RU2319492C2 - Method for treating obliterating diseases of inferior limbs arteries - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: out of 400-600 ml patient's blood it is necessary to obtain erythrocytic mass and plasma enriched with thrombocytes that contains thrombocytes at the quantity being 1.5-2.5 times higher against their content in autoblood. Erythrocytic mass should be returned to the patients by infusion. Plasma enriched with thrombocytes should be introduced into soft tissues of a patient's shin and foot starting from the upper third of shin, per one seance, fan-shapely and diffusely distributing it in tissues. The above-mentioned procedures provide the release of thrombocytic growth factors at the quantity being sufficient for angiogenesis that provides efficient therapy in combination with minimal side effects due to shortening the volume of the preparation under injection and decreased number of the procedures conducted.

EFFECT: higher efficiency of therapy.

2 ex, 1 tbl

Description

The invention relates to medicine and can be used in the treatment of obliterating diseases in which arteries of the lower extremities are affected.

Known methods of treating various diseases, involving the use of blood of the patient, from which partially removed or in excess of certain components. In this case, both the part of the blood from which some components are removed and the other part of the blood in which the components removed from the first part are located is used for treatment (see, for example, patents for inventions RU No. 2261706, 2235545, IPC ⁶ A61K 35/14 , RU No. 94012668 IPC ⁶ A61K 35/18).

There is a method of treating obliterating diseases of the arteries of the lower extremities by interstitial administration of biological fluids (see, for example, patent application RU No. 94017263, IPC ⁶ A61K 31/725, as well as the book "Questions of hematology, blood transfusion and blood substitutes", Kiev, 1958 p. 45-47). However, these methods do not provide a sufficient improvement of collateral circulation and revascularization.

The effect of platelet growth factors on the formation of connective tissue during cell proliferation is known (V. A. Glushkov. “Platelet growth factors” / Hematology and Transfusiology, 1987, pp. 38-42). However, the formation of these factors for the treatment of obliterating diseases of the lower extremities is unknown.

The closest in technical essence and the achieved result to the claimed invention is a method of treating obliterating diseases of arteries of the lower extremities by increasing the number of collaterals in the soft tissues of the lower extremities using autologous blood, in which autologous blood is injected into the soft tissues of the lower extremities twice with an interval of 10-14 days in an amount 60-80 ml to the foot and 150-180 ml to the lower leg.

In this case, collaterals are formed, which are included in the microcirculation system.

However, this treatment method is designed for 30 days, that is, it requires a long stay in the hospital, it is quite traumatic, due to the fact that this painful procedure is carried out 4 times in accordance with the description of the known method: on the 1st day and on the 14th day the legs are treated , on the 7th and 21st day, the feet are treated. In addition, as practice shows, the known method does not sufficiently provide improved collateral circulation and adequate development of revascularization in the tissues of the lower extremities, which leads to various complications or insufficiently good treatment results. For example, an increase in the distance without painful walking does not occur in a short time or does not occur significantly.

Distance without pain walking (DBH) is currently the main indicator of improvement in limb function and is used in clinical practice in patients after reconstructive and indirect revascularizing operations on the lower extremities.

The claimed invention solves the problem of creating a less traumatic, reducing the time spent in the hospital, as well as a more effective method of treating obliterating diseases of the arteries of the lower extremities.

The technical result of the proposed method is to reduce the length of hospital stay, trauma, and also to increase the effectiveness of treatment by improving the regeneration of micro arteries that improve collateral circulation, revascularization.

This result is achieved by the fact that in the treatment of obliterating diseases of the arteries of the lower extremities by increasing the number of collaterals in the soft tissues of the lower extremities using autologous blood, autologous blood is taken in an amount of 400-600 ml, it is divided by thrombocytosis into equal volumes of erythromass and autoplasma containing platelets, in an amount 1.5-2.5 times higher than the platelet content in autologous blood, after which the erythromass is infusion returned to the patient, and the increase in collaterals in the soft tissues of the lower extremities fected administration of platelet-rich autoplasma, wherein the platelet-rich plasma was administered in a single session in soft tissue leg and foot, ranging from the upper third of the leg, diffusely spreading fan-like and the drug in the tissues.

This set of features is unknown from information sources.

The method is as follows. 400-600 ml of autologous blood is taken from the patient. This volume is divided into equal volumes of autoplasma enriched with platelets (200-300 ml), with a platelet content of 1.5-2.5 higher than the platelet content in autologous blood, and erythromass (200-300 ml). To do this, use intermittent thrombocytopheresis, carried out, for example, using a refrigerated centrifuge, after which the erythromass is immediately returned to the patient by infusion. The lower limit of the amount of blood taken for the procedure is due to the fact that a smaller amount will not allow to obtain autoplasma with the necessary platelet count for the formation of angiogenic factors in order to adequately develop revascularization. The upper limit is due to the fact that a larger amount of blood taken can adversely affect the physical condition of the patient. The preparation and storage of autoplasma enriched with red blood cells was carried out in accordance with the “Instructions for the preparation of platelets from one donor by intermittent thrombocytopheresis using polymer containers,” approved by the Ministry of Health of the Russian Federation on 05/29/95. The procedure is carried out in the conditions of separation of gravitational blood surgery in accordance with the claimed method. At the same time, the obtained erythromass is infusion returned to the patient, and autoplasma enriched with platelets is injected into the patient’s soft tissues of the lower leg and foot, starting from the upper third of the lower leg, fan-shaped and diffusely distributing the drug in the tissues in proportion to the muscle mass at the injection site in one session. On average, 2 sessions of thrombocytopheresis are taken to take 400-600 ml of whole blood and 200-300 ml of autoplasma enriched with platelets are obtained.

For the operation, conduction anesthesia of the affected lower limb is performed, the leg is treated, the limb is covered with sterile surgical underwear.

On average, in one session, up to 20 injections are performed on the anterolateral, posterolateral surface of the lower leg, as well as in the rear of the foot and in the toe spaces of the foot. The introduction of the drug is not carried out in the region of the neurovascular bundle of the lower leg and in the place of exit of nerve trunks and the passage of arteries under the skin. 150-300 ml were injected into the shin area at the same time, that is, in one session, 50-100 ml of the drug was injected into the foot area. After the procedure is completed, an aseptic alcohol dressing is applied to the foot and lower leg. In the postoperative period, pain medications are prescribed. At the same time, walking is allowed only on the second day after the operation. This is done in order to fix the drug in the tissues of the lower leg and foot, and also to prevent the blood product from flowing down under the influence of gravity during walking in the early postoperative period. After surgery, standard conservative therapy is prescribed. Dressings are carried out daily with treatment of injection sites with iodine solution for 5-9 days.

A group of patients who received treatment in accordance with the claimed method was observed for 2-9 months. It was found that in all cases there was an increase in the distance without pain walking, an average of 4-5 times higher compared with patients who did not receive such treatment. Moreover, an increase in the distance without painful walking was observed earlier than in patients who received treatment in accordance with the prototype method.

Example 1. Patient An.-Mr. A.Ya., born in 1943

The patient was admitted to the Department of Vascular Surgery on January 21, 2005 (medical history No. 108/30), was in hospital treatment from January 21, 2005 to January 30, 2005.

Diagnosis: Condition after resection of a ruptured aneurysm of the infrarenal aorta, bifurcation aortic-femoral prosthetics from 06/27/2004 Ureterocystoneostomy on the right, cystostomy from 05/31/2004. Condition after allovenous femoral-posterior tibial prosthetics to the right of 9/11/04 Postthrombotic occlusion. Chronic arterial insufficiency of the right lower limb, grade 3 Takayasu syndrome. Condition after carotid endarterectomy on the right with lateral allovenous grafting of September 7, 2004. Chronic cerebrovascular insufficiency of 1-2 degrees. Concomitant diseases: coronary heart disease, angina pectoris, functional class II, post-infarction cardiosclerosis, cardiac arrhythmias, atrial fibrillation, permanent form, tachysystole, chronic bilateral pyelonephritis, hydronephrotic transformation of both kidneys, chronic renal failure of the II degree.

Upon admission, he complained of pain in the right leg, more in the right foot of a “breaking” character at rest, worse at night, chilliness of the right foot, alternating limp in the right leg after 100 meters or less.

Previously operated on for a ruptured aneurysm of the infrarenal aorta. Occlusion of the femoral-popliteal segment of arteries on the right arose some time after prosthetics of the abdominal aorta (embolism) with the development of a clinic of chronic arterial insufficiency IIB-III degree. No trophic disorders on the leg. In November 2004, he was operated on for femoral-popliteal occlusion on the right leg. Before surgery, the ankle-brachial index on the right is 0.36. The operation showed a marked diffuse lesion of the tibial arteries in the area of trifurcation of the popliteal artery. Retrograde blood flow from the posterior tibial artery was obtained only after waking up. On the 5-6th day after prosthetics, due to a poor distal bed, thrombosis of an allovenous prosthesis occurred without an increase in the degree of ischemia of the right lower limb.

In order to improve the distal bed and thereby collateral circulation in the leg after 2 months, the patient was admitted to the Department of Vascular Surgery for indirect revascularization in accordance with the claimed method using autoplasma enriched with platelets.

Before surgery: OAK dated January 24, 2005, hemoglobin 117 g / l, CP 0.94, platelets 150 × 10 ⁹ . Blood group A (II) Rh +.

On January 25, 2005, 2 hours before surgery, gravitational surgery took 600 ml of autologous blood, obtained by centrifugation of plasma enriched with platelets (POT) in a volume of 300 ml, autoerythrocytes in a volume of 300 ml were returned infusion to the patient. Analysis of POT for cell elements from January 25, 2005: in 1 ml of POT of leukocytes 1.3 × 10 ⁹ , red blood cells 0.03 × 10 ¹² , platelets 225 × 10 ⁹ .

January 25, 2005, the operation was performed in accordance with the claimed method by introducing 300 ml of POT into the tissues of the lower leg (200 ml) and foot (100 ml). The operation was performed under conduction anesthesia.

In the postoperative period (on days 5–7), a decrease in pain in the foot area was noted: “breaking” pains in the area of the plantar of the right foot disappeared. The patient subjectively noted an improvement in the form of warming of the right foot and lower leg.

A day after the operation. General blood test dated January 26, 2005. Red blood cells 3.8 × 10 ¹² , hemoglobin 119 g / l, CP 0.93, white blood cells 9 × 10 ¹² , e 1%, s / I 6%, s / I 46%, lymphocytes 42%, monocytes 5%, ESR 17 mm per hour. After surgery, there were no significant changes in hemoglobin and red blood cells.

In the postoperative period, infusion therapy was carried out: glucose 5% - 250 ml, novocaine 0.25% - 250 ml, pentoxifylline 2% - 5.0 ml, nicotinic acid 1% - 4.0 ml iv once a day, disaggregants (aspirin 0.125 1 time per day, pentoxiffilin 100 mg, 1 tab. 3 times per day).

After 8 months, examined again. Pain in the leg alone does not bother. The distance without painful walking increased to 400-500 m (4-5 times). LBI did not increase -0.33 (was 0.36). Local status: the right leg is slightly cooler, the saphenous veins of the right foot are contoured, well filled. Satisfied with the result of the operation.

Example 2. Patient Pat-A.N., born in 1964

He was hospitalized at OSX-1 of the State Health Institution "RKD" from June 6 to June 21, 2005. Case history No. 987/267.

It was previously operated on in OCX-1 in February 2005 for acute thrombosis of the femoral-popliteal segment of the arteries on the left. After the operation, pulsation was restored only on the popliteal artery (incomplete revascularization). After 1.5 months after the operation, a walking limit of up to 50 m arose sharply, the leg began to freeze, numb at rest. On examination, pulsation on the popliteal artery of the left leg is absent, on the thigh - distinct. Diagnosed with thrombosis of the prosthesis. Upon receipt, the saphenous veins of the left foot are poorly filled, the leg itself is pale, cool to the touch, at the same time pain at rest does not bother, the distance traveled is up to 50 m.

Diagnosed with Obliterating atherosclerosis of the arteries of the n / limbs. Condition after femoral arthroplasty on the left. Lumbar sympathectomy to the left of February 28, 2005. Transplant thrombosis. Ischemia of tension of the left n / a.

When OAK was received from 06/07/2005, erythrocytes 5.27 × 10 ¹² , hemoglobin 170 g / l, CPU 0.96, platelets 190 × 10 ⁹ , white blood cells 9.9 × 10 ⁹ , 1%, e 2%, s / I 1%, s / I 58%, lymphocytes 29%, monocytes 9%, ESR - 1 mm per hour.

On June 14, 2005, in blood OGHK conditions, autologous blood was taken in a volume of 400 ml. After this, thrombocytopheresis is performed to separate autologous blood into autoplasma enriched with platelets, the amount of which is 2.5 times the number of platelets in autologous blood, and erythromass. Erythromass was immediately intravenously returned to the patient. At the same time, autoplasma was obtained in a volume of 150 ml. Analysis autoplasma on cellular elements: leucocytes 0.07 × ¹⁰ September, hemoglobin 2 × ¹⁰ December, platelet September ¹⁰ × 475 (which is 2.5 times higher than in autologous blood).

06/15/2005 Operation: extravasation of autoplasma enriched with platelets, foot tissues (30 ml) and left lower leg (100 ml) under conduction anesthesia. The postoperative period is uncomplicated. Discharged for outpatient aftercare. When re-examined 2 months after the operation, an increase in the traveled distance to 500 m (10 times) was noted. The operated leg is warm, the saphenous veins of the left foot are full-blooded. The results of the operation are satisfied.

To confirm the results of treatment, two representative groups of patients were created, each of 14 people. The first group was treated in accordance with the prototype method, and the other in accordance with the claimed method. The results are presented in table.

No. p / p Indicators Prototype method The inventive method one Number of patients fourteen fourteen 2 The number of patients in whom increase improvement 3 fourteen walkable distance has come 2 months after surgery 3 Hospital stay 30 days 9-15 days

Such results are due to the fact that the adhesion and destruction of platelets after they enter the tissue leads to the release of significant quantities of polypeptide growth factors, many of which have powerful angiogenic effects. Thus, the use of autoplasm than autologous blood in the treatment of patients with thrombotic obliterating diseases of the arteries of the lower extremities allows an increase in the number of angiogenic facts in soft tissues by the same amount of the administered drug as in the prototype. But to achieve the above technical result, it is necessary to introduce a certain amount of autoplasma enriched in platelets (containing 1.5-2.5 times more platelets than autoblood). Therefore, the effectiveness of treatment is higher than in the prototype, and positive treatment results are observed earlier.

Claims (1)

A method for the treatment of obliterating diseases of the arteries of the lower extremities by increasing the number of collaterals in the soft tissues of the lower extremities using autologous blood, characterized in that autologous blood is taken from the patient in an amount of 400-600 ml, it is divided by thrombocytosis into equal volumes of erythromass and autoplasma containing platelets in an amount 1.5-2.5 times higher than the platelet content in autologous blood, after which the erythromass is infusion returned to the patient, and the increase in collaterals in the soft tissues of the lower extremities wasps They inject autoplasma enriched with platelets into the soft tissues of the lower leg and foot, starting from the upper third of the lower leg, in one session, fan-shaped and diffusely distributing the drug in the tissues.