RU2634419C1 - Method for treatment of lower limbs chronic arterial insufficiency of i-iia degree - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: for treatment of lower limbs chronic ischemia, lumbar chemical sympathectomy is carried out by introducing an ethanol solution. The basal level of the transcutaneous oxygen tension and the ankle-brachial index (ABI) are determined. With basal ABI less than 0.90, the need for limb revascularization is determined. With basal ABI of 0.90 or more, a stress test is performed, with a decrease in the load ABI of less than 0.90, or 15% or more compared to basal, sympathectomy is performed. The volume of ethyl alcohol 70% for sympathectomy is determined by the height and body mass index of the patient. After 1 day, the transcutaneous oxygen tension is determined, with an increase of 15% or more from the basal level, therapy including calf muscles electrostimulation within 60 minutes by pulses of less than 0.05 W, stimulation rate of 60-75 muscle contractions per minute is recommended. If no increase by 15% or more from the basal level in the transcutaneous oxygen tension is observed after chemical sympathectomy, indications for revascularization are determined, the transcutaneous oxygen tension is examined monthly.

EFFECT: method allows to increase the treatment effectiveness for patients with lower limbs chronic ischemia, due to the timely detection of patients with clinically not-manifested lower limbs chronic ischemia.

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Description

The invention relates to medicine, namely to surgery, and can be used to treat chronic lower limb ischemia of the I-IIa degree.

The relevance of the method is due to the prevalence of chronic ischemia of the lower extremities. Diseases of the peripheral arteries make up more than 20% of cardiovascular diseases; up to 3% of the entire population suffers from them [11, 17]. Among people aged 40-60 years, the incidence of chronic obliterating diseases of the arteries is 8-10% [8]. Chronic obliterating diseases of the arteries of the lower extremities in 20-70% of cases are complicated by decompensation of blood circulation with the development of critical ischemia [2, 3, 18].

The individual risk of arterial disease of the lower extremities is due to the following factors: age younger than 50 years in the presence of diabetes mellitus and one of the risk factors for atherosclerosis (smoking, dyslipidemia, hypertension, hyperhomocysteinemia); age 50-69 years and the presence of diabetes mellitus or smoking; age 70 years and older; ischemic nature of pain in the legs; pathological changes in the pulse of the vessels of the lower extremities; the presence of the already known pathology of atherosclerotic etiology in the field of coronary, carotid or renal arteries [9, 10].

In the Russian Federation, the classification of chronic arterial insufficiency of the lower extremities is used A.V. Pokrovsky [4, 5, 6], in the classification of five degrees: I degree - the occurrence of intermittent claudication when walking over 1000 m; IIa degree - intermittent claudication occurs when walking at a distance of more than 200 meters; IIb degree - intermittent claudication occurs when walking at a distance of less than 200 meters; III degree - pain in a sick limb at rest; IV degree - stage of trophic disorders.

Indications and methods for treating chronic lower limb ischemia are defined and presented by national and international recommendations [9, 10]. Angiotropic therapy and the possibilities of vascular surgery make it possible to achieve positive treatment results for a large part of patients, however, patient treatment limitations are associated with “distal” forms of arterial damage, for which pharmacotherapy is effective in the early stages of the disease, and the results of surgical treatment for the development of critical ischemia are unsatisfactory [1] .

An affordable method of objective research into reducing arterial inflow and the risk of critical ischemia is the ankle-brachial index (LPI). An ABI is determined by the ratio of systolic blood pressure (BP) on the medial ankle to systolic blood pressure on the upper limbs. Normally, in a healthy person, the arterial pressure in the brachial artery corresponds to systolic arterial pressure in the tibial artery, LPI is 1.00. In case of impaired arterial patency, perfusion blood pressure in the lower extremity decreases and LPI decreases less than 1.00 [6]. The limiting value of LPI used to diagnose peripheral artery disease is ≤0.90 when measured at rest. The examination protocol requires measuring the LPI before loading. Then the patient is asked to start walking on the treadmill (treadmill) at a speed of 3.2 km / h with an inclination angle of 10-12% until pain appears in the limb (or within 5 minutes), after which the LPI is measured again. A decrease in LPI by 15-20%) confirms the diagnosis of peripheral arterial disease [9, 10].

One of the links in the pathogenesis of the development of tissue ischemia is an increase in arterial tone and a decrease in pulse arterial blood flow in response to the overflow of the venous part of the capillary bed [14, 20]. Desympatization of the limb has a pathogenetic effect on the course of the obliterating disease. Given the traumatic nature of lumbar sympathectomy [13, 15], there is no consensus on the feasibility of lumbar sympathectomy for chronic lower limb ischemia [12, 13]; chemical desympatization is an alternative.

When performing chemical lumbar desympathization, it is advisable to take into account the constitutional features of the patient. The determination of the alimentary status of a patient is known by the index of body mass index (BMI), the body mass index is equal to the ratio of body mass in kilograms (kg) to the square of body growth in meters (m) (BMI = kg / m ² ) [16].

During chemical desympatization with paravertebral access, similarly to lumbar sympathetic blockade, the spinous process of the II lumbar vertebra is noted, a line is drawn through it, 5 cm outwards from the spinous process of the II lumbar vertebra there is an injection point. First, the needle was inserted with a cranial deviation to determine the depth of the transverse process, then perpendicular to the body surface, with a slight deviation medially to reach the front edge of the vertebral body [7].

In the study of patent literature, the following methods were identified for diagnosing and treating chronic arterial insufficiency of the lower extremities, as well as stratifying the risk of atherosclerotic vascular damage.

The well-known "Method for determining the degree of risk of the formation of clinical complications of atherosclerosis" [RU 2498307 C, IPC G01N 33/53, published 10.11.2013], in which the content of oxidized low density lipoproteins (LDL) is determined in the blood serum of people by the method of enzyme immunoassay. With an LDL concentration of more than 400 ng / ml, an increased risk of the formation of clinical complications of atherosclerosis is established.

The disadvantages of the method is the uncertainty of clinical recommendations in the "establishment of an increased degree of risk of the formation of clinical complications of atherosclerosis." The method is based on the study of the concentration of LDLP, however, this criterion cannot objectively determine the clinical dynamics of chronic arterial insufficiency of the lower extremities.

The well-known "Method for the diagnosis of the degree of atherosclerotic vascular lesion" [RU 2158532 C, IPC AB 5/02, G01N 33/86, published 10.11.2000], in which immediately before removing the arterial tourniquet from the cubital veins of the test and contralateral limb, venous blood is sampled, in which heparin concentration, antithrombin III activity, prothrombin time, factor VIII activity, maximum erythrocyte aggregate strength, amplitude of collagen-induced platelet aggregation, plasminogen activity, activir are determined Bathing partial thromboplastin time and determine the index A according to a formula based on the values A judge presence initial stage of atherosclerotic vascular lesions either the pronounced vascular atherosclerotic lesions.

The disadvantages of the method are associated with the use of a large number of calculations and a special formula, while the objectivity of the method is at the level of “initial or severe lesion”. Recommendations when interpreting the results of calculations also do not represent value for practical use - “it contributes to a more accurate choice of therapeutic tactics, which should be more active in the case of severe lesions”.

The well-known "Method for determining the severity of ischemia of tissues of the lower extremities in patients with atherosclerosis obliterans of the lower extremities" [RU 2473082 C, IPC G01N 33/48, published 01/20/2013], in clinical and laboratory studies to determine the severity of ischemia of lower limb tissue in in patients with obliterating atherosclerosis of the vessels of the lower extremities in the blood serum determine the vascular endothelial growth factor and monocytic chemotactic protein-1, calculate the ratio of vascular endothelial growth factor to monocytic chem otactic protein-1. With a value from 0.89-0.7, I degree of obliterating atherosclerosis of the vessels of the lower extremities is diagnosed. With a coefficient value of 0.69-0.6 - II degree. When the coefficient value is from 0.59-0.5 - III degree. When the coefficient value is less than 0.5, the IV degree of obliterating atherosclerosis of the vessels of the lower extremities is diagnosed.

The disadvantages of the method are associated with the lack of clinical recommendations, based on the interpretation of data from clinical and laboratory studies. The study used in the method of clinical and laboratory data is difficult with prolonged outpatient treatment of the patient.

Known "A tool for the treatment of obliterating atherosclerosis of the vessels of the lower extremities and a method for its treatment" [RU 2190404 C, IPC A61K 31/4412, A61P 9/10 published 10/10/2002], the method differs in that additional 2-ethyl -6-methyl-3-hydroxypyridine succinate at a dose of 400 mg per day: intravenously twice a day in 200 ml of 0.9% sodium chloride.

The disadvantages of the method are due to the lack of techniques aimed directly at increasing arterial flow to the tissues of the lower extremities.

The well-known "Method of treating atherosclerosis" [RU 2243767 C, IPC A61K 31/402, A61K 31/198, A61K 38/08, A61K 31/787, A61K 31/4178, A61P 9/10, A61M 1/38 published on 10.01.2005 ], which is carried out against the background of drug therapy with drugs of the group of statins, tevetene, polyoxidonium and conducting plasmapheresis sessions with removal of 800 ml of plasma 2 times a week No. 5 by additional administration of 0.005% - 1.0 intramuscular injection of No. 10 immunofluane and 300 mg fluimucil to the patient intravenously daily No. 5-10, the general course of treatment is 2 months.

The disadvantages of the method are due to the lack of techniques aimed directly at increasing arterial flow to the tissues of the lower extremities.

The well-known "Method for the treatment of patients with chronic ischemia of the lower extremities III-IV degree [RU 2275901 C, IPC A61K 31/02, A61P 19/00 published 05/10/2006], in which perftoran is administered intravenously in a dose of 3 to 5 ml / kg body weight in addition to the standard treatment regimen.

The disadvantages of the method are due to the lack of techniques aimed directly at increasing arterial flow to the tissues of the lower extremities.

The well-known "Method for the treatment of chronic ischemia of the lower extremities II B - IV degree" [RU 2351334 C, IPC A61K 31/4706, A61K 33/14, A61P 7/00, published 04/10/2009] in which the blood substitute is infused at a dose of 200-300 ml, then dalargin is injected bolus intravenously and the infusion of blood substitute is continued at a dose of 200-500 ml.

The disadvantages of the method are due to the lack of techniques aimed directly at increasing arterial flow to the tissues of the lower extremities.

There is a “Method for the treatment of patients with atherosclerosis obliterans of the lower limb arteries” [RU 2411965 C, IPC A61N 1/18, published 02.20.2011], in which the patient’s lumbosacral sympathetic ganglia are affected by a spatially distributed rotating field of electric current pulses. The position of the current vector is continuously changing according to a given program. The bulk density of current pulses has a maximum value in the projection of the sympathetic ganglia. The pulse repetition rate is in the range of 5-100 Hz, the duration is 50-500 μs, the amplitude is 5-8 mA, the duration of the procedure is 15 minutes, 2 effects lasting 5 minutes with a 5-minute break, daily, for a course of 10 procedures.

The disadvantages of the method are due to the lack of techniques aimed directly at increasing arterial flow to the tissues of the lower extremities.

The known "Method of combined desympatization in patients with chronic ischemia of the lower extremities" [RU 2441603 C, IPC АВВ 17/00, published 02.10.2012], in which lumbar ganglionic sympathectomy is performed sequentially, then periarterial sympathectomy and potentiate the sympatholytic effect due to the introduction of antispasmodics and local anesthetics in the arterial bed of the operated limb.

The disadvantages of the method are due to its high invasiveness, and the irreversibility of developing effects.

The prototype of the invention, as the closest in combination of features to the claimed method, is a "Method for the treatment of open trophic disorders due to chronic venous insufficiency of the lower extremities" [RU 2289399 C, IPC A61K 31/17, A61K 31/045, A61P 17/02, A61M 5/158 published on December 20, 2006], in which, under ultrasound control, a local anesthetic chemical is first introduced into the paraneural space of the sympathetic trunk. Then a chemical that causes superficial damage to the membranes of the sympathetic nerve.

The method is not intended for the treatment of lower limb ischemia due to a distal form of arterial damage. The method does not take into account the constitutional features of the patient and does not determine the severity of chronic ischemia of the lower extremities.

The task of the invention is to increase the effectiveness of the treatment of patients with chronic arterial insufficiency of the lower extremities of the I-IIa degree.

The task is achieved by the fact that at an individual risk of vascular arterial pathology, they determine the basal level of transcutaneous oxygen tension and LPI, with a decrease in load LPI <0.90, or 15% or more, the volume of ethyl alcohol is determined by growth and BMI of 70% for desympatization they perform desymptization, after 1 day they determine the transcutaneous oxygen tension, with an increase in the transcutaneous oxygen tension by 15% or more from the basal level, they recommend a therapy that includes electrical stimulation of the calf muscles during 60 minutes, pulses with a power of less than 0.05 W, stimulation frequency of 60-75 muscle contractions per minute, in other cases, indications for revascularization are determined, the transcutaneous oxygen tension is examined monthly.

The method is as follows. In a patient with an individual risk of arterial vascular pathology, LPI is determined according to the standard method, with LPI <0.90, the vascular surgeon determines the need for revascularization of the limb. With an LPI ≥0.90, a stress test is carried out on a treadmill (treadmill) at a speed of 3.2 km / h with an inclination angle of 10-12% until pain appears in the limb, or within 5 minutes. Determine the loading LPI, if the loading LPI does not decrease to <0.90, or 15% of the initial one, the patient does not have chronic arterial insufficiency of the lower extremities. With a decrease in load LPI <0.90, or 15% or more from the initial, arterial insufficiency of the lower extremities is established. The severity of chronic lower limb ischemia is determined. The patient determines the growth, BMI and basal level of transcutaneous oxygen tension in the 1st interdigital gap on the back of the foot. According to growth and BMI, the volume of ethyl alcohol is 70% for chemical desympathization [Fig. one]. In the patient’s position on the abdomen, the skin is treated with an antiseptic solution, the intervention zone is limited with sterile material. Perform local anesthesia with a solution of lidocaine 1.0%. Under the control of the electron-optical transducer, the spinous process of the II lumbar vertebra is determined, on the side of the sympathy, 5-7 cm from the spinous process of the II lumbar vertebra, a needle is injected with an external diameter of 2.2 mm. Layer-by-layer infiltration anesthesia with a lidocaine solution of 1.0% is performed. In this case, the needle is first introduced with a cranial deviation to the transverse process of the II lumbar vertebra, then perpendicular to the surface of the patient’s body, with a slight deviation medially to reach the front edge of the II lumbar vertebra body. A solution of ethyl alcohol of 70% is introduced in three equal parts, the volume of which is determined in accordance with the growth and BMI of the patient. A third of the volume is injected at the level of the upper edge of the II lumbar vertebra, a third of the volume is injected at the level of the lower edge of the II lumbar vertebra, a third of the volume is injected at the level of the middle of the body of the II lumbar vertebra. An aseptic dressing is applied, bed rest is prescribed for 30 minutes. After 1 day, the transcutaneous oxygen tension is determined. In the absence of an increase in transcutaneous oxygen tension after chemical desympathization by 15% or more from the basal level, the vascular surgeon determines the need for revascularization of the limb. With an increase in transcutaneous oxygen tension after chemical desympathization by 15% or more from the basal level, complex therapy is recommended in accordance with national recommendations, as well as electrical stimulation of the lower leg muscles. Electrical stimulation of the calf muscles is carried out cyclically: daily electrical stimulation is carried out for 3 days, then 1 day interval - electrical stimulation is not carried out. The mode of electrical stimulation of the calf muscles: for 60 minutes, with pulses of less than 0.05 W power, the stimulation frequency of 60-75 muscle contractions per minute. Repeated studies of transcutaneous oxygen tension are performed at least 1 time per month.

The method was tested in 12 patients in the Department of Surgery No. 1 NUZ "Road Clinical Hospital at the station. Rostov-Glavny ”, Russian Railways OJSC, Rostov-on-Don, and the Surgery Department, MBUZ“ City Hospital No. 7, Rostov-on-Don ”.

An example of a specific implementation of the method

Patient S., 54 years old, turned to the Surgery Department No. 1 of the NIH “Road Clinical Hospital at st. Rostov-Glavny ”JSC“ Russian Railways ”Rostov-on-Don 10/12/2015. With complaints of pain in the lower extremities, more on the right, occurring when walking at a distance of more than 500 m, a history of smoking. The patient’s height is 172 cm, BMI is 31.1, the transcutaneous oxygen tension in the 1st interdigital space on the back of the foot is 32.0 mm Hg. The results of ultrasonic triplex scanning of the arteries of the lower extremities: on the right - stenosis of PKA 50%, stenosis BOTH 70-75%, occlusion of PBA from the mouth to the lower third, according to PKA, ZBA, PBA, collateral blood flow; on the left - heterogeneous atherosclerotic plaques of BOTH, with the formation of stenosis of 20-30%. Based on the data of objective and instrumental studies, a clinical diagnosis was established: obliterating atherosclerosis of the lower extremities, chronic ischemia of the lower extremities IIa degree. LPI 0.95, with a load test on a treadmill at a speed of 3.2 km / h with an inclination angle of 10-12% for 5 minutes, the load LPI decreased to 0.83. By growth and BMI, the volume of ethyl alcohol was determined to be 70% for chemical desympathization of 6.0 ml. 10/14/2015 in the patient’s position on the stomach, the skin was treated with an antiseptic solution, the intervention zone was limited with sterile material. Local anesthesia was performed with a lidocaine solution of 1.0% 10 ml. Under the control of the electron-optical transducer, the spinous process of the II lumbar vertebra was determined, 6 cm to the right of the spinous process of the II lumbar vertebra, they injected a needle with an external diameter of 2.2 mm. Layer-by-layer infiltration anesthesia with a lidocaine solution of 1.0% was performed. In this case, the needle was first introduced with a cranial deviation to the transverse process of the II lumbar vertebra, then perpendicular to the body surface, with a slight deviation medially to reach the front edge of the II lumbar vertebra body. Three equal parts (2.0 ml each) were injected with a solution of ethyl alcohol 70%. Ethyl alcohol 70% 2.0 ml was injected at the level of the upper edge of the II lumbar vertebra, ethanol 70% 2.0 ml was injected at the level of the lower edge of the II lumbar vertebra, ethyl alcohol 70% 2.0 ml was injected at the level of the middle body of the II lumbar vertebra . An aseptic dressing was applied, bed rest was prescribed for 30 minutes. The postoperative period without features. 10/15/2015 the transcutaneous oxygen tension in the 1st interdigital gap on the back side of 38.0 mmHg The transcutaneous oxygen tension after chemical desympathization increased by 18.75%). In accordance with national recommendations, complex therapy was prescribed, as well as electrical stimulation of the lower leg muscles. Electrical stimulation of the leg muscles for 1 month was carried out cyclically: daily electrical stimulation was performed for 3 days, then interval 1 day - electrical stimulation was not performed. The mode of electrical stimulation of the leg muscles: 60 minutes, pulses with a power of less than 0.05 W, stimulation frequency of 70 muscle contractions per minute. 11.11.2015 no complaints of pain in the lower extremities, notes an increase in the distance without pain walking more than 500 m, a transcutaneous oxygen tension of 67.0 mm Hg, an LPI of 0.95, no aggravation of chronic ischemia of the lower extremities was continued, conservative therapy was continued .

Compared with the prototype, the method has the following advantages: promotes the timely identification of patients with clinically not manifest chronic ischemia of the lower extremities threatening the development of critical ischemia; helps to identify the cohort of patients requiring follow-up for the timely establishment of chronic lower limb ischemia; when chronic ischemia of the lower extremities is established, the I-IIa degree determines the tactics of minimally invasive surgical care.

These advantages of the method can improve the effectiveness of the treatment of patients with chronic ischemia of the lower extremities of the I-IIa degree.

Bibliography

1. Gavrilenko A.V., Voronov D.A., Bochkov N.P. Comprehensive surgical treatment of patients with chronic lower limb ischemia using angiogenesis gene inducers // Surgery 2, 2013. - P. 25-29.

2. Gavrilenko A.V., Skrylev S.I. Surgical treatment of patients with critical lower limb ischemia in lesions of the arteries of the femoral-popliteal tibial segment // Surgery 8, 2004. - P. 36-42.

3. Zatevakhin I.I. Treatment of chronic lower limb arterial insufficiency of stage IV atherosclerotic genesis as a problem of vascular and purulent surgery. Minutes of the 2590th meeting of the Moscow Society of Surgeons dated 04/20/06. // Surgery 12, 2006 - S. 57-58.

4. Classification of the severity of chronic arterial insufficiency of the lower extremities. Textbook (edited by Academician B.C. Savelyev). - M .: Ministry of Health of the Russian Federation, 2002. - 8 p .;

5. Clinical Angiology: A Guide for Physicians: 2 vol. / Ed. A.V. Pokrovsky. - M .: Medicine, 2004 .-- 1696 p.

6. Clinical surgery: national leadership: in 3 vol. / Ed. B.C. Saveliev, A.I. Kiriyenko - M., 2010 .-- T. III. - 1008 s.

7. Local anesthesia: Illustrated practical guidance / Malroy M .; trans. from English Panfilova S.A .; ed. Emelyanov S.I. - M., 2003 - 301 s.

8. Mikulyak A.I., Nikolsky V.I., Temnikov V.A. Long-term results of lumbar ganglionic sympathectomy and expanded desympatitis // Electronic Scientific and Educational Bulletin "Health and Education in the XXI Century" 2, 2012, Volume 14. - P. 17-18.

9. National guidelines for the management of patients with diseases of the lower limb arteries. Russian consensus document. M., 2013 .-- 68 p.

10. National guidelines for the management of patients with vascular arterial pathology (Russian consensus document). Part 1. Peripheral arteries - M., 2010. - 176 p.

11. Pokrovsky A.V. The state of vascular surgery in 2009, M, 2010. - 45 p.

12. The use of lumbar sympathectomy in the treatment of obliterating diseases of the arteries of the lower extremities - a modern view of the problem / A.V. Gavrilenko [et al.] // Angiology and Vascular Surgery 3, 2004. V. 10. - P. 90-96.

13. Staroverov I.N., Lonchakova O.M. Comparative characteristics of open and chemical desympathization of the lumbar ganglia during recurrent ischemia after reconstructive operations on the arteries of the lower extremities // Russian Medical and Biological Bulletin named after Academician I.P. Pavlova 4, 2014 .-- S. 112-119.

14. Sukovatykh B.S., Nazarenko P.M., Belikov L.N. et al. Pathogenesis and surgical treatment of trophic ulcers of the lower extremities on the basis of varicose veins // Herald of Surgery 6, 2000. - P. 25-30.

15. Sukovatykh B.S., Sukovatykh M.B., Itinson A.I., Knyazev V.V. Chemical desympathization in the treatment of trophic ulcers with varicose veins of the lower extremities // Surgery 9, 2013. - P. 44-47.

16. “BMI Classification)) Global Database on Body Mass Index. World Health Organization. 2006. Retrieved July 27, 2012.

17. Norgren L., Hiatt W.R., Dormandy J.A. al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vase Endovasc Surg 2007; 33: Suppl 1: S1-S75.

18. Selvin E., Erlinger T.P. Prevalence of and Risk Factors for Peripheral Arterial Diseasein the United States. Circulation 2004; 110: 738-743.

Claims (1)

A method for the treatment of chronic lower limb ischemia, including lumbar chemical desympathization, characterized in that they determine the basal level of transcutaneous oxygen tension and the ankle-brachial index (LPI), with basal LPI less than 0.90 determine the need for revascularization of the limb, with basal LPI 0.90 and conduct a load test more, with a decrease in the load LPI of less than 0.90, or 15% or more compared with the basal, they perform desymptization, while the volume of ethyl alcohol 70% for desympathization is determined by p the core and the patient’s body mass index, after 1 day, the transcutaneous oxygen tension is determined, with an increase in the transcutaneous oxygen voltage by 15% or more from the basal level, a therapy is performed that includes electrical stimulation of the leg muscles for 60 minutes, pulses with a power of less than 0.05 W, stimulation frequency 60-75 muscle contractions per minute, in the absence of an increase in transcutaneous oxygen tension after chemical desympathization by 15% or more from the basal level, indications for revascularization, transcutaneous tension are determined Oxygen is tested monthly.

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