RU2553203C1 - Method of complex treatment of patients with purulent-necrotic forms of diabetic foot syndrome - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: minor amputation of the foot with the further necrectomy is performed. After the application of an antimicrobial bandage and drainage, the wound is hermetised from the environment by the creation of a negative pressure above the wound in a combination with drug treatment. The reatment is performed in two steps. At the first step the wound with the antimicrobial bandage and drainage is first hermetised from above with an adhesive film, with the creation and support of the negative pressure not lower than 80 mm Hg. Urokinase 500000 U is additionally introduced daily intravenously by drop infusion per 100 ml of physiological solution, Vessel-Due-F in a dose of 600 LU per 100 ml of physiological solution and VAP 20 - alprostadil in a dose of 40 mcg per 100 ml of physiological solution. In addition Antistax in capsules is introduced to the patient. At the second stage active 24-hour vacuum aspiration with the change of the negative pressure from 10 to 80 mm Hg within a day is carried out. Additionally introduced is Vessel-Due-F in a dose of 1 capsule with 250 LU 2 times per day between meals and Antistax. At the first and second stages Antistax is introduced in a dose of 2 capsules in the morning 30-40 minutes before meal, daily. Duration of each stage constitutes not less than 7 days.

EFFECT: increase of the treatment efficiency due to the complete and timely purification of the wound from pathological exudates, elimination of the progression of the purulent-necrotic process, increase of the regenerative activity of tissues, activation of local immunity, recovery of microcirculation and oxygenation of the affected tissues.

2 cl, 2 ex

Description

The method of complex treatment of patients with purulent-necrotic forms of diabetic foot syndrome relates to medicine and can be used to accelerate wound cleansing, restore and activate local immunity and increase the regenerative activity of affected tissues.

Known methods for treating patients with complicated forms of the diabetic foot by alternately exposing the limb to positive and negative pressure (AS USSR No. 243787, class A61M 16/02, 1969) and additional exposure to the body with oxygen with a pressure of 1-2 kg / cm ² (USSR AS No. 946555, class A61M 16/62, 1982).

This method is designed for a long period of treatment and showed insufficient effectiveness in treating patients with diabetic foot syndrome.

A known method and device for the treatment of ischemic conditions of the lower extremities by exposing the patient to centrifugal forces in the direction of the head - lower limbs on a special stand (AS USSR No. 1674838, class A61M 1/60, 1991; AS USSR No. 1245314 Cl. A61M 16/02, 1986).

In this method, using the device, along with increasing arterial inflow, venous outflow is impeded, which limits their use in clinical practice, in addition, the device used is very difficult in design, has a high cost and requires highly qualified staff.

The well-known "Method of treating patients with atherosclerosis obliterans of the lower limb arteries" according to patent RU 2363499 dated 01/30/2007, published on 08/10/2009, IPC A61M 1/38 (2006.01), A61N 5/067 (2006.01), A61K 31/5575 (2006.01), A61K 33/14 (2006.01), A61P 9/10 (2006.01), which is carried out by blood sampling, centrifugation, isolation of the erythrocyte fraction, plasma removal and the return of the erythrocyte fraction, while an angiotropic drug substance is introduced into the isolated fraction in the amount of an average therapeutic dose per 200 ml of erythrocyte fraction, irradiate with low-intensity by laser radiation of a helium-neon laser with a power of 1.2 mW for 20 minutes, add 100 ml of physiological solution to 200 ml of the erythrocyte fraction into the erythrocyte fraction and return it within 1.5-2 hours; as an anthropic substance, the drug alprostadil under the trade name vazaprostan in the amount of 40 μg dissolved in 5 ml of physiological saline is used.

This method is complicated in execution, requires the use of laser equipment and does not provide effective treatment due to the lack of adequate drainage of wounds in complicated forms of diabetic foot.

The well-known "Method for the treatment of patients with complicated forms of diabetic foot syndrome" according to the application RU 2010103097 dated 01/29/2010, published on 08/10/2011, IPC A61K 31/00, which is carried out by blood sampling, centrifugation, plasma removal, erythrocyte fraction isolation, introduction of the red blood cell into it angiotropic medicinal substance, irradiation with laser radiation with a power of 12 mW for 20 min, add 100 ml of physiological saline to 200 ml of erythrocyte fraction and reinfuse for 1.5-2 hours, while together with the angiotropic substance in erythrocyte the total fraction is injected with 2 ml of ATP, the erythrocyte fraction is reinfused after 1 day, alternating with intravenous administration of Vesel-Douay-F 600 LU intravenously and 5 ml of actovegin per 100 ml of physiological saline, with a general course of treatment of 10 days.

This method also does not provide effective treatment due to the lack of adequate drainage of wounds in complicated forms of diabetic foot, it is difficult for widespread use in conventional hospitals, since it requires laser equipment.

The well-known "Method of treating patients with purulent-necrotic lesions of the feet with diabetes mellitus" according to patent RU 2253427 dated 12/18/2003, published on 10.06.2005, IPC A61G 10/02, A61K 31/185, A61P 41/00, A61B 17/00, in which the foot is continuously washed for several days by placing it in a sealed container with an antiseptic, followed by evacuation at a vacuum of 0.2-0.4 kgf / cm ² , and the alternation of procedures is carried out at intervals of 3-4 hours.

This method with frequent alternation of procedures requires additional medical staff time and high consumption of antiseptics, is complicated in execution, differs in bulkiness of the equipment with insufficient treatment efficiency due to the lack of an integrated approach to treatment.

The closest is the "Method of complex surgical treatment of diabetic foot syndrome complicated by purulent-necrotic process" according to patent RU 2405472 dated 11/18/2009, published on 12/10/2010, IPC A61B 17/00, including opening an abscess or phlegmon of soft tissues of the foot, revision of pockets and purulent sagging, excision of non-viable tissues, debridement of the wound, then the wound is isolated from the external environment using a closed elastic container and is also jet-affected by proteolytic enzymes - trypsin and chymotrypsin, 50 mg of each cient dissolved in 200 ml of 0.9% saline for 1.5 h, then over the wound within 3 hours provide a negative pressure of 70-80 mmHg with active vacuum aspiration; after a 1-hour interval, the 1st cycle is repeated, and the wound is treated with a 0.06% sodium hypochlorite solution in combination with low-frequency ultrasound by active aspiration under the same conditions.

This method is complicated in execution, with insufficient treatment effectiveness due to the lack of complex drug treatment, requires ultrasound equipment and is not applicable everywhere in small hospitals.

The objective of this technical solution is to reduce the treatment time and increase the effectiveness of treatment of patients with purulent-necrotic forms of diabetic foot syndrome.

The problem is solved by the method of complex treatment of patients with complicated forms of the diabetic foot by small amputation of the foot followed by necrectomy, sealing the wound from the external environment after applying the antimicrobial dressing and drainage, creating negative pressure over the wound in combination with drug treatment, and the treatment is carried out in two stages, at the first stage, the wound with an antimicrobial dressing and drainage is sealed with a sticky film on top, a negative pressure is created and maintained over the wound at least 80 mm Hg, in combination with a daily intravenous drip of Urokinase 500000 IU per 100 ml of saline, Vesel-Douay-F 600 IU per 100 ml of saline and VAP 20 - alprostadil 40 μg per 100 ml saline and the introduction of Antistax in capsules; at the second stage, active round-the-clock vacuum aspiration is continued with a change in negative pressure from 10 to 80 mm Hg. during the day in combination with the introduction of Vesel-Douay-F 1 capsule of 250 LE 2 times a day between meals and Antistax; at the same time, at the first and second stages of Antistax, 2 capsules are administered in the morning 30-40 minutes before meals, daily; the duration of each stage is at least 7 days; create negative pressure over the wound and aspirate with a Suprasorb SNP P1 device (Germany) from Lohmann Rausher International GmbH Co.

The implementation of the method in two stages allows you to adjust the frequency of change and the limits of pressure change over the wound during the transition to the second stage, as well as to clarify the dosage and duration of the drugs used in the second stage.

The inventive method of complex treatment of patients with purulent-necrotic forms of diabetic foot syndrome, divided into stages, reduces the treatment time for patients with purulent-necrotic forms of diabetic foot syndrome, significantly increases the effectiveness of treatment and contributes to a longer preservation of the achieved therapeutic effect due to the acceleration and more complete cleansing wounds from pathological exudate in combination with an increase in the regenerative activity of foot tissues by suppressing the activity of the pathogen purulent-n ekrotic process, activation of local immunity of affected tissues, restoration of microcirculation, oxygenation and regeneration of these tissues.

The method of complex treatment of patients with purulent-necrotic forms of diabetic foot syndrome is implemented as follows.

The method is carried out in two stages, which allows, when switching to the second stage, to adjust the frequency of change and the limits of pressure change over the wound, as well as to clarify the dosage and duration of the drugs used in the second stage.

At the first stage, as a result of purulent-necrotic complications of the diabetic foot syndrome, after performing small amputations and thorough necrectomy, the Kerlix antimicrobial dressing is placed (the dressing is impregnated with polyhexamethylene biguanide, which is effective against gram-positive and gram-negative microorganisms). If necessary, cut the dressing according to the size of the wound. Lay flat wound drainage (Soft Drain) to the bottom of the wound over the previously laid antimicrobial dressing over the entire length of the wound. One or more layers of Kerlix antimicrobial dressing are placed on top of the drainage to skin level or slightly higher. Seal the wound with a sticky film. To do this, the necessary piece of adhesive film Suprasorb F is glued to the dressing with a margin, capturing intact skin. (The Suprasorb F film is gas- and vapor-tight and does not cause diaper rash, protects the wound from secondary infection.) To seal the drainage exit area, the Suprasorb F adhesive film is folded in two layers with an adhesive layer to the outside. One layer to the skin under the drainage tube, the second layer to the outside. Additionally, the dressing is sealed by compressing the Suprasorb F film around the drain pipe with your fingers. Then the dressing is completely sealed by gluing an additional piece of the Suprasorb F adhesive tape on the loose outer adhesive layer and on the dressing itself. Next, connect the drain pipe to the Suprasorb CNP P1 connector. And they create the necessary negative pressure in the wound of 80 mm Hg, which is maintained around the clock, in combination with drug treatment with Urokinase, Vesel-Douay-F, VAP 20 and Antistax, for 7 days.

Unlike other methods, local treatment of the wound by creating negative pressure with the Suprasorb CNP P1 device helps to completely and timely remove wound exudate, excludes the progression of the purulent-necrotic process, its further spread in the foot, and the formation of secondary necrosis, in addition, allows for the nature and quantity of the removed wound exudate to determine the speed and effectiveness of the ongoing wound process and when moving to the second stage allows you to adjust the frequency of change and before To change the pressure over the wound, as well as to clarify the dosage and timing of the drugs used in the second stage.

With prolonged local exposure to negative pressure on the wound, inflammatory and degenerative changes in the wound steadily decrease and regenerative processes accelerate after surgical treatment of purulent-necrotic forms of diabetic foot syndrome. A persistent transition of the wound process to the second phase is noted.

To reduce the duration of local exposure to negative pressure on the wound, reduce the duration of treatment, with increased treatment effectiveness, the patient is prescribed complex drug treatment, for which Urokinase, Vesel-Douay-F, VAP 20 and Antistax are prescribed intravenously.

Urokinase is administered at the first stage for 7 days, 500,000 units intravenously dropwise per 100 ml of physiological saline, daily, which, having fibrinolytic agents, is a direct activator of fibrinolysin (plasmin); activates foolofibrinolysins and lysprofibrinolysins, turning them into fibrinolysin, causing enzymatic destruction of fibrin; lyses a blood clot from the outside and inside; fibrinogen breakdown products then block platelet and erythrocyte aggregation, reduce blood viscosity.

The introduction of urokinase prevents the formation of anaerobic non-clostridial bacteria under the action of heparinase in patients with purulent-necrotic forms of diabetic foot syndrome, pathological thrombosis in the microvasculature, and a decrease in blood viscosity.

At the same time, at the first stage, Vesel-Doué-F (sulodexide) is administered for 7 days at a dose of 600 LU intravenously per 100 ml of physiological saline, which daily, having antithrombotic and angioprotective effects, with a diabetic foot, reduces the thickness of the basement membrane and the production of extracellular matrix by reducing the proliferation of mesangium cells; the mechanism of angioprotective action is associated with the restoration of the structural and functional integrity of vascular endothelial cells, restoration of the normal density of the negative electric charge of the pores of the vascular basement membrane.

In the second stage, Vesel-Douai-F (sulodexide) is prescribed 1 capsule (250 LU) 2 times a day between meals.

To reduce the severity of pain and analgesic consumption, at the first stage, VAP 20 (alprostadil) is injected 40 micrograms intravenously per 100 ml of physiological saline daily for 7 days at the first stage, which improves peripheral blood circulation and microcirculation, has a vasodilating effect , helps to increase the elasticity of red blood cells, reduces platelet aggregation.

To speedily reduce postoperative edema and normalize venous outflow and venous wall tone, the venotonic Antistax is included in the complex treatment at the first and second stages, 2 capsules in the morning 30-40 minutes before meals, daily, which is not used separately for the treatment of complicated forms of diabetic foot.

In order to effectively remove wound exudate and reduce bacterial load, stimulate blood flow, form new cells and develop granulations, increase the regeneration of affected tissues, reduce wound swelling and reduce the size of the wound itself, the second stage of this complex treatment of purulent-necrotic forms of diabetic foot syndrome continues to be active round-the-clock vacuum aspiration with a Suprasorb CNP P1 device (Germany) from Lohmann Ransher International GmbH Co by changing the negative pressure over the wound from 10 to 80 mm Hg during the day in combination with taking Vesel-Douay-F and Antistax in capsules for another 7 days; Vesel-Douai-F is prescribed 1 capsule (250 LE) 2 times a day between meals; Antistax is prescribed 2 capsules in the morning 30-40 minutes before meals, daily. The change in negative pressure above the wound from 10 to 80 mm Hg during the day, the patient himself can exercise, reducing every hour by 10 mm Hg.

Based on clinical experience, objective research, the nature and amount of wound exudate removed, the assessment of subjective symptoms in patients, using the claimed method of complex treatment of patients with purulent-necrotic forms of diabetic foot syndrome, there is a more rapid relief of pain, a decrease in the feeling of heaviness, relief of edema, a more rapid decrease in the inflammatory type of cytogram and a significant decrease in the inflammatory-degenerative type of cytogram in the wound, with such an early transition of the wound process to the second phase, the absence of the need for repeated necrectomies, faster regeneration of the affected tissues and epithelization of the wound itself, in contrast to the prior art using a longer local impact of negative pressure on the wound separately, or using one or a combination of two - three drugs, but without local exposure to negative pressure on the wound.

The proposed method, excluding daily dressings, reducing labor costs and dressings, can be used in all departments of medical institutions, especially in the departments of purulent surgery.

Clinical examples

Patient K., 61, was admitted with complaints of pain, swelling, hyperemia of the left foot, the presence of necrosis of 2-3-4-5 toes. She had type 2 non-insulin-dependent diabetes mellitus for 8 years. I took 6-year-old tablets of sugar-lowering drugs - diabetes mellitus MB 1-2 tablets in the morning. The duration from the onset of purulent-necrotic complications of the diabetic foot to admission to the hospital is 12 days. On the day of admission, amputation of 2-3-4-5 toes was performed with resection of the heads of the metatarsal bones. Further, along with the basic drugs (analgesics, antibiotics), a course of Urokinase, sulodexide (Vesel-Douay-F), alprostadil (VAP 20) and Antistax in capsules, in combination with local wound treatment using negative pressure with the Suprasorb CNP P1 apparatus, were prescribed . Treatment with urokinase included the introduction of 500,000 units intravenously per 100 ml of physiological saline, daily. Vesel-Douay-F was administered 600 LU intravenously dropwise per 100 ml of physiological saline, daily. VAP 20 (alprostadil) was administered daily at a dose of 40 μg intravenously per 100 ml of physiological saline. Antistax was prescribed 2 capsules in the morning 30-40 minutes before meals, daily. At the same time, the Suprasorb CNP P1 apparatus was used to create negative pressure over the wound, for which immediately after amputation of the fingers and resection of the heads of the metatarsal bones a thorough necrectomy was performed and a Kerlix antimicrobial dressing was applied to the foot wound. They laid a flat wound drainage (Soft Drain) on the bottom of the wound over the previously laid layer of antimicrobial dressing along the entire length of the wound. On top of the drainage, another layer of Kerlix antimicrobial dressing was placed slightly above skin level. The wound was sealed with Suprasorb F adhesive film. At the same time, the outlet area of the drainage was also sealed with the Suprasorb F adhesive film in two layers. Then the dressing was completely sealed with an additional piece of Suprasorb F overlapping adhesive film. Next, they attached the suction port of the Suprasorb SNP P1 apparatus and created a pressure of 80 mmHg around the clock. The course of this treatment was 7 days. During the transition to the second stage of the complex treatment of this patient by the nature and quantity of wound exudate removed, active round-the-clock vacuum aspiration was continued with a Suprasorb CNP PI apparatus (Germany) from Lohmann Rausher international GmbH Co, by changing the negative pressure in the wound from 10 to 80 mm Hg. Art. during the day, in combination with taking Vesel-Douay-F and Antistax in capsules for another 7 days; Vesel-Douay-F was prescribed 1 capsule (250 LE) 2 times a day between meals; Antistax was prescribed 2 capsules in the morning 30-40 minutes before meals, daily.

The results and effectiveness of the treatment were determined by assessing subjective symptoms, by the nature and amount of wound exudate removed and the change in the cytogram before and after the treatment. Cytological examination of wounds was performed on 1.7 and 14 days after surgery. At the end of the course of treatment with this method, the pain syndrome completely stopped in the foot for 5 days, along with a significant decrease in the amount of wound discharge, the feeling of heaviness in the legs significantly decreased, swelling disappeared. The inflammatory type of cytogram decreased by 7 days. The inflammatory and degenerative type of cytogram decreased by 7 days. On the 14th day from the start of treatment, a regenerative type of cytogram was noted. A persistent transition of the wound process to the second phase was noted already on the 7th day from the start of treatment. Repeated necrectomy was not required. There were no bleeding from the wound that would require any additional therapeutic measures, against the background of the application of this method of complex treatment of patients with purulent-necrotic forms of diabetic foot syndrome. Removal of the Suprasorb CNP P1 device during this course of treatment was not required. The patient was discharged on the 15th day.

Patient S. 53 years old with a diagnosis of non-insulin-dependent type 2 diabetes mellitus for 10 years was admitted with complaints of severe pain in the foot, pain and swelling, hyperemia of the 1st and 2nd toes of the right foot, the presence of necrosis of the 1st and 2nd toes. I took sugar-lowering drugs for 5 years - 3.5 maninil 1 tablet 2 times a day. 20 days ago, injured the foot. At first I didn’t apply, I was treated with iodine. Then she was treated on an outpatient basis in a clinic for a week - analgesics, dressings with furatsilin, took ciprolet. As a result of an increase in pain in the foot, edema, the appearance of necrosis of the 1st and 2nd toes, it is sent to a hospital. On the day of admission, amputation of 1 and 2 toes was performed with resection of the heads of the metatarsal bones. Then, basic therapy was carried out - analgesics, ceftriaxone with metronidazole, dressings with water-soluble antiseptics, received therapy according to the treatment program for a patient with complicated forms of diabetic foot. On the 7th day - pain and swelling, severe hyperemia persist, profuse wound discharge. On the 3rd and 7th day, a repeated necrectomy was performed twice. The inflammatory-degenerative type of cytogram predominates. There is no regenerative type of cytogram. It was decided to change the treatment methodology. They prescribed a course of urokinase, sulodexide (Vesel-Douay-F), alprostadil (VAP 20) and Antistax capsules, in combination with local wound treatment using negative pressure with Suprasorb CNP P1. Treatment with urokinase included 500,000 units intravenously dropwise per 100 ml of physiological saline, daily. Vesel-Douay-F was administered at 600 LU intravenously per 100 ml of physiological saline, daily. VAP 20 (alprostadil) was administered daily at a dose of 40 μg intravenously per 100 ml of physiological saline. Antistax was prescribed 2 capsules in the morning 30-40 minutes before meals, daily. The course of this treatment was 7 days. The second stage of this treatment, the patients continued active round-the-clock vacuum aspiration with the Suprasorb CNP P1 apparatus by changing the negative pressure in the wound from 10 to 80 mm Hg. during the day in combination with taking Vesel-Douay-F and Antistax in capsules for another 7 days; Vesel-Douay-F was prescribed 1 capsule (250 LE) 2 times a day between meals; Antistax was prescribed 2 capsules in the morning 30-40 minutes before meals, daily.

As a result of this complex treatment method, the pain syndrome completely stopped in the foot for 5 days, the feeling of heaviness in the legs decreased significantly, the swelling disappeared. The inflammatory type of cytogram decreased by 7 days. The inflammatory and degenerative type of cytogram decreased by 7 days. On the 14th day from the start of complex treatment, a regenerative type of cytogram was noted. A persistent transition of the wound process to the second phase, by the nature and amount of wound exudate removed, was noted already on the 7th day from the start of treatment. There were no additional necrectomies. There was no bleeding from a wound with the use of this method for the complex treatment of patients with purulent-necrotic forms of diabetic foot syndrome. Removal of the Suprasorb CNP P1 device during this course of treatment was not required. The patient was discharged on 21 days.

Information sources

1. Auth. testimonial. USSR No. 243787, class A61M 16/02, 1969.

2. Auth. testimonial. USSR No. 946555, class A61M 16/62, 1982.

3. Physiotherapy exercises in the system of medical rehabilitation. A guide for doctors. Ed. A.F. Kaptelina, I.P. Lebedeva. M., 1955.

4. Auth. testimonial. USSR No. 1674838, class A61M 1/60, 1991.

5. Auth. testimonial. USSR No. 1245314, cl. A61M 16/02, 1986.

6. Patent RU 2363499 dated January 30, 2007, published August 10, 2009, IPC A61M 1/38 (2006.01), A61N 5/067 (2006.01), A61K 31/5575 (2006.01), A61K 33/14 (2006.01), A61P 9 / 10 (2006.01).

7. P.A. Vorobiev. Intermittent therapeutic plasmapheresis. M., 1998, p. 18-24.

8. Application RU 2010103097 dated January 29, 2010, published August 10, 2011, IPC A61K 31/00.

9. Patent for the invention RU No. 2363499 C2 from 08/10/2009.

10. Patent RU 2253427 dated 12/18/2003, published June 10, 2005, IPC A61G 10/02, A61K 31/185, A61P 41/00, A61B 17/00.

11. Patent RU 2405472 dated November 18, 2009, published December 10, 2010, IPC A61B 17/00.

12. The register of medicines of Russia. "Radar-21 issue." Moscow 2012. Vyshkovsky G.L.

Claims (2)

1. A method for the complex treatment of patients with complicated forms of diabetic foot, including small amputation of the foot followed by necrectomy, sealing the wound from the external environment after applying an antimicrobial dressing and drainage, creating negative pressure over the wound in combination with drug treatment, characterized in that the treatment is carried out in two stages, at the first stage, the wound with an antimicrobial dressing and drainage is sealed with a sticky film on top, a negative pressure of at least 80 mm is created and maintained over the wound Hg, in combination with daily intravenous drip of Urokinase 500000 IU per 100 ml of saline, Vesel-Douay-FU 600 LU per 100 ml of saline and VAP 20 - alprostadil 40 μg per 100 ml of saline and the introduction of Antistax in capsules; at the second stage, active round-the-clock vacuum aspiration is continued with a change in negative pressure from 10 to 80 mm Hg. during the day in combination with the introduction of Vesel-Douay-F 1 capsule of 250 LE 2 times a day between meals and Antistax; at the same time, at the first and second stages of Antistax, 2 capsules are administered in the morning 30-40 minutes before meals, daily; the duration of each stage is at least 7 days. 2. The method according to p. 1, characterized in that they create negative pressure over the wound and aspirate with a Suprasorb SNP P1 apparatus (Germany) from Lohmann Rausher international GmbH Co.