Method for complex therapy of lower limbs' ischemia in patients with diabetes mellitus

FIELD: medicine, endocrinology, physiotherapy.

SUBSTANCE: the present innovation deals with introducing preparations of antioxidant, antiaggregate, antithrombotic and hypolipoedemic action as detralex and sulodexide along with the impact of low-intensity laser radiation (LILR) (at wave length of 0.97 mcm and power of 5-7 W). Moreover, LILR impact should be performed by contact since the 1st d of conservative therapy on projection of the main vessels of lower limbs in, at least, 2 o\points at every of them per 1-2 min/every point, and high-intensity laser radiation (HILR) impact should be carried out by contact-free technique from the distance of 1-3 cm for visually altered part of affected limb's skin in area of trophic disorders up to the border with intact tissue, beginning from toes towards talocrural joint and longitudinally towards knee joint, proximally up to the lower third of femur.

EFFECT: higher efficiency of therapy and decreased traumatism.

1 cl, 2 ex

 

The invention relates to medicine, namely to endocrinology and physiotherapy, and can be used to treat lower limb ischemia in patients with diabetes mellitus.

Known methods of treatment of vascular complications in diabetes mellitus by diet, medicines: antiplatelet agents, anti-hypertensive drugs, antioxidants, vitamins, and physiotherapeutic methods: UHF, electrophoresis with vasodilators, thermotherapy and others (see Balabolkin M.I. diabetes. M: Medicine, 1994, str-321).

All of the above methods have disadvantages, namely unstable effect.

There is a method of treatment of vascular complications in patients with diabetes mellitus, which consists in intravenous laser irradiation of blood helium-neon laser radiation power at the end of the light guide 2-5 mW, exposure time 30 minutes daily for 7 days (efferent Methods and quantum therapy in clinical practice. Izhevsk, 1995, str).

A significant drawback of this method is the fact that it applies only in the vascular complications of limb, and with other vascular complications (retinopathy, nephropathy, enteropathy, etc. is not applicable.

The known method the treatment of lower limb ischemia in patients with diabetes mellitus, is selected as the closest analogue is, includes conservative therapy involving the administration of drugs with antioxidant and antiplatelet effect combined with the effect of low-intensity laser radiation (see patent RU No. 2169539, IPC 7: A 61 N 5/067, publ. 27.06.2001,).

According to the authors of this method, it is possible to significantly improve the effectiveness of treatment and to prevent side effects.

This method consists in carrying out the preparation of laser therapy for 10-14 days in antioxidants (aevit) and antiplatelet agents (Teledom or chimes), then, continuing therapy with antioxidant and antiplatelet agents, conduct of intravascular laser irradiation of blood (ILIB) for 10-15 minutes, power on the end of the fiber is 0.8-1.5 mW, the treatment course of 8-10 sessions daily or every other day, used helium-neon laser.

However, this method is time-consuming, traumatic enough for this category of patients, requires additional preparation of the patient for the course of therapy, but most importantly, is not efficient enough.

Thus, the technical result for the solution of which this invention is directed, is to increase the effectiveness of treatment of lower limb ischemia in patients with diabetes and reducing its morbidity.

The specified technical result is achieved by those who, in the known method the treatment of lower limb ischemia in patients with diabetes mellitus, combining conservative therapy, which consists in the introduction of drugs with antioxidant and antiplatelet effects, with the effect of low-intensity laser radiation, according to the invention additionally conservative therapy involves intravenous drugs with antiplatelet and lipid-lowering effect, which is used as sulodexide, as a drug with antioxidant and antiplatelet action use Detralex, the effect of low-intensity laser radiation carried out contact with the 1st day of conservative therapy in place of the projections of the main vessels of the lower extremities at least 2 points on each of them for 1-2 minutes on each of the points using a laser with a wavelength of 0,890 μm with a capacity of 20-40 mW and additionally carry out contactless effect of high-intensity laser radiation on the skin of the affected limb, starting with the toes towards the ankle and longitudinally in the direction of the knee joint, proximal to the lower third of the thigh, using radiation with a wavelength of 0.97 μm with a capacity of 5-7 watts in continuous mode, and this impact is my only visually changed portion of the skin in the area of trophic disorders to the border with unmodified cloth.

This sulodexide is administered in the amount of 600 units/day for the first 14-21 days, then 30-40 days 250 units twice a day to 100.0 ml of physiologic saline, and Detralex administered 3,000 mg on the first day and 1000 mg on the second day until the end of treatment.

The authors experimentally established that it is the combination of conservative therapy, including the administration of the drug with antioxidant and antiplatelet action - Detralex, and the introduction of additional drug that has antiplatelet and lipid-lowering effect, namely, sulodexide, with the effect of low-intensity laser radiation on the claimed area, and high-intensity laser radiation on the claimed area contributes significantly increase the effectiveness of treatment.

Experimentally, the authors found that the use of only low-intensity laser radiation in the infrared range in the complex treatment of these patients can significantly improve the results of treatment. At the heart of pathogenic effect is the stimulation of blood flow in microvessels of the affected limb. Improvement of microcirculation of ischemic tissues contributes to their trophic and reduction of pain syndrome in patients with severe ischemia of the lower extremities. Changes in the microcirculation can serve as important is the second indicator, to verify the influence of laser radiation on tissue. The dynamics of the structural parameters of microcirculation in patients with peripheral occlusive arterial vessels of the lower extremities indicates the systematic stimulation of microcirculation in the above method of laser irradiation.

It was established experimentally that the additional effects of high-intensity laser radiation on the background of the application of the claimed drugs can significantly faster improve microcirculation and blood rheology.

Exposure to high-intensity laser radiation on the claimed area contributes to the warming of the treated tissue to a temperature of 40-50°that results in the first day to the disclosure of existing collaterali, and after 5-7 days to the formation of new blood vessels circulatory channel.

It was established experimentally that the combined effects of low-intensity and high-intensity laser radiation on the claimed area, and the introduction of the proposed drugs improves the transport of substances from the blood into the tissues, reduces the occurrence of hypoxia, a decrease of lymphostasis, reduce swelling, normalizes water-salt balance.

As a result of the treatment significantly increases the rate of volumetric blood flow in astonishment the limbs.

By the end of the first day visually improvement was observed in the affected limb until about mid-thigh, on the 2nd day - to mid calf, on the third day stop.

By the end of treatment angiography revealed an enlarged collateral vessels in the affected limb.

Joint use of drugs Detralex and sulodexide in combination with exposure to laser radiation helps prevent the appearance of free radicals, suppression of the activity system of a compliment, increase lymph flow, increase of oncotic pressure of lymph, and improving the frequency and amplitude of peristalsis lymphatic vessels, inhibition of leukocyte adhesion to the endothelium, prevents their migration into perevalne space and blocks the release of these toxic components, thus has a direct protective effect on microcirculation, provides anticoagulation venous-antithrombotic, antiproliferative, anti-sclerotic and antilipidemics activity.

In addition, and this is also confirmed experimentally, after treatment significantly improves carbohydrate metabolism and normal lipid metabolism, reduces the need for traditional antidiabetic drugs.

The authors experimentally found that the best results are achieved what I exactly when the claimed drug dosages and modes of the laser radiation and that when exposed to declare areas affected limb. The method is as follows. Patients with ischemia of the lower extremities with diabetes appoint conservative therapy, which consists in taking a drug that has antiplatelet and antioxidant - Detralex - 3,000 mg on the first day and second day 1000 mg / day until the end of treatment. Simultaneously with this drug the patient is prescribed a drug that has antiplatelet and lipid-lowering action - sulodexide in the amount of 600 units/day in the first 14-21 day, and then in the next 30-40 days 250 units 2 times per day on 100 ml of physiologic saline intravenously.

From the first day of taking these drugs the patient is prescribed the effect of low-intensity laser radiation on the projection of the main vessels in the affected limb. This impact exercise contact at least two points of each of the treated vessel for 1-3 minutes on each point. As laser radiation using radiation with a wavelength of 0,890 μm with a capacity of 20-40 mW. Additionally, after a session of laser therapy on the projection of the main vessels in the skin of the affected limb of the patient without contact from a distance of 1-3 cm effect of high-intensity laser radiation, starting from the toes towards the ankle and longitudinally toward the knee su is tabu, proximally to the lower third of the thigh, and is processed only visually affected part of the skin in the area of trophic disorders to the border with unmodified cloth. As laser radiation using radiation with a wavelength of 0.97 μm with a capacity of 5-7 watts in continuous mode.

The method is confirmed by the examples.

Example 1. Patient S. 67 years. He enrolled in the Department of vascular surgery, diagnosed with atherosclerosis obliterans of the lower limbs, occlusion crural artery to the right of the III degree Fantano. Diabetes mellitus, type 2, severe, insulin dependent. Diabetic micro-macroangiopathies.

The Department simultaneously with the achievement of full compensation of carbohydrate metabolism patient were treated by the present method.

Medical therapy included the appointment of the drug Detralex on the first day (3,000 mg (6 tablets on the first day) and 1000 mg (2 tablets) at the second day until the end of treatment and sulodexide 600 per day intravenously per 100 grams. physiologic saline.

From the first day of reception of the above medications the patient has made the processing of the affected limbs laser radiation.

The right limb was handled remotely from a distance of 1 cm high-intensity laser radiation with a wavelength of 0.97 μm 5 watt in the area of the foot (dorsal and plantar areas, IU the finger spacing), the lower third of the leg, processing visually changed portion of the skin in the area of trophic disorders to the border with unmodified fabric and low-intensity laser radiation in contact on space projections of major vessels in 2 points of each of them for 1 minute on each point. Used radiation with a wavelength of 0.89 μm 20 mW. Moreover, low-intensity radiation processed alternately right and left limbs.

The result of therapy on day 12 was a significant subjective improvement with disappearance of all complaints for the receipt.

Objective research methods (laser Doppler plumeria, evaluation of transcutaneous oxygenation) confirmed full normalization of microcirculation left and right, and improvement of microcirculation and tissue trophism right limb on 83,7% of the original (at receipt).

Observation of the patient in the dynamics revealed the preservation of a stable clinical effect within 18 months after the treatment in the hospital.

Example 2. Patient E. 64 years. The diagnosis of atherosclerosis. Stenosis of the iliac artery to the left. Occlusion prednamerennoe artery on the right. Ischemia of the extremities 2A right, 4A on the left. Diabetes.

Medication similar to example 1. From the first day of reception of drugs hurt the have produced the treatment the affected limbs laser radiation.

The right and left limbs were processed remotely from a distance of 3 cm high-intensity laser radiation with a wavelength of 0.97 μm, 7W power in the area of the foot (dorsal and plantar areas, interdigital intervals) lower third of the leg, processing visually changed portion of the skin in the area of trophic disorders to the border with unmodified fabric and low-intensity laser radiation on the locations of the projections of the great arteries 1-2 points each of them for 2 minutes on each point. As a low-intensity laser radiation used radiation with a wavelength of 0.89 microns with a capacity of 40 mW.

At 14 days there was a significant subjective improvement with disappearance of all complaints for the receipt.

Using objective methods of examination confirmed complete normalization of microcirculation to the right and to the left and to the improvement of microcirculation and trophism of the affected limbs in 87.1% of the original (at receipt).

Observation of the patient in the dynamics within 20 months revealed the preservation of a stable clinical effect.

1. The method of complex treatment of lower limb ischemia in patients with diabetes mellitus, combining conservative therapy, which consists in the introduction of drugs with antioxidant and antiplatelet effects, with impacts neither contentionem laser radiation, characterized in that it further conservative therapy involves intravenous drugs with antiplatelet and lipid-lowering effect, which is used as sulodexide, as a drug with antioxidant and antiplatelet effects, use Detralex, the effect of low-intensity laser radiation carried out contact with the 1st day of conservative therapy in place of the projections of the main vessels of the lower extremities at least 2 points on each of them, for 1-2 minutes on each of the points using a laser with a wavelength of 0,890 μm with a capacity of 20-40 mW, and additionally carry out contactless from a distance of 1-3 cm effect of high-intensity laser radiation on the skin of the affected limb, starting with the toes towards the ankle and longitudinally in the direction of the knee joint, proximal to the lower third of the thigh, using a laser with a wavelength of 0.97 μm with a capacity of 5-7 watts in continuous mode, and this impact only on visually changed portion of the skin in the area of trophic disorders to the border with unmodified cloth.

2. The method of complex treatment of lower limb ischemia in patients with diabetes mellitus according to claim 1, characterized in that the sulodexide designate is Alceste 600 units/day for the first 14-21 days then 30-40 days 250 units twice a day to 100.0 ml of physiologic saline, and Detralex administered 3,000 mg on the first day and 1000 mg on the second day until the end of treatment.



 

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