A Retrospective Analysis of the Clinical Studies of a Drug "Flakozid" in the Treatment of Diseases of the Hepatobiliary System

Introduction. The medicine "Flakozid" with hepatoprotective effect has been developed at the VILAR. The drug is presented in dosage form-tablets of 0.1 g for oral drug administration

Aim. To analyze the clinical efficacy and safety of "Flakozid" therapy according to clinical laboratory methods, as well as the motility of the gallbladder and bile ducts in patients with diseases of the hepatobiliary system.

Materials and methods. The results of clinical studies of "Flakozid" (0.1 g tablets) were analyzed in 99 patients with chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy, conducted in 2 clinical institutions: Perm State Medical University. Academician E. A. Wagner of the Ministry of Health of Russia and the Central Research Institute of Gastroenterology. "Flakozid" was prescribed against the background of a therapeutic diet (Table No. 5) of 0.1-0.2 g 3 times a day after meals for 32 days and repeated courses (3-5) for 6-12 months. Analysis of the efficacy and safety of "Flakozid" was carried out on the basis of the results of clinical and laboratory studies: general and biochemical blood analysis, general urinalysis, electrocardiogram. To study the motility of the gallbladder and biliary tract, the method of multifractional duodenal probing was used to determine the functional state of the sphincter apparatus of the gallbladder and biliary tract. In cystic and hepatic bile, its biochemical composition was determined. All patients underwent X-ray examination of the gastrointestinal tract, liver scanning and hepatography with iodine-131-bengal-roz.

Results and discussion. In chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy the use of "Flakozid" orally in daily doses of 0.3-0.6 g for 25-45 days led to an improvement in the General condition of patients, a decrease in pain in the right hypochondrium, a decrease in dyspeptic disorders, and an improvement in appetite. According to cholecystography, the indicators of concentration and contractility of the gallbladder improved. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to silibor and carsil, and in some indicators (improvement of the motility of the gallbladder and biliary tract) significantly exceeded them.

Conclusions. Treatment of "Flakozid" improved functional state of the liver, reducing the syndrome of cytolysis and cholestasis. "Flakozid" is recommended in clinical practice in the complex treatment of diseases of the hepatobiliary system, such as chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy.

1. Pimpin L., Cortez-Pinto H., Negro F., Corbould E., Lazarus J. V., Webber L., Sheron N. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies. Journal of Hepatology. 2018;69(3):718-735. DOI: 10.1016/j.jhep.2018.05.011.

2. Bueverov A. O., Bueverova E. L. The evolution of ideas about medicinal liver damage. Eksperimental'naia i klinicheskaia gastroente-rologiia = Experimental & clinical gastroenterology. 2019;(3):89-96. (In Russ.) DOI: 10.31146/1682-8658-ecg-163-3-89-96.

3. Gastroenterologiya [Gastroenterology]. Moscow: Eksmo; 2010. 558 p. (In Russ.)

4. Gastroenterologiya. Natsional'noe rukovodstvo [Gastroenterology. National leadership]. Moscow: GEOTAR-Media; 2015. 480 p. (In Russ.)

5. Lazebnik L. B., Radchenko V. G., Dzhadhav S. N., Sitkin S. I., Seliverstov P. V. Systemic inflammation and non-alcoholic fatty liver disease. Eksperimental'naia i klinicheskaia gastroenterologiia = Experimental & clinical gastroenterology. 2019;165(5):29-41. (In Russ.) DOI: 10.31146/1682-8658-ecg-165-5-29-41.

6. Singh S., Osna N. A., Kharbanda K. K. Treatment options for alcoholic and non-alcoholic fatty liver disease: A review. World Journal of Gastroenterology. 2017;23(36):6549-6570. DOI: 10.3748/wjg.v23.i36.6549.

7. Li S., Tan H. Y., Wang N., Cheung F., Hong M., Feng Y. The Potential and Action Mechanism of Polyphenols in the Treatment of Liver Diseases. Oxidative Medicine and Cellular Longevity. 2018:1-25. DOI: 10.1155/2018/8394818.

8. Beaton M. D. Current treatment options for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Canadian Journal of Gastroenterology. 2012;26(6):353-357. DOI: 10.1155/2012/725468.

9. Beyoglu D., Idle J. R. Metabolomic insights into the mode of action of natural products in the treatment of liver disease. Biochemical Pharmacology. 2020;180:114171. DOI: 10.1016/j.bcp.2020.114171.

10. Bortnikova V. V., Krepkova L. V. The experimental toxicological study of antiviral phytodrug flakoside. Vestnik Rossiyskogo universiteta druzhby narodov. Seriya: Meditsina = RUDN Journal of Medicine. 2008;7:92-95. (In Russ.)

11. Vichkanova S. A., Baginskaya A. I., Shipulina L. D., Kolkhir V. K., Bortnikova V. V., Gorodnyuk T. I. Flakozid - effektivnoe rastitel'noe sredstvo dlya lecheniya gepatitov virusnoy i ne virusnoy etiologii, a takzhe virusnykh porazheniy kozhi. V kn.: Sbornik nauchnykh trudov VILAR: khimiya, tekhnologiya, meditsina [Flacoside is an effective herbal remedy for the treatment of viral and non-viral hepatitis, as well as viral skin lesions. In: Collection of scientific works VILAR: chemistry, technology, medicine]. Moscow: VILAR; 2000. 316-323 p. (In Russ.)

12. Vichkanova S. A., Kolkhir V. K., Sokol'skaya T. A., Voskoboynikova I. V., Bykov V. A. Lekarstvennye sredstva iz rasteniy [Medicines from plants]. Moscow: ADRIS, 2009. 432 p. (In Russ.)

13. Bortnikova V. V., Krepkova L. V., Arzamastsev E. V., Kuznetsov Yu. B., Borovkova M. V. Protivovospalitel'nye svoystva nekotorykh rastitel'nykh antimikrobnykh i protivovirusnykh preparatov. V kn.: Sbornik nauchnykh trudov VILAR: khimiya, tekhnologiya, meditsina [Anti-inflammatory properties of some herbal antimicrobial and antiviral drugs. In: Collection of scientific works VILAR: chemistry, technology, medicine]. Moscow: VILAR; 2000. 369-375 p. (In Russ.).

14. Bortnikova V. V., Karabaeva V. V., Krepkova L. V., Sidelnikova G. F., Mizina P. G., Karabaeva O. N. Flakozid - drug from the leaves of phellodendron amurense rupr., in treatment of diseases of the hepatobiliary system. Voprosy biologicheskoy, meditsinskoy i farmatsevticheskoy khimii = Problems of Biological, Medical and Pharmaceutical Chemistry. 2020;23(2):18-23. (In Russ.).