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.
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.
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.
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.
Dolzhenko M.N., Šipulin V.P., Sokolova L.K.
Research in primary and secondary prevention of atherosclerosis has shown that statin therapy can significantly reduce total and cardiovascular mortality.6,8,9 A number of patients could not take statins for a long time because of parenchyma liver damage and hepatocellular necrosis. In the treatment with the other groups of products in these patients fail to achieve a reduction in levels cholesterol and low density lipoproteins (LDL) to target values.
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.
Chernikhova E.A., Anikhovskaya I.A., Gataullin Yu.K., Zakirova D.Z., Ivanov V.B., Saveliev A.A., Yakovlev M.Yu.
The study of 25 patients with chronic inflammatory diseases (HID) in stage of remission has demonstrated efficiency of intestinal absorption method (enterosorption) to reduce significantly the total concentration of bacterial lipopolysaccharide (LPS) in the general circulation. Endotoxin aggression (EA) of intestinal etiology is a universal factor in the pathogenesis of many diseases and syndromes and may be the immediate cause of local inflammation, acute and chronic SIRS (systemic inflammatory response syndrome - systemic inflammatory response syndrome), allergic and autoimmune reactions.
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).