RU2268039C2 - Method for preventing the development of nonthrombogenic complications in postoperational period - Google Patents

Abstract

FIELD: medicine, surgery.

SUBSTANCE: one should study functional state of hemostasis system based upon electro- and biochemical coagulogram, and at availability of a friable clot: the value of minimal amplitude of electrocoagulogram being above 0.6 c.u. - it is necessary to introduce dicynon per 250 mg intravenously 4 times daily and additionally in case of hypothrombinemia one should carry out infusion of freshly frozen plasma intravenously at the dosage of 3-6 ml/kg patient's body weight, and at availability of hyperactivation of fibrinolysis one should introduce inhibitors of proteases: at first intravenously by bolus technique, and then - as intravenous continuous infusion; moreover, in case of medicinal correction of hemostasis system with anticoagulants in case of hypothrombinemia their dosages should be decreased till achieving normocoagulation. The present innovation enables to restore body hemostasis system due to individually matched therapeutic tactics that, in its turn, enables to prevent postoperational complications.

EFFECT: higher efficiency and accuracy of prophylaxis.

1 cl, 1 dwg, 3 ex, 1 tbl

Description

The present invention relates to medicine, namely to surgery, and can be used for postoperative treatment of patients.

Prevention of the occurrence of non-thrombogenic complications in the postoperative period (limited fluid formations - exudates, hematomas) is still a rather difficult problem (Kulber DA, Bacilious N., Peters ED, Gayle LB, Hoffman L. The use of fibrin sealant in the prevention of seromas // Plast Reconstr Surg. - 1997. - V.99, N 3. - P.842-849). The occurrence of such complications is fraught under certain conditions with the development of intracavitary abscesses, requires additional diagnostic and treatment procedures (puncture and drainage of the exudate, ultrasound monitoring of the effectiveness of drainage, increased antibiotic prophylaxis), and also helps to extend the patient’s hospital stay by an average of 2-3 of the day (Gilly FN, Francois Y., Sayag-Beaujard AC, Glehen O., Brachet A., Vignal J. Prevention of lymphorrhea by means of fibrin glue after axillary lymphadenectomy in breast cancer: prospective randomized trial // Eur. Surg. Res. . - 1998. - V.30, N6. - P.439-443).

An important role in the occurrence of non-thrombogenic complications is played by disorders in the functional state of the hemostatic system (Idell S., Girard W., Koenig KB, McLarty J. Abnormalities of pathways of fibrin turnover in the human pleural space // Am. Rev. Respir. Dis. - 1991 . - V.144, N 1. - P.187-194). Almost all plasma and cellular factors involved in the process of hemostasis affect the permeability of the vascular wall. Namely, increased vascular permeability underlies the pathogenesis of non-thrombogenic complications.

Despite the continuing relevance of the problem, measures to prevent the occurrence of limited fluid formations and hematomas in the postoperative period are rather poorly developed in world practice.

An analogue of the proposed method is a method for the prevention of postoperative purulent-inflammatory complications in abdominal surgery (Turgunov E.M., Kozhamberdin K.E. Prevention of postoperative purulent wound complications in patients at high risk in abdominal surgery // Materials of the Third Congress of the Association of Surgeons named after N. I. Pirogova, Moscow, 2001). The method consists in the impact of the energy of pulsed electrical discharges on the surgical wound. Method of electropulse sanitation of the surgical wound: after completion of the main stage of the operation - removal of the infection site and sanitation of the abdominal cavity, the parietal peritoneum is restored, the surgical wound is filled with sterile physiological saline, and the electrode connected to the URAT-1m device is immersed (for endoscopic cystolithotripsy). After applying voltage and the appearance of a stable spark luminescence of the active end of the electrode, the bottom and walls of the surgical wound are treated in a circular motion from a distance of 10-15 mm from the surface. The exposure depends on the cultivated area, averaging 1-2 s / cm ² .

The disadvantage of this method is ignoring the pathogenetic mechanisms of the occurrence of purulent-inflammatory complications, which reduces the reliability of the result.

There is also a method for the prevention of postoperative purulent-inflammatory complications in colorectal surgery (Darwin V.V., Ilkanich A.Ya., Beriashvili Z.A., Pekhoto G.G., Lysak M.M., Bespalov A.A. -septic complications in colorectal surgery // Materials of the Third Congress of the Association of Surgeons named after N.I. Pirogov, Moscow, 2001). The developed prophylaxis program includes the following elements: 1 hour before the start of surgery, 1.0 g of amikacin diluted in 20 ml of physiological saline is administered intravenously (endolymphatically), 50 mg of lysozyme and 5 doses of bifilis are administered intramuscularly. After surgery, after 1 day, 50 mg of lysozyme is administered intramuscularly and 5 doses of bifilis are given orally. Implementation of the developed program allows to reduce the frequency of purulent-septic complications in the early postoperative period from 16.0 to 4.2% and to reduce the hospital stay of patients from 21.5 ± 2.7 to 15.4 ± 2.3 hospital days.

The disadvantage of this method is, as in the first case, the underestimation of all pathogenetic mechanisms of the occurrence of purulent-inflammatory complications.

The prototype of the proposed method adopted a method for the prevention of non-thrombogenic complications (the formation of fluid accumulations) after lymphadenectomy in thoracic surgery, based on the medical correction of vascular permeability (Gilly FN, Francois Y., Sayag-Beaujard AC, Glehen O., Brachet A., Vignal J. Prevention of lymphorrhea by means of fibrin glue after axillary lymphadenectomy in breast cancer: prospective randomized trial // Eur. Surg. Res. - 1998. - V30, N6. - P.439-443). The essence of the method lies in the fact that patients operated on for lung cancer, after lymphadenectomy, apply a special fibrin glue to the axillary region.

The disadvantages of this method:

- underestimation of all pathogenetic mechanisms of the occurrence of postoperative fluid accumulations, which leads to insufficient therapeutic effect;

- violation of microcirculation in the area of surgical intervention when using fibrin glue.

TASKS:

1. Development of an effective and affordable in practical application method for the prevention of non-thrombogenic complications of the postoperative period (limited fluid formations and hematomas).

2. Reducing the incidence of postoperative non-thrombogenic complications.

The essence of the proposed method lies in the fact that if the patient, upon admission from the operating room, in the process of a comprehensive assessment of the functional state of the hemostasis system, an increase in the value of the minimum amplitude of the electrocoagulogram is greater than 0.6 cu - the presence of a loose clot (Zabolotskikh IB, Sinkov SV, Manuilov AM The role of hemostasiological disorders in the development of postoperative limited fluid formations // Kuban Scientific Medical Bulletin. - 2001. - No. 2. - P.100-108), then he is prescribed dicinone 250 mg intravenously 4 times a day. In addition to this:

- in the presence of hypothrombinemia (activated partial thromboplastin time more than 43 s and prothrombin index less than 85%), the doses of the used anticoagulants are gradually reduced until normal coagulation is achieved and the freshly frozen plasma is infused intravenously at a dose of 3-6 ml / kg of patient body weight;

- with a decrease in the aggregation properties of platelets (the degree of aggregation on the aggregatogram is less than 20% when using ADP in a concentration of 1.25 μmol), disaggregants are canceled;

- in the presence of hyperactivation of fibrinolysis (Hageman-dependent fibrinolysis time is less than 4 minutes, Tes electrocoagulogram index - clot lifetime - less than 1.0 min, electrocoagulogram AF index - fibrinolytic potential - more than 1.1 cu) protease inhibitors are prescribed - first intravenous bolus, and then in the form of an intravenous continuous infusion (50 thousand units of bolus and 100-300 thousand units / day of infusion of trasilol (kontrikala) or 500 thousand units of bolus and 1-3 million units / day of infusion gordoksa or 75 units bolus and 150-450 IU / day of infusion-infiltration).

Prevention is carried out under the supervision of an electrocoagulogram and a biochemical coagulogram until the risk factors for the development of non-thrombogenic complications are completely eliminated.

The method is as follows. When a patient arrives from the operating room, he is examined for the functional state of the hemostasis system based on an electro- and biochemical coagulogram. A biochemical coagulogram should include a set of the most informative and fast-performing tests (activated partial thromboplastin time, prothrombin index, platelet count, ADP-induced platelet aggregation, Hageman-dependent fibrinolysis). Simultaneously with the registration of the graphic parameters of the electrocoagulogram, its integral indicators, in particular the fibrinolytic potential (AF), are calculated (Vetlitskaya N.A., Borukhov S.A., Tursunov B.S., Perova M.D., Yakovenko P.P. , Bergen TP Express diagnostics, prevention and treatment of acute and chronic coagulopathies // Methodical recommendations for clinicians and laboratory assistants. - Tashkent, 1989). When identifying risk factors for the development of non-thrombogenic complications (Zabolotskikh IB, Sinkov SV, Manuylov AM The role of hemostasiological disorders in the development of postoperative limited fluid formations // Kuban Scientific Medical Bulletin. - 2001. - No. 2. - С .100-108) the patient is prescribed specific prophylaxis, consisting in medical correction of the functional state of the hemostatic system and vascular permeability.

The effectiveness of the proposed method for the prevention of non-thrombogenic complications was tested in 550 patients operated on for malignant tumors of the abdominal cavity. Each of these patients, upon admission from the operating room, assessed the risk of developing non-thrombogenic complications and, based on this, the question of the need for their prevention was decided (Appendix 1).

When the value of the minimum amplitude of the electrocoagulogram is more than 0.6 cu - the presence of a loose clot - was administered dicinone 250 mg intravenously 4 times a day. In addition to this:

- in the presence of hypothrombinemia, the dose of anticoagulants used was gradually reduced until normocoagulation was achieved and freshly frozen plasma was infused intravenously at a dose of 3-6 ml / kg of patient body weight;

- with a decrease in platelet aggregation properties, disaggregants were canceled;

- in the presence of hyperactivation of fibrinolysis, protease inhibitors were prescribed - first an intravenous bolus, and then as an intravenous continuous infusion (50 thousand units of bolus and 100-300 thousand units / day of infusion of trasilol (contracal) or 500 thousand units of bolus and 1-3 million IU / day of infusion Gordox or 75 IU bolus and 150-450 IU / day of infusion-initrile).

The control was a group of patients with a similar pathology in which prophylaxis of non-thrombogenic complications was not carried out. The results obtained are presented in table 1. At the same time, the effect on the occurrence of non-thrombogenic complications of the used antithrombotic drugs (unfractionated heparin - UFH or enoxaparin) was taken into account.

Table 1
Effect on the incidence of postoperative non-thrombogenic complications of the proposed scheme for their prevention Control group Prevention Group UFH (n = 250) enoxaparin (n = 300) UFH (n = 250) enoxaparin (n = 300) 9.6% 18.3% four%* 6.6% * * - p <0.05 compared with the control group.

Thus, using the proposed method, it was possible to reduce the incidence of postoperative non-thrombogenic complications by 2.5-3 times.

Examples.

1. Patient N., 54 (source No. 963) was admitted to the intensive care unit on July 6, 1999, after saw-preserving pancreatoduodenal resection for pancreatic cancer. The duration of the operation was 18 hours. The condition at admission was regarded as very serious, which was due to unstable hemodynamics due to the hemorrhagic shock of III stage. The patient needed inotropic and respiratory support. 3 hours after admission, a biochemical and electrocoagulogram was performed. The formation of a loose clot on the electrocoagulogram was found (minimum amplitude — Ao = 2.4 cu), elongation of activated partial thromboplastin time (APTT) - 44.5 s, decrease in prothrombin index (IPT) - 83.5%. The data obtained indicated hypothrombinemia (consumption coagulopathy) and a high risk of non-thrombogenic complications. As a prophylaxis of non-thrombogenic complications, it was prescribed: freshly frozen plasma intravenously at a dose of 250 ml, dicinone 250 mg 4 times a day. On the 2nd day after the operation, the state of the hemostatic system normalized. An ultrasound examination of the fluid in the postoperative period was not found.

2. Patient B., 58 years old (source No. 1613), was admitted to the intensive care unit on November 25, 1999, after hemicolectomy for colon cancer. The duration of the operation was 7 hours. The condition at admission was regarded as stably severe. 5 hours after admission, a biochemical and electrocoagulogram was performed. The formation of a loose clot on the electrocoagulogram (the minimum amplitude is A0 = 0.8 cu), a shortening of the clot's lifetime (index T _{cc of the} electrocoagulogram — 0.8 min), and an increase in fibrinolytic activity (AF index of the electrocoagulogram — 1.6 g were detected. e.). The obtained data testified to hyperactivation of fibrinolysis and the presence of a high risk of non-thrombogenic complications. As a prophylaxis of non-thrombogenic complications, 50 thousand units of contracal were administered intravenously by bolus, and then 200 thousand units / day in the form of continuous intravenous infusion through a dispenser, 250 mg dicinone 4 times a day. On the 2nd day after the operation, the state of the hemostatic system normalized. An ultrasound examination of the fluid in the postoperative period was not found.

3. Patient K., 48 years old (No. 1012), was admitted to the intensive care unit on 08/12/1999 after a gastrectomy with a conceptual gastroenterostomy for gastric cancer. The duration of the operation was 12 hours. The condition at admission was regarded as stably severe. 3 hours after admission, a biochemical and electrocoagulogram was performed. The formation of a loose clot on an electrocoagulogram was found (minimum amplitude - Ao = 1.2 cu), a low degree of platelet aggregation - 15%. The data obtained indicated a decrease in platelet aggregation activity and a high risk of non-thrombogenic complications. As a prophylaxis of non-thrombogenic complications: 250 mg dicinone was prescribed 4 times a day, disaggregants (reopoliglyukin, trental) were excluded from the intensive care plan. On the 2nd day after the operation, the state of the hemostatic system normalized. An ultrasound examination of the fluid in the postoperative period was not found.

Medical and social effect - the proposed method allows, when used, to increase the effectiveness of prevention in the postoperative period of limited fluid accumulations and hematomas.

Claims (2)

1. A method for preventing the development of non-thrombogenic complications in the postoperative period, including drug correction of the hemostatic system, characterized in that the functional state of the hemostatic system is examined on the basis of an electro- and biochemical coagulogram and in the presence of a loose clot: the minimum amplitude of the electrocoagulogram is more than 0.6 cu . dicinone is administered at a dose of 250 mg intravenously 4 times a day, and additionally, in the presence of hypothrombinemia, freshly frozen plasma is infused intravenously at a dose of 3-6 ml / kg of the patient’s body weight, and in the presence of hyperactivation of fibrinolysis, protease inhibitors are administered, first by intravenous bolus, and then as an intravenous continuous infusion. 2. The method according to claim 1, characterized in that in the case of drug correction of the hemostatic system with anticoagulants in the presence of hypothrombinemia, their doses are reduced until normal coagulation is achieved.