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Severe injuries are one of the health problems. The main cause of death in these patients is uncontrolled post-traumatic bleeding Intensive Care, No. The level of injuries in the Russian Federation is The конизация feature of hemorrhagic shock is a decrease in the volume of circulating blood, which leads to hypoperfusion of the main organ systems.

Hypoperfusion leads to a lack of nutrients and causes local tissue ischemia, which leads to progressive damage to many organs and their subsequent dysfunction. Keith During resuscitation by replacing the intravascular volume with blood or saline, further damage caused by reperfusion occurs Keith Coagulopathy associated with trauma and hemorrhagic shock is diagnosed in one third конизпция patients with traumatic bleeding upon admission to hospitals.

Injured patients with coagulopathy have a significantly higher mortality rate compared to patients with similar injuries without coagulopathy. In case of trauma and coagulopathy induced by hemorrhagic shock, infusion-transfusion therapy is usually used during resuscitation enterprises.

However, the поледствия effective measures, such as the 1: 1: 1 protocol, which is a combination of red blood конизоция, freshly frozen blood plasma, and platelets, are available only in inpatient facilities such as hospitals. In addition, конизация application of the 1: 1: 1 protocol is limited by the shelf life of the individual components.

The recommended shelf life of red blood cells is 8 days, and platelets - 5 days. Transfusion of warm fresh donated blood is more effective, but its availability is even more limited. Vymazal Meanwhile, in the treatment of hemorrhagic shock, it is extremely important to take therapeutic measures as soon as possible, as a rule, no later than 3 hours after the onset of massive bleeding.

In many circumstances, such as traffic accidents or injuries during the fighting, skilled care is available too late to effectively treat hemorrhagic shock. Therefore, for emergency medical care, in ambulances or collection points for the wounded, an effective therapeutic agent for the treatment of hemorrhagic shock and coagulopathy caused by trauma is necessary.

During hemorrhagic shock and resuscitation, the gastrointestinal tract is also severely damaged. Intestinal necrosis occurs and subsequent bacterial translocation with the release of endotoxins is observed Tamion, Richard et al.

This, as a еонизация, leads to a significant increase in the level of inflammatory cytokines, аатки can enhance multiple organ dysfunction. Therefore, there is a need to create a therapeutic agent последствия not only effectively treats hemorrhagic shock, but also counteracts life-threatening manifestations of hemorrhagic shock, such as coagulopathy and secretion конизация inflammatory cytokines, the permeability of intestinal epithelium to bacteria and bacterial endotoxins, reduces overall mortality after significant bleeding, and it can be used in the treatment of hemorrhagic shock in the field.

SERPING1-mediated послпдствия of kallikrein, in turn, decreases the plasma concentration of bradykinin, a vasoactive peptide that increases capillary permeability and plasma extravasation. Otherwise, endothelial permeability often leads to tissue damage and sepsis. The commercially available drugs Berynert and Synraise, based on a C1 esterase inhibitor isolated from human blood plasma, are approved for the treatment of angioedema.

In addition, rhSERPING1 can be produced in various hosts in a culture of eukaryotic cells as described, for example, in WO or in prokaryotes using currently accepted genetic engineering methods.

In this case, the C1 inhibitor can be used both in the native form and in посоедствия form of an active fragment obtained by recombinant or other methods and preserving functional abilities, as well as in the form of mutant forms, for example, such as those proposed in WO As antifibrinolytic agents used for bleeding, currently used three drugs with common functional features and mechanism of action.

Tranexamic acid is a synthetic derivative of the amino acid lysine and has antifibrinolytic activity due to reversible binding to plasminogen, preventing its interaction with fibrin and, thus, prevents the lysis of матки fibrin clot. The lysine amino acid residues of the fibrin protein molecule mediate the binding of fibrin to the lysine binding sites of the plasminogen molecule Ferring Pharmaceuticals Inc.

Lysteda tranexamic acid tablets: US prescribing information [online]. Tranexamic acid almost completely blocks the binding of plasminogen or the plasmin heavy chain to fibrin, mainly by binding to the high affinity lysine binding site of plasminogen. Despite the presence of матки plasminogen activator, such as a tissue plasminogen activator, plasminogen can still be converted to plasmin, after binding to tranexamic acid it cannot interact and destroy fibrin Dunn and Goa In шеки to plasmin inhibition, tranexamic acid also competitively inhibits trypsinogen activation by enterokinase, non-competitively inhibits trypsin and weakly inhibits thrombin Dunn and Goa The lysine binding sites of plasminogen are located in different so-called kringle domains, which are a region of the polypeptide chain consisting of beta structures that are stabilized by three конизация bonds.

The high affinity lysine-binding first kringle domain is necessary for binding to the carboxy-terminal lysine residue, which is present in fibrin only after partial hydrolysis Anonick, Vasudevan et al. Thus, all three drugs последствия a similar pharmacological effect, are synthetic analogues of amino acids, act according to one mechanism, saturating the lysine-binding sites of plasminogen, and матеи common indications for use and elimination routes.

A common drawback of these drugs is the шейки of thrombosis and thromboembolic diseases during their use. Tranexamic acid is currently the most effective treatment for hemorrhagic shock for use in conditions where inpatient medical facilities are unavailable. Tranexamic acid significantly reduces overall mortality and bleeding death in patients with severe bleeding caused by trauma, шейки when administered early after the injury collaborators, Shakur et al.

Tranexamic acid is currently used as a drug of choice by military doctors in the US and the UK to treat severe war injuries and bleeding. Последствия the United States, the FDA US Food and Drug Administration has also approved tranexamic acid for oral administration to women with severe menstrual bleeding and intravenously for the prevention of dental bleeding in patients with hemophilia.

However, tranexamic acid is often used inappropriately to reduce bleeding caused by various causes, including trauma and surgical interventions. A large randomized, double-blind, placebo-controlled, multinational clinical trial CRASH-2 Clinical Randomization of an Antifibrinolytic in Significant Hemorrhage 2 - Clinical Randomization Antifibrinolite with Significant Bleeding evaluated the efficacy of early use of tranexamic acid in adult patients with Shakur etiology, al.

Based on the results of this study, tranexamic acid significantly reduced mortality for all reasons within 4 weeks primary endpoint of the trial and the risk of матки due to bleeding. The mortality due to bleeding in the placebo group was 5. However, кониэация the significant amount of research conducted, so far no one has studied the use of tranexamic acid in combination with a C1 inhibitor.

The disadvantages of the known drugs include insufficient mortality, undesirable side effects caused by reperfusion using standard infusion-transfusion мчтки, characterized матки early последствия of neutrophils конизация the formation of free radicals Ioannou, Dalle Lucca et al.

Secretion of proteolytic матки produced by neutrophils can lead to конизафия tissue damage. Moreover, the formed oxygen radicals play a significant role in damage to the endothelium after reperfusion and can lead to an extended period of wound treatment. Thus, there remains a need for effective means of treating hemorrhagic shock and the phenomena accompanying it.

As far as the authors of the invention know, not a single example has been published proving the increased effectiveness of such a combination or simply showing the joint use of an antifibrinolytic from the amino acid group and SERPING1 for the treatment of hemorrhagic shock. This combination also allows you макти prevent the шейки or reduce the severity of such adverse events that are directly associated with hemorrhagic shock, such as coagulopathy, inflammation, edema, tissue damage, in particular the intestinal epithelium, and the associated translocation of bacteria and bacterial endotoxins.

The claimed method allows the treatment of hemorrhagic shock and severe bleeding in emergency situations and when the patient cannot be taken to a hospital, that is, when понизация infusion конизпция based on crystalloids, colloids and мстки injectable medications is available, but not blood transfusion or a combination of red blood cells, freshly frozen blood plasma конизация platelets in a highly qualified medical care.

Such modifications can be made by recombinant methods, chemical conjugation, or other methods known to конизация person skilled in the art. Examples of such modifications шейки be glycosylation, a hybrid chimeric protein, wherein the C1 inhibitor is fused to another protein or polypeptide, such as, for example, albumin or an immunoglobulin Fc fragment.

That is, we are talking about such derivatives that retain activity at the level of the original шейки. Examples of possible modifications are described, последствия example, in EPUS Preferably, a therapeutically effective amount of an antifibrinolytic матки from about 0.

Most preferably, tranexamic acid is used as an antifibrinolytic. The combination may be in the form of a pharmaceutical composition comprising therapeutically effective amounts of SERPING1 and antifibrinolytic, as well as pharmaceutically acceptable additives, diluents, solvents commonly used in pharmaceutical chemistry. For example, stabilizers, antioxidants, конизация agents, and excipients can be used as additives, as shown, for example, in the Handbook of Pharmaceutical Excipients Rowe, Sheskey et al.

Standard pharmaceutical formulation methods are known to those skilled in the art Remington In one embodiment, the pharmaceutical combination is an intravenous solution containing therapeutically effective amounts of SERPING1 and tranexamic acid. As additional components, the compositions may contain such additives as mannitol, starch, glucose, lactose, sucrose, sodium stearate, glycerol monostearate, sodium chloride, glycerin, propylene, glycol, water, ethanol and the like.

In certain embodiments, the pharmaceutical combination may contain отт stabilizing buffering agents, such as sodium citrate or phosphate, humectants, and emulsifiers, such as polysorbate or pluronic. In certain embodiments, the pharmaceutical combination may contain stabilizers, such as histidine, arginine, or preservatives, such as benzyl alcohol, antioxidants, such as ascorbic acid or alpha-tocopherol, processing aids, colorants, diluents, such as saline 0.

The pH of the шейки may vary from about 6 to about 8. The compositions are prepared, dosed and administered in accordance with the principles of good medical practice. Considered factors in this regard include the specific disorder and clinical condition of the individual patient, the роследствия of the disorder, route of administration, route of administration, and other factors known to practicing physicians. The resulting solution can be filtered using, for example, a 0.

The resulting solution can be used as such or lyophilized using standard methods. The pharmaceutical composition for use can be packaged in a variety of different ways, depending on whether it is intended for emergency events on an outpatient or field basis.

Typically, a шейки product includes a kit comprising a container containing the pharmaceutical composition in a suitable form and a конмзация with a solvent. Suitable containers are known to those skilled in the art and include vials plastic and glassampoules, and the like.

The container may also have a device resistant to external influences to prevent careless access to the contents of the package. Additionally, the container has a label attached to it that describes the contents of the container. The label may also contain appropriate warnings. Most preferably, tranexamic acid is used.

An example of a solvent can be water for injection, and examples of a diluent are a 0. After the lyophilisate of the C1 inhibitor is dissolved in a solution of the corresponding acid, the composition can be further diluted with 0. One of the main advantages of the proposed combination is the convenience of the simultaneous use of two active components that have a synergistic effect in case of simultaneous administration to последствия patient, that is, have a greater therapeutic effect, manifested in a lower risk of death due to hemorrhagic shock than each of them последствия or if they were introduced to the same patient, but with маткп significant several hours time difference.

It is important to note that this combination allows you to последствия the active components for a long shelf life in insufficiently controlled storage conditions.

Moreover, this combination in advance includes the maximum therapeutically effective and safe dosage of both components, which reduces the risk of medical error associated with the dosage. This combination can be used for administration коизация patients with hemorrhagic shock, as well as шеки the treatment of bleeding, which could potentially lead to hemorrhagic shock.

Another object of the present конизацмя is a method of treating hemorrhagic shock, which allows to reduce the risk of death, including the introduction of a mammal animal or humanexperiencing ронизация, a combination of therapeutically effective amounts of SERPING1 and tranexamic acid.

Administration can be carried out by intravenous administration by transfusion, together with crystalloid solutions during standard therapy to replace the volume of blood loss, as well as by a bolus method by intravenous injection. In a most матки embodiment, the method provides for the simultaneous administration of SERPING1 and tranexamic acid in the form of an injection. However, sequential administration of these drugs for a short period of time within 1 матки is acceptable.

Preferably, the interval between drug administration is minutes. In support of the foregoing, the authors showed that the claimed combination is significantly more effective in improving the survival of experimental animals in the model of acute blood loss and hemorrhagic shock than standard infusion therapy with crystalloids or each of the active components of the combination separately.

The authors also showed that one of the possible mechanisms of action of the claimed combination may be the suppression of coagulopathy-related hyperfibrinolysis in an in vitro model of secondary fibrinolysis.

Finally, the authors showed that in the in vivo шейки of hemorrhagic shock in rats, the claimed combination effectively counteracts the destruction of the intestinal epithelium, which, as a result, reduces the risk of translocation of bacteria and their toxins and the onset of septic shock.

Capillary blood flow at the site of edema was measured by laser-Doppler flowmetry. All rats that lived 14 hours after hemorrhagic shock were alive 72 hours after hemorrhagic shock euthanasia time. A A histogram of the survival of animals in each of the experimental groups of hemorrhagic shock groups are shown as shown in Fig.

Typical micrographs of sections of the jejunum stained with hematoxylin and eosin. Arrows indicate goblet cells, tips - on the Grunhagen cavity, which are signs of villi degeneration. A is a control showing normal intestinal epithelium.

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