RU2737491C1 - Method of complex treatment of patients with purulonecrotic complications of diabetic foot syndrome - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to surgery, can be used to accelerate the healing of postoperative foot wounds, activate local immunity, increasing regenerative activity of involved tissues, preventing microthrombosis of peripheral arterial bed in patients with purulonecrotic complications of diabetic foot syndrome. Treatment is conducted in three phases. At the first stage, the wound of the foot is sealed from the external environment by the application of a sterile sponge and an adhesive film, constant negative pressure of 100 mm Hg is created above the wound with the port and VIT Medical portable vacuum aspiration device for 10 days. Simultaneously, drug-induced treatment is carried out, including intravenous drop introduction of Vessel DUE F 600 LE per 200 ml of 0.9 % sodium chloride solution per day, introduction of Vasaprostan 60 mcg once a day intravenously drop-by-drop on 200 ml of 0.9 % sodium chloride solution and oral administration of Trombovazim 800 units twice a day. At the second stage, oscillations of negative pressure over the wound are created by automatic change of the pressure level from 100 to 20 mm Hg and back, with change of 20 mm Hg per hour during a day for six to eight days. At the same time, Vessel DUE F 250 LE 1 capsule is taken orally twice a day, Trombovazim 800 units twice a day. At the third stage, the local foot wound treatment is performed with the "G-Derm" histoequivalent-bioplastic material with a dressing interval of two to three days, which is moistened twice a day with 0.9 % sodium chloride solution, in a combination with oral administration of Vessel DUE F 250 LE 1 capsule twice a day with a total course of 8 weeks, oral administration of Trombovazim 800 units twice a day with a total course of twenty days. After completing receiving Trombovazim oral administration of Xarelto 2.5 mg twice a day, course 12-24 weeks.

EFFECT: method enables higher effectiveness and reduced length of treatment of patients with purulonecrotic complications of diabetic foot syndrome ensured by a combination of methods of the declared method.

1 cl, 1 ex

Description

The invention relates to medicine, namely to surgery, can be used to accelerate the healing of postoperative wounds of the foot, activate local immunity, increase the regenerative activity of affected tissues, prevent microthrombosis of the peripheral arterial bed in patients with purulent-necrotic complications of diabetic foot syndrome.

A known method of surgical treatment of deep and extensive purulent-necrotic complications of diabetic foot syndrome consists in amputation, which is carried out at different levels (Great Medical Encyclopedia, M., ed. "Soviet Encyclopedia", 1980, vol. 24, pp. 298-299) ...

The disadvantage of this method is that it is currently moving away from this direction towards organ-preserving operations and reducing the total number of disabled people.

There is a known method of using urokinase in patients suffering from diabetic angiopathy, when, in addition to the main treatment, patients received the drug slowly intravenously drip at a dosage of 300,000 IU for 1.5-2 hours, having previously diluted it in 200 ml of 0.9% sodium chloride solution ( Koreyba K.A. Thrombolytics in the complex treatment of diabetic foot syndrome // Actual problems of diagnosis, treatment and prevention of diabetic foot syndrome: Materials of the IV All-Russian scientific and practical conference with international. - Kazan, 2012. - P. 79-82).

The disadvantage of this method is that the drug quickly accumulates in the liver and kidneys and, in order to create an adequate concentration in the affected area, it is necessary to administer large doses of the drug, leading to hemorrhagic complications.

There is a known method of treating diabetic foot by regional fibrinolytic therapy, which consists in the fact that after applying a rubber bandage to the lower third of the leg, urokinase medak is injected into the heel bone of the affected limb in a dose of 100,000 IU 1 time per day for 5 days. The disadvantages of this method include its high cost, as well as the risk of developing hemorrhagic and bone-destructive septic complications (RF patent No. 2539385, A61K 38/49, 02.12.2014).

A known method for the treatment of chronic wounds, in which a subclavian catheter is installed in the wound, then covered with a bioplastic membrane "Collost" and an aseptic bandage is applied. Further treatment includes daily administration of platelet-rich plasma through a catheter, which is obtained by drawing blood from a patient's peripheral vein (RF patent No. 2627814, A61B 17/00, 11.08.2017).

This method is difficult to implement, impossible on an outpatient basis, and requires blood centrifugation.

A known method of treating patients with complicated forms of diabetic foot syndrome, in which blood is taken, centrifuged, plasma is removed, erythrocyte fraction is isolated, an angiotropic drug is introduced into it, laser irradiation with a power of 12 mW for 20 minutes is added, then 100 ml is added 0.9% sodium chloride solution per 200 ml of erythrocyte fraction and reinfusion is performed; while with an angiotropic substance, 2 ml of ATP is injected into the erythrocyte fraction. Reinfusion of the erythrocyte fraction is performed after 1 day, alternating with intravenous administration of Wessel DUE F 600 LE intravenously and 5 ml of Actovegin per 100 ml of 0.9% sodium chloride solution (RF patent No. 2504385, A61K 35/14, 01/20/2014).

However, this method does not provide effective treatment due to the lack of adequate drainage of wounds in complicated forms of diabetic foot; difficult for routine use, since it requires the use of laser equipment and blood centrifugation.

A known method of treatment of purulent-necrotic lesions of the lower extremities in patients with diabetes mellitus, in which first a surgical operation is performed using a high-energy laser, then postoperative detoxification and antibacterial therapy and local wound therapy. The first two days after the operation, intravenous laser blood irradiation is additionally carried out, then, within 5-7 days, antioxidant therapy is administered intramuscularly with 100-200 mg of mexidol per day, and local wound therapy is carried out using dialdehyde cellulose napkins containing immobilized trypsin and insulin (patent RF No. 2157207, A61K 31/44, 10.10.2000).

The disadvantages include the need to use a high-energy laser, the need to frequently change special dressings, which is not economically viable.

A known method of treating diabetic foot syndrome, in which intravenous administration of dalargin in 10.0 ml of physical. solution in a daily dose of 4 mg (in 2 divided doses) for a course of 10 days and a repeated course of 10 days with an interval of 2 weeks (RF Patent No. 2144831, A61K 38/02, 01/27/2000).

The disadvantages of this method is the lack of adequate anticoagulant therapy and surgical treatment of the wound itself.

A known method of treating diabetic foot syndrome of neuro-ischemic form, in which roncoleukin IL-2 is applied locally (patent of the Republic of Kazakhstan No. 23378).

This method is not applicable for purulent-necrotic complications of diabetic foot syndrome.

There is a known method of treating patients with purulent-necrotic lesions of the feet in diabetes mellitus in which the foot is continuously washed for several days by placing it in an airtight container with an antiseptic, followed by evacuation at a rarefaction of 0.2-0.4 kgf / cm ² , and the alternation procedures are carried out at intervals of 3-4 hours (RF patent No. 2253427, A61G 10/02, 10.06.2005).

The disadvantage of this method is that it solves only local problems in the wound and requires a special sealed container.

There is a method of complex surgical treatment of diabetic foot syndrome complicated by a purulent-necrotic process, which includes opening an abscess or phlegmon of soft tissues of the foot, revision of pockets and purulent leaks, excision of non-viable tissues, wound debridement, then the wound is isolated from the external environment using a closed elastic container and they also jet proteolytic enzymes - trypsin and chymotrypsin, 50 mg of each enzyme, dissolved in 200 ml of 0.9% sodium chloride solution for 1.5 hours, after which a negative pressure of 70-80 mm Hg is created over the wound. with active vacuum aspiration; after 1 hour, the 1st cycle is repeated, while the wound is treated with 0.06% sodium hypochlorite solution in combination with low-frequency ultrasound and carried out by active aspiration under the same conditions (RF patent No. 2405472, А61В 17/00, 12.10.2010) ...

This method is complicated in execution, requires ultrasonic equipment and a special container.

The closest in essence to the claimed invention is a method for the complex treatment of patients with purulent-necrotic forms of diabetic foot syndrome, which consists in the fact that a small foot amputation is performed, followed by necrectomy. After applying an antimicrobial dressing and drainage, the wound is sealed from the external environment by creating negative pressure over the wound in combination with drug treatment. In this case, the treatment is carried out in two stages. At the first stage, the wound with an antimicrobial bandage and drainage is sealed from above with an adhesive film, a negative pressure of at least 80 mm Hg is created and maintained over the wound. Additionally, Urokinase 500,000 IU per 100 ml of saline, Vesel-Duet-F, 600 LE per 100 ml of saline, and VAP 20 - alprostadil, 40 μg per 100 ml of saline, are injected daily by intravenous drip. In addition, Antistax is administered to the patient 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. Additionally, Vesel-Duet-F is administered in 1 capsule of 250 LE 2 times a day between meals and Antistax. At the same time, at the first and second stages, Antistax is administered 2 capsules in the morning 30-40 minutes before meals, every day (RF patent No. 2553203, A61B 17/03, 06/10/2015).

The disadvantages of this method include the high cost of treatment, a high risk of developing significant hemorrhagic complications, as well as the absence of a prolonged anticoagulant effect.

The technical result achieved by the invention consists in increasing the efficiency and reducing the time of treatment of patients with purulent-necrotic complications of diabetic foot syndrome.

The stated technical result is achieved due to the step-by-step complex treatment of purulent-necrotic complications of the diabetic foot syndrome, which includes carrying out a small amputation within the foot with subsequent postoperative complex treatment, while the treatment is carried out in three stages. At the first stage, the foot wound is sealed from the external environment by applying a sterile sponge and an adhesive film, and a constant negative pressure of 100 mm is created over the wound. Hg using a port and a portable VIT Medical vacuum aspiration apparatus for 10 days, in combination with drug treatment, including intravenous drip of Wessel DUE F 600 LE per 200 ml of 0.9% sodium chloride solution per day, administration of Vazaprostan 60 μg 1 time per daily intravenous drip in 200 ml of 0.9% sodium chloride solution and oral administration of Trombovazim 800 units twice a day. At the second stage, oscillations of negative pressure over the wound are created by automatically changing the pressure level from 100 to 20 mm. Hg and vice versa, with a change of 20 mm Hg for every hour during a day lasting six to eight days, in combination with oral administration of Wessel DUE F 250 LE, 1 capsule twice a day, oral administration of Trombovazim 800 IU twice a day. At the third stage, local treatment of foot wounds is carried out using a histoequivalent bioplastic material "G-Derm" with a dressing interval of two to three days, which is moistened twice a day using 0.9% sodium chloride solution, in combination with oral administration Wessel DUE F 250 LE 1 capsule twice a day for a general course of 8 weeks, oral administration of Trombovazim 800 IU twice a day for a general course of twenty days; after the end of which, oral administration of Rivaroxaban (Ksarelto) is prescribed, 2.5 mg twice a day, for a course of 12-24 weeks.

In practice, the method is carried out as follows.

After a small amputation within the foot, the first step is to apply a finely porous, hypoallergenic Vivano Med Foam Hartmann sponge to the wound, which easily adapts to the shape of the wound (due to the open pore structure, pressure is evenly distributed throughout the sponge). The sponge is cut individually according to the shape of the wound. A sterile adhesive Hydrofilm Hartmann film is glued on top of the sponge so that the film overlaps the edges of the unchanged skin, with the sticky side to the wound. In the projection of the wound defect, a 2 × 6 cm window is cut out on the film, to which the VivanoTec Port Hartmann port is glued. Next, connect the drainage tube of this port to the connector of the portable vacuum aspiration apparatus VIT Medical (Russia). With the help of this vacuum aspiration apparatus, the necessary negative pressure is created in the foot wound at the level of 100 mm Hg, which is maintained around the clock, for up to 10 days.

Unlike other methods, local treatment of a foot wound by creating a negative pressure over it with a portable VIT Medical device contributes to the complete and timely removal of wound exudate, excludes the progression of the purulent-necrotic process, its further spread, and also allows determining the nature and amount of the removed wound exudate the effectiveness of treatment and the phase of the wound process, and also allows the patient to move around the room.

In addition, at the first stage, drug treatment is carried out with drugs: Trombovazim, Vazaprostan, Wessel DUE F.

Thrombovazim is prescribed orally at 800 IU 2 times a day. Thrombovazim has a positive effect on the oxidative function of blood neutrophils and tissue macrophages, improves peripheral blood flow, and also reduces dynamic vascular resistance and has a cardioprotective effect. Due to the lysis of blood clots, macro- and microcirculation is restored, which suffers in patients with diabetes mellitus, especially in the presence of purulent-necrotic complications of diabetic foot syndrome. The anti-flammable effect interrupts vascular wall remodeling and promotes endothelial restoration.

At the same time, at the first stage, Wessel DUE F (Sulodexide) is injected at 600 LE intravenously in 200 ml of 0.9% sodium chloride solution, daily, for 10 days. The drug has an angioprotective and antithrombotic effect, reduces the thickness of the basement membrane and the production of extracellular matrix by reducing the proliferation of mesangial cells, and also restores the density of the negative electric charge of the pores of the basement membrane of the vessels.

Also, at the first stage, the drug Vazaprostan is administered at a dosage of 60 μg 1 time per day intravenously drip in 200 ml of 0.9% sodium chloride solution, for a course of 10 days. This improves peripheral circulation and microcirculation. The drug has a vasodilating effect, increases the elasticity of red blood cells, and also reduces platelet aggregation.

At the second stage, they continue to create negative pressure over the wound using the VIT Medical apparatus, while changing the pressure level from 100 to 20 mm Hg. and back during the day. The decrease occurs automatically using the built-in software, by 20 mm Hg. for every hour; similarly, the level of negative pressure rises. The application of the second stage of vacuum aspiration lasts 6-8 days until the transition of the wound process to the stage of epithelialization.

Also, at the second stage of treatment, Thrombovazim is continued to be taken orally, 800 IU 2 times a day.

At the second stage, Wessel DUE F (Sulodexide) is already prescribed orally, 1 capsule (250 LE) 2 times a day.

Next, the third stage is carried out, which includes the treatment of the foot wound with the help of histoequivalent bioplastic material "G-Derm". The two-phase structure of this biomaterial allows the formation of a full-fledged biological scab in the wound, which is from the outside as a plate, and the side facing the wound takes the form of a viscous hydrocolloid. The two-phase structure of the material, due to the difference in tensile forces, gives it a unique macro-relief pattern.

"Ji-Derm" is used in the following way: the material is previously immersed in 0.9% sodium chloride solution for 5 minutes. A flap is formed according to the size and contours of the skin defect. The "G-Derm" flap is placed with a smooth surface on the wound and straightened until tight fixation along the relief of the defect. At the same time, air bubbles and exudate drops are removed. After the closure of the wound defect, the material "Ji-Derm" is covered with a bandage soaked in an aqueous solution of chlorhexidine 0.05%). The dressings are moistened twice a day with 0.9% sodium chloride solution. Dressings are carried out with an interval of 2-3 days. Biodegradation of the "G-Derm" material occurs within 10 days. If necessary, make repeated applications of the material "Ji-Derm" - until complete epithelialization of the wound.

At the third stage, oral administration of Trombovazim is continued at 800 IU twice a day, for a general course of 20 days.

At the third stage, oral administration of Wessel DUE F (Sulodexide) is continued, 1 capsule (250 LE) twice a day, for a general course of 8 weeks.

In addition, at the third stage, after the end of taking Trombovazim, oral administration of the drug Rivaroxaban (Ksarelto) is prescribed at a dosage of 2.5 mg twice a day, the general course is 12-24 weeks. It is used for further prevention of the formation of blood clots in the microcirculatory bed. Rivaroxaban (Xarelto) is not used alone as a treatment for complications of diabetic foot syndrome. When using the drug in such a dosage, there is no risk of hemorrhagic complications.

This method eliminates daily dressings, reduces labor costs for dressings, allows you to save a limb and, thereby, avoid disability, can be used in surgical departments of round-the-clock hospitals, departments of purulent surgery, departments of the surgical profile of the primary medical and social link.

Clinical example

Patient A., 63 years old, was admitted with complaints of pain, edema, hyperemia of the right foot, the presence of an extensive purulent-necrotic wound on the plantar surface of the foot. The patient has been suffering from non-insulin dependent diabetes mellitus of the second type for 6 years. Took tableted antihyperglycemic drugs Maninil 3.5 mg twice a day. The duration from the onset of manifestation of purulent-necrotic complications of the diabetic foot to admission to the hospital was 18 days. On the second day of inpatient treatment, 3-4-5 toes of the right foot were amputated with resection of the metatarsal heads. Further, the treatment was carried out in three stages.

At the first stage, lasting 17 days, Trombovazim was prescribed 800 mg twice a day orally, Wessel DUE F (Sulodexide) 600 LE intravenously drip in 200 ml of 0.9% sodium chloride solution daily, Vasaprostan 60 mcg once a day intravenously drip in 200 ml of 0.9% sodium chloride solution. A portable VIT Medical vacuum aspiration apparatus was used for local treatment of foot wounds. For this, a hypoallergenic Vivano Med Foam Hartmann sponge was applied to the foot wound, and a sterile Hydrofilm Hartmann film was glued over the sponge. A VivanoTec Port Hartmann port was glued on top of the film, which was connected to a portable vacuum aspiration apparatus through a drainage film. A negative pressure was created in the foot wound at the level of 100 mm Hg, which was maintained around the clock. At the beginning of treatment, there was abundant fibrinous-purulent discharge. As a result of the treatment, a sharp decrease in edema and pain in the lower extremity was noted by the 6th day.

During the transition to the second stage of complex treatment, the dynamics of changes in the wound was assessed by the nature and amount of the removed wound exudate and subjective symptoms. The cessation of the release of fibrinous-purulent exudate by the 7th day from the start of treatment was noted. Signs of the transition of the wound to the regeneration phase. Active vacuum aspiration was continued with the VIT Medical apparatus by changing the negative pressure in the wound from 100 to 20 mm Hg. and back during the day, for a period of 8 days. The pressure reduction was performed automatically using the built-in software, by 20 mm Hg. for each hour up to the level of 20 mm Hg. The rise in the level of negative pressure to the level of 100 mm Hg was carried out in a similar way. In addition to this, Wessel DUE F (Sulodexide) was administered orally 1 capsule (250 LE) twice a day, and Trombovazim was continued according to the above scheme.

During the transition to the third stage, the nature of the wound discharge was assessed. By the 14th day, exudation from the wound stopped, and the transition of the wound to the phase of epithelization was noted. After removing the portable VIT Medical apparatus, the foot wound was treated using the histoequivalent bioplastic material "G-Derm". The dressings were moistened twice a day with 0.9% sodium chloride solution. Dressings were changed once every 3 days. At the third stage, they continued taking the drug Trombovazim according to the above scheme, for a general course of 20 days. Oral administration of Wessel DUE F was also continued according to the above scheme, for a total course of 8 weeks. After the end of Trombovazim's administration, Rivaroxaban (Ksarelto) 2.5 mg twice a day was prescribed for 12 weeks.

In addition to the clinical evaluation of the effectiveness, a cytological study was performed from the foot wound on days 1, 7, and 14 after the operation. On the 1st day, an inflammatory-degenerative type of cytogram was noted. On the 7th day - an inflammatory type of cytogram. On the 14th day from the start of treatment, a regenerative type of cytogram was recorded.

The complete biodegradation of the “G-Derm” material occurred on the 9th day after application. Epithelialization of the wound occurred on the 20th day from the start of treatment.

As a result of the treatment, the limb was preserved in this patient. The patient was discharged in a satisfactory condition on the 24th day from the start of treatment.

The patient was examined after 3, 4, 6 and 12 months, there is no evidence of relapse, he started his previous work.

Claims (1)

A method of complex treatment of purulent-necrotic complications of diabetic foot syndrome, including carrying out a small amputation within the foot with subsequent postoperative complex treatment, characterized in that the treatment is carried out in three stages, while at the first stage, the foot wound is sealed from the external environment by applying a sterile sponges and adhesive film, create a constant negative pressure of 100 mm Hg over the wound. using a port and a portable VIT Medical vacuum aspiration apparatus for 10 days, in combination with drug treatment, including intravenous drip of Wessel DUE F 600 LE per 200 ml of 0.9% sodium chloride solution per day, administration of Vazaprostan 60 μg 1 time per daily intravenous drip in 200 ml of 0.9% sodium chloride solution and oral administration of Trombovazim 800 units twice a day; at the second stage, fluctuations in negative pressure over the wound are created by automatically changing the pressure level from 100 to 20 mm Hg. and vice versa, with a change of 20 mm Hg for every hour during a day for six to eight days, in combination with oral administration of Wessel DUE F 250 LE 1 capsule twice a day, oral administration of Trombovazim 800 IU twice a day ; at the third stage, local treatment of a foot wound is carried out using a histoequivalent bioplastic material "G-Derm" with a dressing interval of two to three days, which is moistened twice a day using 0.9% sodium chloride solution, in combination with oral administration Wessel DUE F 250 LE 1 capsule twice a day for a general course of 8 weeks, oral administration of Trombovazim 800 IU twice a day for a general course of twenty days; after the end of which, oral administration of Ksarelto is prescribed, 2.5 mg twice a day, for a course of 12-24 weeks.