Method for preventing severe pregnancy complications in thrombophilic patients

FIELD: medicine.

SUBSTANCE: to prevent severe pregnancy complications in thrombopillic patients, 1-2 months prior to planned pregnancy, preparation VESSEL DUE F is introduced in a dose 1000 units/day - 2 tablets twice a day to ensure decrease in lupus anticoagulant (LA) activity by at least 0.8. Then onset of pregnancy follows. During the first pregnancy trimester, VESSEL DUE F is substituted for Clexane injected in abdomen subcutaneously in a dose 0.4 ml/day daily. Starting from thirteenth week of pregnancy, VESSEL DUE F therapy is recommenced in a previous dose - 2 tablets twice a day until delivery. Introduction of VESSEL DUE F is prolonged continue within the first postpartum month.

EFFECT: integrated effect on all the links of haemostasis system, prolonged intake of tableted formulation without side effects on a foetus during pregnancy and lactation.

2 ex

 

Scope

The present invention relates to medicine, namely to obstetrics and gynecology. Can be used by doctors of other specialties.

Hereditary and acquired forms of thrombophilia are one of the main problems of obstetrics, leading to such serious complications as a habitual miscarriage, severe toxaemia up to pre-eclampsia and eclampsia, HELLP syndrome, sub - and decompensated forms of primary placental insufficiency, antenatal fetal death at different periods and thrombophilic complications in the mother (thrombosis of large vessels, pulmonary embolism (PE).

A breakthrough in the treatment of these pathological conditions observed only when on the pharmaceutical market there were drugs, combining anticoagulant properties with effects on platelet hemostasis, improves microcirculation and restore normal function and biopotency vascular endothelium.

The level of technology

Analogues: Know the use of acetylsalicylic acid in the prevention of thrombophilic complications[5, 8, 10, 12, 15].

Acetylsalicylic acid has many proprietary names, among which the most widespread aspirin.

The main mechanism of action of aspirin is the inhibition of the enzyme cyclooxygenase which, resulting in impaired synthesis of thromboxane in platelets and are disaggregating properties of the drug. Unfortunately, the inhibition of cyclooxygenase by aspirin is accompanied by violation of prostacyclin synthesis, the synthesis of which is when the majority of thrombophilic States already reduced. This circumstance leads to an increased risk of thrombosis due to worsening disorders in primary hemostasis.

In addition, drugs acetylsalicylic acid does not exert antithrombotic effects on other components of the hemostatic system, which significantly reduces their therapeutic effect.

The prototype of the present invention is the use of low molecular weight heparins (NMG) in thrombophilic States in midwife practice[1, 3, 4, 8, 12, 14].

The use of these drugs is due to their ability to provide immediate, pronounced and prolonged antithrombotic action.

The anticoagulant effect is caused primarily by the inhibition of factor XA and, to a lesser extent, the binding of anti-thrombin plasma, i.e. the effect on the procoagulant hemostasis and natural anticoagulant pathway.

Having a high anti-factor XA and anti-IIa-factor activity, MWF slightly inhibit the formation of thrombin and practically does not influence the t on primary hemostasis (adhesion and platelet aggregation and fibrinolysis system, that is a significant negative factor in the treatment of patients with thrombophilia and requires additional prescription drugs from other pharmacological groups (antiplatelet, activators of fibrinolysis) for stabilization of hemostasis[3, 11, 14].

In addition, NMG have only injectable form of introduction, which hampers their use in the outpatient setting.

The essence of the invention.

The purpose of the invention is to develop a way to prevent severe complications of pregnancy in women with thrombophilia by complex pathogenetic effects on various components of the hemostatic system drug SELL-DOUAI-f, belonging to the group of heparinoids.

The choice of the drug VESSEL DUE f based on its ability to exert a complex effect on all components of the hemostatic system, which is important for the correction coagulopathies disorders in thrombophilic States in obstetrics.

VESSEL DUE f has a complex effect on the endothelium, microcirculation and the hemostatic system. The uniqueness of the drug due to its ability to restore the glycosaminoglycan content in the structure of microvessels, to increase the negative charge of endothelial cells, stimulate fibrinolysis (F), to weaken the adhesion and, to a lesser extent, agregati the platelets, and with long-term use to reduce the level of fibrinogen (FG) in the plasma, to provide a moderate gipolipidemicheskoe and antiatherosclerotic action[6, 7, 9, 12, 15].

The inner hemostasis VESSEL DUE f has diverse effects, qualitatively and quantitatively different from MWF.

The main components of the influence of the VESSEL DUE f plasma hemostasis are the following[9, 12, 15]:

- the drug does not cause reduction of anti-thrombin III (AT III) in plasma even with prolonged use;

moderately inhibited in ATIII complex with factor XA and thrombin, without leading to decreased activity of ATIII, while the effects of VESSEL DUE f inferior MWF;

- significantly stimulates fibrinolysis, which is one of the important aspects of validity VESSEL DUE f to distinguish it from NMG;

- reduces blood viscosity by reducing the concentration of plasma lipids and fibrinogen, and moderate venomotor effect, which leads to improvement of microcirculation;

- prolonged use of a VESSEL DUE f is significantly less than when using heparins, is the risk of hemorrhagic complications - effect on bleeding time in 2 times lower than the NMG;

- similarly, NMG has no affinity platelet factor 4 and does not cause immune thrombocytopenia

- ESSEL DOUAI f does not pass through the placental barrier, does not accumulate in the tissues of the fetus and does not cause hemorrhagic complications in the past, can be used during lactation.

- VESSEL DUE f has a preformed shape that facilitates its administration on an outpatient basis.

Thus, the antithrombotic effect of VESSEL DUE f occupies an intermediate position between vasoprotection, heparins, antiplatelet agents and activators of fibrinolysis, acting on all these links of hemostasis complex, but somewhat weaker than the representatives of each of the following groups of drugs separately.

All of the above features of the VESSEL DUE f, and the possibility of its long-term therapeutic and prophylactic both parenteral and oral administration without control over the parameters of hemostasis and tolerability make possible the use of this drug in patients with various forms of thrombophilia, including during pregnancy.

The method is as follows:

1-2 months prior to planned pregnancy women with thrombophilia is prescribed as monotherapy, the drug VESSEL DUE f at a dose of 1000 IU/day (2 tablets 2 times a day). The effectiveness of therapy are judged by the decrease in the rate of activity of lupus anticoagulant (VA), which is the integral display is elem of the coagulation potential of blood, developed and patented in the Federal state institution "research Institute of MME and gynecology", original thromboelastographic method (patent No. 2104552 from 10.02.98). This indicator is controlled before you start taking the drug and in the future, with an interval of 2-3 weeks. Conception Pets by reducing the activity indicator VA not less than 0.8 of the original.

After the pregnancy during the first trimester drug VESSEL DUE f replace therapy, 40 mg under the skin of the abdomen once a day, and with the 13th week of pregnancy resume your treatment VESSEL DUE f in the same dose (2 tablets 2 times a day) until delivery and for 1 month after birth.

VESSEL DUE f applied at the stage pregravidarnoy training and from the second trimester of pregnancy, by assigning it to 1000 IU/day, both independently and as part of a comprehensive protivotromboznoe therapy if there are changes at all levels of the hemostatic system. Use the tablet form of the drug is used long-term, adjusting the dose according to the state of the hemostatic system.

The efficacy and tolerability of the treatment VESSEL DUE f evaluated on the dynamics of clinical and laboratory manifestations of thrombophilic process: the value of the activity index VA, platelet count, fibrinolytic activity of the blood (F) and condition of the fetoplacental complex is by ultrasound with Doppler ultrasound of the uterine and umbilical arteries.

Clinical example 1.

Sick N, 24 years. History 1 medical abortion and 3 regressing the gestation periods of 12, 16 and 10 weeks. Repeatedly examined in the centers for miscarriage, cause habitual noncarrying of pregnancy was not diagnosed. During examination at our institution revealed the diagnosis of Primary APS (VA identified with the activity indicator +1,8)conducted pregravidarnaya training with the use of the drug vessel-DOUAI-f at a dose of 1000 IU/day for 6 weeks.

The activity indicator VA after treatment decreased from +1.8V to+0.8. Against this background of pregnancy. With early pregnancy the patient was administered therapy at a dose of 40 mg under the skin of the abdomen once a day, and with the 13th week of pregnancy was resumed therapy drug VESSEL DUE f in the same dose of 1000 IU/day (2 tablets 2 times a day).

Further, during pregnancy, in patients receiving VESSEL-DOUAI-f at a dose of 1000 IU/day activity index VA was stabilized at the numbers +1.1 to+1.3 to. By ultrasound were signs compensated NEF, however, no violation of blood circulation in the placenta, no lag biometric measurements of the fetus registered never had.

The pregnancy ended in an independent emergency childbirth, on the background of basic therapy WESSEL-DOUAI-f at a dose of 1000 IU/day, the intake of which is was b continue for one month after birth.

The boy was born weighing 3570 g, length 51 see the Total blood loss in childbirth was 200 ml.

Clinical example 2.

A female patient, 36 years. In the history of the two Contracting pregnancy in the 1st trimester and two premature births, some of which with antenatal death of a fetus at 30 weeks, other - abdominal, due to placental abruption in term of 33 weeks of pregnancy, the child died. Six months after cesarean section, the patient has happened ileofemoral thrombosis of right, requiring installation cava filter.

With the purpose of planning of pregnancy the patient turned a year and a half after iliofemoral thrombosis. During this time she continuously took indirect anticoagulants (warfarin), which have cancelled one month prior to treatment.

After comprehensive examination, the patient was diagnosed with Primary APS, due to the presence of two groups of AFA-VA, with activity indicator +2,1 and a/t to prothrombin in high titer.

Pregravidarnaya training was conducted by the drug VESSEL-DOUAI-f 1000 IU/day (2 tablets 2 times a day). After a month of therapy VA decreased to +1,2, state platelet and fibrinolytic hemostasis was not a cause for concern. Was a planned pregnancy.

Next time the patient asked to take 6 weeks is nasty. The survey: the activity indicator VA was +1,3, deviations in the primary and fibrinolytic the hemostasis has not been recorded, by ultrasound pregnancy is developing normally, signs threats interrupts are not detected. During the 1st trimester of pregnancy VESSEL-DOUAI-f was replaced with therapy at a dose of 40 mg/day under the skin of the abdomen, and 13 weeks of pregnancy continued therapy WESSEL-DOUAI-f at a dose of 1000 IU/day.

The activity indicator VA during pregnancy, the patient ranged from +1.2 to +1,5, thrombotic complications were recorded.

In the period 37-38 weeks of pregnancy, against the backdrop of ongoing antithrombotic therapy, the patient was rodorazresheniye way of caesarean section in a planned manner, taking into account the presence of a uterine scar. A girl was born weighing 2350 g, length 48 cm, grade Apgar 7/8 points. Operating 600 ml of blood loss In the postoperative period within 5 days postpartum women received therapy at a dose of 0.4 ml/day, then within one month SELL-DOUAI-f at a dose of 1000 IU/day.

Thus, the proposed method of treatment of thrombophilic States in obstetrics with the drug VESSEL DUE f is a highly effective, pathogenetically justified and less aggressive compared to previously proposed, the drug WEIGHT IS EATING DOUAI f can be applied directly to the delivery, that does not increase the amount of blood loss in childbirth and reliably prevents thrombosis during pregnancy, generic and operational stress in patients with defects of hemostasis.

Literature

1. Bitsadze V.O. Principles of diagnosis and pathogenetic prevention of major complications of pregnancy, due to thrombophilia: dis...doctor. Sciences. / Vouches. - M., 2003. - 268 S.

2. Krysova L.A. Extragenital manifestations of the antiphospholipid syndrome in women with obstetric pathology / Lagrave, Navbarname // Mother and child: Mat. Rostrum. - M., 2006. - S.

3. The makatsariya ROAD of Thrombophilia and antithrombotic therapy in obstetrics / Addmagazine, Whobecame // M: Triada-X, 2003. - 904 S.

4. Addmagazine, Vouches, Sveningson. The system inflammatory response syndrome in obstetrics / M: MIA, 2006. - 470 C.

5. Nasonov EL Antiphospholipid syndrome. / Elenasnow. - M: Littera, 2004. - 440 S.

6. Putilova, NV New approaches to diagnosis and treatment of antiphospholipid syndrome / Navpalib // Mother and child: Mat. Rostrum. - M., 2006. - S.

7. Putilova NV ON the prevention of thrombophilia in pregnancy in women with circulating antiphospholipid antibodies and obstetric pathology / Navutulevu, Lagrave // Modern technologies in the prevention of perinatal and maternal mortality: proc. The age of three. Plenum Association is akush.-gin. - M., 2000. - C-177.

8. Reshetnik T.M. "Trombo ass in the prevention of vascular disorders in antiphospholipid syndrome / Timersync, ASAC, Annaalexandrova // Klin. the honey. - 1999. No. 10. - P.30-35.

9. Reshetnik T.M., Alakbarova SS, Nasonov EL Antiphospholipid syndrome: diagnosis and principles of treatment / Klined. 1998. 3. P.36-40.

10. Sidelnikov V.M. Drug therapy in pregnant women with antiphospholipid syndrome / Vmesatelistve // Man and medicine: abstracts. Dokl. I Ross. mi. fo. (Moscow, 12-16 April 1992). - M., 1992. - P.21.

1l. Braunstein J. B.Interaction of Hemostatic Genetics With Hormone Therapy: New Insights To Explain Arterial Thrombosis in Postmenopausal Women / J.B.Braunstein, D.W.Kershner, G.Gerstenblith //CHEST - 2002. - Vol.l21. - P.906-920.

12. Cano A. The mechanisms of thrombotic risk induced by hormone replacement therapy / A.Cano, W.M.Van Baa // Maturitas. - 2001. - Vol.4. - P.17-38.

13. Cushman M.Women''s Health Initiative Investigators. Estrogen plus progestin and risk of venous thrombosis M. Cushman // J.A.M.A. - 2004. - Vol.292, No. 13. - P.1573-1580.

14. D.M. Herrington Estrogen Receptor Polymorphism Augments Effects of 1 Replacement Therapy on E-Selectin but Not C-Reactive Prot / D.M.Herrington, D.Howard, K.B.Brosnihan // Circulation. - 2002. - Vol.105. - P.1879-1882.

15. Kennon S. The effect of aspirin on C-reactive protein as a marker of risk in unstable angina / S.Kennon, C.P.Price, P.G.Mills // J. Amer. Coll. Cardiol. - 2001. - Vol.37. - P.1266-1270.

The way to prevent severe complications of pregnancy in women with thrombophilia, characterized in that, in order to correct coagulopathies disorders, patients 1-2 months prior to planned pregnancy prescribe the drug VESSEL DUE f at a dose of 1000 IU/day 2 tablets 2 times a day, and when the decrease in activity of lupus anticoagulant (VA) is not less than 0.8 accept a pregnancy in the first trimester which the VESSEL DUE f replace therapy at a dose of 0.4 ml/day under the skin of the abdomen once, and the 13th week of pregnancy resume treatment VESSEL DUE f in previous dose - 2 tablets 2 times a day until delivery and the first month after birth.



 

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FIELD: medicine.

SUBSTANCE: method involves introducing Sulodexid as coagulant at a dose determined in correspondence with coagulation constant KK. Its value being equal to 6.67±0.21 min, initial Sulodexid dose is equal to 40 LRU/kg/day. KK value being less than 18 min one day later, the initial Sulodexid dose is increased by 5 LRU/kg/day. The value being greater than 30 min, the dose is reduced by 5 LRU/kg/day. No inflammatory phenomena being observed and burn wound epithelialization signs appearing, Sulodexid therapy is cancelled reducing its dose by 1/3 of the initial one.

EFFECT: stable antithrombotic; reduced risk of hemorrhagic and pyoinflammatory complications; early injured skin epithelialization.

1 dwg

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