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.
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.
Nagornaya N.V., Dubovaya А.V.
The article describes different types of intoxication, presents a method of intracorporeal detoxification, and includes a classification of gastrointestinal adsorbents (enterosorbents). It summarizes the experience that has been gained with the intestinal adsorbent Enterosgel in the combination therapy of children and adults suffering from allergic diseases, gastrointestinal disorders, burn disease, chronic pyelonephritis, and recurrent non-specific vaginitis.
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.
Melnykov O.F., Zabrodskaya L.V., Tymchenko M.D., Sydorenko T.V., Naumova O.A.
This article demonstrates the clinical efficacy of Enterosgel in the treatment of food allergy. Enterosgel was shown to have beneficial effect on the allergy status and promote normalization of total serum IgE levels, early interferon, and pro-allergic cytokine (interleukin-5) concentrations in patients with food allergy manifesting by angioedema. The reported studies the benefits of gastrointestinal sorption (enterosorption) achieved with Enterosgel during the combination treatment in patients with food allergy manifesting by angioedema.
Lasitsya A.I. , Okhotnikova A.M., Revutskaya G.E., Gritsishina S.M., Tsigankova I.S.
To evaluate the efficacy of the combined treatment using Enterosgel in the children with the pathology in the form of dermal respiratory syndrome (DRS).
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.
Petukhov A.B., Lysikov Yu.A., Shakhovskaya A.K., Maltsev G.Yu., Sokolnikov A.A., Vasiliev A.V.
The present problem’s urgency is known to steam from a practical lacking of any important advances in treatment modalities for as common diseases as pathological conditions of the small intestine with allergic manifestations as well as those due to the gastric and small intestine resections of different length (malabsorption syndrome), colonic pathology with dysbiosis manifestations (irritable bowel syndrome, constipation syndrome). At the same, it should be mentioned that the disponible modalities of selective enterosorption and nutritional correction of impaired homeostasis are not utilized sufficiently enough.
In the past decade, the methods of extracorporal detoxication, such as hemosorption, enterosorption, and applicative sorption, have found a wide utility in medicine. Enterosorption is a safe and efficient method, which is applied upon diseases of different etiology. Enterosorption can be used both as monotherapy and in combination with conventional therapy. The application of enterosorption in treatment of allergic diseases is especially feasible.
We studied the efficacy of the enterosorbent Enterosgel in the complex therapy of patients with
allergic diseases. All patients were divided in three groups.
Baranov A.A., Geppe N.A., Karpushkina A.V.
The medication Enterosgel offered by the enterprise "SILMA" approved itself as the efficient agent for treatment of various allergic pathology. Taking of Enterosgel by patients having the atopic genesis of bronchial asthma and dermatitis helps to arrest the broncho-obstructive syndrome and skin syndrome due to adsorption of allergens. Enterosgel allowed patients to withdraw from antihistamine drugs, reduce the administration time of bronchial spasmolytics. It showed a high clinical activity in the therapy of both acute and chronic digestive diseases.
Thus, Enterosgel is the efficient supplement to conventional treatment of allergic and gastrointestinal diseases in children.
Peculiarities of allergodermatoses of different origin have been studied. Using the obtained results and taking into account clinical the characteristic, complex technique for allergodermatoses treatment with the use of enterosorption and application sorption with new preparations based on polymethyloxane sorbing gels and immobilized on their basis phytopreparations and antibiotics was developed. The new method proved to be highly effective for the treatment of the patients.
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).