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.
The use of endoscopy recanalization of intestinal lumen upon acute or partial colon obstruction in rectal cancer patients in combination with entero- and colonosorption allows: quickly eliminate the symptoms of intestinal insufficiency syndrome; perform adequate chemoradiotherapy in preoperative period; facilitate the performance of primary reparative operation and the course of post-operative period; achieve significant decrease in the number of obstructive resections without worsening the prognosis of the main disease.
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.
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.
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).
Kaban O.P., Hunina L.M., Shevchenko Iu.M., Chornyĭ V.O., Korobko V.B., Valets'kyĭ V.L., Sorokin B.V., Litvinenko O.O., Chornyĭ V.V., Lial'kin S.A.
There was studied the influence of medicinal preparations, created on the base of methylsiliconorganic matrix, on immediate and late follow-up result of treatment of more than 2000 patients with the digestive channel malignancy. High efficacy of application in complex of preoperative preparation of immobilized antibiotics and cytostatics, enterosorpent enterosgel for the purulent-inflammatory complications prophylaxis, lowering of bilirubin level in tumoral obturative jaundice, and in intraoperative usage for the tumor and metastases recurrences prophylaxis.