ln order to assess the characteristics of the medical device ENTEROSGEL, establish the method of its use and the safety for users, this report was drawn up in the form of a critical evaluation of the relevant published clinical studies conducted with ENTEROSGEL and with other at least partially comparable medical devices already placed on the European market.
T.G. Malanicheva, B.A. Shamov
Objective: to define level of systemic endotoxemia in children with AD and evaluate drug Enterosgel (polymethylsiloxane polyhydrate) in complex therapy of the pathology.
Kudin M.V., Tsaregorodtsev A.D., Fedorov Y.N., Dlin V.V.
Nowadays the problem of interaction between the environment chemical composition and the health of the population is a challenge not only in Russia but also in other parts of the world. The level of overall health and quality of the environment (taking into account natural and anthropogenic factors) are to different extent determined by biogeochemical features in different regions of Russia. With intensification of industrial and human activities, urban growth, creation of "megalopolises" and major industrial centers the load has increased so intensively that a special ecological environment was formed, with high concentrations of anthropogenic products – i.e. with a serious pollution of air, soil and water basins.
The term “enterosorption” has been proposed to define a method of sorption therapy based on daily oral administration of “enterosorbents”. Enterosorbents were known in the past because the tradition of eating natural clays in case of poisoning, for improvement of well-being, jugulation of diarrhea, and, possibly, for treatment of deficiency in microelements, goes back to bygone times, and as a phenomenon known as geophagia it was observed particularly in primates [6, 7]. However, Enterosgel, comparing to other sorbents has unique hydrophobic and selective sorption properties, which made it effective and safe in wide range of medical applications. Enterosgel has proven it’s safety and efficacy during 35 years of clinical studies and use in major hospitals of the Soviet Union, it is recommended in the official guidance of Ministry of Health for treatment of various diseases. Since 2008 Enterosgel is certified as a medical device class IIa and available as an OTC treatment in Europe.
Yurchenko A.V., Nikolaev V.G., Mamyedova E.S., Antonenko Z.V., Fedorenko S.V., Riabokon S.V., Harytonyuk A.V., Babeshko Y.S.
1. Application of Enterosgel enterosorbent in the patients with AIDS in the development of adverse reactions to antiretroviral therapy promotes more rapid reduction of diarrhea and intoxication syndrome (disappereance of subjective complaints, reduction of mean values of intoxication indexes, rod nuclear cells and eosinophils, positive dynamics of reduce of transaminase average level).
2. No adverse reactions caused by Enterosgel has been identified during its application as a part of complex therapy of pathological conditions in HIV-infected patients.
Tkachenko E.I., Avalueva E.B., Ivanov S.V., Lapinskii I.V.
In this research possibility of using the drug Enterosgel®, appointed to reduce severity of intoxication in healthy individuals, has been scientifically substantiated.
Study director: Head of the Department of Internal Medicine propaedeutics, MD, Professor Tkachenko E.I.
Responsible person: Professor of the Department of Internal Medicine propaedeutics, MD Avalueva E.B.
Approximately 5-10% of the adult population are the persons suffering from alcoholism or consuming alcohol regularly or in large quantities. In everyday life a small amount of alcohol reduces sense of tension, fear, loneliness, frustration, boredom, depression.
Extensive clinical experience on the use of an innovative intestinal adsorbent Enterosgel has been accumulated over the past 20 years. Enterosgel provides a wide range of the therapeutic effectiveness due to its ability to bind toxins, allergens and pathogens in the gastrointestinal tract and eliminate these from the body.
The results of clinical studies of using Enterosgel in gastroenterology are presented in the collection. Enterosgel has proven itself as an effective agent for the treatment of peptic ulcer disease, inflammatory bowel disease, and diseases of the liver.
Gavrysh I. M. VISNYK VDNZU «Ukrai'ns'ka medychna stomatologichna akademija»
Patients with liver cirrhosis and comorbid intestinal dysbiosis show significant changes in biochemical parameters as improving MMP on the background of nucleotide - peptide index reduction in serum, indicating the presence of SEI in the studied patients. The combined treatment of patients with liver cirrhosis and intestinal dysbiosis by medication of «LB» and «MAH» leads to the normalization of these indicators by SEI eliminating.
Extensive clinical experience on the use of the innovative intestinal adsorbent Enterosgel has been accumulated over the past 20 years. Enterosgel provides a wide range of the therapeutic effectiveness due to its ability to bind toxins, harmful substances, pathogens and allergens in the gastrointestinal tract and eliminate these from the body. This collection of research papers presents study results of the application of Enterosgel in allergology, immunology and dermatology. Enterosgel was shown to be an effective treatment for asthma, dermal-respiratory syndrome, food allergy, urticaria, atopic dermatitis, acne vulgaris.
Yulish E.I., Krivuschev B.I.
The work focuses on the role of the toxic syndrome and endointoxemia in the pathogenesis of infectious and noninfectious diseases. Enterosorption method in the treatment of endotoxemia is analyzed.
THE STUDY DRUG SAFETY OF "ENTEROSGEL®, PASTA FOR INTAKE (SWEET)" ALLOWS TO RECOMMEND ITS SUBMISSION TO THE TO THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION AS LOW-TOXICITY DRUG AS THE PROCEDURE FOR EXPANDING INDICATIONS AND CHANGES IN INSTRUCTION FOR USE.
Osadchaya O.I., Shmatova E.A., Boyarskaya A.M.
Study of the clinical efficacy of intestinal detoxification therapy (enterosorption) in patients with ALD for the decrease of metabolic intoxication manifestations in the acute stage of the disease.
Koval M.I., Pokotylo O.S.
The results of the influence of enterosorbent "Enterosgel" on the LPO and activities of antioxidant protection enzymes in the one, six-, and twelve-month white rats are given. The study was performed on the model of experimental paracetamol damage of the liver of white rats. It is established that the enterosorbent Enterosgel has antioxidant properties, which were manifested in the decrease of plasma levels of diene conjugate (DC) and malonic dialdehyde (MDA), as well as in the recovery of activities of SOD and catalase in the blood plasma of experimental animals, especially, one- and twelve-month ones.
Yu.N. Shevchenko, Yu.A. Serezhko
To identify effective methods of intestinal sorption (enterosorption) with the new-generation adsorbent Enterosgel during gamma teletherapy (EBRT) and chemoradiotherapy (CRTx).
Poteryaeva E.L., Bobrova S.V., Kazeka E.Z.
The procedural guidelines describes the main physicochemical properties of the enterosorbent "Enterosgel", its mechanism of action, indications for therapeutic or prophylactic application in patients suffering from chronic intoxication and working under exposure to industrial toxins.
Soboleva M.K., Zorkina T.V., Plotnikova O.V., Simantovskaya T.P., Golisheva M.N.
The problem of elimination of toxic substances from the body is one of the most pressing in pediatrics. Hemosorption, hemodialysis and plasmapheresis has been successfully used in pediatric practice for a long time; however, the risk of their use may exceed expediency in some cases (for example, in case of moderate toxicity). Pediatricians have been always interested in non-invasive detoxification methods, in this context we have piloted Enterosgel, a new enterosorbent, in addition to infusion therapy, plasmapheresis, and in some cases as the unique detoxification therapy.
Bezlyuda N.P., Baranyuk A.P.
Novel intestinal and topical adsorbent drugs with detoxifying effect (studies were conducted in 1980-1990 by order of Main Military Clinical Hospital of the Ministry of Defense of Ukraine) were widely evaluated in military medical facilities. The Military Hospital of Kyiv (nowadays the Main Military Clinical Hospital of the Ministry of Defense of Ukraine) participated in the medical and biological evaluation of novel drugs from the beginning of their development (V.N. Fadeev, F.G. Novikov, N.P. Bezlyuda).