DYNAMICS OF MARKERS OF INTRAHEPATIC CHOLESTASIS IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS WHEN APPLYING AN INTEGRATED PROTEIN-AMINO ACID AND VITAMIN PRODUCT (MARE’S MILK)
Introduction: Primary biliary cholangitis (PBC), formerly primary biliary cirrhosis, is a rare progressive cholestatic liver disease, whose hallmark features include a persistently elevated alkaline phosphatase level, presence of anti‐mitochondrial antibodies (AMA) and characteristic histology. For 30 yearsursodeoxycholic acid (UDCA), a bile acid, has been the only available therapeutic agent. PBC is associated with the development of end‐stage liver disease, increased morbidity and mortality. UDCA has been shown to improve serum biochemistries, histology and delay the need for liver transplantation. The clinical issue is that approximately 25%‐40% of patients do not respond to this standard therapy. In recent years, many trials have investigated alternative and adjunctive treatments.In way of the search for a safe and effective treatment for PBC mares milk acquires high potential in terms of affecting one of the links in the pathogenesis of PBC by modeling the composition of the intestinal microbiome. The intestinal microbiome plays an important role in the pathogenesis of PBC by regulating bile acid metabolism and immune responses.
The aim of the study – to evaluate the effect of a complex protein-amino acid and vitamin product (mares milk) on the indicators of markers of intrahepatic cholestasis in patients with PBC (primary endpoint).
Material and methods of the study. From September 2018 to the present time, an interventional non-randomised clinical trial (identifier NCT03665519) has been conducted in National Scientific Medical Center and currently, 23 patients have completed the study. Inclusion сriteria: Patients with verified diagnosis of PBC, aged 18 to 75 years. Exclusion criteria: alcohol and/or drug dependence, presence of liver cirrhosis class C based on Child Pugh classification, allergic reaction to dairy products, pesence of mental diseases, severe concomitant pathology, regnancy and/or lactation, lactose intolerance. Participants from experimental (main) group were administered a supplement (sublimated mare milk 40 g/day) for 3 months accompanied with standard UDCA therapy (dosage of 15/kg/day). PBC patients from control group were administered only UDCA therapy (dosage of 15/kg/day). Markers of intrahepatic cholestasis were evaluated: gamma-glutamyltranspeptidase (GGT) and alkaline phosphatase (ALP) at the beginning of the study and after 3 months in patients of both groups.
Comparison of the dynamics between the groups was carried out in the context of visits using the one-way analysis of variance based on the Fisher criterion and the non-parametric Kruskal-Wallis test.
The level of statistical significance in the comparative analysis was adopted at 0.95 (α = 0.95). It means the expected level of reliability, statistical significance, at which the null hypothesis of the absence of statistical differences in the comparative analysis is rejected, should be less than 0.05 (p <0.05).
The results of the study. In patients of the main group, the level of ALP was significantly reduced to 6,72 ± 0,632 compared with the observation in the control group (9,30 ± 1,553). Comparing the dynamic level of GGTP in patients of the main group, this indicator was significantly reduced to 3.88 ± 0.611 compared with the control group (5.53 ± 0.770). The study showed a significant decrease in the main markers of intrahepatic cholestasis in patients with complex protein-protein and vitamin product (mare's milk).
The conclusion: The study showed a significant decrease in the main markers of intrahepatic cholestasis in patients after taking complex protein-amino acid and vitamin product (mares milk). Thus, the use of mares milk is an effective addition to the standard therapy of PBC.
Maya S. Zhumabayeva1, https://orcid.org/0000-0002-2632-6717
Gulmira S. Dossatayeva1, https://orcid.org/0000-0003-4226-3741
Galiya M. Shaimardanova1, https://orcid.org/0000-0002-1414-8618
Larissa V. Kozina1, https://orcid.org/0000-0002-0581-6231
Viktor A. Tkachev2, https://orcid.org/0000-0003-4455-3427
1 JSC "National Scientific Medical Center",
Nur-Sultan city, Republic of Kazakhstan;
2 NJSC "Medical University of Astana", Department of Propaedeutics of Internal Diseases,
Nur-Sultan city, Republic of Kazakhstan.
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Жумабаева М.С., Досатаева Г.С., Шаймарданова Г.М., Козина Л.В., Ткачев В.В. Динамика маркеров интрагепатического холестаза у пациентов с первичным билиарным холангитом при применении интегрированного протеин-амино-кислотного и витаминного продукта (саумал) // Наука и Здравоохранение. 2019. 5 (Т.21). С. 110-115.Похожие публикации:
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