MD1561Z - Method for complex treatment of SARS-CoV-2 virus infection - Google Patents

Abstract

The invention relates to medicine, in particular to infectious diseases and pneumology, and can be used for complex treatment of SARS-CoV-2 virus infection.Summary of the invention consists in that it is administered azithromycin 500 mg once a day for 9 days, cefuroxime 500 mg 1 tablet 2 times a day, for 14 days, enoxaparin sodium solution 0.4 ml 2 times a day, subcutaneously, for 5 days, deflazacort 45 mg, for 3 days, then 37.5 mg, for 3 days, then 30 mg, for 5 days, then 22.5 mg, for 5 days, then 15 mg, for 6 days, acetylcysteine 600 mg once a day, for 10 days; adjuvant therapy with the use of gastroprotective drugs, drugs that affect the energy metabolism of the body, amino acids, drugs to improve the intestinal biocenosis and sedatives; simultaneously is intravenously administered 500 ml of 0.9% NaCl ozonated solution with an oxygen-ozone mixture, with an ozone concentration of 5 µg/mL once a day, for 7 days, then prolonged with the specified solution with the ozone concentration of 3 µg/mL once a day, for 5 days, nasal and rectal insufflations are also performed with an oxygen-ozone mixture, at the same time the nasal insufflations are performed with a mixture with ozone concentration of 10 µg/mL, which are performed for 5…7 min, daily, for 12 days, and rectal insufflations are performed by administering 150…300 mL of a mixture with ozone concentration of 10…25 µg/mL, daily, for 7 days.

Description

The invention relates to medicine, in particular to infectious diseases and pneumology, and can be used for the complex treatment of SARS-CoV-2 virus infection.

At the current stage, the health sector is being shaken to its foundations by the SARS-CoV-2 infection, the evolution of which is aggravated by the presence of chronic concomitant diseases specific to the consumer society such as cancer, diabetes, cardiovascular diseases, COPD, tobacco and alcohol addiction, and obesity. The current epidemiological situation requires prompt intervention with the revolutionization of therapeutic methods in the case of chronic diseases such as COVID-19, with the involvement in the therapeutic management of the patient by changing the lifestyle, the eating style, but also by introducing alternative and complementary treatment methods, such as ozone therapy, which ensure the rebalancing of the health balance more naturally, more quickly and sustainably (WHO Recommendations. Clinical management of acute respiratory infection suspected with coronavirus 2019 nCoV WHO/nCoV/Clinical/2020/ WHO Recommendations. Home care for patients with suspected novel coronavirus (COVID-19) infection presenting with mild symptoms, and management of their contacts, Interim guidance 04 February, 2020.)

The use of antiviral therapy for the treatment of severe acute respiratory syndrome in patients with SARS-CoV-2 virus infection is known, namely the administration of remdesivir [1].

Another known method of treating SARS-CoV-2 infection is the administration of antiviral therapy, namely remdesivir, which is the only drug approved by the Food and Drug Administration for the treatment of COVID-19. Immunological therapy includes some human blood-derived products that are obtained from people who have recovered from SARS-CoV-2 infection (e.g., convalescent plasma, immunoglobulin products). These heterogeneous products have direct antiviral properties, like convalescent plasma, and/or immunomodulatory effects, like those observed with mesenchymal stem cells (Shetty AK. Mesenchymal Stem Cell Infusion Shows Promise for Combating Coronavirus (COVID-19)- Induced Pneumonia. Aging Dis. 2020, 11(2), p. 462-464. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32257554.). Other agents in this group include therapies for the treatment of other immune and/or inflammatory syndromes. These agents include corticosteroids (e.g., glucocorticoids), which possess a wide range of mechanisms for reducing systemic inflammation, and more targeted anti-inflammatory treatments, such as interleukin inhibitors (Shakoory B, Carcillo JA, Chatham WW, et al. Interleukin-1 receptor blockade is associated with reduced mortality in sepsis patients with features of macrophage activation syndrome: reanalysis of a prior Phase III trial. Crit Care Med. 2016, no 44(2), p. 275-281. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26584195), interferons (Zhou Q, Wei X, Xiang X, et al. Interferon-a2b treatment for COVID-19. medRxiv. 2020; Preprint. Available at: https://www.medrxiv.org/content/10.1101/2020.04.06.20042580v1)., kinase inhibitors (Cao Y, Wei J, Zou L, et al. Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): a multicenter, single-blind, randomized controlled trial. J. Allergy Clin. Immunol. 2020, vol. 146(1), p. 137-146. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32470486) and others. Adjuvant therapy, which includes antithrombotic therapy, vitamins and minerals [2].

The disadvantages of known methods are that they are not effective in severe forms of SARS-CoV-2 infection and in patients with concomitant chronic pathologies, such as diabetes, cardiovascular diseases, oncological diseases, and also lead to the occurrence of severe acute respiratory syndrome and complications from vital organs.

The problem solved by the invention consists in developing an effective method for treating SARS-CoV-2 virus infection, which would eliminate the disadvantages of known methods, would allow for a faster and more stable reduction of clinical manifestations, such as fatigue and asthenic syndrome, dyspnea, reflected by objective examination data, oxygen saturation values, heart rate and blood pressure, with the aim of preventing the occurrence of severe acute respiratory syndrome and complications from vital organs.

The essence of the invention consists in administering azithromycin 500 mg once a day for 9 days, cefuroxime 500 mg 1 tab. 2 times a day for 14 days, enoxaparin sodium solution 0.4 ml 2 times a day, subcutaneously, for 5 days, deflazacort 45 mg, for 3 days, then 37.5 mg, for 3 days, then 30 mg, for 5 days, then 22.5 mg, for 5 days, then 15 mg, for 6 days, acetylcysteine 600 mg once a day for 10 days; adjuvant therapy with the administration of gastroprotective preparations, preparations with an effect on the body's energy metabolism, amino acids, preparations for improving the intestinal biocenosis and sedatives; simultaneously, 500 ml of 0.9% ozonated NaCl solution with an oxygen-ozone mixture, with an ozone concentration of 5 µg/ml, is administered intravenously once a day for 7 days, then it is prolonged with the aforementioned solution with an ozone concentration of 3 µg/ml once a day for 5 days, nasal and rectal insufflations are also performed with an oxygen-ozone mixture, at the same time, nasal insufflations are performed with a mixture with an ozone concentration of 10 µg/ml, which is performed for 5...7 min, daily, for 12 days, and rectal insufflations are performed by administering 150...300 ml of a mixture with an ozone concentration of 10...25 µg/ml, daily, for 7 days.

The result of the invention consists in a faster and more stable reduction of clinical manifestations, such as fatigue and asthenic syndrome, dyspnea, reflected by objective examination data, oxygen saturation values, heart rate and blood pressure, with the aim of preventing the occurrence of severe acute respiratory syndrome and complications from vital organs.

Ozone therapy is the procedure, which consists of subcutaneous, intravenous, intramuscular or intraarticular injection of a mixture of oxygen and ozone, through different techniques. The experience of ozone treatment begins 20 years ago, through the treatment of hundreds of patients with various pathologies and has been expressed in articles published in specialized journals. Ozone (О3) - is an isomeric form of oxygen, a stronger oxidant than oxygen, which by interacting with the double bonds of polyunsaturated fatty acids forms ozonides responsible for activating crucial biological functions, such as oxygen supply, immunity activation, lysis of viruses and bacteria, hormone release and induction of antioxidant enzymes (Maslennikov O.V., Kontorshikova C.N., Gribkova I.A. Ozone therapy in Practice. Health Manual, Ministry Health Service of The Russian Federation The State Medical Academy Of Nizhny Novgorod, Russia, 2008. http://www.absoluteozone.com/assets/ozone_therapy_in_practice.pdf. 1 ed2008.)

Biochemical and clinical studies have demonstrated that ozone therapy has numerous etiopathogenetic levers, which influence the human body through:

- anti-inflammatory effect, due to the oxidation of inflammatory mediators rich in double bonds;

- in addition, ozone reduces the degree of tissue hypoxia and restores metabolic processes in the affected tissues at the site of inflammation, as well as corrects pH and electrolyte balance;

- analgesic effect of ozone, which is achieved by the gradual supply of oxygen to the area of inflammation and the oxidation of pain mediators, modulatory action on prostaglandins, which regulate the inflammatory cellular reaction, which are also involved in the transmission of nociceptive signals to the CNS in acute pain;

- activation of metabolism (oxygen-dependent processes) - activates oxygen-dependent metabolic processes in hypoxic states by accelerating glycolysis, increasing glucose uptake by tissues and organs, reducing the content of oxidized metabolites in plasma, improving microcirculation and rheological properties of blood, increasing the volume of oxygen in plasma and facilitating the release of oxygen to cells by oxyhemoglobin and increasing the partial pressure of oxygen in the blood - antihypoxic mechanisms, which reduce the severity of tissue hypoxia, ensuring good oxygenation of tissues, especially those insufficiently irrigated with blood; improves mitochondrial transport processes, which determines the increase in the metabolism of all cells and defense against mutations;

- detoxification effect by activating the microsomal system of hepatocytes and enhancing renal filtration;

- antibacterial/antimycotic/antiviral;

- immunomodulatory properties, by activating the specific and non-specific defense system, both cellular and humoral immunity;

- optimization of pro- and antioxidant systems, which restore the dynamic balance between the level of peroxidative oxidation products and antioxidant defense systems, by stimulating the antioxidant system (superoxide dismutase, catalase, glutathione peroxidase), mainly in erythrocytes, myocardium, liver and other tissues and reducing the intensity of the lipid peroxidation process;

- the rheological effect, which contributes to maintaining a relatively high blood flow velocity in the microcirculatory bed, vasodilation by increasing the concentration of nitric oxide, correction of erythrocyte metabolism and resistance (Schwartz-Tapia A., Martínez-Sánchez G., Sabah F., Alvarado-Guémez F., Bazzano-Mastrelli N., Bikina O., Borroto Rodrígez V., Cakir R., Clavo B., González-Sánchez E., Grechkanev G., Najm Dawood A. H., Izzo A., Konrad H., Masini M., Peretiagyn S., Pereyra V. R., Ruiz Reyes D., Shallenberger F., Vongay V., Xirezhati A., Quintero-Marino R. Madrid Declaration on Ozone Therapy. 2nd ed. Madrid: 2015, 50 p. ISBN 978-84-606-8312-4).

- The direct antiviral activity of ozone therapy is expressed by:

- denaturation of virions through direct contact with ozone, which destroys the membrane with multiple double bonds, vulnerable to the oxidizing action of ozone, lesions that do not allow their survival and reproduction;

- ozone alters the glycoprotein structures through which viruses attach to host cells, which prevents the adhesion and penetration of viruses into the cell;

- ozone administration induces the formation of protein and lipid peroxides, which are not toxic to the host, but possess oxidative and antiviral properties;

- the action of ozone on viral particles consists in modifying viruses at the genome level, so that they remain structurally intact but non-pathogenic, which allows the host to increase the degree of sophistication of the immune response, a fact also called host-specific autovaccine.

Ozone manifests itself on viral infection and indirectly through:

- its immunomodulatory action;

- anti-inflammatory effect;

- optimizer of the pro-/antioxidant system;

- blood circulation optimizer;

- revitalizing, regenerating effect;

- anti-algesic effect;

- detoxifying effect;

- activation of metabolism.

The most widespread methods of using ozone for curative purposes are intravenous administration with systemic effect of physiological solution, rectal insufflations of the oxygen-ozone gas mixture, auto-hemotherapy and local ozone therapy in the form of nasal insufflations, external applications of ozone in a gaseous state, internal applications of ozonated distilled water, ozonated oil and subcutaneous introduction of ozone gas.

In the fight against the SARS-CoV-2 virus, in addition to basic treatment, therapy with the administration of ozonated physiological solutions, rectal and nasal insufflations was included in patients.

Ozonated physiological solution for infusions:

Materials needed:

- personal protective equipment for COVID-19;

- tourniquet, gloves, sterile compresses, disposable infusion systems;

- 0.9% physiological saline solution, 500 ml.

The method is performed in the following way:

- the 0.9% physiological solution is bubbled at an ozone concentration of 5 µg/ml, for 10 min;

- the saline solution bubbled with ozone is administered i/v to patients by infusion at a rate of 80/120 drops/min;

- ozonated saline solution is administered every day for 7 days;

- over the next 5 days, reduce the concentration to 3 µg/ml.

Nasal insufflations with oxygen-ozone mixture.

Materials needed:

- personal protective equipment for COVID-19;

- gloves, 50 ml disposable syringes, nasal connector.

The method is performed in the following way:

- the patient is in a sitting position, at the moment of maximum inspiration, nasal insufflations are made, then the patient is asked to hold his breath;

- the procedure and the position to be respected are explained to the patient;

- prepare the oxygen-ozone mixture with an ozone concentration of 10 µg/ml in the syringe, place the connector at the end of the syringe tube;

- insufflations are made in each nostril, blocking the other nostril alternately. The procedure lasts 5...7 minutes daily, for 12 days.

Rectal insufflations with oxygen-ozone mixture.

Materials needed:

- personal protective equipment for COVID-19;

- gloves, sterile compresses, sterile bags, sterile cannulas.

The method is performed in the following way:

- the bag is filled with oxygen-ozone mixture, the concentration starting from 10 µg/ml and then increasing it to 25 µg/ml;

- the oxygen-ozone mixture is administered through a special sterile cannula in an amount of 150...300 ml by rectal insufflation;

- the amount of gas insufflated gradually increases, and insufflations are performed every day, for 7 days.

Including ozone therapy in the patient's treatment regimen allows for a faster and more stable reduction of clinical manifestations: fatigue and asthenic syndrome, dyspnea, reflected by objective examination data, oxygen saturation values on pulse oximetry, heart rate and blood pressure.

The method is performed in the following way.

The patient is diagnosed with SARS-CoV-2 virus infection after taking the sample and performing the Real Time PCR molecular test. The patient is administered azithromycin 500 mg once a day for 9 days, cefuroxime 500 mg 1 tab. 2 times a day for 14 days, enoxaparin sodium solution 0.4 ml 2 times a day, subcutaneously, for 5 days, deflazacort 45 mg, for 3 days, then 37.5 mg, for 3 days, then 30 mg, for 5 days, then 22.5 mg, for 5 days, then 15 mg, for 6 days, acetylcysteine 600 mg once a day for 10 days; adjuvant therapy with the administration of gastroprotective preparations, preparations with action on the body's energy metabolism, amino acids, preparations for improving intestinal biocenosis and sedatives; simultaneously, 500 ml of 0.9% ozonated NaCl solution with an oxygen-ozone mixture, with an ozone concentration of 5 µg/ml, is administered intravenously once a day for 7 days, then it is prolonged with the aforementioned solution with an ozone concentration of 3 µg/ml once a day for 5 days, nasal and rectal insufflations are also performed with an oxygen-ozone mixture, at the same time, nasal insufflations are performed with a mixture with an ozone concentration of 10 µg/ml, which is performed for 5...7 min, daily, for 12 days, and rectal insufflations are performed by administering 150...300 ml of a mixture with an ozone concentration of 10...25 µg/ml, daily, for 7 days.

The claimed method has been used to treat more than 400 patients, with satisfactory results.

Example

Patient A., 45 years old, presented with complaints of dyspnea, wet cough with approximately 20 ml of sputum in 24 h, moderate intercostal pain upon deep inspiration, palpitations, arrhythmia, moderate diffuse headache, insomnia, marked general weakness, and pronounced fatigue.

He was admitted to the IMSP SCMSM and PS, with worsening health. General condition of average severity, pale skin, cyanotic lips, respiratory rate 18 breaths/min, SaO2= 93…94%. He received treatment according to the claimed invention. Azithromycin, 500 mg, was administered once a day for 9 days, cefuroxime 500 mg, 1 tab. twice a day, for 14 days, enoxaparin sodium solution, 0.4 ml twice a day, subcutaneously, for 5 days, deflazacort 45 mg, for 3 days, then 37.5 mg, for 3 days, then 30 mg, for 5 days, then 22.5 mg, for 5 days, then 15 mg, for 6 days, acetylcysteine 600 mg, once a day, for 10 days, adjuvant therapy with the administration of gastroprotective preparations - tab. Pulcet 40 mg, 1 tab. per day, with 100 ml of water, for 14 days, preparations with an effect on the body's energy metabolism - tab. mildronate 500 mg, 1 tab. 2 times a day, for 14 days, amino acids - enhancer solution 5 g, 1 ampoule per day, for 20 days, preparations for improving intestinal biocenosis - lactobex powder 1 sachet 2 times for 10 days, then 1 sachet once a day, for 20 days and sedatives - herbastress tab. 1 tab. per day, for 14 days; At the same time, 500 ml of ozonated NaCl 0.9% solution with an oxygen-ozone mixture, with an ozone concentration of 5 µg/ml, was administered intravenously, once a day, for 7 days, then it was prolonged with the aforementioned solution with an ozone concentration of 3 µg/ml, once a day, for 5 days, nasal and rectal insufflations were also performed with an oxygen-ozone mixture, where nasal insufflations were performed with a mixture with an ozone concentration of 10 µg/ml, which were performed for 7 min, daily, for 12 days, and rectal insufflations were performed by administering 300 ml of a mixture with an ozone concentration of 20 µg/ml, daily, for 7 days.

Against the background of the associated treatment, on the third day the complaints presented upon admission significantly diminished, objectively the patient had pale pink skin, was more active, SaO2 = 97%, respiratory rate: 16 breaths/min. He was discharged in satisfactory condition.

1. Lai C.C., Shih T.P., Ko W.C., Tang H.J., Hsueh P.R. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrobial Agents. Feb 17, 2020, 105924

2. Treatments Your Healthcare Provider Might Recommend if You Are Sick. NIH COVID-19 Treatment Guidelines. Centers for Disease Control and Prevention. NCIRD, Dec. 8, 2020, Found Internet.> https://www.cdc.gov/coronavirus/2019-ncov/your-health/treatments-for-severe-illness.html

Claims (1)

Complex treatment method for SARS-CoV-2 virus infection, which consists of administering azithromycin 500 mg once a day for 9 days, cefuroxime 500 mg 1 tab. 2 times a day for 14 days, enoxaparin sodium solution 0.4 ml 2 times a day, subcutaneously, for 5 days, deflazacort 45 mg, for 3 days, then 37.5 mg, for 3 days, then 30 mg, for 5 days, then 22.5 mg, for 5 days, then 15 mg, for 6 days, acetylcysteine 600 mg once a day for 10 days; adjuvant therapy with the administration of gastroprotective preparations, preparations with an effect on the body's energy metabolism, amino acids, preparations for improving the intestinal biocenosis and sedatives; simultaneously, 500 ml of 0.9% ozonated NaCl solution with an oxygen-ozone mixture, with an ozone concentration of 5 µg/ml, is administered intravenously once a day for 7 days, then it is prolonged with the aforementioned solution with an ozone concentration of 3 µg/ml once a day for 5 days, nasal and rectal insufflations are also performed with an oxygen-ozone mixture, at the same time, nasal insufflations are performed with a mixture with an ozone concentration of 10 µg/ml, which is performed for 5...7 min, daily, for 12 days, and rectal insufflations are performed by administering 150...300 ml of a mixture with an ozone concentration of 10...25 µg/ml, daily, for 7 days.