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

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Resumo

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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Sobre autores

I. Nikitin

Pirogov Russian National Research Medical University

Autor responsável pela correspondência
Email: igor.nikitin.64@mail.ru
ORCID ID: 0000-0003-1699-0881

Dr. Sci. (Med.), Professor, Head of the Department of Hospital therapy named after Academician G.I. Storozhakov

Rússia, Moscow

A. Danilov

Institute of Interdisciplinary Medicine; I.M. Sechenov First Moscow State Medical University

Email: danilov@intermeda.ru
ORCID ID: 0000-0001-8904-2538

Dr. Sci. (Med.), Head of the Department of Nervous Diseases, Institute of Professional Education

Rússia, Moscow; Moscow

A. Poromov

Mechnikov Research Institute for Vaccines and Sera; Patrice Lumumba Peoples Friendship University of Russia

Email: poromov-aa@rudn.ru
ORCID ID: 0000-0002-2004-3935

Cand. Sci. (Biol.), Associate Professor

Rússia, Moscow; Moscow

T. Yankovaya

Smolensk State Medical University

Email: yankovaya-tn@yandex.ru

Cand. Sci (Med.) Associate Professor

Rússia, Smolensk

I. Rybnikova

Multidisciplinary Medical Center «Expert Clinic»

Email: irarib84@mail.ru

Therapist

Rússia, Smolensk

O. Mikhailova

Kuzbass Regional Clinical Hospital named after S.V. Belyaev

Email: olgavladmix@mail.ru

Gastroenterologist

Rússia, Kemerovo

N. Chuprakova

City Clinical Polyclinic No.4, Perm

Email: marina159.59@mail.ru

Gastroenterologist

Rússia, Perm

A. Kudryavtseva

Municipal Healthcare Institution «City Polyclinic No. 19», Kazan

Email: kud.a72@mail.ru

Therapist

Rússia, Kazan

O. Yunusova

State Autonomous Budgetary Institution Zelenodolsk Central Regional Hospital

Email: igor.nikitin.64@mail.ru

Osinovskaya Multidisciplinary Polyclinic, Therapist

Rússia, Republic of Tatarstan, Zelenodolsk district, Osinovskoye rural settlement, Osinovo village

N. Makarova

Medical and Diagnostic Center «BIOMED»

Email: habiba1982@bk.ru

Gastroenterologist

Rússia, Kazan

L. Shavalieva

Medical Consultative and Diagnostic Center №7 «Aibolit»

Email: leilaax@rambler.ru

Gastroenterologist

Rússia, Kazan

L. Demidova

State Autonomous Budgetary Institution Zelenodolsk Central Regional Hospital

Email: demidova8@bk.ru

Osinovskaya Multidisciplinary Polyclinic, Therapist

Rússia, Republic of Tatarstan, Zelenodolsk district, Osinovskoye rural settlement, Osinovo village

V. Kozlov

Clinic of Individual Medicine «G Clinic Genesis Group»

Email: equilibrium92@yandex.ru

Gastroenterologist

Rússia, Kazan

F. Karimullina

City Clinical Hospital of the Russian Railways «Medicine»

Email: fatimakarimullina@yandex.ru

Polyclinic №1, Therapist

Rússia, Kazan

Z. Fazylova

Multidisciplinary Clinic «SITIDOK-expert»

Email: zilya87@inbox.ru

Gastroenterologist

Rússia, Kazan

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2. Figure 1. Diagram of changes in the concentration of alkaline phosphatase by visits before and after therapy with Phosphogliv® URSO (Wilcoxon test, p<0.0001)

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3. Figure 2. Diagram of changes in total cholesterol concentration by visits before and after Phosphogliv® URSO therapy (Wilcoxon test, p<0.0001)

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4. Figure З. Vеnn diagram, combination of the most common side effects during therapy with Phosphogliv® URSO

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