INFLUENCE OF ADDING ZINC ARGINYLE-GLYCINATE TO IMPROVE EFFICACY OF BIOREGULATORY PEPTIDES OF THE PROSTATE GLAND IN...

The drug Prostatilen® AC, rectal suppositories were developed on the basis of the previously registered medicine containing bioregulatory peptides of the prostate gland - Prostatilen® rectal suppositories, 3 mg, from whom it differs by the addition of аctive pharmaceutical ingredient zinc arginyle-glycinate dihydrochloride (ZAG). The aim of this study was to analyze the positive effect of adding ZAG to the drug in patients with impaired spermatogenesis. A total of 98 men aged 25-45 years (an average of 35.2±4.3 years) with a verified diagnosis of chronic abacterial prostatitis and related reproductive dysfunctions in the phase III, randomized, multicenter, open-label clinical trial was examined. The duration of participation of patients in the study was 14-16 days, the screening period was 2-3 days, the duration of therapy was 10 days, and the final examination was 2-3 days. A study group (n=49) received therapy with Prostatilen AC once daily, a control group (n=49) had Prostatilen once daily. All patients underwent conventional semen analysis before and after treatment. The obtained parameters were compared. During the analysis of the average statistical data in the comparison groups, it was found that treatment with Prostatilen AC leads to an increase in the total population of motile spermatozoa (cells A + B + C) by 14.3%, and the reference drug Prostatilen contributes to an increase in this indicant by 4.1% compared with the results of a screening examination with significantly higher efficiency in increasing the relative count of spermatozoa with a fast progressive motility (After therapy Prostatilen/Prostatilen AC p=0.0004). Prostatilen AC showed significantly higher efficiency in terms of increasing the count of normal forms of spermatozoa in the ejaculate than the reference drug Prostatilen (After therapy Prostatilen/Prostatilen AC p=0.0118). In patients who received the drug Prostatilen AC the number of abnormal forms of spermatozoa decreased by 12.4% (After therapy - 55.57%), and in the comparison group (drug Prostatilen) by 6.5% (After therapy - 58.90%) with significant decrease in forms of abnormal spermatozoa with head, acrosome, or neck pathology for Prostatilen AC compared to control. Prostatilen AC compared to Prostatilen had a statistically significant and clinically significantly superior efficacy in relation to initially impaired sperm parameters (improve of sperm motility, restoration of morphologically normal sperm, decrease in forms of abnormal spermatozoa with head, acrosome or neck pathology). This drug could be recommended to use in the treatment of patients in whom chronic prostatitis occurs with concomitant disorders of sexual and reproductive functions.