Information service “Database OF Clinical Trials of Pharmaceutical Products” in rational use of hepatoprotectors in preferential pharmaceutical provision

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Abstract

The problem of rational hepatoprotector use in patients in the system of preferential pharmaceutical provision has become significantly relevant recently because of the increase in hepatobiliary system diseases, namely, hepatitis, nonalcoholic fatty liver disease, and cirrhotic lesions. Appropriate pharmacotherapy with this drug class can be prescribed only when healthcare professionals receive evidence-based information obtained from medical electronic databases. The work aimed to fill the information service “Database of Clinical Trials of Pharmaceutical Products” with the results of randomized clinical trials, systematic reviews, and meta-analysis for the most frequently purchased and prescribed drugs from the hepatoprotector group (phospholipids + glycyrrhizinic acid and ademetionine) in the preferential segment, as well as the development of recommendations for the rational use of these drugs. The study used official data of the state portals “State Register of Pharmaceutical Products” (www.grls.rosminzdrav.ru) and “Unified Information System in Procurement” (http://zakupki.gov.ru) on medicinal products with hepatoprotective action, namely, phospholipids in combination with glycyrrhizinic acid and ademetionine, which were purchased for the “Program for the provision of necessary drugs to certain categories of citizens” in 2014–2020. The study results were searched in MEDLINE (PubMed) websites (https://www.ncbi.nlm.nih.gov/pubmed/), EMBASE (https://www.elsevier.com/), COCHRANE (https://www.cochrane.org/), eLibrary, and CyberLeninka (https://cyberleninka.ru/). The data obtained were entered into the information service “Database of Clinical Trials of Pharmaceutical Products,” which is based on the ontological principle. It was developed by the specialists from the Institute of Automation and Control Processes of the Far Eastern Branch of the Russian Academy of Sciences. The effectiveness of the hepatoprotectors being studied in relation to “surrogate” endpoints in the form of a significant reduction in clinical symptoms, improvement in biochemical parameters, and decrease in viral load in liver pathology limits their use and inclusion in the lists for preferential provision. The presented information resource and recommendations developed by the authors can be used for the rational prescription of hepatoprotectors.

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About the authors

Ekaterina V. Eliseeva

Pacific State Medical University

Email: yeliseeff23@gmail.com
ORCID iD: 0000-0001-6126-1253

MD, PhD, DSc, Professor

Russian Federation, 690002, Vladivostok

Elena S. Maneeva

Pacific State Medical University

Author for correspondence.
Email: alena_nice_angel@mail.ru
ORCID iD: 0000-0002-2582-0705

MD, PhD

Russian Federation, 690002, Vladivostok

Valeriya V. Gribova

Institute of Automation and Control Processes

Email: gribova@iacp.dvo.ru
ORCID iD: 0000-0001-9393-351X

D. Sci. in Techical Sciences

Russian Federation, 690041, Vladivostok

Dmitry B. Okun

Institute of Automation and Control Processes

Email: okdm@dvo.ru
ORCID iD: 0000-0002-6300-846X

MD, PhD

Russian Federation, 690041, Vladivostok

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2. Часть интерфейса информационного сервиса «База данных клинических исследований лекарственных средств» с данными о рандомизированном клиническом исследовании Veterans Affairs Cooperative Study of Polyenylphosphatidylcholine in Alcoholic Liver Disease.

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