A risk–based approach to the quality of clinical trial (CT) data provides the appropriate conditions for the use of materials at clinical trial site (CTS). One of the most important parameters requires careful monitoring of the temperature mode for storing samples. In case of any temperature failure there can be the data loss that may affect quality of any CT. The procedure of temperature mapping enables to confirm the uniformity and stability parameters of the temperature distribution within the freezers at CTS. Aim. To analyze the guidelines regulating the quality of CT and develop a standard operating procedure (SOP) of the mapping process for freezing equipment at the CTS. Materials and methods. At the Clinical and Diagnostic Center (CDC) of the NUPh the temperature mapping was performed according to the requirements of the WHO in order to prevent risks associated with temperature fluctuations in storage areas of biological samples. This procedure is quite important for the further installation of portable temperature registration systems (data loggers), which are necessary to monitor the temperature regime during CT. Results. At the moment, the documents regulating the mapping procedure are relevant for pharmaceutical manufacturing. However, continuous scientific and technical development, as well as automation of equipment requires the development and implementation of the mapping process into the CT process. Temperature mapping is carried out through a number of requirements, which are partially mentioned in various guidelines on the quality of medical products and the operation of freezing equipment at CTS – guidelines of good practices: Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Distribution Practice (GDP) and Good Automated Manufacturing Practice (GAMP). The latest 2012th edition of the International Society for Pharmaceutical Engineering (ISPE) GAMP–5 is a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. All of these good practices establish the mapping procedure as a required part of the operational and performance qualifications of the freezing equipment used to store drugs in manufacturing, storage facilities and during their transportation, particularly as a part of the “cold chain”. As far as properly calibrated freezing equipment is used during the CT, mapping can also be considered as part of the qualification in a regulatory procedure at CTS. We have developed SOP, which determines the requirements and the algorithm for conducting the mapping procedure at CTS. Conclusions. The current requirements of ISPE GAMP–5 pharmaceutical engineering indicate that mapping is an automated process that has several advantages over the manual data capturing of temperature fluctuations. The mapping process allows continuously recording and storing temperature values at a specified interval for several days using temperature sens
{"title":"The mapping procedure as an essential process during clinical trials","authors":"A. Komarova, K. Zupanets, O. Andrieieva","doi":"10.24959/cphj.19.1508","DOIUrl":"https://doi.org/10.24959/cphj.19.1508","url":null,"abstract":"A risk–based approach to the quality of clinical trial (CT) data provides the appropriate conditions for the use of materials at clinical trial site (CTS). One of the most important parameters requires careful monitoring of the temperature mode for storing samples. In case of any temperature failure there can be the data loss that may affect quality of any CT. The procedure of temperature mapping enables to confirm the uniformity and stability parameters of the temperature distribution within the freezers at CTS. Aim. To analyze the guidelines regulating the quality of CT and develop a standard operating procedure (SOP) of the mapping process for freezing equipment at the CTS. Materials and methods. At the Clinical and Diagnostic Center (CDC) of the NUPh the temperature mapping was performed according to the requirements of the WHO in order to prevent risks associated with temperature fluctuations in storage areas of biological samples. This procedure is quite important for the further installation of portable temperature registration systems (data loggers), which are necessary to monitor the temperature regime during CT. Results. At the moment, the documents regulating the mapping procedure are relevant for pharmaceutical manufacturing. However, continuous scientific and technical development, as well as automation of equipment requires the development and implementation of the mapping process into the CT process. Temperature mapping is carried out through a number of requirements, which are partially mentioned in various guidelines on the quality of medical products and the operation of freezing equipment at CTS – guidelines of good practices: Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Distribution Practice (GDP) and Good Automated Manufacturing Practice (GAMP). The latest 2012th edition of the International Society for Pharmaceutical Engineering (ISPE) GAMP–5 is a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. All of these good practices establish the mapping procedure as a required part of the operational and performance qualifications of the freezing equipment used to store drugs in manufacturing, storage facilities and during their transportation, particularly as a part of the “cold chain”. As far as properly calibrated freezing equipment is used during the CT, mapping can also be considered as part of the qualification in a regulatory procedure at CTS. We have developed SOP, which determines the requirements and the algorithm for conducting the mapping procedure at CTS. Conclusions. The current requirements of ISPE GAMP–5 pharmaceutical engineering indicate that mapping is an automated process that has several advantages over the manual data capturing of temperature fluctuations. The mapping process allows continuously recording and storing temperature values at a specified interval for several days using temperature sens","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"11 1","pages":"38-44"},"PeriodicalIF":0.0,"publicationDate":"2019-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74335180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
One of the most widespread plants in Ukraine is sweet flag (Acorus calamus). Acorus calamus leaves possess the pharmacological properties. In recent years there have been data on the neurotropic properties of Acrous calamus extracts. Aim. To determine the effect of Acorus calamus leaves on the animal’s behavioral responses, anxiety, depression, as well as the muscle tone and the coordination of movements. Materials and methods. The dealcoholized water-alcohol extract of Acorus calamus leaves (conditional name ECL) was obtained by M.S. Yaremenko, a postgraduate student at the Department of Botany of the NUPh under the supervision of prof. T.M. Gontova. The psychotropic and neurotropic properties of the original extract from Acorus calamus leaves in the doses of 1 and 5 ml/kg by the behavioral responses of mice in the open field test, manifestations of depression in the tail suspension test, the course of thiopental-induced anesthesia and physical endurance in the forced swim test were studied. Results. It has been found that the extract from Acorus calamus leaves has a dose-dependent effect on the locomotor, orienting-exploratory activity, as well as the muscle tone and the movement coordination of the experimental animals. In the doses of 1 and 5 ml/kg the extract from Acorus calamus leaves demonstrated a moderate actoprotective activity. The extract from Acorus calamus leaves in the dose of 5 ml/kg showed a moderate analeptic effect. The reference drug Bilobil in a single dose of 100 mg/kg did not show a significant effect on the behavioral responses, manifestations of depression, the course of thiopental-induced anesthesia and physical endurance of mice. Conclusions. The extract from Acorus calamus leaves shows a dose-dependent effect on the animal’s behavioral responses, anxiety, depression, as well as the muscle tone and the coordination of movements. The extract from Acorus calamus leaves demonstrates a moderate actoprotective activity and a moderate analeptic effect. The data obtained indicate the necessity for further in-depth studies of extracts from Acorus calamus leaves to create effective drugs based on them for the correction of the central nervous system disorders.
{"title":"The experimental study of psychotropic and neurotropic properties of Acorus calamus leaves","authors":"L. Derymedvid, L. Korang, V. Tsyvunin","doi":"10.24959/cphj.19.1511","DOIUrl":"https://doi.org/10.24959/cphj.19.1511","url":null,"abstract":"One of the most widespread plants in Ukraine is sweet flag (Acorus calamus). Acorus calamus leaves possess the pharmacological properties. In recent years there have been data on the neurotropic properties of Acrous calamus extracts. Aim. To determine the effect of Acorus calamus leaves on the animal’s behavioral responses, anxiety, depression, as well as the muscle tone and the coordination of movements. Materials and methods. The dealcoholized water-alcohol extract of Acorus calamus leaves (conditional name ECL) was obtained by M.S. Yaremenko, a postgraduate student at the Department of Botany of the NUPh under the supervision of prof. T.M. Gontova. The psychotropic and neurotropic properties of the original extract from Acorus calamus leaves in the doses of 1 and 5 ml/kg by the behavioral responses of mice in the open field test, manifestations of depression in the tail suspension test, the course of thiopental-induced anesthesia and physical endurance in the forced swim test were studied. Results. It has been found that the extract from Acorus calamus leaves has a dose-dependent effect on the locomotor, orienting-exploratory activity, as well as the muscle tone and the movement coordination of the experimental animals. In the doses of 1 and 5 ml/kg the extract from Acorus calamus leaves demonstrated a moderate actoprotective activity. The extract from Acorus calamus leaves in the dose of 5 ml/kg showed a moderate analeptic effect. The reference drug Bilobil in a single dose of 100 mg/kg did not show a significant effect on the behavioral responses, manifestations of depression, the course of thiopental-induced anesthesia and physical endurance of mice. Conclusions. The extract from Acorus calamus leaves shows a dose-dependent effect on the animal’s behavioral responses, anxiety, depression, as well as the muscle tone and the coordination of movements. The extract from Acorus calamus leaves demonstrates a moderate actoprotective activity and a moderate analeptic effect. The data obtained indicate the necessity for further in-depth studies of extracts from Acorus calamus leaves to create effective drugs based on them for the correction of the central nervous system disorders.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"11 1","pages":"10-16"},"PeriodicalIF":0.0,"publicationDate":"2019-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85313033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The methodology for development and standardization of medicinal, veterinary and cosmetic agents based on sapropel and its processing products","authors":"O. Strus, N. Polovko","doi":"10.24959/cphj.19.1505","DOIUrl":"https://doi.org/10.24959/cphj.19.1505","url":null,"abstract":"","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"88 1","pages":"52-62"},"PeriodicalIF":0.0,"publicationDate":"2019-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74274678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
experiment The treatment of burns with topical preparations, namely ointments, which consist of herbal ingredients, becomes relevant among the population due to the fact that this dosage form is the most convenient to apply as self-medication; and biologically active substances that are part of these medicines are less toxic, and at the same time, they are not less effective than synthetic drugs against burn damages. Aim . To study the wound-healing effect of drugs containing biologically active herbal ingredients using the model of burn wound. Materials and methods . The study was conducted on 24 white female rats weighing 200-240 g. The experimental animals were divided into 4 groups: Group 1 – pathology (n = 6); Group 2 – animals treated with Wundahyl ointment (n = 6); Group 3 – animals treated with Spasatel Forte ointment (n = 6); Group 4 – animals treated with 2 % thiotriazoline ointment (n = 6). Results . When treating the burn wounds with Wundahyl ointment and 2 % thiotriazoline ointment the wound-healing progression was better. The burn wound area for the following two weeks of observation (Days 14-21) decreased faster compared to the application of Spasatel Forte ointment and much faster in compared to the group of pathology. On Day 28, the burn wound was epithelized completely. Conclusions . According to the results of the experiment, the effect of Wundahyl ointment was the most pronounced in relation to all the soft dosage forms under study.
{"title":"The study of the impact of herbal medicinal products in soft dosage forms on the burn wound progression in the experiment","authors":"T. Iermolenko, N. Ruda, Elena Pautina","doi":"10.24959/cphj.19.1506","DOIUrl":"https://doi.org/10.24959/cphj.19.1506","url":null,"abstract":"experiment The treatment of burns with topical preparations, namely ointments, which consist of herbal ingredients, becomes relevant among the population due to the fact that this dosage form is the most convenient to apply as self-medication; and biologically active substances that are part of these medicines are less toxic, and at the same time, they are not less effective than synthetic drugs against burn damages. Aim . To study the wound-healing effect of drugs containing biologically active herbal ingredients using the model of burn wound. Materials and methods . The study was conducted on 24 white female rats weighing 200-240 g. The experimental animals were divided into 4 groups: Group 1 – pathology (n = 6); Group 2 – animals treated with Wundahyl ointment (n = 6); Group 3 – animals treated with Spasatel Forte ointment (n = 6); Group 4 – animals treated with 2 % thiotriazoline ointment (n = 6). Results . When treating the burn wounds with Wundahyl ointment and 2 % thiotriazoline ointment the wound-healing progression was better. The burn wound area for the following two weeks of observation (Days 14-21) decreased faster compared to the application of Spasatel Forte ointment and much faster in compared to the group of pathology. On Day 28, the burn wound was epithelized completely. Conclusions . According to the results of the experiment, the effect of Wundahyl ointment was the most pronounced in relation to all the soft dosage forms under study.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87321215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
V. Kapustnik, B. Shelest, Yu. O. Kovalyova, O. Shelest, V. Brek
The combined course of arterial hypertension (AH) with overweight or abdominal obesity is considered as one of the most common type of comorbid pathology leading to a significant increase of cardiovascular complications. Aim. To study the effects of telmisartan on the intracardiac hemodynamics, the functional state of the myocardium, the lipid and carbohydrate profile in patients with arterial hypertension (AH) and obesity. Materials and methods. 50 patients with AH of stage II were examined, they were divided into 2 groups. The first (main) group consisted of 23 patients with stage II arterial hypertension and the normal body weight. In the second group (reference group) there were 27 patients, who were diagnosed with AH of stage II and obesity. The diagnosis was verified using laboratory instrumental methods in accordance with the recommendations of the European Cardiologic Society (2013). Obesity was assessed by the body mass index and the waist to the hip ratio. The lipid profile was determined by the enzymatic method. Results. It has been found in the study that the level of values of systolic blood pressure (SBP) in hypertensive patients with the normal body weight treated with telmisartan decreased by 14.5 %, while diastolic blood pressure (DBP) reduced by 11.4 %. In patients with AH of stage II having obesity the SBP level also decreased by 13.4 % and DBP – by 11.5 %. In 3 months of treatment the regression dynamics of the end-diastolic and end-systolic dimensions of the heart in the group of patients without obesity led to a significant decrease in these parameters compared to the baseline values. In obese patients these indicators also decreased; however, they did not reach reliable values. When treating with telmisartan there was a decrease in lipids in AH patients (total cholesterol (TC)– (5.5 %), cholesterol of low density lipoproteins (LDL) – 6.2 %, triglycerides (TG) 7.8 %, cholesterol of HDL – by 10.4 % (p <0.05), there were also unreliable changes in AH patients associated with obesity (total cholesterol – by 5.9 %, LDL – 5.1 %, TG – 8.8 % and increased cholesterol of HDL – by 6.4 %). After the treatment the indicators of carbohydrate metabolism decreased (glycosylated hemoglobin (HbA1c) by 8.45 % and 19.17 %, insulin – by 3.2 % and 13.38 % glucose – by 5.65 % and 4.73 %, respectively, in groups). Conclusions. The study has shown that telmisartan has indirect positive effects on intracardiac hemodynamics due to decrease of blood pressure both in AH patients having the normal body weight and patients with obesity. The use of telmisartan as an antihypertensive agent gives a hypolipidemic effect, improves the parameters of the carbohydrate metabolism in AH patients with the normal body weight and with obesity. These data can be markers for assessing the effectiveness of hypotensive therapy with telmisartan.
{"title":"The use of telmisartan in the treatment of arterial hypertension with obesity","authors":"V. Kapustnik, B. Shelest, Yu. O. Kovalyova, O. Shelest, V. Brek","doi":"10.24959/CPHJ.18.1447","DOIUrl":"https://doi.org/10.24959/CPHJ.18.1447","url":null,"abstract":"The combined course of arterial hypertension (AH) with overweight or abdominal obesity is considered as one of the most common type of comorbid pathology leading to a significant increase of cardiovascular complications. Aim. To study the effects of telmisartan on the intracardiac hemodynamics, the functional state of the myocardium, the lipid and carbohydrate profile in patients with arterial hypertension (AH) and obesity. Materials and methods. 50 patients with AH of stage II were examined, they were divided into 2 groups. The first (main) group consisted of 23 patients with stage II arterial hypertension and the normal body weight. In the second group (reference group) there were 27 patients, who were diagnosed with AH of stage II and obesity. The diagnosis was verified using laboratory instrumental methods in accordance with the recommendations of the European Cardiologic Society (2013). Obesity was assessed by the body mass index and the waist to the hip ratio. The lipid profile was determined by the enzymatic method. Results. It has been found in the study that the level of values of systolic blood pressure (SBP) in hypertensive patients with the normal body weight treated with telmisartan decreased by 14.5 %, while diastolic blood pressure (DBP) reduced by 11.4 %. In patients with AH of stage II having obesity the SBP level also decreased by 13.4 % and DBP – by 11.5 %. In 3 months of treatment the regression dynamics of the end-diastolic and end-systolic dimensions of the heart in the group of patients without obesity led to a significant decrease in these parameters compared to the baseline values. In obese patients these indicators also decreased; however, they did not reach reliable values. When treating with telmisartan there was a decrease in lipids in AH patients (total cholesterol (TC)– (5.5 %), cholesterol of low density lipoproteins (LDL) – 6.2 %, triglycerides (TG) 7.8 %, cholesterol of HDL – by 10.4 % (p <0.05), there were also unreliable changes in AH patients associated with obesity (total cholesterol – by 5.9 %, LDL – 5.1 %, TG – 8.8 % and increased cholesterol of HDL – by 6.4 %). After the treatment the indicators of carbohydrate metabolism decreased (glycosylated hemoglobin (HbA1c) by 8.45 % and 19.17 %, insulin – by 3.2 % and 13.38 % glucose – by 5.65 % and 4.73 %, respectively, in groups). Conclusions. The study has shown that telmisartan has indirect positive effects on intracardiac hemodynamics due to decrease of blood pressure both in AH patients having the normal body weight and patients with obesity. The use of telmisartan as an antihypertensive agent gives a hypolipidemic effect, improves the parameters of the carbohydrate metabolism in AH patients with the normal body weight and with obesity. These data can be markers for assessing the effectiveness of hypotensive therapy with telmisartan.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"30 1","pages":"4-9"},"PeriodicalIF":0.0,"publicationDate":"2018-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75898048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Y. Grintsov, A. Fedosov, Moroz Va, Y. Timchenko, A. Shalamay
Today herbal medicines become more and more popular in the world due to their inherent advantages over drugs of the chemical origin. A long historical experience of application, the high safety profile, its complex action, as well as the possibility of the long-term use without significant side effects cause an increase in their consumption around the world. At the same time, the practice of using herbal medicines is significantly hindered by the lack of scientific information about their mechanisms of action, potential adverse reactions, contraindications and interactions with other drugs and food. The publication considers scientometric data on the possible use of medicines based on leaves of artichoke and garlic in the clinical medicine. The existing information based on the preclinical and clinical studies has been analyzed. Particular attention is paid to the results of controlled clinical trials. The attention is drawn to very good tolerability and safety of herbal medicines from artichoke and garlic, which, in particular, allows their use in children, geriatric patients, pregnancy, etc. The conclusion has been made that these medicines have significant prospects for widespread use, and the existing scientific data allow their wide clinical use separately and in combination with a variety of diseases and pathological conditions.
{"title":"Prospects of application of the complex with artichoke and garlic in clinical medicine","authors":"Y. Grintsov, A. Fedosov, Moroz Va, Y. Timchenko, A. Shalamay","doi":"10.24959/CPHJ.17.1431","DOIUrl":"https://doi.org/10.24959/CPHJ.17.1431","url":null,"abstract":"Today herbal medicines become more and more popular in the world due to their inherent advantages over drugs of the chemical origin. A long historical experience of application, the high safety profile, its complex action, as well as the possibility of the long-term use without significant side effects cause an increase in their consumption around the world. At the same time, the practice of using herbal medicines is significantly hindered by the lack of scientific information about their mechanisms of action, potential adverse reactions, contraindications and interactions with other drugs and food. The publication considers scientometric data on the possible use of medicines based on leaves of artichoke and garlic in the clinical medicine. The existing information based on the preclinical and clinical studies has been analyzed. Particular attention is paid to the results of controlled clinical trials. The attention is drawn to very good tolerability and safety of herbal medicines from artichoke and garlic, which, in particular, allows their use in children, geriatric patients, pregnancy, etc. The conclusion has been made that these medicines have significant prospects for widespread use, and the existing scientific data allow their wide clinical use separately and in combination with a variety of diseases and pathological conditions.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"2 1","pages":"11-20"},"PeriodicalIF":0.0,"publicationDate":"2017-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78662374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Non-alcoholic fatty liver disease and non-alcoholic steatohepatitis (NASH) have become the most common liver diseases in the world. Aim. To conduct the clinico-economic analysis of pharmacotherapy in patients with NASH, who underwent treatment in one of the healthcare institutions of Kharkiv in 2013. Materials and methods. The study materials were case histories of patients and such regulatory documents of the Ministry of Health of Ukraine as the State Formulary (SF) of Medicines of Ukraine (2013), methodological recommendations on the diagnosis and pharmacotherapy of the digestive system diseases (2007), the Unified Clinical Protocol (UCP) “Non-alcoholic steatohepatitis” (Order No. 826 dated November 6, 2014). The pharmacoeconomic methods used were ABC, VEN and frequency analyses. Results. The results of the study demonstrated that the pharmacotherapy of patients with NASH complied with the main requirements specified in the Ukrainian Methodological Recommendations (2007), but did not meet the requirements of the NASH UCP by the approaches of the pathogenetic therapy prescribed. The results of “formal” VEN analysis showed that most drugs prescribed (76 %) were classified as group V – vital drugs since they were present in the SF of Ukraine. A predominant portion (83.2 %) of costs associated with the pharmacotherapy in patients with NASH was spent on these drugs. However, 16.8 % of the costs spent on 24 % of drugs, which are absent in the SF, indicates the need for further correction of the NASH pharmacotherapy in the healthcare institution under study. Conclusions. The pharmacotherapy of patients with NASH in the healthcare institution of Kharkiv is rational from clinical and economic point of view, but requires further correction in accordance with the SF and the new UCP for NASH.
{"title":"The clinico-economic analysis of pharmacotherapy in patients with non-alcoholic steatohepatitis","authors":"O. Tkachova, M. Allaberdiev","doi":"10.24959/CPHJ.17.1416","DOIUrl":"https://doi.org/10.24959/CPHJ.17.1416","url":null,"abstract":"Non-alcoholic fatty liver disease and non-alcoholic steatohepatitis (NASH) have become the most common liver diseases in the world. Aim. To conduct the clinico-economic analysis of pharmacotherapy in patients with NASH, who underwent treatment in one of the healthcare institutions of Kharkiv in 2013. Materials and methods. The study materials were case histories of patients and such regulatory documents of the Ministry of Health of Ukraine as the State Formulary (SF) of Medicines of Ukraine (2013), methodological recommendations on the diagnosis and pharmacotherapy of the digestive system diseases (2007), the Unified Clinical Protocol (UCP) “Non-alcoholic steatohepatitis” (Order No. 826 dated November 6, 2014). The pharmacoeconomic methods used were ABC, VEN and frequency analyses. Results. The results of the study demonstrated that the pharmacotherapy of patients with NASH complied with the main requirements specified in the Ukrainian Methodological Recommendations (2007), but did not meet the requirements of the NASH UCP by the approaches of the pathogenetic therapy prescribed. The results of “formal” VEN analysis showed that most drugs prescribed (76 %) were classified as group V – vital drugs since they were present in the SF of Ukraine. A predominant portion (83.2 %) of costs associated with the pharmacotherapy in patients with NASH was spent on these drugs. However, 16.8 % of the costs spent on 24 % of drugs, which are absent in the SF, indicates the need for further correction of the NASH pharmacotherapy in the healthcare institution under study. Conclusions. The pharmacotherapy of patients with NASH in the healthcare institution of Kharkiv is rational from clinical and economic point of view, but requires further correction in accordance with the SF and the new UCP for NASH.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"126 1","pages":"4-9"},"PeriodicalIF":0.0,"publicationDate":"2017-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86802098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Although hemophilia A is a rare disease, its treatment is costly, and expenses are mainly related to the cost of factor VIII concentrates. Aim. To evaluate the clinical and economic feasibility of rFVIIa (NovoSeven®) for the treatment of patients with hemophilia A compared to the schemes based on the use of APCC (Feiba). Matherials and methods. Clinical and economic analysis was conducted by the “total cost of illness” method using modeling by building a “decision tree”. This study identifies only the direct costs of pharmacotherapy. The cost of a vial of each of the concentrates analyzed meets the declared value as of December 2016. Results. The analytical model of the “decision tree” was designed to calculate the costs for the outpatient treatment of mild and moderate bleedings. Due to higher clinical efficacy the use of rFVIIa as the first-line therapy saves 32 % to 42 % in the treatment of a patient; in the conditions of the modern Ukrainian pharmaceutical market it is from UAH 170,326.4 to UAH 252,990.4 (with an adapted variant of therapy) and UAH 291,743.1 in the basic variant. When using rFVIIa as the first-line therapy the costs for life appeared to be lower by approximately 10 % than when taking APCC. Conclusions. The use of NovoSeven® is more feasible economically and allows both to improve outcomes and to spend financial resources more efficiently to treat these patients.
{"title":"Clinical and economic analysis of different strategies for the treatment of hemophilia A","authors":"N. Bezditko, O. Stasyshyn","doi":"10.24959/cphj.17.1414","DOIUrl":"https://doi.org/10.24959/cphj.17.1414","url":null,"abstract":"Although hemophilia A is a rare disease, its treatment is costly, and expenses are mainly related to the cost of factor VIII concentrates. Aim. To evaluate the clinical and economic feasibility of rFVIIa (NovoSeven®) for the treatment of patients with hemophilia A compared to the schemes based on the use of APCC (Feiba). Matherials and methods. Clinical and economic analysis was conducted by the “total cost of illness” method using modeling by building a “decision tree”. This study identifies only the direct costs of pharmacotherapy. The cost of a vial of each of the concentrates analyzed meets the declared value as of December 2016. Results. The analytical model of the “decision tree” was designed to calculate the costs for the outpatient treatment of mild and moderate bleedings. Due to higher clinical efficacy the use of rFVIIa as the first-line therapy saves 32 % to 42 % in the treatment of a patient; in the conditions of the modern Ukrainian pharmaceutical market it is from UAH 170,326.4 to UAH 252,990.4 (with an adapted variant of therapy) and UAH 291,743.1 in the basic variant. When using rFVIIa as the first-line therapy the costs for life appeared to be lower by approximately 10 % than when taking APCC. Conclusions. The use of NovoSeven® is more feasible economically and allows both to improve outcomes and to spend financial resources more efficiently to treat these patients.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"39 1","pages":"10-18"},"PeriodicalIF":0.0,"publicationDate":"2017-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81107965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anthracycline antitumor antibiotics are widely used for the treatment of malignancies, but this group of drugs is known for their cytotoxic effects, especially cardiotoxicity. It has been proven that the adverse effect of anthracyclines on tissues is based on formation of the reactive oxygen species that enhance development of the oxidative stress. Among the body biomolecules proteins are the most sensitive to peroxidation; they can be the primary markers in determining this pathological process at the cellular level. To identify and prevent the oxidative stress is important for prevention of further tissue apoptosis and necrosis. The aim of the study was to investigate the effect of nicotinic acid and the complex compound of germanium with nicotinic acid (MIGU-1) on oxidative modification of myocardial and hepatic proteins in the experimental chronic intoxication with doxorubicin (CID) in rats. The pattern of modifications in the content of protein peroxidation products (neutral and basic 2,4-dinitrophenylhydrazine) in cardiomyocytes and hepatocytes in rats has been determined; it shows intensification of the oxidative stress in CID. Nicotinic acid in the dose of 10 mg/kg daily did not exhibit the hepatoprotective effect in CID. It has been proven that the use of the new complex compound of germanium with nicotinic acid in the dose of 10 mg/kg daily provide attenuation of protein peroxidation in rats’ cardiomyocytes and hepatocytes in CID. The results obtained allow considering MIGU-1 as a drug with a possible cytoprotective activity, and its further study may be topical and prospective.
{"title":"The effect of the germanium complex with nicotinic acid on oxidative modification of cardiac and hepatic proteins in the experimental chronic intoxication with doxorubicin in rats","authors":"V. Narokha","doi":"10.24959/CPHJ.16.1381","DOIUrl":"https://doi.org/10.24959/CPHJ.16.1381","url":null,"abstract":"Anthracycline antitumor antibiotics are widely used for the treatment of malignancies, but this group of drugs is known for their cytotoxic effects, especially cardiotoxicity. It has been proven that the adverse effect of anthracyclines on tissues is based on formation of the reactive oxygen species that enhance development of the oxidative stress. Among the body biomolecules proteins are the most sensitive to peroxidation; they can be the primary markers in determining this pathological process at the cellular level. To identify and prevent the oxidative stress is important for prevention of further tissue apoptosis and necrosis. The aim of the study was to investigate the effect of nicotinic acid and the complex compound of germanium with nicotinic acid (MIGU-1) on oxidative modification of myocardial and hepatic proteins in the experimental chronic intoxication with doxorubicin (CID) in rats. The pattern of modifications in the content of protein peroxidation products (neutral and basic 2,4-dinitrophenylhydrazine) in cardiomyocytes and hepatocytes in rats has been determined; it shows intensification of the oxidative stress in CID. Nicotinic acid in the dose of 10 mg/kg daily did not exhibit the hepatoprotective effect in CID. It has been proven that the use of the new complex compound of germanium with nicotinic acid in the dose of 10 mg/kg daily provide attenuation of protein peroxidation in rats’ cardiomyocytes and hepatocytes in CID. The results obtained allow considering MIGU-1 as a drug with a possible cytoprotective activity, and its further study may be topical and prospective.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"36 1","pages":"35-38"},"PeriodicalIF":0.0,"publicationDate":"2016-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88906106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Epidemiological data indicate the widespread dissemination and constant dynamics of the incidence rate of herpesvirus infections due to a variety of forms and transmission paths of the virus, highly contagious and life-long persistence of the herpes virus in the body of the infected persons and the lack of effectiveness of existing treatments. Acyclic guanosine derivatives are the main group of antiviral drugs traditionally used for the causal treatment of herpes infections. They have a number of disadvantages, in particular formation of the virus resistance in a long-term use, the need to involve immunotherapy, as well as the high cost of treatment. The accumulated clinical experience with the original Ukrainian drug Proteflazid® (drops) in treating viral infections, including HHV- infections, shows its high clinical efficacy and safety. A relative estimation of the course treatment costs of herpes-induced infections using antiviral drugs has demonstrated the economic expediency of Proteflazid® with the purpose of treatment and maintenance therapy. Proteflazid® takes the medium sized niche among other antiherpetic drugs. In addition, due to the multi-vector nature of its pharmacodynamic effects (direct antiviral, immunomodulating, interferon-stimulating, antioxidant, apoptosis-modulating, etc.) Proteflazid® allows to exclude antioxidants, immunomodulators from the antiherpetic therapy scheme, or to adjust their use, and it can significantly reduce the cost per a course of treatment.
{"title":"Proteflazid®: clinical and economic substantiation for use in therapy of herpes infection","authors":"I. Zupanets, T. Sakharova","doi":"10.24959/CPHJ.16.1396","DOIUrl":"https://doi.org/10.24959/CPHJ.16.1396","url":null,"abstract":"Epidemiological data indicate the widespread dissemination and constant dynamics of the incidence rate of herpesvirus infections due to a variety of forms and transmission paths of the virus, highly contagious and life-long persistence of the herpes virus in the body of the infected persons and the lack of effectiveness of existing treatments. Acyclic guanosine derivatives are the main group of antiviral drugs traditionally used for the causal treatment of herpes infections. They have a number of disadvantages, in particular formation of the virus resistance in a long-term use, the need to involve immunotherapy, as well as the high cost of treatment. The accumulated clinical experience with the original Ukrainian drug Proteflazid® (drops) in treating viral infections, including HHV- infections, shows its high clinical efficacy and safety. A relative estimation of the course treatment costs of herpes-induced infections using antiviral drugs has demonstrated the economic expediency of Proteflazid® with the purpose of treatment and maintenance therapy. Proteflazid® takes the medium sized niche among other antiherpetic drugs. In addition, due to the multi-vector nature of its pharmacodynamic effects (direct antiviral, immunomodulating, interferon-stimulating, antioxidant, apoptosis-modulating, etc.) Proteflazid® allows to exclude antioxidants, immunomodulators from the antiherpetic therapy scheme, or to adjust their use, and it can significantly reduce the cost per a course of treatment.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"7 1","pages":"6-12"},"PeriodicalIF":0.0,"publicationDate":"2016-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82250334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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