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Vestnik Rossiiskoi Akademii Meditsinskikh Nauk ; 76(3):268-278, 2021.
Article in Russian | EMBASE | ID: covidwho-1411069


Coronavirus disease 2019 (COVID-19) is a viral infection that, in severe course, leads to the development of a cytokine storm, systemic inflammatory response and coagulopathy. Unlike other sepsis-associated disseminated intravascular coagulopathy, COVID-19 induced coagulopathy is realized mainly in thrombosis. Researchers around the world are currently developing adequate diagnostic, monitoring and anticoagulant therapy approaches to safely and effectively manage patients with severe COVID-19. The need to develop laboratory monitoring is due to the fact that 20% of patients have changes in hemostasis indicators, while in patients with a severe form of the disease, they are present in 100% of cases. In case of deaths from COVID-19, there is an increase in the concentration of D-dimer and fibrinogen degradation products. Thus, the severity of hemostasis disorders has an important prognostic value. Anticoagulant therapy is included in the list of all recommendations as an effective means of reducing mortality from COVID-19. The questions of the recommended groups and doses of anticoagulant drugs are still open. The approach to the choice of an anticoagulant should be based not only on risk factors, characteristics of the course of the disease, anamnesis, but also on the wishes of the patient during long-term therapy at the post-hospital stage.

Drug Development and Registration ; 10(3):138-146, 2021.
Article in Russian | Scopus | ID: covidwho-1405635


Introduction. The article discusses significant changes in the procedure for pharmaceutical inspection of drug manufacturers for compliance with the requirements of the rules of good manufacturing practice (GMP) of the Eurasian Economic Union (EAEU), related to restrictions due to the COVID-19 pandemic. Text. The article presents the main international guidelines describing the remote conduct of pharmaceutical inspections, which is the basis for further updating the relevant procedures in the law of the EAEU. An overview of the foreign practice of pharmaceutical inspection during the pandemic is given. In addition, the changes in the Russian regulatory approaches to control and supervision in the Russian legislation are presented. Conclusion. These data give an idea that, with considering the above, there is a need for further convergence of the requirements, the practice of conducting pharmaceutical inspections for compliance with the requirements of GMP Rules in order to harmonize the norms between Russian regulatory documents, the norms of the EAEU law and international standards. This requires the development of a dialogue with the participation of stakeholders. © Meshkovskiy A. P., Beregovykh V. V., Shestakov V. N., Pyatigorskaya N. V., Aladysheva Z. I., Nikolenko N. S., Pyatigorskiy A. M., Nesterkina E. I., 2021.

Obstetrics, Gynecology and Reproduction ; 15(3):295-312, 2021.
Article in Russian | EMBASE | ID: covidwho-1344586


Our knowledge regarding chemical structure and properties of heparin and its derivatives, including biological properties in blood plasma, on the cell surface and while interacting with receptors, has been progressively growing. New insights are followed by the expansion of therapeutic opportunities and indications for the use of heparins. There are prerequisites for the creation of new generation drugs with modified properties that reduce a bleeding risk while applied for a non-anticoagulant goal. The non-anticoagulant heparin properties allow to consider it as a candidate for pathogenetic treatment of patients with COVID-19. This review focuses on the anticoagulant and non-anticoagulant heparin properties as well as the underlying molecular mechanisms.