Clinical efficacy of the dietary supplement «Astracit-Asfarma» as a synergistic adjuvant to standard therapy for the elimination of residual fragments after endoscopic and shock wave lithotripsy in patients with urolithiasis (a pilot study)

Fomkin R.N., Osnovin O.V., Popkov V.M., Fomkina O.A.

Research Institute of Fundamental and Clinical Uronephrology, Department of Urology, Saratov State Medical University n.a. V.I. Razumovsky Ministry of Health of Russia, Saratov, Russia

Despite technological advances in the treatment of urolithiasis, the problem of residual fragments (RF) larger than 2–4 mm remains relevant, and their effective metaphylactic treatment, along with fundamental metabolic correction, is a critically important unresolved task. The aim of the study: to evaluate the clinical efficacy, litholytic and lithokinetic potential of the biologically active food supplement (DS) «Astracit – Asfarma» (potassium citrate + magnesium citrate) as part of complex therapy for RF after endoscopic (RIRS) and remote (SWL) lithotripsy. Materials and methods. A prospective, randomised, comparative, open-label study was conducted involving 100 patients with nephro-ureterolithiasis who underwent planned lithotripsy using SWL or RIRS. Patients were randomised into three equal groups: group 1 – SWL + standard therapy + dietary supplement «Astracit – Asfarma»; group 2 – RIRS + standard therapy + dietary supplement ‘Astracit-Asfarma’; group 3 (control): subgroup 3A SWL + standard therapy only; subgroup 3B RIRS + standard therapy only. The following were evaluated: total volume and density of fragments (by CT), proportion of patients without visualisable RF concretions ≤ 2 and ≤ 4 mm (stone-free rate, SFR) after 60 days, as well as the dynamics of biochemical urine parameters (pH, citraturia, oxaluria, magnesiuria, calciuria, uraturia, relative salt supersaturation indices) and blood. Results: The addition of the dietary supplement ‘Astracit - Asfarma’ to standard therapy accelerated the elimination and litholysis of RF: the total volume of residual stones after 30 and 60 days decreased by ~30% from the initial postoperative level and more than twice compared to the control group, the density of fragments decreased by 10–12% (maximum in group 2). Analysis of the frequency of achieving stone-free status (SFR) on the 60th day of observation showed that in the groups with adjuvant therapy, there was a numerical increase in the proportion of patients without visualisable RF. For the SFR ≤2 mm threshold, the proportion of such patients was 60% in group 1,72% in group 2, and 52% in the control group. For the SFR ≤4 mm threshold, the corresponding figures reached 80, 92, and 76%. Against the background of taking the dietary supplement «Astracit-Asfarma» in combination with standard therapy, a sustained correction of key biochemical urine parameters was identified: an increase in the average urine pH to 6,2 (compared to 5,9 in the control group; p<0,001), a 60% increase in citrate excretion to normal values (>2,0 mmol/day; p<0,001), a 1,3-fold increase in magnesium excretion (p<0,001) and a 20–25% decrease in oxaluria (p<0,001). No significant changes in these indicators were observed in the control group. These positive changes were achieved with a favourable safety profile: no clinically significant adverse events or serious adverse events were reported during the 60-day course, kidney and liver function indicators remained stable, and adherence to therapy exceeded 96%. Conclusion: A 60-day course of adjuvant therapy with the dietary supplement Astracit-Asfarma dietary supplement demonstrates a high safety and clinical efficacy profile in the treatment of residual fragments after lithotripsy, as confirmed by the realization of litholytic and lithokinetic potential, ensuring their accelerated litholysis and elimination.

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About the Authors

Corresponding author: R.N. Fomkin – Candidate of Medical Sciences, Associate Professor, Associate Professor of the Department of Urology, Senior Researcher, V.I. Razumovsky State Medical University of Saratov, Russian Ministry of Health, Research Institute of Fundamental and Clinical Uronephrology, Saratov, Russia; e-mail: rnfomkin@mail.ru

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