Method for postoperative rehabilitation of patients suffering glaucoma

FIELD: medicine.

SUBSTANCE: invention refers to medicine, ophthalmology. A method involves a sinus trabeculectomy, a local sclerectomy and a drug delivery to a posterior pole of eyeball following by a restorative treatment. The local sclerectomy is performed in an inferior-internal segment of the eye with a cross-section of the incision being semi-circular. The local sclerectomy uses Histochrom as a drug substance. The restorative treatment comprises subconjunctival drug injections in a combination with the exposure to a physical factor. Starting from the first postoperative day, Histochrom is injected into a sub-Tenon's space. There are 9 injections performed once a day. Starting from the second postoperative day, a magnetic stimulation is used at frequency 100 Hz, length 16 minutes once a day for 7-10 days. The first 3 sessions involve the exposure to a pulsating monopolar magnetic field of intensity 6.25 mT. The following 4-7 sessions involve the exposure to an alternating bipolar magnetic field of intensity 12.5 mT.

EFFECT: method provides stabilising and enhancing the visual functions.

5 cl, 1 dwg, 1 ex

 

The invention relates to medicine, in particular to ophthalmology, and can be used to improve the efficiency of surgical treatment of primary open-angle glaucoma patients with elevated or normal intraocular pressure (IOP) with unstabilized visual functions in early postoperative period.

Glaucoma is one of the most common eye diseases. It leads to severe, irreversible changes in the eye and significant loss of vision, up to complete blindness. According to the world health organization, the number of glaucoma patients in the world ranges from 60,5 up to 105 million people, and in the next ten years it will increase by another 10 million According to literature data, in the world every minute from glaucoma fades one person every 10 minutes per child. In recent years, glaucoma is one of the main causes of irreversible blindness. The frequency of disability caused by glaucoma is 15-20% of all eye diseases. The observed steady and stable growth rates of different demographic groups, chronic disease with progressive deterioration of visual function, leading ultimately to the loss of health, accompanied by a high rate of morbidity and a significant amount of the patient and the fourth overall, allow to speak about glaucoma as medico-social disease. In this regard, the glaucoma is a public task for which it is necessary to conduct an active and broad measures for its early diagnosis and treatment (National guide to glaucoma, Moscow, 2011).

Basic principles of treatment of glaucoma is to reduce IOP, improvement of ocular blood flow, neuroprotection. The first task is achieved by the use of antihypertensive drugs, and in the absence of the effect of laser and surgical treatment.

At the same time, the normalization of IOP is not always contributes to the stabilization of visual functions. According to many authors (Nesterov A.P., 2007, Smith E.A., 2001, Melnikov WA, 1999), collapse of visual function continues after conducting antiglaucomatous operations and achieve normalization of intraocular pressure in 40-60% of patients. Deterioration of visual functions can be explained partly by the body's response to the intervention, because the surgery is stress, which results in the release of various biologically active substances that exacerbate ischemia.

The results of the patent search revealed no direct analogues of the proposed solutions.

There is a method of treatment of patients with primary open-angle glaucoma, including during sinustrabeculectomia local sclerectomy and with the ability to deliver drugs to the optic nerve using a blunt cannula, and as medicines use the Medication (see YEAR Kamenskih, DR. Myshkin, DR. Radchenko. The use of medication in the treatment of patients with primary open-angle glaucoma // Terra Medica No. 3, 2006 - p.54-56).

This solution has poor efficacy of surgical treatment of glaucoma, because the local sclerectomy is performed in the outer segment of the eye, away from the optic nerve, the drug is administered only once in subtenancies space and there is no complete restorative therapy in the postoperative period.

As the closest analogue is adopted a method of treating patients with glaucoma, including during antiglaucomatous operations, namely sinustrabeculectomia, local sclerectomy with the ability to deliver drugs to the posterior pole of the eye by implantation of collagen hemostatic sponge size 510 mm, and a subsequent recovery therapy in injection drug under the conjunctiva of the eyes, combined with the influence of physical factors, and as a drug in the course of sinustrabeculectomia and rehabilitation therapy using Cortexin, and as a physical factor use magnetoresistance (see Krasnogorsk V.N., Basinski, S., alumina E.V. and other Results of magnetoresistance in combination with Cortexin in the treatment of decompensated severe primary open-angle glaucoma /Glaucoma: theory, trends, and technology: collected scientific articles. Art. [Ed. by Acad. The RAMS A.P. Nesterov]. - M., 2007, pp.261-266).

Disadvantages closest analogue is the low efficiency of surgical treatment of glaucoma by performing local sclerectomy in the outer segment of the eye, away from the optic nerve, as well as a fairly high probability of formation of various complications in the postoperative period.

The technical task of the invention is to develop an integrated method of rehabilitation of patients with glaucoma, aimed at stabilizing and strengthening visual functions (informirovanie) with the aim of preserving the fibres of the optic nerve.

Technical result achieved when the task is reducing the complexity, the expansion of the scope through the use of known drugs (Histogram) for non-standard purposes, and also increase the effectiveness of surgical treatment of glaucoma due to the following factors:

- the possibility of targeted delivery of drugs to the destination, namely the optic nerve, through the implementation of local sclerectomy and imp is antali collagen hemostatic sponge size 510 mm in subtenancies space in the bottom of the inner segment of the eye;

- prevention of unwanted side effects due to the use as a drug of Histogram with antioxidant, neuroprotective, antiproliferative and protivogemorragicheskim action;

- additional revascularizable effect due to the use of collagen hemostatic sponge on the background of a significant difference of IOP;

- prevention of complications such as edema, inflammation and circulatory disorders, as well as normalization of tone of smooth muscles in the walls of arteries and analgesic effect in the postoperative period due to use as a physical factor FMS two different modes;

- cosmetic effect due to the incision of the conjunctiva semicircular cross section.

The problem is solved in that in the method of rehabilitation of patients with glaucoma in the postoperative period, including during antiglaucomatous operations, namely sinustrabeculectomia, local sclerectomy with the ability to deliver drugs to the posterior pole of the eye and subsequent rehabilitation therapy in injection drug under the conjunctiva of the eyes, combined with the influence of physical factors, local sclerectomy perform in the bottom of the inner segment of the eye and the cross-section incision is made semicircular shape, during local sclerectomy as drug use Histogram, and rehabilitation therapy perform 9 injections Histogram in subtenancies space eye 1 times a day, starting with the first day after surgery, in addition, the effect of the physical factor is a session FMS frequency of 100 Hz and a duration of 16 minutes, carried out 1 time a day for 7-10 days, starting from the second day after surgery, and the first 3 sessions effect of monopolar magnetic field pulse shape intensity of 6.25 MT, and the subsequent 4-7 sessions - biopolar magnetic field of the form variable intensity of 12.5 MT.

In addition, as antiglaucoma operations perform sinustrabeculectomia with basal iridectomy, delivery of drugs to the posterior pole of the eye shall be implemented by collagen hemostatic sponge size 5 to 10 mm, when rehabilitation therapy produce injection of 0.5 ml of 0.02% solution of Histogram in the bottom of the internal segment of the eye, when FMS first 3 sessions are affected by a magnetic field with depth of modulation of the pulses of 50% and squareknot pulses of 1:2, and the subsequent 4-7 sessions - magnetic field with depth of modulation of 100% and squareknot pulses of 1:1.

Comparative analysis of significant prospect who signs the proposed technical solutions with significant signs analogues demonstrates its compliance with the criterion of "novelty".

This distinctive features in the claims solves the following functional tasks.

Sign local sclerectomy runs in the bottom of the inner segment of the eye can increase the effectiveness of surgical treatment of glaucoma due to the possibility of targeted delivery of drugs to the destination, namely the optic nerve.

The sign "cross-section incision is made semicircular shape allows to achieve high cosmetic effect due to the small size scleractinia "open" and imposing fewer seams in a less visible area of the eye.

The sign "during local sclerectomy as drug use Histogram, and rehabilitation therapy perform 9 injections Histogram in subtenancies space eye 1 times a day, starting with the first day after operation helps to prevent unwanted processes inside the eye due to the use of drugs with antioxidant, neuroprotective, antiproliferative and protivogemorragicheskim action.

The characteristic physical impact factor is a session FMS frequency of 100 Hz and a duration of 16 minutes, carried out 1 time a day for 7-10 days, starting from the second day after surgery" pozvolyayet the effectiveness of rehabilitation therapy in the postoperative period.

Sign "of the first 3 sessions effect of monopolar magnetic field pulse shape intensity of 6.25 MT" enables prevention of complications such as swelling, inflammation and bleeding.

The sign "next 4-7 sessions - biopolar magnetic field of the form variable intensity of 12.5 MT allows to normalize the tone of smooth muscles in the walls of arteries and improve the blood circulation.

1 shows a sagittal section of the eye, holding local sclerectomy.

The drawing shows the posterior pole 1 eye, section 3 of the conjunctiva 2, the limb 4, subtenancies space 5, collagen hemostatic sponge 6, scleractinia window 7.

Section 3 of the conjunctiva 2 length 4 mm is performed in 5 mm from the limbus 4.

Collagen hemostatic sponge 6 has dimensions of 5 x 10 mm and impregnated with the medicinal product, namely Histogram.

The cross-section scleractinia "window 7 is made semicircular shape, and its size is half of the diameter of the round trephine drills (3 mm).

The method is as follows.

At the initial stage in the lower-inner eye segment, concentric limbu 4, carry out section 3 of the conjunctiva 2. Later in Sultanova space 5 form a tunnel (not shown) to the rear pole 1 and perform sclerectomy base to limb 4 coord is m scleractinia "open" 7. In subtenancies space 5 is injected collagen hemostatic sponge 6, leading edge which is placed on scleractinia window 7. The wound sutured. Then hold sinustrabeculectomia by the standard method.

In the next step, perform 9 injections of 0.5 ml of 0.02% solution of Histogram in subtenancies space eye 1 times a day, starting with the first day after surgery. In parallel, starting from the second day after the operation, conduct sessions FMS frequency of 100 Hz and a duration of 16 minutes, carried out 1 time a day for 7-10 days, with the first 3 sessions effect of monopolar magnetic field pulse shape with a depth of modulation of the pulses of 50% and squareknot pulses of 1:2 intensity of 6.25 MT, and the subsequent 4-7 sessions - biopolar magnetic field of variable shape with a depth of modulation of 100% and squareknot pulse 1:1 intensity of 12.5 MT.

According to this method, treated 8 patients with primary open-angle glaucoma, one of them with the initial stage (I) - 1 person, advanced stage (II) (2), advanced (III) - 5 people. The follow - up period of 6 months.

The invention is illustrated by the following examples.

Clinical example No. 1. Patient L., 63,, a diagnosis of primary open-angle advanced with moderately elevated IOP on maximal hypotensive mode glow the Ohm's left eye.

Before surgery: visual acuity 1.0; IOP - 31 mm Hg, the field of vision (for a total of 8 meridians) to 375 degrees, vasoconstrictory in the midrange - 540%; kcsm 21 Hz; data HRT: excavation (CupVDisc Area Ratio) - 0.770, the area of neural ring (Rim Area) - 0.504; the amount of neural ring (Rim Volume) - 0.036, the average thickness neuroretinal fibers (Mean RNFL Thickness) - 0.050.

The patient underwent operation: sinustrabeculectomia with basal iridectomy, local sclerectomy with implant in subtenancies space collagen sponge soaked Histogram.

In the early postoperative period completed a course of injections Histogram under the conjunctiva No. 9 in combination with FMS, the first 3 sessions which worked monopolar magnetic field pulse shape intensity of 6.25 MT, and the following 6 sessions - biopolar magnetic field of the form variable intensity of 12.5 MT.

After 1.3 months after surgery: visual acuity 1.0-0.9-corrected; IOP - 12-13 mm Hg, the field of vision (for a total of 8 meridians) expanded - 520,525 degrees, vasoconstrictory in the midrange - 600%; kcsm 22 Hz; data HRT: excavation (CupDisc Area Ratio) - 0.348, the area of neural ring (Rim Area) - 1.431; the amount of neural ring (Rim Volume) - 0.275, the average thickness neuroretinal fibers (Mean RNFL Thickness) - 0.204.

Clinical example 2. Patient T., 62 The., the diagnosis of primary open-angle advanced with moderately elevated IOP on maximal hypotensive mode unstabilized glaucoma of the left eye.

Before surgery: visual acuity 1.0 correction; IOP of 30 mm Hg, the field of vision (for a total of 8 meridians) to 465 degrees, vasoconstrictory in the midrange - 600%; kcsm 17 Hz; data HRT: excavation (CupVDisc Area Ratio) - 0.571, the area of neural ring (Rim Area) - 1.169; the amount of neural ring (Rim Volume) - 0.104, the average thickness neuroretinal fibers (Mean RNFL Thickness) - 0.066.

The patient underwent operation: sinustrabeculectomia with basal iridectomy, local sclerectomy with implant in subtenancies space collagen sponge soaked Histogram.

In the early postoperative period completed a course of injections Histogram under the conjunctiva No. 9 in combination with FMS, the first 3 sessions which worked monopolar magnetic field pulse shape intensity of 6.25 MT, and the next 5 sessions - biopolar magnetic field of the form variable intensity of 12.5 MT.

At 1 month after surgery: visual acuity 1.0 without correction; IOP was 16 mm Hg, the field of vision (for a total of 8 meridians) expanded - 525 degrees vasoconstrictory in the midrange - 600%; kcsm 32 Hz.

3 months after operation data HRT: ek is Kavala (CupDisc Area Ratio) - 0.456, the area of neural ring (Rim Area) - 1.431; the amount of neural ring (Rim Volume) - 1.483, the average thickness neuroretinal fibers (Mean RNFL Thickness) - 0.079.

Based on the results of the solution of the technical problem the following conclusions. Visual acuity remained stable in 6 patients improved by 10-20% in 2 patients. The field of vision (for a total of 8 meridians) has increased in all patients at 20-150 degrees, on average, 65 degrees (19%) from the source. Ccsm increased 2-15 Hz, at about 5 Hz (22.8%). IOP decreased 5-19 mm Hg from the original and kept in the postoperative period in the range of 13-20 mm Hg Size and depth of excavation of the optic nerve disc (optic nerve head) remained unchanged in 2, decreased in 6 cases.

The proposed solution allows not only to normalize IOP, but also to stabilize and improve visual function in patients with primary open-angle glaucoma in early and long-term (3-6 months) postoperative period.

1. The method of rehabilitation of patients with glaucoma in the postoperative period, including during antiglaucomatous operations, namely sinustrabeculectomia, local sclerectomy with the ability to deliver drugs to the posterior pole of the eye and subsequent rehabilitation therapy in injection drug under conjunctive the eye in combination with the influence of physical factors, characterized in that the local sclerectomy perform in niininen eye segment, and the cross-section incision is made semicircular shape, a local sclerectomy as drug use Histogram, and rehabilitation therapy perform 9 injections Histogram in subtenancies space eye 1 times a day, starting with the first day after surgery, in addition to the physical impact factor is a session FMS frequency of 100 Hz and a duration of 16 minutes, carried out 1 time a day for 7-10 days, starting from the second day after surgery, and the first 3 sessions effect of monopolar magnetic field pulse shape the intensity of 6.25 MT, and the subsequent 4-7 sessions - biopolar magnetic field of the form variable intensity of 12.5 MT.

2. The method of rehabilitation of patients with glaucoma in the postoperative period, according to claim 1, in which as antiglaucoma operations perform sinustrabeculectomia with basal iridectomy.

3. The method of rehabilitation of patients with glaucoma in the postoperative period, according to claim 1, in which the delivery of drugs to the posterior pole of the eye shall be implemented by collagen hemostatic sponge size 5 to 10 mm.

4. The method of rehabilitation of patients with glaucoma in the postoperative PE is the iodine according to claim 1, where rehabilitation therapy produce injection of 0.5 ml of 0.02% solution of Histogram in the bottom of the internal segment of the eye.

5. The method of rehabilitation of patients with glaucoma in the postoperative period, according to claim 1, in which at FMS first 3 sessions are affected by a magnetic field with depth of modulation of the pulses of 50% and squareknot pulses of 1:2, and the subsequent 4-7 sessions - magnetic field with depth of modulation of 100% and squareknot pulses of 1:1.



 

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SUBSTANCE: claimed are compounds of general formula I , where values of radicals are given in description, possessing inhibiting action on sodium-dependent cotransporter of glucose SGLT. Present invention also claims pharmaceutical compositions, possessing inhibiting effect with respect to SGLT, and methods of obtaining said compounds and synthetic intermediates, as well as methods of obtaining said compounds per se or in combination with other therapeutic agents for treatment of diseases or states, subjected to impact of SGLT inhibition, for instance such disease as type 1 and 2 diabetes mellitus, hyperglucemia, diabetic complications, insulin resistance, metabolic syndrome, hyperinsulinemia, hypertension, hyperuricemia, obesity, edemas, dislipidemia, chronic heart failure and atherosclerosis.

EFFECT: increasing efficiency of application of derivatives.

21 cl, 23 ex, 1 tbl, 8 dwg

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