Vol 10, No 3 (2022)


Cluster analysis of integrated “drug supply” concept

Barkaev G.S., Kabakova T.I., Goryachev A.B.


The aim of the article is the structure and content specification of the subject area professional term “drug supply” in order to deepen and concretize the conceptual apparatus in the field of the pharmaceutical activity.

Materials and methods. The review presents the analysis of 389 titles of scientific pharmaceutical publications for the periods of 1995–1998 and 2010–2019. The selection of publications was carried out by the random sampling based on the phrases: «drug provision», «medical care», «provision of medicines», «pharmaceutical care», «medicinal services», «drug supply» and their English-language counterparts in Russian and foreign electronic information sources. A methodological base of the study was a cluster analysis of the subject area concept of “drug supply” according to the methodology proposed by E.A. Korzhavykh and I.V. Voronovich. In this study, a cluster was interpreted as a set of publications in which a certain pair of terms was simultaneously cited with a preset frequency of co-citation.

Results. When analyzing the publications, two clusters of the “drug supply” concept were formed for the time periods indicated above. The comparison of the clusters showed an increase in the activity of the scientific research to expand the structure and content of the subject area of the “drug supply” concept. For the modern cluster, 124 co – cited pairs of lexical units were selected. They were grouped into 9 hierarchy levels according to the strength of relationship between an interval of 10 units and mentioning frequencies of the “drug supply” term. At the final stage, a graphical model of the “drug supply” concept cluster was formed. It was established that the lexical units included from the first to the fifth level, are the cluster nucleus of the “drug supply” concept as the most stable part of the lexical array, which it is advisable to rely on when developing a definition for the concept under study.

Conclusion. Thus, the subject field of the “drug supply” concept is characterized by the scientific research, reflecting the socio-economic significance of the objects under study in the field of pharmaceutical activities, and its content is characterized by a high level of pharmaceutical knowledge which describes the most stable elements that make it possible to formulate an adequate definition of the “drug supply” definition.

Pharmacy & Pharmacology. 2022;10(3):232-243
pages 232-243 views

Phytochemical and microbiological aspects of the Nigella sativa l. herbs study

Mubinov A.R., Kurkin V.A., Avdeeva E.V., Kolpakova S.D., Zhestkov A.V.


Nigella sativa L. is a promising plant object, herbal medicinal raw materials of which can be comprehensively used for the development of drugs with an antimicrobial activity.

The aim of the study was to screen and compare the antimicrobial activity of water-ethanolic extractions from the Nigella sativa L. herbs with a eucalyptus tincture of as a reference preparation.

Materials and methods. Chromatograms of the extracts were obtained by thin layer chromatography in the system of chloroform – ethanol – water (26:16:3). The detection of adsorption zones was carried out in daylight, in the UV light at λ=254 nm and λ=365 nm, as well as by treatment with reagents – a 3% alcohol solution of aluminum chloride and a solution of diazobenzosulfonic acid in a 20% sodium carbonate solution. The next step was to determine the minimum inhibitory concentration by the method of double serial dilutions in Mueller-Hinton nutrient broth (Bio-Rad, USA). As test cultures, the strains of the American Type Culture Collection (ATCC) microorganisms were used: Staphylococcus aureus (ATCC 29213), Escherichia coli (ATCC 25922), Pseudomonas aeruginosa (ATCC 27853), as well as Candida albicans (a clinical strain). Simultaneously, an experiment to establish a “negative” control was carried out. For the comparative evaluation of the studied samples activity, its activity was compared with the reference preparation with a proven antimicrobial activity – a eucalyptus tincture.

Results. For all water-ethanolic extractions and the Nigella sativa L. herb tincture, the adsorption zones characteristic of flavonoids with Rf1 = 0.28, Rf2 = 0.15, Rf3 = 0.11 were revealed, and under the action of an alcoholic solution of aluminum chloride, the fluorescence of the adsorption zones was also enhanced, which indicates the phenolic nature of these compounds.

In the course of the study, it was found out that all water-ethanolic extractions from the Nigella sativa L. herbs have the greatest antimicrobial effect against the Pseudomonas aeruginosa strain. When compared with the reference preparation – a eucalyptus tincture, it was notified that the specified tincture of the Nigella sativa L. herbs has an advantage in the antimicrobial activity over the strain of Pseudomonas aeruginosa – the action at the 16-fold dilution vs the 4-fold dilution. The action on the Escherichia coli and Candida albicans strains is comparable for the both tinctures.

Conclusion. The obtained results of phytochemical and microbiological analyses will be used as a rationale for the introduction of antimicrobial preparations based on the Nigella sativa herbs in medical and pharmaceutical practice.

Pharmacy & Pharmacology. 2022;10(3):244-254
pages 244-254 views

Optimization technology of fat-soluble vitamins production based on alkaline hydrolysis

Sysuev E.B., Stepanova E.F., Noskova V.D.


In the group of fat-soluble vitamins, vitamin D is one of the most relevant objects, that is why the problem of its technology optimization is under consideration. In general, there is a number of ways to obtain this substance, although it is not produced in Russia yet.

The aim of the study was to select optimal process conditions to increase the efficiency of protein transformation with the isolation of a fat fraction containing fat-soluble vitamin D.

Materials and methods. Various types of fish and the vitamins contained in them are described as the main research models. Variants of technological solutions have been considered: the possibility of using extraction to obtain the vitamin D substance has been tested. Classical maceration and intensifying maceration have been used; the circulating extraction method and the alkaline hydrolysis method have been applied. The yield of the target product has been determined by HPLC.

Results. Methods for obtaining the substance of fat-soluble vitamin D from fish raw materials have been considered in detail. The optimal technological characteristics of the vitamin release by alkaline hydrolysis with a 12.5% decrease in the concentration of the hydrolyzing alkaline component – potassium hydroxide – has been established; that concentration ensured the maximum yield of the fat fraction containing vitamin D.

Conclusion. The use of the resulting substance makes it possible to develop domestic standard samples applicable both in the pharmaceutical field and in the field of technical regulation.

Pharmacy & Pharmacology. 2022;10(3):255-266
pages 255-266 views

Polypharmacy in managment of in-patients with novel coronavirus disease (COVID-19)

Petrov V.I., Ryazanova A.Y., Privaltseva N.S., Nekrasov D.A.


The aim. To identify polypharmacy cases and develop the ways to optimize pharmacotherapy of patients with COVID-19 hospitalized in infectious disease facilities.

Materials and methods. ATC/DDD analysis with calculation of DDDs/100 bed days and a sample analysis of 500 patients’ prescriptions were performed for presenting drug utilization statistics in the infectious disease facilities of Volgograd region, which had been reassigned to treat patients with COVID-19 in 2020 and 2021.

Results. Five or more drugs were administered simultaneously in 96.8% of patients. Antibacterial drugs were in 74.3% of the analyzed prescriptions in 2020 and in 73.5% in 2021. The total consumption of antibiotics was 102.9 DDDs/100 bed-days in 2020 and 95.7 DDDs/100 bed-days in 2021. The cases of multiple administrations of biological disease modifying antirheumatic drugs and the use of cyclophosphamide have been identified. In 73.6% of prescriptions in 2020 and 85.4% of 2021, omeprazole at the dose of 40 mg per day was used (77.3 and 84.6 DDDs/100 bed-days, respectively). In 2021, there were cases of concomitant intravenous prescribing of acetylcysteine under the trade name of Fluimucil® with tableted forms of ambroxol and acetylcysteine under the name of ACC®. The cumulative consumption of hepatotoxic drugs was 269.2 DDDs/100 bed-days in 2020 and 401.5 DDDs/100 bed-days in 2021.

Conclusion. Lack of drugs with proven effectiveness for treatment of COVID-19, worked-out treatment algorithms, a high mortality of patients in the hospitals led to polypragmasy, excessive prescribing of drugs in the hospitals. The prescription of antibacterial drugs, omeprazole, mucolytics, hepatotoxic drugs, immunosuppressors in infectious hospitals should be monitored by clinical pharmacologist.

Pharmacy & Pharmacology. 2022;10(3):267-277
pages 267-277 views

Clinical and economic evaluation of atezolizumab + vemurafenib + cobimetinib combination and nivolumab + ipilimumab combination: administration in metastatic melanoma treatment with BRAF-confirmed mutation in adult patients

Krysanov I.S., Makarova E.V., Ermakova V.Y.


The aim of the study was to conduct a pharmacoeconomic evaluation of the atezolizumab, vemurofenib and cobimetinib (ATZ+VM+COB) combination and the nivolumab and ipilimumab (NIVO+IPI) combination for the treatment of BRAF-confirmed metastatic melanoma in adult patients.

Materials and methods. With the help of mathematical modeling methods, a pharmacoeconomic “cost-effectiveness” ana- lysis; a “budget impact” analysis; a sensitivity analysis to the changes in the initial parameters of the model, were carried out.

Results. The analysis of literature sources made it possible to conclude that the combination of ATZ+VM+COB compared with the combination of NIVO+IPI (15.1 and 11.2 months, respectively) has a greater clinical efficacy in terms of a progression-free survival (PFS) in patients with metastatic melanoma. When choosing the ATZ+VM+COB combination, the total cost of treatment for one adult patient with metastatic melanoma per course was lower, compared to the NIVO+IPI combination (RUB 8 326 864.89 vs RUB 7 172 751.68); the difference amounted to 1 154 113.21 rubles. When calculating the “cost-effectiveness” ratio for a year of a progression-free survival, the advantage of the ATZ + VM + COB combination in comparison with the NIVO + IPI combination, remained (5 700 200.01 rubles vs 8 942 400.10 rubles); the difference amounted to 3 242 200.09 rubles. The sensitivity analysis demonstrated the developed model stability to an increase in the cost of the ATZ + VM + COB course up to + 16%, a decrease in the cost of the NIVO + IPI course to –13%, and a reduction in the PFS to –37% against the background of the ATZ + VM + COB course. The “budget impact” analysis showed the possibility of reducing costs by 8 655 849.11 rubles with an increase from 5% to 20% in the proportion of the patients administrated with the ATZ+VM+COB combination, and with a decrease from 95% to 80% in the proportion of the patients administrated with the NIVO+IPI combination.

Conclusion. The results of the work have shown that within the healthcare system of the Russian Federation, the triple combination of ATZ+VM+COB is a clinically cost-effective option for the treatment of adult metastatic melanoma patients with a confirmed BRAF mutation.

Pharmacy & Pharmacology. 2022;10(3):278-288
pages 278-288 views

Evaluation of weight reduction efficacy and safety of sibutramin-containing drugs in patients with alimentary obesity

Demidova T.Y., Izmailova M.Y., Ushakova S.E., Zaslavskaya K.Y., Odegova A.A., Popova V.V., Nevretdinova M.E., Verbovoy A.F., Bely P.A.


The article presents clinical study results of the efficacy and safety of combination therapy with sibutramine and metformin (fixed combination) in comparison with sibutramine therapy with microcrystalline cellulose in patients with alimentary obesity.

The aim is to evaluate the efficacy and safety of using the sibutramine+metformin fixed dose combination (Reduxin® Forte) and compare it with the sibutramine + microcrystalline cellulose combination (Reduxin®) in patients with alimentary obesity in the course of the obesity therapy.

Materials and methods. Male and female patients (240 people) aged 18 to 65 years inclusive with alimentary obesity, meeting the inclusion criteria and not meeting the non-inclusion criteria, were randomized into 2 groups in a 1:1 ratio. One group (n=120) received sibutramine+ metformin p. o., 1 tablet (850 mg + 10 mg) once per day, the second group (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days. The randomization list was generated by the factory method of random numbers. The efficacy and safety were assessed by anthropometric, clinical and laboratory parameters and the SF-36 questionnaire. The proportion of patients who achieved a decrease in body weight by more than 5% in 6 months, the magnitude and dynamics of changes in body weight and body mass index, waist and hip measurements, their ratios, changes in lipid profile, blood pressure, as well as the total number of adverse events, their frequency and nature of occurrence were analyzed.

Results. The both drugs have demonstrated efficacy in all parameters of the obesity therapy. At the same time, in a compa- rative analysis, a statistically significant advantage of therapy with sibutramine + metformin was demonstrated in relation to the proportion of patients who had achieved more than 5% weight loss (body weight dynamics). Significant benefits were shown in terms of the magnitude of the change in body mass index (BMI); there was a statistically significant increase in the proportion of the patients who had switched from one category of BMI to another. By the end of the study, the vast majority of patients had no longer met the criteria for the diagnosis of “Obesity”. There was also a statistically significant benefit of sibutramine + metformin in terms of lowering triglycerides and low-density lipoprotein levels. The analysis of the safety parameters of sibutramine + metformin confirms a high safety profile of the drug, a comparative statistical analysis of adverse events in terms of their presence, severity, causal relationship with therapy and outcome have not revealed intergroup differences. Adverse events were transient and did not require discontinuation of therapy.

Conclusion. The results of the study showed that therapy with Reduxin® and Reduxin® Forte provides a pronounced decrease in body weight. However, the use of a fixed combination has a more effective positive effect on the lipid profile and patients’ quality of life, which, combined with a high safety profile, proves the possibility and expediency of using Reduxin® Forte for the treatment of obesity and restoring metabolic health, even in patients without additional carbohydrate metabolism disorders.

Pharmacy & Pharmacology. 2022;10(3):289-304
pages 289-304 views

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