Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis
Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An a...
Ausführliche Beschreibung
Autor*in: |
V. V. Karabaeva [verfasserIn] L. V. Krepkova [verfasserIn] A. N. Babenko [verfasserIn] V. V. Bortnikova [verfasserIn] T. V. Fateeva [verfasserIn] P. G. Mizina [verfasserIn] N. S. Mikheeva [verfasserIn] O. N. Karabaeva [verfasserIn] |
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Russisch |
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2021 |
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In: Разработка и регистрация лекарственных средств - LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020, 10(2021), 4, Seite 169-176 |
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volume:10 ; year:2021 ; number:4 ; pages:169-176 |
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DOI / URN: |
10.33380/2305-2066-2021-10-4-169-176 |
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DOAJ035198389 |
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520 | |a Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. | ||
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700 | 0 | |a V. V. Bortnikova |e verfasserin |4 aut | |
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10.33380/2305-2066-2021-10-4-169-176 doi (DE-627)DOAJ035198389 (DE-599)DOAJ13b31762b73b46ea9ead0ecd807846e0 DE-627 ger DE-627 rakwb rus HD9665-9675 V. V. Karabaeva verfasserin aut Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. «флакозид» вирусный гепатит а вирусный гепатит в вирусный гепатит с экспериментальные и клинические исследования Pharmaceutical industry L. V. Krepkova verfasserin aut A. N. Babenko verfasserin aut V. V. Bortnikova verfasserin aut T. V. Fateeva verfasserin aut P. G. Mizina verfasserin aut N. S. Mikheeva verfasserin aut O. N. Karabaeva verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 10(2021), 4, Seite 169-176 (DE-627)1760622966 26585049 nnns volume:10 year:2021 number:4 pages:169-176 https://doi.org/10.33380/2305-2066-2021-10-4-169-176 kostenfrei https://doaj.org/article/13b31762b73b46ea9ead0ecd807846e0 kostenfrei https://www.pharmjournal.ru/jour/article/view/1076 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 10 2021 4 169-176 |
spelling |
10.33380/2305-2066-2021-10-4-169-176 doi (DE-627)DOAJ035198389 (DE-599)DOAJ13b31762b73b46ea9ead0ecd807846e0 DE-627 ger DE-627 rakwb rus HD9665-9675 V. V. Karabaeva verfasserin aut Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. «флакозид» вирусный гепатит а вирусный гепатит в вирусный гепатит с экспериментальные и клинические исследования Pharmaceutical industry L. V. Krepkova verfasserin aut A. N. Babenko verfasserin aut V. V. Bortnikova verfasserin aut T. V. Fateeva verfasserin aut P. G. Mizina verfasserin aut N. S. Mikheeva verfasserin aut O. N. Karabaeva verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 10(2021), 4, Seite 169-176 (DE-627)1760622966 26585049 nnns volume:10 year:2021 number:4 pages:169-176 https://doi.org/10.33380/2305-2066-2021-10-4-169-176 kostenfrei https://doaj.org/article/13b31762b73b46ea9ead0ecd807846e0 kostenfrei https://www.pharmjournal.ru/jour/article/view/1076 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 10 2021 4 169-176 |
allfields_unstemmed |
10.33380/2305-2066-2021-10-4-169-176 doi (DE-627)DOAJ035198389 (DE-599)DOAJ13b31762b73b46ea9ead0ecd807846e0 DE-627 ger DE-627 rakwb rus HD9665-9675 V. V. Karabaeva verfasserin aut Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. «флакозид» вирусный гепатит а вирусный гепатит в вирусный гепатит с экспериментальные и клинические исследования Pharmaceutical industry L. V. Krepkova verfasserin aut A. N. Babenko verfasserin aut V. V. Bortnikova verfasserin aut T. V. Fateeva verfasserin aut P. G. Mizina verfasserin aut N. S. Mikheeva verfasserin aut O. N. Karabaeva verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 10(2021), 4, Seite 169-176 (DE-627)1760622966 26585049 nnns volume:10 year:2021 number:4 pages:169-176 https://doi.org/10.33380/2305-2066-2021-10-4-169-176 kostenfrei https://doaj.org/article/13b31762b73b46ea9ead0ecd807846e0 kostenfrei https://www.pharmjournal.ru/jour/article/view/1076 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 10 2021 4 169-176 |
allfieldsGer |
10.33380/2305-2066-2021-10-4-169-176 doi (DE-627)DOAJ035198389 (DE-599)DOAJ13b31762b73b46ea9ead0ecd807846e0 DE-627 ger DE-627 rakwb rus HD9665-9675 V. V. Karabaeva verfasserin aut Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. «флакозид» вирусный гепатит а вирусный гепатит в вирусный гепатит с экспериментальные и клинические исследования Pharmaceutical industry L. V. Krepkova verfasserin aut A. N. Babenko verfasserin aut V. V. Bortnikova verfasserin aut T. V. Fateeva verfasserin aut P. G. Mizina verfasserin aut N. S. Mikheeva verfasserin aut O. N. Karabaeva verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 10(2021), 4, Seite 169-176 (DE-627)1760622966 26585049 nnns volume:10 year:2021 number:4 pages:169-176 https://doi.org/10.33380/2305-2066-2021-10-4-169-176 kostenfrei https://doaj.org/article/13b31762b73b46ea9ead0ecd807846e0 kostenfrei https://www.pharmjournal.ru/jour/article/view/1076 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 10 2021 4 169-176 |
allfieldsSound |
10.33380/2305-2066-2021-10-4-169-176 doi (DE-627)DOAJ035198389 (DE-599)DOAJ13b31762b73b46ea9ead0ecd807846e0 DE-627 ger DE-627 rakwb rus HD9665-9675 V. V. Karabaeva verfasserin aut Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. «флакозид» вирусный гепатит а вирусный гепатит в вирусный гепатит с экспериментальные и клинические исследования Pharmaceutical industry L. V. Krepkova verfasserin aut A. N. Babenko verfasserin aut V. V. Bortnikova verfasserin aut T. V. Fateeva verfasserin aut P. G. Mizina verfasserin aut N. S. Mikheeva verfasserin aut O. N. Karabaeva verfasserin aut In Разработка и регистрация лекарственных средств LLC Center of Pharmaceutical Analytics (LLC «CPHA»), 2020 10(2021), 4, Seite 169-176 (DE-627)1760622966 26585049 nnns volume:10 year:2021 number:4 pages:169-176 https://doi.org/10.33380/2305-2066-2021-10-4-169-176 kostenfrei https://doaj.org/article/13b31762b73b46ea9ead0ecd807846e0 kostenfrei https://www.pharmjournal.ru/jour/article/view/1076 kostenfrei https://doaj.org/toc/2305-2066 Journal toc kostenfrei https://doaj.org/toc/2658-5049 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 10 2021 4 169-176 |
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Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. 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The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. 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HD9665-9675 Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis «флакозид» вирусный гепатит а вирусный гепатит в вирусный гепатит с экспериментальные и клинические исследования |
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Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis |
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Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis |
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V. V. Karabaeva |
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V. V. Karabaeva L. V. Krepkova A. N. Babenko V. V. Bortnikova T. V. Fateeva P. G. Mizina N. S. Mikheeva O. N. Karabaeva |
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retrospective analysis of experimental and clinical studies of flakozid in viral hepatitis |
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Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis |
abstract |
Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. |
abstractGer |
Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. |
abstract_unstemmed |
Introduction. Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. In vitro experiments have established a high antiviral activity of flakozid against the hepatitis C virus, which justifies the possibility of conducting clinical studies of the drug in patients with the viral hepatitis C. |
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Retrospective Analysis of Experimental and Clinical Studies of Flakozid in Viral Hepatitis |
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Viral hepatitis (HV) by its socio-economic significance occupies one of the leading places in human infectious pathology, therefore, the development of fundamentally new methods of prevention, diagnosis and treatment, as well as the creation of new antiviral drugs remain relevant. An antiviral herbal drug "Flakozid" has been created in VILAR, which is presented in a dosage form – 0,1 g tablets for oral administration.Аim. To analyze the experimental and clinical efficacy and safety of flakozid therapy in viral hepatitis.Materials and methods. Experimental study of the effect of flakozid on viral hepatitis A (HAV). The AGMK cell culture (BS-C-1 line) and the hepatitis A virus strain HM 175 adapted to it were used in the work. The studies were conducted in two series of experiments using different concentrations of the drug, which was introduced into cultures simultaneously with the infection of HAV. Experimental study of the effect of flakozid on viral hepatitis C (HCV). In the present experiments, a virus-containing culture fluid collected from infected cultures of chicken embryo fibroblasts containing 7,0 lg TCD50/ml of infectious HCV (genotype 1b) was used. The cytotoxic, viricidal and antiviral activity of flakozid was studied using transplanted cultures of pig embryo kidney cells (SPEV) obtained from the collection of cell lines of the D. I. Ivanovsky Research institute of virology of the Ministry of Health of the Russian Federation. In the experiments, a one-day monolayer of cells grown in 96-well plastic culture panels was used. ID50 – the concentration of the drug "Flacozid", which inhibits the development of the virus in the monolayer by 50 %, and CD50 – its minimum concentration, which causes cytotoxic destruction of 50 % of the cells of the monolayer, as well as the CTI – chemotherapeutic index, calculated as the ratio of CD50 to ID50, were determined. A well – known domestic antiviral agent, "Ribavirin", was used as a comparison drug. Clinical studies of flakozid in viral hepatitis A. The results of clinical studies of the antiviral drug "Flakozid" (0,1 g tablets) were analyzed in 258 patients with viral hepatitis A. "Flakozid" was prescribed to patients with a moderate course of the disease, 0,1 g 3 times a day for 20 days against the background of basic therapy: diet, alkaline drinking, Enterodes®. The therapeutic effect was assessed by clinical (weakness, decreased appetite, nausea, vomiting) and biochemical parameters (the level of direct bilirubin, transaminase activity), as well as by the severity of hepatolienal syndrome. Clinical studies of flakozid in viral hepatitis В. The results of clinical studies of the antiviral drug "Flakozid"(0,1 g tablets) were analyzed in 410 patients with acute viral hepatitis B, which was regarded as moderate. "Flakozid" was prescribed against the background of basic therapy: diet and detoxification therapy: 5 % glucose solution, 5 % ascorbic acid solution, "Hemodesi", at a daily dose of 0,3–0,8 g for up to 38 days. The comparison group received the same basic therapy without flakozid. The dynamics of clinical symptoms (general weakness, headache, sleep disorders, dizziness, nausea, vomiting, impaired appetite, itchy skin, pain in the right hypochondrium, jaundice, etc.), data from laboratory examination methods were evaluated, markers of hepatitis B – HBeAg and Australian antigen (HBsAg) were determined every 10 days and indicators of cellular immunity before the appointment and after 21 days of treatment; the absolute number of lymphocytes, the total number of T-lymphocytes, as well as theophylline-resistant and theophylline-sensitive cells.Results and discussion. The results of experimental studies revealed the antiviral effect of flakozid against the hepatitis A virus, confirmed during clinical studies in adult patients. Treatment with flakozid in patients with viral hepatitis A against the background of basic therapy at a daily dose of 0,3 g for 20 days led to a significant reduction in the symptoms of intoxication, a reduction in the jaundice period, normalization of the size of the liver and spleen. Treatment with flakozid as part of complex therapy of patients with acute viral hepatitis B (AHVB) of moderate severity in daily doses of 0,3–0,8 g for 38 days showed its high effectiveness, contributing to a faster disappearance of clinical symptoms of the disease (improvement of the general condition of patients, reduction of the severity and disappearance of clinical symptoms of intoxication, reducing of the jaundice period), normalization of biochemical parameters (reducing the level of bilirubin and transaminase activity), as well as elimination of HBsAg from the blood, stimulation of cellular immunity. "Flakozid" was well tolerated, did not cause allergic reactions. Based on the results of clinical studies, "Flakozid" is approved for medical use as an antiviral agent (registration number 90/248/7). The high antiviral activity of flakozid against the hepatitis C virus in cell cultures was established. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to ribavirin, and in terms of CTI it was noticeably superior.Conclusion. Treatment with flakozid in patients with viral hepatitis A and B showed its high efficiency, contributed to a faster disappearance of clinical symptoms of the disease, normalization of biochemical parameters, elimination of HCV from the blood, good tolerability. "Flakozid" is recommended in clinical practice in the complex treatment of hepatitis A and B. 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Krepkova</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">A. N. Babenko</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">V. V. Bortnikova</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">T. V. Fateeva</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">P. G. Mizina</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">N. S. 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