The study involved 120 persons suffering from viral hepatitides of different degrees of severity, as well as alcohol-induced liver injury, cholelithiasis, fatty liver and other diseases of the hepatobiliary system. Some patients received the polyprenolic preparation as a hepatoprotector, the other were given Essentiale. Against the background of administration of polyprenols, such clinical symptoms of liver pathology as weakness, headache, itching, fever, loss of appetite, abdominal pain and others decreased, as well as blood parameters normalized. The improvement occurred much faster, than in the case of treatment with Essentiale.
Solagran Limited, Melbourne, Australia
St. Petersburg Medical Academy of Postgraduate Studies of the Ministry of Health and Social Development of the Russian Federation, Saint Petersburg, Russia
S.M. Kirov Academy of Forestry Engineering in Saint Petersburg, Saint Petersburg, Russia
Chronic viral hepatitides and other diffuse liver diseases are a topical section of internal pathology. This is due to their wide occurrence, severity and high lethality. Over the past 20 years, there has been a trend towards an increase in the number of liver diseases around the world. Preparations with selective protective effect on the liver – hepatoprotectors – that restore homeostasis in the organ, increase its resistance to the influence of pathogenic factors, normalize functional activity and stimulate regeneration processes in the liver tissue are widely used in the pathogenetic therapy of liver diseases. Due to the insufficient efficiency and/or undesirable side effects, the existing hepatoprotectors do not fully satisfy the needs of clinical practice, therefore the search for new plant hepatoprotectors is topical.Study Purpose
Evaluation of the efficacy and safety of the new hepatoprotective medical preparation made of polyprenols extracted from needles of spruce (Picea abies L. karst).Methods
Dynamics of subjective complaints (intensity of the main clinical syndromes of a disease), assessment of the general condition of a patient, the degree of restoration of the liver function on the basis of laboratory studies data were criteria of efficiency of the compared preparations. Laboratory tests included clinical and biochemical blood tests, urine test. The above studies were conducted prior to the use of the compared medications, in the dynamics against their background, and after a course of treatment.Results
120 patients with various forms of pathology of the hepatobiliary system were included in the comparative randomized double blind study. The study was conducted in 4 clinical centers, with 30 patients in each center. About 70% of patients suffered from chronic viral hepatitides C, B, B+C, A; in the remaining patients, the main diagnoses were chronic cholecystopancreatitis, cholelithiasis, fatty liver, alcohol-induced liver injury. In each center, patients orally received the polyprenolic preparation* in the dose of 3 drops 2 times a day within 3 months and the comparator of "Essentiale Forte" (produced by Rhone-Poulenc Rorer, USA — France) in the dose of 1 capsule 3 times a day within 3 months. It was revealed that polyprenols* in patients with chronic viral hepatitides and other pathologies of the hepatobiliary system provide a wide range of pharmacological effects providing hepatoprotective action. The pharmacological action of polyprenols* is based on the substitutive effect in cases of deficit of dolichol and insufficiency of the dolichol phosphate cycle that occurs in cases of chronic inflammatory degenerative liver diseases. The clinical efficacy of the polyprenolic preparation* was higher than that of the comparator (Essentiale Forte). Polyprenols* weakened the subjective and objective clinical signs of liver pathologies, such as weakness, headache, itching, fever, loss of appetite, stomach pain, dyspeptic disorders. Normalization of the clinical symptoms of liver injury in patients against the background of treatment with polyprenols* was observed earlier than that against the background of administration of Essentiale Forte. Against the background of administration of the polyprenolic preparation*, an earlier positive dynamics of indicators of the cytolytic enzymatic activity (reduction of ALT and AST), blood lipid spectrum (increase of antiatherogenic lipoproteids, decrease of the atherogenicity coefficient) was observed compared with Essentiale Forte. The application of polyprenols* also revitalized the adaptogenic mechanisms (increased the activity of the antioxidant system), which was not observed in the case of Essentiale Forte. During the application of polyprenols* there were no clinically significant adverse events.Conclusions
The polyprenolic preparation* is an effective and safe medicinal preparation and is recommended for clinical use as a hepatoprotector in patients with chronic viral hepatitides and other pathologies of the hepatobiliary system. (Published in the proceedings of the International Conference "Development of Scientific Research and Surveillance of Infectious Diseases"/ edited by A.B. Zhebrun. — SPb.: Louis Pasteur Research Institute of Epidemiology and Microbiology in Saint Petersburg, Federal Budgetary Institution of Science of Rospotrebnadzor (Federal Service for Supervision of Consumer Rights Protection and Human Well-Being), 2010)
* A polyprenolic preparation of Ropren was used the study, which is a pure concentrate of polyprenols (the total fraction is 95%). The text of the study is provided by courtesy of Solagran.