No 4-6 (2020)

Full Issue

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Articles
Frantsiya i Kitay nachali klinicheskie ispytaniya preparatov protiv COVID-19
Article E.
Abstract
Как сообщила газета Global Times, китайские специалисты приступили к испытанию на людях первой вакцины против нового коронавируса. Она появилась на свет благодаря совместным усилиям китайской фармы и специалистов Академии военных медицинских наук Народноосвободительной армии Китая (НОАК). По информации издания, были использованы наработки по созданию вакцины против вируса Эбола.
REMEDIUM. 2020;(4-6):3-5
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Prospects for further development of biobanks and genetic research: ethical implications
Nadelyaeva I.I.
Abstract
In early 2019, the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor) developed and presented a draft federal law on human biological and genetic data as directed by Order of the President of the Russian Federation No. Pr-295 of December 1, 2017. It is believed that after adoption of the document, two federal laws, On Personal Data and On the Protection of Consumers’ Rights, will be immediately amended at one time.In so doing, the state makes attempts to lay the groundwork for a national control system in the area of human biomaterials. The international law has established regulatory practice in this area, while several problems remain unresolved.
REMEDIUM. 2020;(4-6):6-15
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Overview of key launches on the Russian pharmaceutical market, 2019
Kalinina N.
Abstract
The launch of a new drug to the pharmaceutical market should be well-thought-out and accompanied by intensive marketing promotion, which is the solution to a master problem - a strong start and subsequent growth of sales of a new drug. Today, this process (“launching”) is one of the key ones in the activities of each pharmaceutical company. The article discusses the most successful launches on the Russian pharmaceutical market following the results of 2019.
REMEDIUM. 2020;(4-6):16-19
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COVID-19 vaccine: seeking salvage
Prozherina Y.
Abstract
The COVID-19 pandemic that suddenly swept the globe has become a real challenge to all parts of the economy. This large-scale challenge that affected every single human being on the Earth has arisen for the first time in the century. The future of not only our country, but the whole humanity depends on the effectiveness of its solution. Scientists, pharmaceutical and medical communities have been searching together approaches to treat the disease and prevent new COVID-19 cases. More than 90 vaccines are being developed against SARS-CoV-2 across the world.
REMEDIUM. 2020;(4-6):20-21
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Redkie i ochen' dorogie: o slozhnostyakh lekarstvennogo obespecheniya patsientov s orfannymi zabolevaniyami
Kuminova E.
Abstract
Редкие (орфанные) заболевания сопровождают немногочисленных пациентов всю их жизнь и, как правило, сильно ее осложняют, приводя к инвалидизации. Спасение таких больных практически не влияет на медицинскую статистику государства в целом, на среднюю продолжительность жизни в стране, не включено ни в какие целевые показатели федеральных программ. Но пациентское, медицинское и фармацевтическое сообщества объединились для спасения больных с редкими и очень дорогостоящими заболеваниями и уже многого добились. Специфика орфанных заболеваний такова, что без мощной финансовой поддержки государства ни лечения, ни даже производства специальных препаратов не будет. Сколько же готово платить государство за продление жизни орфанным пациентам?
REMEDIUM. 2020;(4-6):22-25
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Russian pharma distributors rating at year-end 2019
Nechaeva Y.
Abstract
According to the State Statistics Service, the wholesale trade turnover in Russia amounted to 31.5 trillion rubles in 2019, which is 7.4% more than in 2018. The figures significantly exceed the retail turnover growth (+ 2.6%). The share of companies engaged in the wholesale trade of pharmaceutical and medical products in this volume accounts for 7.6%. Thus, the total figure is estimated at 2.4 trillion rubles, which is 12% more than in the same period of the previous year. As a result, we see that companies engaged in the wholesale trade of pharmaceutical and medical products demonstrate higher growth rates than the broad market.
REMEDIUM. 2020;(4-6):26-29
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Server lights. Rating of Russian pharmacy chains according to the Q1 2020 results
Bespalov N., Rasshchupkin P.
Abstract
The document legalizing the possibility of online drug retail was very lucky: there was an epidemic of coronavirus, self-isolation and boom in the development of remote services. All this made it impossible to further delay the adoption of the document. However, its «opponents» did everything possible to slow down the entry to the market for new players, including the giants of Internet retail. In fact, the process has been launched, but the main battle online is still ahead.
REMEDIUM. 2020;(4-6):30-32
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Antipsychotic drugs market: issues of regional procurement
Prozherina Y.
Abstract
Schizophrenia is one of the most common mental disorders characterized by combined positive and negative symptoms, behavioural and cognitive impairments that can lead to adverse social and economic outcomes. The disease is characterized by a chronic nature or course with frequent exacerbations and prolonged hospitalization, cumulative personality changes and a high level of disability, a higher rate of somatic concomitant diseases and a shorter life span of patients than the general population [1].
REMEDIUM. 2020;(4-6):34-41
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Updated recommendations of the American College of rheumatology for the management of patients with osteoarthritis
Shavlovskaya O.A., Naumov A.V.
Abstract
In the complex therapy of osteoarthritis (OA), both medicinal and non-medicinal methods are used. In Russia, they are guided by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). According to the recommendations of the American College of Rheumatology American College (ACR) in 2019, new approaches to OA therapy are proposed. Each of the methods of treatment, non-drug (changes in physical activity, body weight correction, kinesiotaping, wearing orthoses, acupuncture) and medication (non-steroidal anti-inflammatory drugs (NSAIDs), chondroprotectors), was evaluated. The appointment of chondroprotetcors (CP) - SYmptomatic Slow Acting Drugs for OsteoArthritis (SYSADOA) is being actively discussed. To chondroprotectors are preparations of chondroitin sulfate (CS) and glucosamine sulfate (GS). Proponents of CS and GS prescribing rely on numerous clinical studies that confirm the clinical efficacy and safety of CP. A randomized blind multicenter placebo-controlled clinical trial was conducted to study the efficacy and safety of Sustagard Artro for patients with parenteral knee OA (400 mg every other day for 6 weeks). An open randomized multicenter study to evaluate the effectiveness and safety of Chondrogard in various administration methods in patients with knee OA. The advantages were noted in the group of combined treatment (intravenous administration + subsequent intravenous administration). With any method of administration, the drug quickly and effectively reduced pain and stiffness, improved the functional state of the joints and with a high safety profile. There was a decrease in the need for NSAIDs.
REMEDIUM. 2020;(4-6):42-52
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Speaking in support of patients with HIV-infection
Prozherina Y., Shirokova I.
Abstract
Since the advent of antiretroviral therapy, HIV infection that was previously among the group of deadly diseases has moved into the category of slowly ongoing, controlled infections. But the problem of morbidity remained open: despite tremendous efforts by the states, the HIV/ AIDS epidemic continues to spread around the world at an epidemic pace. Under these circumstances, the following factors are particularly important: improvement of antiretroviral therapy, the development and introduction of new drugs, which allow a patient not only virtually stop the development of infection and extend his life, but also maximize its quality. It is vital to remind about it on the eve of World AIDS Day to be held on 17 May.
REMEDIUM. 2020;(4-6):54-57
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Diabet pod kontrolem dazhe vo vremya epidemii
Shirokova I.
Abstract
Несмотря на достижения современной медицины, сахарный диабет (СД) остается одной из важнейших проблем здравоохранения в мире, в первую очередь ввиду своей высокой распространенности. По данным Международной федерации диабета (IDF), в 2019 г. число людей в возрасте 20-79 лет, страдающих СД, приблизилось к 463 млн [1]. В 2020 г. ситуацию усугубила эпидемия коронавируса - заболевания, наиболее опасного для людей с хроническими патологиями, в том числе с СД. В этих условиях особое значение приобретает грамотное управление СД, и прежде всего самоконтроль с помощью современных глюкометров.
REMEDIUM. 2020;(4-6):59-61
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Osobo opasnaya infektsiya: privivka ot meningita dolzhna voyti v NKPP
Article E.
Abstract
Минздрав РФ предлагает расширить Национальный календарь профилактических прививок за счет вакцинации от ветрянки, ротавирусной, папилломавирусной и менингококковой инфекции. Об этом шла речь на парламентских слушаниях по иммунопрофилактике 17 февраля. Разработана и внесена в правительство Стратегия развития иммунопрофилактики до 2025 г. Иммунопрофилактика позволила взять под контроль многие тяжелые инфекции. Так, благодаря масштабной вакцинации населения заболеваемость дифтерией снизилась в 5 тыс. раз, краснухой - в 4 тыс. раз, корью - в 333 раза. На слуху - грандиозные успехи вакцинации от гриппа: в 2019 г., по данным Роспотребнадзора, удалось привить почти 70 млн россиян, или 46,4% населения страны. Но в это самое время незаметно поднялась заболеваемость менингококковой инфекцией. В Москве она за год выросла на 41% и в четыре раза превысила среднюю заболеваемость по стране. О том, чем опасен менингит и почему назрела необходимость массовой вакцинации от этой инфекции, мы побеседовали с директором ФГБУ «Детский научно-клинический центр инфекционных болезней ФМБА» академиком Юрием Владимировичем Лобзиным в кулуарах научно-практической конференции «Менингококковая инфекция - недооцененные проблемы», прошедшей в Санкт-Петербурге 10-11 февраля.
REMEDIUM. 2020;(4-6):60-61
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Thioctic acid: an evidence-based medicine perspective
Shirokova I., Prozherina J.
Abstract
Multiple clinical trials (CT) have confirmed the feasibility of using thioctic (alpha-lipoic acid) in the treatment of diabetic polyneuropathy (DPN) defined as specific peripheral nervous disfunction associated with diabetes mellitus (DM). Due to its high level of efficacy and safety, thioctic acid is included in the clinical guidelines for the treatment of DPN in some countries. This issue is also topical for the Russian medicine.
REMEDIUM. 2020;(4-6):62-65
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What do Russians prefer: review of the laxative market
Prozherina Y.
Abstract
Constipation is observed in 10-20% of the world’s population, regardless of age and social affiliation, and about 70% of patients are women. Up to 30% of children between the ages of 6 and 12 are currently having difficulty with bowel emptying. Treatment of constipation is an important medical task, as it is associated with the possibility of developing or worsening the severity of a number of diseases and pathological conditions [1].
REMEDIUM. 2020;(4-6):66-68
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Yuriy Kucheryavyy: «V osnove profilaktiki zaporov lezhit zdorovyy obraz zhizni»
Article E.
Abstract
На сегодняшний день запор остается широко распространенным явлением. О природе запоров, особенностях профилактики и современном подходе к лечению мы решили узнать у Юрия КУЧЕРЯВОГО, доцента кафедры пропедевтики внутренних болезней и гастроэнтерологии Московского государственного медико-стоматологического университета, главного гастроэнтеролога Центральной дирекции здравоохранения «РЖД-Медицина».
REMEDIUM. 2020;(4-6):69-70
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A comparative characteristic of business models of leading pharmaceutical manufacturers: aspects of investment activities
Yasinskaya L.E.
Abstract
In addition to a detail analysis of various domestic pharmaceutical company’s business models there were investigated companies investment programs, as well as their capital structure and specificity of manufacturing processes that affect the companies investment activity.Objective: Analysis of the investment activity of the domestic pharmaceutical manufacturing companies working in the frame of different business models, as well as determination of their investment activity risks triggers.Research methodology: The analysis was conducted for four business models (biotechnology companies, generic companies, specialized pharmaceutical companies, manufacturers of active pharmaceutical ingredients) on the base of at least three companies in each business model. The database included the information on company’s investment activity for the period from2013 till 2018.Results: Biotech companies focus their long-term investment programs both on R&D projects and market entry to developed countries with a strong regulation system. Long- or medium-term investment programs of generic companies focus on creating huge production capacities, while short-term investment budgets allocate for marketing. Specialized companies, including in the framework of their collaboration with foreign manufacturers, realize their investment programs aimed at developing their own portfolio. Manufacturers of active pharmaceutical ingredients invest in renovations or building manufacturing facilities having a goal to meet GMP standards. Domestic pharmaceutical companies are characterized by an intricate multi-stage owner capital structure, which can negatively affect on attracting external investors.
REMEDIUM. 2020;(4-6):66-78
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Advances in synthetic biology and regulatory policy of the state
Mokhov A.A., Chaplenko A.A., Yavorskiy A.N.
Abstract
Synthetic biology is a new interdisciplinary area of research applies the principles of engineering design in genetic and biomedical research. Progress in the development of tools used to modify natural biological systems (or used for creation of new ones) has allowed the development of traditional biomedicine and genomics. At the beginning of this review article, we look at the key achievements of synthetic biology over the past ten years. Despite the fact that the contribution of synthetic biology to fundamental research in the field of biology, medicine, ecology and other life sciences is undeniable, the potential risks for biological safety and security associated with the further development synthetic biology also require attention. This problem has become particularly relevant in recent years, as the technology becomes less expensive, more advanced and affordable. A brief assessment of the risks associated with the possible misuse or abuse of synthetic biology technologies is given from the point of view of danger to humanity and nature as a whole. To solve the problems arising due to the rapid progress of synthetic biology, technical, ethical and legal measures have been developed and planned.
REMEDIUM. 2020;(4-6):79-86
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Medical device manufacturing: results of 2019
Romanova S.
Abstract
The analysis of the pharmaceutical industry enterprises’ activity was carried out according to the data of the state statistical reporting of the enterprises of the branch of P-1 urgent monthly form. In 2019, the production of drugs in Russia increased by 27.12% as compared to the previous year (by aggregate index) and amounted to 386.665 billion rubles.
REMEDIUM. 2020;(4-6):87-91
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Medical devices market: main factors in the osteosynthesis devices market
Vanin A.
Abstract
The market research has been conducted using information on public procurement of osteosynthesis devices and the export-import transaction database of the official customs statistics. In the article, the term “osteosynthesis devices” is used to indicate the medical devices of this type. The purchase of such devices is most important to meet the needs of the public health system.The osteosynthesis implants consumption in value terms amounted to RUB 4.530 bil. in 2018. For the purposes of research, the regional groups of manufacturers of these products such as EU&US, Asian and Locals were identified.The Asian group manufacturers - 33% and Locals - 24% showed outperforming growth rates over the period from 2015 to 2018. The increase in the supplies of EU&US group manufacturers - 12% is below the market average figures. At the same time, a significant EU&US supplies gain was reported from 2017 to 2018. In 2018, a supplies gain for EU&US group accounted for more than 30%, as compared to 2017.According to MDpro, the total consumption of traumatology and orthopaedic devices amounted to about RUB 23.8 bil. at final prices in 2018. Of which, public procurement amounted to about RUB 22.1 bil., i.e. 92.7% of total consumption. Osteosynthesis implants make the greatest contribution to the private consumption. The share of Russian products in the domestic market of traumatology and orthopedic devices in2018 amounted to approximately 13% or about RUB 3.1 bil. at final prices.
REMEDIUM. 2020;(4-6):92-94
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Vse ushli v onlayn: kak apteki vyzhivayut v usloviyakh samoizolyatsii
Kuminova E.
Abstract
После ажиотажного спроса на лекарства в середине марта в апреле на аптечном рынке в России наблюдался резкий спад продаж. В Москве в середине апреля он составил порядка 25%, в регионах - на уровне -15%. При этом цены на лекарства выросли на 5-10%. Трансформация аптечного рынка неизбежна, считают эксперты. Как она будет происходить, они рассказали в ходе онлайн-конференций, прошедших в апреле.
REMEDIUM. 2020;(4-6):95-96
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Koronavirusnaya pandemiya kak proschet v biopolitike
Kuminova E.
Abstract
Любая прорывная технология может стать спасением в одних руках и обернуться катастрофой в других. Особенно если она имеет огромный прикладной потенциал как молекулярная генетика. Ее стремительное развитие открывает перед человечеством не только качественно новый уровень решения его проблем, но и привносит новые, неизведанные угрозы. Широкому спектру этих угроз - от ионизирующего облучения до бактериологического оружия и ГМО-людей - был посвящен Международный симпозиум «Правовые проблемы обеспечения биологической безопасности в Российской Федерации», проведенный Московским государственным юридическим университетом им. О.Е. Кутафина и Российской медицинской академией непрерывного профессионального образования 22 мая в онлайн-формате.
REMEDIUM. 2020;(4-6):97-98
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TOP-pozitsii. Pokazateli vedushchikh mirovykh i otechestvennykh proizvoditeley i distrib'yuterov
Article E.
Abstract
Согласно данным ИАС «Клифар: Импорт-Экспорт», всего за период с января по декабрь 2019 г. в нашу страну ввезено ГЛС на сумму порядка 12,1 млрд долл., что на 39% выше аналогичного показателя в прошлом году.
REMEDIUM. 2020;(4-6):99-104
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