Method of preventing development of post-operative venous thromboembolic complications in patients with colorectal cancer

FIELD: medicine.

SUBSTANCE: before operation analysis of patient's haemostasis by means of thrombodynamics is carried out, and 12 hours before beginning operation anticoagulant prophylaxis with enoxaparin in dose 40 mg s/c 1 time per day performed. Analysis of thrombodynamics and coagulogram are repeated one day after operation, In case of detection of hypercoagulation (increase of one or some indices of thrombodynamics - initial speed of clot growth, stationary speed of clot growth, clot density, appearance of spontaneous clots) dose of enoxaparin is increased to 60 mg one time per day, and in case of detection of hypocoagulation (reduction of one or several indices of thrombodynamics - initial speed of clot growth, stationary speed of clot growth, clot density, delay of clot growth) dose of anticoagulant is reduced twice - 20 mg of enoxaparin per day.

EFFECT: method makes it possible to prevent development of post-operative venous thromboembolic complications in patients with colorectal cancer; said regimen of enoxaparin introduction provides prevention of both thromboembolic and hemorrhagic complications in said group of patients.

2 ex

 

The invention relates to medicine, namely to surgery, vascular surgery, Oncology, and can be used for the prevention of postoperative venous thromboembolic complications in cancer patients.

The problem of postoperative venous thromboembolic complications (VTEO) in cancer patients is a priority.

Patients in this category are in most cases not detected violation of hemostasis, which is reflected by a higher frequency of thrombosis in the postoperative period and the frequent development of hemorrhagic syndrome on the background of the use of anticoagulants.

Typically, the indices of coagulation, such as activated partial thromboplastin time (APTT), prothrombin time (TLG) and other, often remain in the normal range with the development of thrombophilia (Z. C. Barragan, A. N. Shilova, S. A. Khodorenko. Pharmacological prevention of thromboembolism in cancer patients treatment. Problems Hematology, 2002/2: 52-59).

In this regard, all the cancer patients classified high risk of thrombotic complications in the postoperative period.

To date, according to the current Order of Ministry of health of the Russian Federation of 9 June 2003, No. 233 "On adoption of the industry standard. Protocol management of patients. Prevention of thromboembolism lagoon�th artery during surgical and other invasive procedures" (at the conclusion of the Ministry of justice of the Russian Federation of June 23, 2003 No. 07/623 8-YOD this order does not need state registration (information published in the Bulletin of the Ministry of justice of the Russian Federation, 2003, №8)) algorithm for prevention of direct anticoagulants involves the application including low molecular weight heparins.

There are two approaches to prescription drugs, based on calculations and on the results of clinical studies. Calculation of the dose from 4,000 to 6,000 IU anti-XA per day. Since there have been studies performed with the level of credibility of evidence And dosages excluding anti-XA activity, the physician in choosing the dosage, you should focus on either the calculated value or the results of research.

The first injection is performed for 2 or 12 hours before surgery (the latter mode is preferable when spinal anesthesia is the credibility of the evidence). Injections under the skin of the abdomen 1 or 2 times a day (no significant differences in the modes of introduction are not).

From the literature it is known that there is a "Method of treatment and prophylaxis of venous thromboembolism" (EN 2500393 C2, AC 31/00, publ. 10.12.2013, bull. No. 20), the essence of which is that patients after the establishment of the high content of homocysteine in the serum of orally administered combined medicine "Angiv�t" 1 tablet 2 times a day for 6-12 months to normalise its content in the blood, through 2-4, 6-8 and 10-12 months examine the content of homocysteine in the serum and by reducing homocysteine levels less than 11.0 µmol/l switch to maintenance therapy with the drug "Angivet run on 1 tablet 1 time a day for 6 months.

The disadvantage of this method in our opinion is that this method is applicable to a limited number of patients with hyperhomocysteinemia and is aimed at correcting the concentration of homocysteine.

Known "Method of prevention of postoperative thromboembolic complications" (see EN 2375066 C2, AC 31/727, AK 31/721, AK 31/02, AR 7/02) during operations on the pelvic organs, including heparin, antiplatelet agents, characterized in that before stitching the wound in the side tissue of the pelvis, introduce a solution of the ozonized perftoran, in the first three days after surgery administered heparin at a dose of 1.5-2.0 thousand UNITS 2 times a day intravenously administered solution reopoliglyukina dose of 7-8 ml per 1 kg of body weight, also 1, 3, 5 days after surgery intravenously administered solution perftoran in a dose of 10-15 ml per 1 kg of body weight.

However, the disadvantage of this method is the low dosage and frequency of administration of heparin, as when injected into the subcutaneous tissue the effect lasts up to 8 hours.

Known "Method of prevention of thromboembolic complications in surgeons�patients die" (see EN 97116776 AND, AC 31/00, publ. 10.07.1999), the essence of which is that heparin was administered at a dose of 2.5 thousand UNITS for 30-60 min before surgery and four times a day after surgery, and for 10 to 15 minutes before the start and throughout operation was orally given sodium hypochlorite at a dose of 1-2 mecl/kg/60-120 ml of 0.06% solution GHN, and after 2-3 days after surgery orally administered acetylsalicylic acid in a dose of 0.5 g twice a day for 10-14 days and also, since 2-3 days after surgery, within 10-14 days is administered subcutaneously or intramuscularly solution of nicotinic acid 100 mg three times a day, while heparin was administered subcutaneously before surgery within 2-3 days after surgery.

The disadvantage of this method is that today, on the recommendation of the Association of phlebology Russia 2010 acetylsalicylic acid is not a means of prevention of venous thrombosis.

Noteworthy is the fact that in all the presented methods do not control the effectiveness of anticoagulant prophylaxis.

The object of the invention is the prevention of postoperative venous thromboembolic complications in patients with colorectal cancer.

The technical result of the claimed us the way is to improve the prevention of postoperative venous thromboembolic OS�of ogneni in patients with colorectal cancer

The technical result is achieved in that before the surgery perform a study of hemostasis of the patient using thrombodynamics, 12 hours before the operation is carried out anticoagulant prophylaxis with enoxaparin at a dose of 40 mg n/a 1 times a day, then a day after the surgery rebuilds the study thrombodynamics and coagulogram, the detection of hypercoagulability (an increase of one or more indicators thrombodynamics is the initial velocity of clot growth, stationary growth rate of clot, clot density, the appearance of spontaneous clots) increase the dose of enoxaparin 60 mg once a day, when identifying anticoagulation (decrease of one or more indicators thrombodynamics is the initial velocity of clot growth, stationary growth rate of clot, clot density, delay clot growth), reduce the dose of anticoagulant twice (20 mg of enoxaparin per day).

The method is as follows.

Before the surgery did research hemostasis of the patient with the help of coagulation and study thrombodynamics. In the case of hypercoagulability and normalerwesie for 12 hours before the surgery is performed anticoagulant prophylaxis with standard doses (enoxaparin 40 mg n/a 1 times a day). A day after the operation is re-ASCS�adowanie thrombodynamics and coagulation.

The detection of hypercoagulability (an increase of one or more indicators thrombodynamics is the initial velocity of clot growth, stationary growth rate of clot, clot density, the appearance of spontaneous clots) it is necessary to increase the dose of enoxaparin 60 mg / day.

When identifying anticoagulation (decrease of one or more indicators thrombodynamics is the initial velocity of clot growth, stationary growth rate of clot, clot density, delay clot growth) it is necessary to reduce the dose of anticoagulant twice (20 mg of enoxaparin per day).

The proposed method has inventive step, as for the specialist does not obviously follow from the prior art. In the known sources of information Russia, CIS and abroad similar method was found.

Here are clinical examples of the application of the method.

Example 1

Patient K., 1950, the case history No. with 3549/g, was admitted to the Department TAO RNII 21.03.2014 diagnosed with rectal cancer stage IV (T3N1M1 (NER)). The body weight of 69 kg.

Before surgery APTT (activated partial thromboplastin time) of 26.7 h (norm 24,0-35,0), MHO (international normalized ratio) 0,92, fibrinogen 4,59 g/l (normal 2-4 g/l)

The initial velocity of clot growth of 50.3 µm/min (38-56), stationary velocity of clot growth of 27.5 μm/min (20-29), size Shust�and after 30 min - 1131 µm (normal 800-1200), the density of the clot - 32893 (norm 15000-32000), spontaneous clots were absent. Tlag 0,9.

Performed abdominoperineal extirpation of the rectum.

On the background of anticoagulant prophylaxis enoxaparin 40 mg

APTT 34,2, MHO 1,24, fibrinogen 6,25 g/l, antithrombin 70%.

Indicators thrombodynamics. The initial velocity of clot growth was 55.8 µm/min (38-56), stationary velocity of clot growth of 30.1 μm/min (20-29), the size of the clot after 30 minutes - 1241 µm (normal 800-1200), the density of the bunch -32722 (norm 15000-32000), spontaneous clots Tlag 0,9

Despite the tendency to anticoagulation on indicators of coagulation, the study thrombodynamics indicated by the presence of hypercoagulability, which requires increasing the dose of anticoagulant to 60 mg.

To 14 days clinical manifestations of pulmonary embolism and thrombosis of deep veins of upper or lower extremities is not revealed. ULTRASOUND signs of pathology trunk veins of the lower extremities have not been identified.

Signs of bleeding not identified, the patient was discharged in satisfactory condition.

Example 2

Patient I., 1952, was admitted to the Department TAO RNII 14.03.2014 diagnosed with rectal cancer stage III (T3NOMO). The body weight of 74 kg.

Before surgery APTT 30,0 h (norm 24,0-35,0), MHO 1,03, fibrinogen 3,27 g/l (normal 2-4 g/l).

The initial velocity of clot growth was 51.1 µm/min (38-56), stationary velocity of clot growth of 31.1 µm/min (20 to 29), ball size che�min 30 min - 1194 μm (normal 800-1200), the density of the clot - 24338 (norm 15000-32000), spontaneous clots were absent, Tlag of 0.8.

Performed abdominoperineal extirpation of the rectum.

On the background of anticoagulant prophylaxis enoxaparin 40 mg

APTT 37,1, MHO 1,20, fibrinogen 3.52 g/l, antithrombin 77%.

Indicators thrombodynamics. The initial velocity of clot growth of 32.3 μm/min (38-56), stationary velocity of clot growth of 10.3 μm/min (20-29), the size of the clot after 30 minutes - 588 µm (normal 800-1200), the density of the clot - 27369 (norm 15000-32000), spontaneous clots, Tlag 1.

In the analysis of the coagulation system revealed hypocoagulation the APTT and indicators research thrombodynamics that requires reduction in the dose of anticoagulant to 20 mg.

To 14 days clinical manifestations of pulmonary embolism and thrombosis of deep veins of upper or lower extremities is not revealed. ULTRASOUND signs of pathology trunk veins of the lower extremities have not been identified.

Signs of bleeding not identified, the patient was discharged in satisfactory condition.

Prevention of postoperative venous thromboembolic complications was performed in 30 patients with colorectal cancer.

The invention is industrially applicable as it can be repeatedly reproduced in institutions with cancer, providing surgical and medicinal treatment.

Method of prevention� of postoperative venous thromboembolic complications in patients with colorectal cancer, including research coagulogram before the surgery, General blood analysis, characterized in that before the surgery perform a study of hemostasis of the patient using thrombodynamics, 12 hours before the operation is carried out anticoagulant prophylaxis with enoxaparin at a dose of 40 mg n/a 1 times a day, then a day after the surgery rebuilds the study thrombodynamics and coagulogram, the detection of hypercoagulability (an increase of one or more indicators thrombodynamics is the initial velocity of clot growth, stationary growth rate of clot, clot density, the appearance of spontaneous clots) increase the dose of enoxaparin 60 mg once a day, when identifying anticoagulation (decrease of one or more indicators thrombodynamics is the initial velocity of clot growth, stationary growth rate of clot, clot density, delay clot growth), reduce the dose of anticoagulant twice (20 mg of enoxaparin per day).



 

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1 cl, 1 ex, 3 tbl

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