Efficacy and safety of the drug Phosphogliv® URSO in patients with indications for oral litholysis: cholelithiasis and the pre-stone stage of the disease

Nikitin I.G., Danilov A.B., Poromov A.A., Yankovaya T.N., Rybnikova I.D., Mikhailova O.V., Chuprakova N.O., Kudryavtseva A.P., Yunusova O.V., Makarova N.V., Shavalieva L.P., Demidova L.I., Kozlov V.I., Karimullina F.M., Fazylova Z.R.

1) Pirogov Russian National Research Medical University, Moscow, Russia; 2) Institute of Interdisciplinary Medicine, Moscow, Russia; 3) I.M. Sechenov First Moscow State Medical University, Moscow, Russia; 4) Mechnikov Research Institute for Vaccines and Sera, Moscow, Russia; 5) Patrice Lumumba Peoples Friendship University of Russia, Moscow, Russia; 6) Smolensk State Medical University, Smolensk, Russia; 7) Multidisciplinary Medical Center «Expert Clinic», Smolensk, Russia; 8) Kuzbass Regional Clinical Hospital named after S.V. Belyaev, Kemerovo, Russia; 9) City Clinical Polyclinic No.4, Perm, Russia; 10) Municipal Healthcare Institution «City Polyclinic No. 19», Kazan, Russia; 11) State Autonomous Budgetary Institution Zelenodolsk Central Regional Hospital, Osinovskaya Multidisciplinary Polyclinic, Republic of Tatarstan, Zelenodolsk district, Osinovskoye rural settlement, Osinovo village, Russia; 12) Medical and Diagnostic Center «BIOMED», Kazan, Russia; 13) Medical Consultative and Diagnostic Center №7 «Aibolit», Kazan, Russia; 14) Clinic of Individual Medicine «G Clinic Genesis Group», Kazan, Russia; 15) Polyclinic №1 of the City Clinical Hospital of the Russian Railways «Medicine», Kazan, Russia; 16) Multidisciplinary Clinic «SITIDOK-expert», Kazan, Russia

Objective: To assess the efficacy and safety of an original combination of ursodeoxycholic acid (UDCA) and glycyrrhizic acid as an oral litholytic agent in routine clinical practice in patients with gallstone disease and other forms of cholelithiasis (e.g. biliary sludge). Materials and methods: A multicenter retrospective study, with the collection and evaluation of data on the efficacy and safety of a UDCA – glycyrrhizinic acid combination, included 3,346 patients with indications for litholytic therapy who received the drug at an average daily dose of 10 mg/kg for 3 months. Efficacy was assessed based on ultrasound data, laboratory indicators, and severity of key clinical symptoms. Safety and tolerability were evaluated based on the frequency and severity of adverse events. Results: By the end of treatment with the UDCA – glycyrrhizinic acid combination, 86% of patients with sludge and microcrystals showed a statistically significant positive change in ultrasound imaging, with their complete regression (p<0.0001). Among patients with small cholesterol stones, 47% exhibited reduced gallbladder wall thickness and 42% showed a decrease in gallbladder size (p<0.0001). After 3 months of treatment, all patients demonstrated a significant reduction in serum alkaline phosphatase and total cholesterol levels (p<0.0001). Additionally, 99.5% of patients reported a reduction or complete disappearance of biliary dyspepsia symptoms. Adverse events were reported in 6% of cases, mainly as transient dyspeptic disorders. Conclusion: The original UDCA – glycyrrhizinic acid combination demonstrated clinical efficacy in patients with indications for oral litholysis by reducing bile lithogenicity, particularly in early stages of gallstone disease. The treatment promoted regression of biliary sludge and dissolution of microliths, improved ultrasound parameters, and exerted anti-inflammatory and hypocholesterolemic effects, with a favorable safety profile

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About the Authors

I.G. Nikitin, Dr. Sci. (Med.), Professor, Head of the Department of Hospital therapy named after Academician G.I. Storozhakov, Pirogov Russian National Research Medical University, Moscow, Russia; igor.nikitin.64@mail.ru, ORCID: https://orcid.org/0000-0003-1699-0881 (corresponding author)
A.B. Danilov, Dr. Sci. (Med.), Head of the Department of Nervous Diseases, Institute of Interdisciplinary Medicine; Institute of Professional Education of the I.M. Sechenov First Moscow State Medical University, Moscow, Russia; danilov@intermeda.ru, ORCID: https://orcid.org/0000-0001-8904-2538
A.A. Poromov, Cand. Sci. (Biol.), Associate Professor, Mechnikov Research Institute for Vaccines and Sera; Patrice Lumumba Peoples Friendship University of Russia, Moscow, Russia; poromov-aa@rudn.ru, ORCID: https://orcid.org/0000-0002-2004-3935
T.N. Yankovaya, Cand. Sci (Med.) Associate Professor, Smolensk State Medical University, Smolensk, Russia; yankovaya-tn@yandex.ru
I.D. Rybnikova, Therapist, Multidisciplinary Medical Center «Expert Clinic», Smolensk, Russia; irarib84@mail.ru
O.V. Mikhailova, Gastroenterologist, Kuzbass Regional Clinical Hospital named after S.V. Belyaev, Kemerovo, Russia; olgavladmix@mail.ru
N.O. Chuprakova, Gastroenterologist, City Clinical Polyclinic No.4, Perm, Russia; marina159.59@mail.ru
A.P. Kudryavtseva, Therapist, City Polyclinic No. 19, Kazan, Russia; kud.a72@mail.ru
O.V. Yunusova, Therapist, State Autonomous Budgetary Institution Zelenodolsk Central Regional Hospital, Osinovskaya Multidisciplinary Polyclinic, Republic of Tatarstan, Zelenodolsk district, Osinovskoye rural settlement, Osinovo village, Russia
N.V. Makarova, Gastroenterologist, Medical and Diagnostic Center «BIOMED», Kazan, Russia; habiba1982@bk.ru
L.R. Shavalieva, Gastroenterologist, Medical Consultative and Diagnostic Center №7 «Aibolit», Kazan, Russia; leilaax@rambler.ru
L.I. Demidova, Therapist, State Autonomous Budgetary Institution Zelenodolsk Central Regional Hospital, Osinovskaya Multidisciplinary Polyclinic, Republic of Tatarstan, Zelenodolsk district, Osinovskoye rural settlement, Osinovo village, Russia; demidova8@bk.ru
V.I. Kozlov, Gastroenterologist, Clinic of Individual Medicine «G Clinic Genesis Group», Kazan, Russia; equilibrium92@yandex.ru
F.M. Karimullina, Therapist, Polyclinic №1 of the City Clinical Hospital of the Russian Railways «Medicine», Kazan, Russia; fatimakarimullina@yandex.ru
Z.R. Fazylova, Gastroenterologist, Multidisciplinary Clinic «SITIDOK-expert», Kazan, Russia; zilya87@inbox.ru

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