1%) and 25 eyes (65,8%) for the 1st and 2nd groups, respectively.

Data on the dynamics of the peripheral visual field are given in table. 2.

When analyzing the dynamics of the peripheral field of view (in the total degree 8 meridians) in patients of the 1st group after treatment of the Peptide in the form of nose drops in 20 out of 25 eyes (80%) was observed expansion of the field of view of the average total of 57.5 degrees, with 253,69,1 to 311,1 (P <0,01). Narrowing of visual fields after the treatment in the study group was not observed. The detected increase in total boundaries of the field of view on color objects 20.5 degrees on the green object and 21.7 degrees at a red object. All patients of the 1st group was marked reduction of the size of the cattle, on average, 20% of the original quantity, and the transition to absolute cattle in Rel is A.

In the 2nd group of patients treated with the Peptide method endonasal electrophoresis, 25 of the 30 eyes (83,3%) identified the expansion of the field of view by 93.1 total degrees, with 234,312,5 to 327,414,1 (P<0,01). Narrowing the field of view was not observed. In 5 eyes field of view has not changed. The total field of vision of the green and red objects increased by 22.3 and 38.7 degrees, respectively. It was noted the reduction of the size of the cattle, on average, 26% identified the transition cattle absolute in the relative.

In the control group patients (29 eyes) changes in the peripheral boundaries of the field of view were less significant. Of the 22 eyes total field of vision increased in 14 eyes (63,6%) on average with 238,6 to 272,8 angular degrees (P> 0,1). No statistically significant increase of the total field and the green and red objects, field of view, respectively, increased by an average of 18 (P>0,1) and 17.6 (P>0,05) angular degrees.

Field of vision in patients of the 1st and 2nd groups increased after treatment to a greater extent and in more cases than in the control group.

The function of the inner layers of the retina and axial beam optic nerve was evaluated by the method of determining the threshold electric custica with Semax of the 69 eyes increased electrical sensitivity and conductivity of the optic nerve according to electrophysiological methods found in 50 eyes (72,5%), in other cases, these values remained unchanged. The averaged data of the threshold electric sensitivity, lability and ccsm red color is shown in table. 3 depending on the method of introduction of Semax.

In the control group of patients with positive dynamics of electrophysiological parameters was small. Deterioration of electrophysiological parameters was not observed in all three groups.

Color vision due to low visual acuity was able to explore in 44 eyes of the 69 eyes. In the study of colour vision using polychromatic tables B. B. Rabkin in 33 cases (75%) were identified violation of colour vision, which was characterized by acquired pathology, in 3 cases (6.8%) - congenital disturbance of colour vision. In the analysis of chromatic sensitivity in most patients there was a decrease in sensitivity to green, with the further development of color pathology increased the frequency of disorders of the red color. On the background of treatment with the drug Semax number unreadable tables decreased to a greater extent than in the control group.

All patients with diseases of the optic nerve different atnorth of view, contrast, the expansion of the field of view.

Adverse reactions or deterioration of visual functions none noted.

Thus, the study showed that the inclusion of the Peptide in the complex therapy of diseases of the optic nerve has a beneficial effect on the severity and pace of the recovery processes, contributing to the improvement of visual functions. The drug can be applied intranasally in instillation, as well as to introduce the method of endonasal electrophoresis, which contributes to neuroelectronic impact on the pathological focus, biological stimulation. A direct result of the stimulatory effect of electric current causes the activation of the blood circulation which enhances the activity of the processes of cellular metabolism. It is known that DC facilitates the passage of drugs through gematologicheskii barrier and gives the possibility of introducing in the eyes of large concentrations of drugs. Thanks electrophoretic method introduction in the pathological focus creates a drug depot, which contributes to prolonged action of the drug.

The use of Semax, special damage: significantly increases positive clinical dynamics, estimated to increase visual acuity, the total field of view, increased electrical sensitivity and conductivity of the optic nerve, improve color vision. The peptide can be used for intranasal clinical application in the form of instillation or method endonasal electrophoresis as nootropic agents for the treatment of diseases of the optic nerve vascular, inflammatory, toxic or allergic etiology, and treatment of partial atrophy of the optic nerve.

1. The method of treatment of diseases of the optic nerve through the use of a drug, characterized in that as a drug used Semax, while it is introduced by the method of endonasal electrophoresis with the positive electrode.

2. The method according to p. 1, wherein the peptide is administered in a daily dose of 400 to 600 mcg.

3. The method according to p. 1 or 2, wherein the electrophoresis is carried out 1 time per day, with a forked positive electrode is applied 8 to 12 drops of Semax 0.1% solution.

 

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